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FDA Continues Food Labeling Crackdown, Warns 17 Companies

Making clear its intent to correct food labeling violations, FDA issued warning letters to 17 food manufacturers last week regarding 22 products said to be making unauthorized health claims. The involved companies, including Gerber, Beech-Nut, Nestle, and Pom, will have 15 days to inform FDA of how they will correct their labels.

On the same day, Commissioner of food and drugs Margaret Hamburg, MD, addressed the industry in an open letter, stating her commitment to improving food labeling practices.

“I have made improving the scientific accuracy and usefulness of food labeling one of my priorities as Commissioner of Food and Drugs,” said Hamburg. “The latest focus in this area, of course, is on information provided on the principal display panel of food packages and commonly referred to as ‘front-of-pack’ labeling…Unfortunately, however, we continue to see products marketed with labeling that violates established labeling standards.”

Hamburg’s open letter also reminded companies of FDA’s plan for upcoming draft guidance related to front-of-pack calorie and nutrient labeling.
published date: 03-08-2010

Update from Orrin Hatch on Dietary Supplement Safety Act

In response to Senator John McCain’s (R-Arizona) introduction of S. 3002, the Dietary Supplement Safety Act, Senator Orrin Hatch (R-Utah) held a nationwide conference call today for representatives of dietary supplement companies.

Hatch echoed concerns that the bill would create “additional regulatory burdens” on responsible members of the dietary supplement industry and would curb the current consumer availability and choices of dietary supplements.

“The intent of the original McCain bill is to give the FDA the authority to remove harmful dietary supplement products from the market, such as anabolic steroids,” said Hatch. “The simple fact is that the small percentage of unscrupulous manufacturers that the McCain bill targets are breaking existing laws.”

Additionally, Hatch agreed that some of the bill’s proposals, such as giving FDA mandatory recall authority on products and requiring annual facility registrations, have already been established in the Food Safety Modernization Act, a bill introduced in 2009 and pending a Senate vote later this year.

Since its introduction on February 3, the Dietary Supplement Safety Act has been met with industry opposition, but Hatch reassured listeners on the call that changes are on the way.

“This issue is changing by the minute,” said Hatch. “I’ve been talking to John McCain a lot over the past few days and, as a result of those conversations, he now understands the serious impact this bill will have on your industry…He has told me that he does not want to do anything to hinder the ability of consumers to purchase their dietary supplements…I think he’s coming around; in fact, I know he is.”

Hatch went on to say that he expects McCain to make an announcement on the matter in Arizona this weekend.

Beyond legislative discussions in Congress, Hatch ended his statement urging dietary supplement companies to remain politically active and visible in Washington.

“You need to invite members of Congress to your facilities so you may introduce and educate them about the dietary supplement industry,” said Hatch. “Show them how hard you work to ensure that your products are safe. Encourage them to ask you questions and not make assumptions about your industry because an open and honest relationship with your members of congress will go a long way. It should your top goal in the 111th Congress.

“In addition, all of you need to become more involved in the legislative process. We need to increase our visibility on Capitol Hill. Many of you may come to Washington once or twice to lobby, but you need to do it more frequently; you need to be involved all year long.”

Senator Orrin Hatch was a co-author of the Dietary Supplement Health and Education Act of 1994 and is a current member of the Senate Subcommittee on Crime and Drugs.
published date: 03-05-2010

CRN Responds to Lawsuit: Fish Oil Poses No Health Risk

Following news of a lawsuit filed today accusing 10 fish oil supplements of failing to meet California’s Prop 65 mandates for toxins, the Council for Responsible Nutrition (CRN; Washington, DC) is assuring consumers that fish oil supplements pose no health risks.

The lawsuit claims that 10 branded fish oil supplements were tested and found to show presence of polychlorinated biphenyl (PCB), an environmental pollutant that has been linked to cancer and reproductive toxicity. The defendants are CVS Pharmacy Inc., General Nutrition Corp. (GNC), Now Health Group Inc., Omega Protein Inc., Pharmavite LLC (Nature Made brand), Rite Aid Corp., Solgar Inc., and TwinLab Corp.

The lawsuit says that even products whose labels state had been refined to remove or reduce pollutants were found to contain traces of PCB. Prop 65 requires that any products sold in California that contain PCB levels over a certain threshold must carry labels warning the consumers.

In its response to the lawsuit, CRN’s Andrew Shao, PhD, senior vice president, scientific and regulatory affairs, for the Council for Responsible Nutrition (Washington, DC), cautioned industry and consumers that the actual levels of PCB found in the majority of the products tested by the lawsuit do not appear to exceed the Prop 65 threshold.

Shao also noted that California is the only state that whose labeling requirement employs the stringent 90 ppb PCB threshold. (FDA’s own permitted level of PCB in fish is markedly higher, at 2000 ppb.)

“It’s simply a labeling issue under a single state—a statute for a single state—that doesn’t affect any other state. It’s a labeling issue, not a safety issue,” Shao told Nutritional Outlook.

In a press statement, Shao added, “This lawsuit does nothing to change the strong science supporting the many health benefits of fish oil, which range from cardiovascular health to cognitive development of infants and young children.”

Fish absorb PCB from their environment, and all oils extracted from fish initially contain trace amounts of PCBs, as do conventional food forms of fish. Fish oil supplements are usually refined to remove traces of PCB.

No official thresholds have yet been established to determine what level of PCB is harmful to consumers. “Everyone probably has a tiny bit of either PCB or dioxins in them, and the best that science can tell us is don’t add any more,” says Chris Manthey, a plaintiff in the case.

The lawsuit’s plaintiffs have signaled their intent to test additional brands of fish oil supplements. “There are more than 100 fish oil supplements on the market…and we have no way of knowing if others have more or less PCB contamination than these first 10 that we tested,” said David Roe, an attorney for the plaintiffs, in a press conference on March 2. Ultimately, he said, the plaintiffs would like to see fish oil marketers test for and reduce the levels of PCB in their products.

Benson Chiles, one of the plaintiffs, says, “Our message to the public when it comes to fish oil supplements is buyer beware.”
In addition to environmentalists Chiles and Manthey, the plaintiffs are Mateel Environmental Justice Foundation, a nonprofit organization with a history of Prop 65 lawsuits.

The supplements selected for the study were chosen based on prior research by Greenpeace, as well as an Environmental Defense Fund survey of manufacturers.
Visit www.fishoilsafety.com for more information on the lawsuit.

List of fish oil supplements accused in lawsuit:
1. Nature Made Cod Liver Oil
2. Nature Made Odorless Fish Oil
3. TwinLab Norwegian Cod Liver Oil
4. TwinLab Emulsified Norwegian Cod Liver Oil
5. Now Foods Shark Liver Oil
6. Now Foods Double Strength Cod Liver Oil
7. Now Foods Salmon Oil
8. Solgar 100% Pure Norwegian Shark Liver Oil Complex
9. Solgar Norwegian Cod Liver Oil
10. GNC Liquid Norwegian Cod Liver Oil
published date: 03-02-2010

Dr. Harry Demopoulos to Explain Glutathione Absorption Efficiency at Expo West

Dr. Harry Demopoulos, MD, former associate professor of pathology at the New York University School of Medicine will be at Expo West to discuss how Setria brand glutathione has been proven to be absorbed orally in animal and human clinical dosing studies. The event is sponsored by Kyowa Hakko USA (New York City).

Glutathione is a tri-peptide made up of glutamic acid, cysteine, and glycine. It is believed to increase the effectiveness of antioxidants like vitamin C and E, and help protect the body from free radicals and other harmful compounds.

Demopoulos’ presentation will be held at Expo West on Saturday, March 13, from 2 to 3 p.m. in room 205A. Visitors will also be able to meet with Kyowa Hakko customers and receive complimentary Setria products. Demopoulos is a recipient of the Research Career Development Award from the National Cancer Institute.
published date: 03-01-2010

BI Nutraceuticals to Host Open House at Long Beach Facility

A day prior to the start of Expo West in Anaheim, BI Nutraceuticals will be offering tours of its 150,000 square foot manufacturing facility in nearby Long Beach.

The tour will include education about the company’s technologies in botanical ingredient certification, quality assurance, dry steam sterilization, and processing.

Morning and afternoon tours will be available with a shuttle service provided at the Expo West lobby at 9:30 a.m. and 1:30 p.m., respectively.

For more information and to RSVP, contact Angela Dorsey-Kockler at 310/669-2163 or adorsey@botanicals.com.
published date: 03-01-2010

Truvia Beats Equal Sales in Some Markets

After only 12 months on the market, sales of stevia-based Truvia have surpassed those of Equal sweetener in some U.S. markets, Cargill (Wayata, MN) reports.

According to Nielsen, Truvia is outperforming Equal in more than 10 U.S. sugar-substitutes markets: Minneapolis, Salt Lake City, Boise, Denver, Portland, San Francisco, Miami, San Diego, Boston, Philadelphia, Dallas, and Atlanta.

Overall, Truvia now holds a 7.9% dollar market share of U.S. sugar-substitute sales, reports Nielsen.

Cargill/Nielsen also report great potential for the sugar-substitutes category, which grew 7.7% in the 52 weeks ending January 23, a year during which stevia sweeteners began hitting the market.

“Since its launch, Truvia natural sweetener is driving new consumers—including those who have not bought sweeteners before—to the grocery and retail sweetener aisles,” says Cargill.

Cargill also claims per Nielsen that Truvia leads the stevia-based sweetener market, with 58% market share. Comparatively, Whole Earth Sweetener’s PureVia holds 9.8% market share, while Cumberland Packing’s Stevia in the Raw has 9.1% dollar market share.
published date: 02-23-2010

Chocolate Brands Partner to Guarantee Cocoa Flavanol Content

Mars Inc. (McLean, VA) and Barry Callebaut AG (Zurich, Switzerland), a producer of cocoa and chocolate products, have partnered to promote flavanol-rich chocolate products with guaranteed flavanol levels.

The companies will cross-license their products to promote flavanol-rich chocolate products on a worldwide scale. This month, Barry Callebaut began displaying Mars’s Cocoapro “bean in hand” logo (indicating a proprietary method of processing cocoa that preserves flavanol content) on its flavanol-rich Acticoa chocolate products.

“This agreement is an important step in making chocolate alternatives with clear flavanol levels available to a much broader audience, around the world,” said Hans P. Vriens, chief innovation officer at Barry Callebaut.

In its press statement, Mars Inc. stated, “The agreement between these global chocolate leaders is seen as the beginning of a path leading to consistent standards for beneficial cocoa flavanol products.”

Flavanols are the natural antioxidant compounds in cocoa that deliver health benefits such as circulatory health. Last year, Mars launched its CirkuHealth flavanol-rich dietary supplement. For more information, read “Mars and the Next Frontier," published in the November/December 2009 issue of Nutritional Outlook, by clicking here.

View Mars's press release here.
published date: 02-17-2010

ABC Publishes Pycnogenol Monograph

The nonprofit American Botanical Council (ABC; Austin, TX) has published a monograph summarizing a selection of scientific and clinical studies on Pycnogenol, a patented dietary ingredient from French maritime pine bark.

The monograph reviews 17 human clinical studies, which evaluate Pycnogenol for potential health benefits such as cardiovascular health and the ability to reduce difficulties associated with chronic venous insufficiency and problems related to thrombosis, the formation or presence of blood clots in blood vessels.

Based on its review, ABC’s monograph notes that Pycnogenol has been shown to have a wide range of potential benefits. Noted possible benefits include the ability of Pycnogenol to improve blood sugar control in patients with type 2 diabetes and to improve the ability of blood vessels to widen through relaxation of the muscular wall of the vessels. ABC says that clinicial trial data also suggests that Pycnogenol may help to decrease swelling in the lower legs, benefit children with attention deficit hyperactivity disorder, be useful as an adjunct asthma therapy, reduce pain associated with menstrual disorders, and improve subjective symptoms of osteoarthritis in the knee.

According to ABC, Pycnogenol’s manufacturer, Horphag Research (Geneva, Switzerland), annually invests $1.5 million in new scientific and clinical research on Pycnogenol.

Click here to view the monograph. It is fourth in a series of product-specific monographs from ABC.

published date: 02-17-2010

FTC Warns over Omega-3 Brain, Vision Claims

On February 16, the Federal Trade Commission (FTC; Washington, DC) announced that it sent warning letters to 11 supplement companies in January regarding claims made by the companies that their omega-3 products benefit children’s brain and vision function and development.

The letters instruct the companies to review their product packaging and labeling to ensure that they have scientific evidence to support any claims that their products boost, improve, enhance, or support brain and vision function and development in children.

FTC also noted claims that were made relating to intelligence, cognitive function, learning ability, focus, mood, memory, attention, concentration, visual acuity, and eye health.

FTC’s letters gave the companies two weeks to respond, warning that it would take enforcement action against any “baseless” health-related claims made without scientific proof.

In its letters to the companies, FTC referenced its recent investigation of similar claims made by Northwest Natural Products Inc. (NNP) about the marketer’s L’il Critters Omega-3 Gummy Fish vitamins. FTC said that in response to its letter, NNP quickly changed its marketing materials, including packaging and labeling, to ensure compliance.

published date: 02-17-2010

Senate Bill Calls for Increased Nanotechnology Research

Newly proposed legislation would require FDA to step up research on nanotechnology. The Nanotechnology Safety Act of 2010 would give FDA $25 million between 2011 through 2015 to assess the health and safety implications of nanotechnology in “everyday products,” and develop best practices for companies using nanotechnology.

The bill was introduced by U.S. Senators Mark Pryor (D-AR) and Benjamin L. Cardin (D-MD) in January. Said Sen. Pryor, “Nanotechnology is one of the most important and enabling technologies being developed right now, and it has hundreds of promising applications…As these products are developed and used, we must understand any potential risks to human health, safety, or the environment. My legislation will help ensure public safety…and it will support companies that employ nanotechnology materials.”
published date: 02-17-2010

Digestive Health Leads Trends, Says NNB

New Nutrition Business names digestive health as the top health trend in its “10 Key Trends in Food, Nutrition & Health 2010” report.

“[Digestive health’s] importance to consumers has been underscored by the impressive growth rates of digestive health brands, with sales of even premium brands increasing 10 to 20% during the recession,” says NNB.

Forecasted by industry expert Julian Mellentin, the report says that digestive health still offers “huge areas” of opportunity in many countries, especially in fiber-fortified products, beverages, and cereals.

Bone health’s market muscle is also growing, notes NNB. For the first time, Bones and Movement ranked on NNB’s top-10 list, thanks largely to the growing 40-plus age population. “It’s a niche that is getting bigger fast, and it’s a significant area of opportunity in every continent—and one that has not been fully exploited anywhere except in Asia.”

As evidence of the category’s potential, NNB says that the Elations joint health brand is anticipating sales of $55 million this year, compared to $15 million in sales two years ago.

“The potential of bones and movement has already got the attention of Europe’s most innovation-minded companies, where the new, ultrarestrictive health claims regime may leave bone health as one of the very few permitted claims,” the report states.

Other top-10 trends Mellentin cites are energy, superfruits, antioxidants, weight management, and healthy snacking. He also names microtrends, in protein powder, children’s nutrition, probiotics, immunity, omega-3, and beauty. For more information, visit New Nutrition Business here .
published date: 02-11-2010

Yogurt Sales May Reach $67 Billion by 2015

By 2015, global yogurt consumption will reach 20.6 million tons, equaling $67 billion in sales, predicts market researcher Global Industry Analysts Inc. (GIA).

Currently, yogurt sales are largely driven abroad, says GIA, with Europe and Asia-Pacific accounting for 80% of the global market. “Asia presents a huge opportunity due to the rising incidence of lifestyle-related health concerns, such as diabetes and obesity, brought on by rapid economic development and rising income levels,” states GIA.

Asia-Pacific yogurt consumption could reach 5.2 million tons by 2012. Narrowing the region down, GIA says that China will be the fastest-growing market, potentially reaching $3.6 billion in sales by the end of this year.

GIA also noted a growing shift in consumer preference from conventional spoonable yogurts to specialty products such as yogurt drinks and children’s products. Demand for organic yogurt products and innovative, premium products, such as “bio-yogurt” or yogurt enhanced with juice and fruits, is also growing.

Sales of refrigerated yogurt products continue to grow fastest, as consumers associate this sector strongly with health benefits.

As for functional ingredients, the report says, “products with the ability to improve immune system and enhance digestive functioning are expected to hold ground in the future.”

Danone continues to lead the market, accounting for 23.6% of sales in 2008. Other leaders are Sodiaal/Yoplait, Yakult Honsha, Nestlé, and Müller. These five companies represent more than 45% of global sales, says GIA.

For more information, visit GIA’s website here.
published date: 02-11-2010

Leading Trade Associations Respond to "Flawed" Herbal Products Review

Citing numerous scientific errors and misinformation, the American Botanical Council (ABC; Austin, TX) and the Council for Responsible Nutrition (CRN; Washington, DC) have responded to an article on herbal products and patients with heart disease published in the current issue of the Journal of the American College of Cardiology.

The article, “Use of Herbal Products and Potential Interactions in Patients With Cardiovascular Diseases,” reviewed common herbs and herbal supplements, and the effects they may have on factors related to heart disease and drug interaction. Both associations noted that the article includes factual errors, generalizations not backed by proper citations, and other serious flaws.

ABC noted that the article’s review of “commonly used herbs” includes toxic herbs and plants not approved for the U.S. dietary supplement market, such as the toxic plant oleander (Nerium oleander), an ingredient presumed to be dried Chinese toad venom, and uzara root (Xysmalobium undulatum), an antidiarrhea herbal drug approved for use in Germany. Both associations’ press releases report a number of other instances of misinformation.

“The article contains sweeping generalizations…including a reference to products—some of which are not actually herbal supplements—that produce adverse effects on the cardiovascular system,” noted CRN vice president of scientific and regulatory affairs, Douglas MacKay, ND.

“Many herbal supplements offer healthful benefits,” added MacKay. “Fiber, garlic, and Hawthorne provide heart health benefits, and the potential risk for a drug interaction can be eliminated by speaking openly with your doctor.”

To read an abstract of the study, click here.
published date: 02-05-2010

John McCain Introduces Dietary Supplement Safety Act

Senator John McCain (R-AZ) held a press conference last week introducing the Dietary Supplement Safety Act of 2010. The proposed legislation, which has been cosponsored by Senator Byron Dorgan (D-ND), would amend the Federal Food, Drug, and Cosmetic Act (FFDCA), making a host of changes to operations of dietary supplement industry.

Under the proposed bill, dietary supplement facilities would be required to file information identifying all brand names, ingredients, and facility names and addresses with which they conduct business. The definition of new dietary ingredients (NDIs) would also be rewritten, with FDA compiling a new list of “Accepted Dietary Ingredients.” Ingredients marketed prior to October 15, 1994, effectively protected as “grandfather ingredients” by the Dietary Supplement Health and Education Act (DSHEA), would have to seek inclusion in the list of Accepted Dietary Ingredients.

Provisions related to recall authority and adverse event reports (AERs) have also been included in McCain’s bill. FDA would also have new mandatory recall authority on any dietary supplements believed to be misbranded, adulterated, or cause serious, adverse health consequences or death. AERs would be affected by the requirement of annual AER reports (even including nonserious AERs).

The Dietary Supplement Safety Act of 2010 has received mixed opinion from the dietary supplement industry. Last week, an official press release from the Council for Responsible Nutrition (Washington, DC) applauded the efforts of the bill, while also noting that “…where the legislation would deter retailers from offering a wide variety of legitimate supplements to consumers or would overburden manufacturers, we will seek alternate solutions.”

The American Herbal Products Association (AHPA; Silver Spring, MD) noted that AER requirements are currently softer on the food industry. “Though we have not yet examined this bill completely, it places new burdens on dietary supplements that are not required for any other class of food,” said AHPA president Michael McGuffin in a press release last Wednesday.

The legislation is currently supported by the United States Anti-Doping Agency (USADA) and a host of professional sports organizations, including Major League Baseball (MLB), the National Basketball Association (NBA), the National Football League (NFL), and the National College Athletic Association (NCAA).

The bill can be read at AHPA’s website here.
published date: 02-05-2010

GAO Questioning Status of "Grandfathered" Ingredients

The U.S. Government Accountability Office (GAO) has sent letters to a selection of dietary supplement marketers, requesting evidence to support their products' "grandfathered ingredient" status. The letters target herbs such as chamomile flower tincture, echinacea root 4:1 powdered extract, and oils of peppermint leaf, ginger root, and fennel seed, according to the American Herbal Products Association (AHPA).

In communication to its members, AHPA said that the letters' recipients were instructed to provide one of the following:

* Evidence that the dietary supplement product was marketed in the United States prior to the enactment of the Dietary Supplement Health and Education Act (DSHEA; October 15, 1994).
* Evidence that the identified product contains only dietary ingredients that have been present in the food supply as an article used for food in a form that has not been chemically altered.
* A copy of documented evidence sent to FDA that shows a history of use or other evidence of safety when used as recommended.
* Details of any extraction methods used.

Industry members are questioning GAO's motives for issuing such letters. Many believe that the congressional watchdog is looking to investigate DSHEA's new dietary ingredient (NDI) provision, which allows "grandfathered" ingredients to legally be sold as old dietary ingredients (ODIs).

In its letters, GAO states that it is reviewing the marketing of "selected herbal supplements" on behalf of the Senate Select Committee on Aging. An AHPA spokesperson informed Nutritional Outlook that GAO has declined to make the Senate committee's request available to the letters' recipients. The association said it is currently investigating why the Senate committee may have made the request to GAO.

Meanwhile, according to some, dietary supplement marketers and their ingredient suppliers may have some difficulty providing some of the evidence GAO is requesting, such as documented evidence that an ingredient was marketed prior to DSHEA's passage.

"The proof GAO may be requiring could include bills of lading, invoices, advertisements, etc., to show that the product was in commercial use prior to 1994," said Cal Bewicke, president of botanicals supplier Ethical Naturals (San Anselmo, CA), in an interview with Nutritional Outlook. "In some cases, a company might not have records going back to 1994. That's 16 years ago, and after all, even tax records only need to be saved for seven years."

Also complicating the matter is the fact that FDA has so far not issued any guidance on establishing NDIs. Last January, GAO issued a report recommending that FDA "issue guidance to clarify when an ingredient is considered a new dietary ingredient, what evidence is needed to document the safety of new dietary ingredients, and appropriate methods for establishing ingredient identity," according to AHPA. Meanwhile, the fact that extraction and testing technologies have advanced since 1994 may further add to the problem of defining a "grandfathered" ingredient passed under DSHEA versus an NDI.

AHPA points out that based on its review of the letters GAO has sent so far, it suspects that GAO "is not entirely clear on the way DSHEA addresses dietary supplements, dietary ingredients, and NDIs." The association suggests that companies that have received a letter from GAO seek legal counsel before responding, and, if needed, request more time before answering.

Read AHPA's notification to its members, as well as its advice on what steps to take, at http://www.ahpa.org/Default.aspx?tabid=69&aId=572&zId=1
published date: 02-01-2010

Industry Should Reform Bioavailability Claims, Supplier Says

A review of a selection of published ingredient studies has concluded that many bioavailability ingredient claims are often weakened by a large variance between the amounts of active ingredients subjects absorbed. The review, published in the January issue of Natural Medicine Journal, looked at studies done on CoQ10 and carotenoids. It was led by ingredients supplier BioActives LLC (Worcester, MA).

"We noticed that in many studies, the intersubject variance--the difference between what individual subjects absorbed--was very large," told the study's lead author, Daniel Kagan, PhD, a managing partner at BioActives, to Nutritional Outlook. (He disclosed that a BioActives study was among the studies reviewed.)

Kagan says that many of the reviewed studies failed to adequately discuss such variances, if they occurred, and their implications. For instance, he says, in many cases when a study concluded that an ingredient was more bioavailable, the ingredient was actually only more bioavailable in a minority of subjects.

Wrote Kagan et al., "The results are reported based on statistically significant differences between the mean scores in different treatment groups...Some studies circumvent statistics altogether by singling out the one data point of the best absorber and [promoting] it as [being] 'up to X times more bioavailable.' While these claims are mostly based on statistically significant differences between treatment groups, they can be misleading, as the average of all the data may include subjects who were poor absorbers as well as those who were super-absorbers."

Or, as Kagan says, "The few super-absorbers are the ones that can drive the results."

As a result of what Kagan calls incomplete reporting, "it is difficult for physicians and consumers to compare the bioavailability claims of different formulations," wrote Kagan et al. Moreover, Kagan points out, if a consumer purchases a product labeled highly bioavailable when data actually showed it is highly bioavailable for some of the subjects and not highly bioavailable for others, then the consumer wouldn't know whether he or she is likely to be represented by the group that does or doesn't absorb the supplement well.

By contrast, Kagan et al. note that, "The pharmaceutical industry has a concrete definition of bioavailability and uses explicit methods for evaluating the bioavailability of drugs...In fact, bioavailability studies are an important part of the information necessary to support an FDA approval."

Kagan et al. suggest that the industry instead adopt new, standard terms when making bioavailability claims that indicate the likely percentage of consumers for whom an ingredient is bioavailable. If a bioavailability claim likely applies to 85% of consumers, an ingredient/product could then be deemed reliably bioavailable. If a claim applies to 99% of consumers, an ingredient/product could be deemed universally bioavailable. (The authors offer a method for calculating these criteria.)

The reviewers concluded, "The benefits derived from nutritional supplements are directly related to their bioavailability, yet the dietary supplement industry lacks well-defined standards to ensure adequate bioavailability."

Kagan adds that improving the accuracy of bioavailability claims may improve the chances that consumers will select supplements that are bioavailable for them. "Think of all the return customers companies are losing because the consumer did not realize the benefit of the supplement," he says.

For more information, e-mail Daniel Kagan at dankagan@earthlink.net.
published date: 02-01-2010

Symrise Acquires Futura Labs

Symrise (Holzminden, Germany) has acquired Futura Labs Group, a flavor and fragrances manufacturer headquartered in Cairo. Through the acquisition, Symrise will expand its presence in several key markets in Egypt.
The company says that Futura Labs’ product portfolio and client list nicely complement Symrise’s operations in Egypt, and that together, the companies will be a market leader in flavor and fragrances in Egypt.
published date: 01-28-2010

Sensient Creates New Botanical Platform

Sensient Flavors and Fragrances Group (Indianapolis) has developed a new marketing platform for its botanical ingredients, called Sensient Natural Origins. The new marketing reflects how the company has expanded its global extraction, R&D, and manufacturing capabilities, including for its previously named Templar natural botanical extract line, which now operates under the Sensient Natural Origins name.
published date: 01-28-2010

Korea Approves Decas’s Cranberry Powder Claim

Decas Botanical Synergies LLC (Carver, MA) has obtained Korean Food and Drug Administration (KFDA) approval for a health claim of supporting urinary health for PACran, its cranberry powder. PACran is a clinically supported and proanthocyanidin-standardized cranberry powder. The supplier says that the approval is the first from KFDA for a health food product for urinary health.
published date: 01-28-2010

ESM Gets GMP-Certified

ESM Technologies (Carthage, MO), a supplier of eggshell and eggshell membrane wellness ingredients, has received Good Manufacturing Practices certification from NSF International. ESM says that such certification verifies that its products have the identity, strength, composition, quality, and purity that they are said to possess.
published date: 01-28-2010

Seltzer Adopts Glanbia Name

Seltzer Companies Inc. (Carlsbad, CA), which includes Seltzer Nutritional Technologies and Seltzer Ingredients, has officially taken on the name of its parent company, Glanbia Nutritionals Inc. The company’s products will now operate under the Glanbia Nutritionals Customized Solutions brand. Glanbia acquired Seltzer in 2006.
published date: 01-28-2010

Piveg Trademarks I-Z Zeaxanthin

Piveg Inc. (Celaya, Mexico) has trademarked its I-Z zeaxanthin. The company has produced zeaxanthin isomer from marigolds for nutritional eye health applications since 1999. “Newer participants in the carotenoid and zeaxanthin field are confusing customers with claims and product nomenclatures that have in fact been available in the industry for years,” says company CEO Roberto Espinoza.
published date: 01-28-2010

Atrium Innovations Joins CRN

Atrium Innovations (Quebec City, QC, Canada), owner of nutrition brands such as Garden of Life and Douglas Laboratories, has joined the Council for Responsible Nutrition (CRN; Washington, DC).
In addition to complying with federal and state regulations governing dietary supplements in the areas of manufacturing, marketing, quality control, and safety, CRN member companies adhere to additional voluntary guidelines, as well as CRN’s code of ethics.
published date: 01-28-2010

SourceOne, Twin Rivers Partner on Omega-3

SourceOne Global Partners (Chicago) is working with Twin Rivers Technologies (TRT; Cincinnati), which will supply SourceOne with U.S.-produced omega-3 in its natural triglyceride form. The companies say that this form of omega-3 is naturally found in foods.
According to the companies, demand for the triglyceride form of omega-3 has increased as awareness grows of studies supporting improved absorption and bioavailability of triglyceride omega-3 over omega-3 in ethyl ester form.
published date: 01-28-2010

Fortitech Enters Russian Market

Participating in the Ingredients Russia trade show for the first time last year, Fortitech Europe ApS (Gadstrup, Denmark) is making its entry into the Russian market, the company reported. The premix supplier has aligned itself with KUK, a distributor in Russia and Eastern Europe, to develop projects with food and beverage manufacturers in those regions.
“The consumer demand for fortified foods and beverages in Russia, as well as the rest of Eastern Europe, is exploding,” says Martin Austin, managing director and general manager of Fortitech Europe ApS.
published date: 01-28-2010

Epax Omega-3 Deemed Sea-Friendly

Omega-3 supplier Epax AS (Aalesund, Norway) has been awarded Friend of the Sea certification for sustainable marine sourcing and production methods. The company’s omega-3 oils have documented, traceable origins from sustainable fisheries.
The certification indicates that products do not originate from overexploited stock, that fishing methods do not impact the seabed, and that fishing methods are selective and below the world average for discards.
published date: 01-28-2010

Morre-Tec Receives ISO Certification

Morre-Tec Industries and its Extract & Ingredients Ltd. division have received ISO 9001:2008 certification. The company is a manufacturer and distributor of bromine intermediates, personal care and nutritional ingredients, and natural extracts. “With ISO 9001:2008, CGMP compliance, and a HACCP [Hazard Analysis and Critical Control Points] plan, we anticipate additional growth,” says president Len Glass.
published date: 01-28-2010

B&D Distributing Solazyme Microalgae Line

B&D Nutritional Ingredients Inc. (Vista, CA) is now distributing Solazyme Health Sciences’ Golden Chlorella line of sustainably grown microalgae powders. The line includes Golden Chlorella Omega and Golden Chlorella High Protein powders for dietary supplements and functional foods. The company says that both provide solutions for heart-healthy, vegetarian, protein-rich functional foods.
published date: 01-28-2010

Danisco Web Site Highlights Sustainable Options

Danisco (New Century, KS) now offers a Web site designed to help food manufacturers find climate-friendly sourcing and manufacturing opportunities among its product offerings. The site addresses five types of sustainable options: those that reduce energy, water, or raw-material consumption; and those the enable material substitution and waste reduction.
“We can show manufacturers how to make direct savings in resource consumption using our ingredients,” says Jesper Kampp, group manager. Visit www.danisco.com/climate for more information.
published date: 01-28-2010

NPA Certifies Natrol

Nutritional product manufacturer Natrol has been certified by the Natural Products Association’s CGMP program. Natrol’s line includes brands such as MRI, Prolab, Promensil, and Trinovin.
published date: 01-28-2010

Fusion Starts Sustainability Program

Contract and private-label manufacturer Fusion Formulations (Phoenix) says that last year it started its sustainability program. The program involves reducing manufacturing waste in all forms—a move that the company says will also result in cost-savings for its partners.
published date: 01-28-2010

Krill Oil Partnership

Norwegian-based krill-oil supplier Aker BioMarine has signed a long-term agreement to provide its Superba krill oil to Valensa International (Eustis, FL) for joint health and eye health products. The companies will also jointly perform clinical studies on Superba as an ingredient in Valensa’s formulations, which will also include Valensa’s own proprietary ingredients, including Zanthin natural astaxanthin.
published date: 01-28-2010

Novus Forms Human-Nutrition Unit

Novus International (St. Louis) has created its human-nutrition division, called Stratum Nutrition. The division will focus on developing specialty and functional ingredients for foods, beverages, and dietary supplements in North America and Europe. Previously, Novus was primarily known for its work in animal agriculture health and nutrition.
published date: 01-28-2010

Missouri Awards Alpha Packaging

Alpha Packaging (St. Louis) was honored by the Missouri Chamber of Commerce and Industry as one of the state’s fastest-growing companies. The nomination-based awards are presented annually and given to companies with the highest rate of growth over a four-year span.
published date: 01-28-2010

Registered Dietitians Value Dietary Supplements, Study Says

The “Life…supplemented” campaign just released results from its 2009 Healthcare Professionals Impact Study, finding that dietary supplements have a considerable impact on healthcare professionals and their relationships with clients.

The survey, conducted by Ipsos Public Affairs (Chicago), found that eight out of every ten registered dietitians (RDs) “view dietary supplements as important for maintaining health.” Eighty-one percent of those surveyed believe that most people can fill gaps in their nutrition with vitamin and dietary supplement use.

The survey found that 91% of RD’s actually take dietary supplements and recommend them to their clients. Popular supplements used by RD’s include multivitamins (84%), specialty supplements (64%), and omega-3 fish oils (47%).

Combining the results of three separate surveys, the “Life…supplemented” survey included 300 nurse practitioners, 300 pharmacists, and 300 registered dietitians. “Life…supplemented” is a campaign of the CRN Foundation, an educational affiliate of the Council for Responsible Nutrition (Washington, DC).
published date: 12-21-2009

Federal Working Group Proposes New Standards for Marketing Food to Children

In response to rising concern about childhood obesity in the United States, the Federal Trade Commission (FTC; Washington, DC), in partnership with other government agencies, has published new nutrition standards for how food should be marketed to children.

The standards, published last week, were developed by the Interagency Working Group on Food Marketed to Children (Working Group), a group made up of representatives from FTC, FDA, the United States Department of Agriculture, and the Centers for Disease Control and Prevention.

Foods marketed to children would be required to “provide a meaningful contribution to a healthful diet,” as characterized by either of two options outlined in the Working Group’s report. Option A would require 50% of a food’s weight to come from healthful foods, including fruit, vegetable, whole grain, nuts, seeds, or beans. Option B would require a marketed food to contain any number of a minimum amount of listed foods that characterize a “healthful diet.” The full list of standards can be viewed here

Foods exempt from the new standards would include 100% content products of fruits, vegetables, non-fat and low-fat milk and yogurt, whole grains, and water.

“The federal government is headed in exactly the right direction with the draft nutrition standards,” said Margo G. Wootan, nutrition policy director for the Center of Science in the Public Interest (Washington, DC) in an official press release, last week. “If adopted, the landscape of kids’ food advertising would shift quite dramatically in favor of foods that promote health, and away from foods that promote obesity and disease.

The working group intends to submit a final report to Congress no later than July 15, 2010.
published date: 12-21-2009

FDA Publishes New Draft Guidance for Liquid Beverages, Supplements

By Justin J. Prochnow, Greenberg Traurig LLP

FDA published a new Draft Guidance, entitled “Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods,” on December 3.

FDA ostensibly issued the Draft Guidance to assist dietary supplement and beverage manufacturers in reaching a determination as to whether a liquid product may be labeled and marketed as a dietary supplement. However, it is clear that FDA’s underlying purpose for issuing such a guidance is its growing concern over the types of products marketed as dietary supplements, perhaps signifying that this area may be one in which FDA will increase its enforcement focus in the near future. This concern is evidenced by FDA’s statement in the Draft Guidance that “we have seen an increase in the marketing of beverages as dietary supplements, in spite of the fact that the packaging and labeling of many liquid products represent the products as conventional foods.”

The full version of this article will be published in Nutritional Outlook's January/February 2010 issue.
published date: 12-08-2009

Associations Still Oppose Swine Flu-Targeted Supplements

Key dietary supplement trade groups are again voicing disapproval of dietary supplements sold as treatments for the H1N1 virus.

Since May, FDA and the FTC have issued 147 warning letters to companies marketing products for the prevention or cure of swine flu, including products such as air filters, facemasks, shampoos, and supplements. Earlier in May, the organizations together released a joint statement discouraging sales of such products.

The associations include the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association, and the United Natural Products Alliance.

The organizations stated that there are dietary supplements that can enhance the body’s general immune function. However, the groups said they are unaware of any scientific data supporting the use of dietary supplements to treat the H1N1 virus. They also emphasized that federal law does not allow dietary supplements to claim to treat any diseases, including swine flu. The groups also advised dietary supplement marketers and retailers to refuse to stock or sell any supplements presented as treating or curing H1N1.

Finally, the groups said: “The organizations supporting this advisory represent the majority of dietary supplement manufacturers. Each of the associations and its member companies remain committed to providing the American public with high-quality products for supporting personal health and permitting ‘self-care’ choices, and encourage FDA and FTC to continue to take aggressive enforcement action against companies that are illegally marketing supplement products to treat the H1N1 virus. Each of the associations is also committed to recognizing that there are some health conditions for which the choice of self-care should be actively discouraged. The current global outbreak of the H1N1 virus is such a condition.”
published date: 12-08-2009

DEA Classifies Three Steroids

The U.S. Drug Enforcement Agency (DEA; Springfield, VA) announced that it has classified boldione, desoxymethyltestosterone, and 19-nor-4,9(10)-androstadienedione as anabolic steroids under the Controlled Substances Act, according to the Natural Products Association (NPA; Washington, DC). This ruling will be made effective January 4, 2010.

NPA released a press release, last week, commending the action by DEA. “The association has maintained all along that federal regulators have the authority they need [to schedule these substances],” said John Gay, executive director and CEO of NPA. “The DEA’s listing of these three steroids demonstrates that federal regulators can indeed safeguard the shelves against these substances.”

The classified substances received increased scrutiny during talks at a September Senate hearing on “hidden steroids” held by the Senate Subcommittee on Crime and Drugs. DEA first received notice for proposed rulemaking on the substances in April 2008. The agency also states that, since August 2008, it has been aware of 58 dietary supplements believed to contain one or more of these substances.

DEA’s full announcement can be read here
published date: 12-08-2009

Consumer Advocate Seeks Ban of Weight Loss Pill Meridia

The consumer advocacy group Public Citizen (Washington, DC) announced yesterday that it is petitioning FDA to pull the weight loss pill Meridia off of the U.S. market, according to AP News. Meridia is a name-brand sibutramine pill manufactured by Abbot Laboratories (Abbot Park, IL).

Public Citizen cites a 10,000 patient study, known as the SCOUT study, in which higher risks of heart problems were connected to the drug. The group also claims that 84 deaths related to the drug have been reported to FDA since June.

In response to the data cited in the SCOUT study, Abbot Laboratories spokesman Kurt Ebenhoch stated that “Sibutramine is not recommended or approved for use in more than 90% of the patients who participated in the SCOUT study.”

Reports state that FDA has not yet announced conclusions about the study’s findings.
published date: 12-04-2009

USADA Unveils Initiative against Nutritional Supplements Containing Drugs

In an effort to raise public awareness of companies selling dietary supplements tainted with steroids and other drugs, the United States Anti-Doping Agency (USADA; Colorado Springs, CO) has introduced its “Supplement Safety Now” initiative.

With the support of national sport organizations, including the National Basketball Association, the National Football League, Major League Baseball, and the United States Olympic Committee, this online campaign aims to motivate Congress to take action against online and over-the-counter sales of tainted sports supplements with grassroots mobilization and media outreach efforts.

“Thirteen million people who are touched fall under the umbrella of these member based organizations,” said Travis Tygart, CEO of USADA, in an interview with Nutritional Outlook. “That’s a group of constituents that we hope to mobilize to influence Congress to enact better legislation on this issue.”

Tygart went on to add that “Supplement Safety Now” will see future developments as the campaign continues.

Steve Mister, president and CEO of the Council for Responsible Nutrition (Washington, DC), released an official statement on USADA’s initiative the day it was launched. “CRN commends USADA and the other supporting organizations for today stepping forward in a united front to find ways to get these illegal products removed from the marketplace,” Mister said. “Where CRN can find common ground on the solutions, we look forward to potentially partnering with these organizations on ‘Supplement Safety Now.’”

NSF International (Ann Arbor, MI) also announced “full support” of the initiative in an official press release, stating, “This campaign will create increased awareness around this important public health issue and help safeguard consumers from taking steroids and other illegal or controlled substances in products that are marketed as ‘safe and legal’ dietary supplements.”

For more details about “Supplement Safety Now,” click here
published date: 12-03-2009

Fruits and Vegetables May Improve Bone Health

A recent University of Toronto study on bone health has found that various nutrients found in fruits and vegetables may improve bone health beyond the assumed benefits of calcium and vitamin D, according to Julie Beun of Canada’s Canwest News Service, who broke news of the story last week.

Researchers at the University of Toronto compared the effects of two nutritional supplements, Bone Builder and Greens +, with calcium supplementation alone, and found the supplements to be more effective at stimulating osteoblasts, cells responsible for bone formation.

“Although calcium is positively associated with increased bone mineral density, there is also evidence to show that calcium alone is not sufficient,” said Leticia Rao, PhD, leader of the study. “Several antioxidants, a number of which are obtained primarily through foods such as fruits and vegetables and nutritional supplements, have been shown in both in vitro and clinical studies that they can counteract oxidative stress and prevent the risk of osteoporosis...other nutritional components [are required] in increasing bone formation.”

Beun reports that these components included three absorbable calcium sources, vitamins D, C, and B; the antioxidant lycopene; magnesium; selenium; zinc; copper; manganese; and the amino acid L-lysine.
published date: 12-01-2009

AHPA Revises Guidelines for Cleanliness and Metal Policies

The American Herbal Products Association’s (AHPA; Silver Spring, MD) board of trustees recently accepted revisions for the association’s guidelines for policies on microorganisms and mycotoxins, and heavy metals. The established guidelines serve as AHPA standards for responsible trade of herbal supplements to benefit the industry and its consumers.

AHPA urges companies to submit information on any ingredients that exceed substance limits outlined in the AHPA in order to ultimately meet those limits.

“The new guidance policies are based on a careful review of microbial and other limits established by governments and organizations across the world,” said AHPA president Michael McGuffin. “AHPA’s limits prioritize consumer safety while remaining sensitive to industry needs – a strategy that promotes both compliance and safety.”

AHPA’s complete guidelines can be viewed here: www.ahpa.org/Portals/0/2009/09_1118_Guidance_Policies.pdf
published date: 12-01-2009

PIVEG Inc. Launches I-Z Trademark for Zeaxanthin Isomer Products

Nutraceutical products manufacturer PIVEG Inc. (PIVEG; Celaya, Mexico) launched its I-Z trademark for Zeaxanthin carotenoid products at the SupplySide West trade show in Las Vegas, last week.

The company produces carotenoid concentrates for eye health, such as Zeaxanthin and Lutein, along with other products at its facilities in Celaya, Mexico.


PIVEG CEO Roberto Espinoza stressed last week that “newer participants in the carotenoid and Zeaxanthin field are confusing customers with claims and product nomenclatures that have in fact been available in the industry for years…reaching for patent protection that does not apply or is not novel.”

PIVEG’s Zeaxanthin Isomer production from marigolds was invented in 1993 and commercialized in 1999. The company’s carotenoids are available in any ratio of concentration and in a variety of formats. PIVEG is FDA-registered and GMP-certified with manufacturing facilities in two countries and sales in Europe, America, and Asia.

For more information, visit www.piveg.com
published date: 11-18-2009

Seltzer Companies is now Glanbia Nutritionals

Seltzer Companies Inc. (Seltzer; Carlsbad, CA) announced today that it has changed its name to Glanbia Nutritionals Inc. and will operate under the Glanbia Nutritionals Customized Solutions brand.

Seltzer, which includes Seltzer Nutritional Technologies and Seltzer Ingredients, is a subsidiary of Glanbia Nutritionals (Glanbia; Monroe, WI).

"As part of the global Glanbia Group since 2006, it is only fitting that we complete the association with our parent company by undertaking this rebranding initiative," said Richard Hazel, Seltzer CEO. "We look forward to continuing to provide our portfolio of nutritional ingredients, colors and customized micronutrient blends to manufacturers of nutritional, food, beverage, human health and personal care products.”

This new branding allows for the combining of Glanbia's plants in Shanghai and Orsingen, Germany with the former Seltzer plants in Carlsbad and Springfield, Missouri.

Glanbia Nutritionals is at Supply Side West in booth #25064.
published date: 11-12-2009

Naturex Releases Cereboost for Brain Health.

Natural ingredients manufacturer Naturex (Avignon, France) has announced its launch of Cereboost, an American Ginseng extract, for cognitive function.

Cereboost will be added to Naturex's NAT Life line of clinically-tested ingredients. A clinical study conducted by the Brain Science Institute at Swinburne University (Melbourne) found that Cereboost positively impacted patients in the area of mental function, namely working memory and alertness.

Naturex launched Cereboost at Supply Side West, currently being held in Las Vegas, and will also showcase the ingredient at next week's Food Ingredients Europe in Frankfurt.
published date: 11-12-2009

Gencor Nutrients to Present Fenugreek Male Libido Study Findings at SupplySide West

Next week at SupplySide West, Gencor Nutrients Inc. (Anaheim, CA) will present the results of a new human clinical study recently completed in Australia on male libido and Testofen, Gencor's proprietary extract of fenugreek. Gencor says that the study's results show Testofen to be a safe and effective product for increasing libido in healthy males.


The randomized, double-blind placebo study tested sexual function, performance, and libido levels in 60 healthy males ranging between the ages of 21 and 50, over a six-week period. Gencor says that results showed that Testofen produced a significant positive change in all parameters of libido, including sexual cognition, sexual arousal, sexual experience, and orgasm.


The company adds that the effects may also be a result of interaction with testosterone via alpha-5 reductase activity.


Details of the study will be presented at SupplySide West in a VendorWorks seminar on November 13 at 2:30 p.m.
published date: 11-04-2009

Kellogg Ceases Immunity Claims for Cereal

Kellogg Co. plans to discontinue use of the phrase, “Now helps support your child’s immunity,” on boxes of Kellogg’s Rice Krispies and Cocoa Krispies cereal. The move was announced after a letter questioning the marketing claim was sent to Kellogg by San Francisco city attorney Dennis J. Herrera.

Herrera’s letter requested that Kellogg provide evidence to back up its immunity claim, which Kellogg started adding to its packaging after the company began adding extra antioxidants to the cereals in question last year.

Herrera’s letter also expressed concern that “the immunity claims may also mislead parents into believing that serving this sugary cereal will actually boost their children’s health,” especially when concerns over swine flu are so heightened.

Kellogg spokesperson Susanne Norwitz said that the company started adding antioxidants to the cereals last year, before the swine flu outbreak. She said that the packaging’s launch coincidentally coincided with rising concerns about the disease.

Kellogg said that it will continue to feature the antioxidants in the products but will phase out the packaging with the immunity claim.
published date: 11-04-2009

KGK Synergize Inc. to Participate in “Penguin Climb” for Charity

KGK Synergize Inc. (KGK; London, ON) is proud to announce that its staff will be participating in the “Climb of the Penguins” charity event in support of The United Way of London & Middlesex, Ontario (United Way of London) on November 5, 2009.

The public charity event is a “climb” of 427 steps to the top of One London Place, the 24-story skyscraper that houses KGK operations.

“The staff has been busy collecting pledges for the event, and has even started training on their lunch hour,” said Najla Guthrie, president and CEO of KGK, who will also participate in the event. “It is very encouraging to see everyone come together and have fun to support such a great cause.”

United Way of London is a non-profit organization dedicated to improving the quality of life for all families, children, and neighborhoods within its communities.

KGK provides product development and research services to the health nutrition, biotechnology, and pharmaceutical industries.

More information on the climb can be found here: www.uwlondon.on.ca.KGK Synergize Inc. Ready to “Climb” for Charity
published date: 10-28-2009

Shoreline Fruit and Anderson Global Introduce CherryPURE Tart Cherry Skin Extract

Grower and manufacturer of cherry products Shoreline Fruit LLC (Traverse City, MI) has joined forces with the ingredient supplier Anderson Global Group LLC (Irvine, CA) to create CherryPURE, a tart cherry skin extract for the North American dietary supplement, personal care, and food industries.

CherryPURE is intended for use in joint health, sleep, superfruit, and antioxidant markets. The companies claim their tart cherry product can provide beneficial levels of polyphenols, anthocyanins, flavanoids, and natural melatonin.

CherryPURE is available in powder form and will be at booth #25045 at next month’s Supply Side West show in Las Vegas.
published date: 10-26-2009

FDA to Crack Down on Front-of-Package Labeling, Smart Choices Suspends Program

Following last week’s FDA announcement that the agency will begin to enforce against misleading front-of-package (FOP) nutrition labels, officials of the recently launched Smart Choices FOP labeling program announced that it would put its program on hold.

Last Tuesday, FDA released a letter to industry stating that the agency will begin policing claims made in FOP labels. This is the first time that the agency has taken an active role in overseeing FOP label claims.

FOP labeling programs have come under new criticism recently, as this summer the Smart Choices logo began appearing on the fronts of food packages of some of the largest food corporations, including Generals Mills, Kraft Foods, and Kellogg Co. Many critics have decried the Smart Choices nutrition criteria as being too lenient, allowing foods high in sugar and fat to use the program’s logo.

Another criticism of FOP labeling programs in general is that there are too many independent FOP logos on the market, ultimately confusing consumers.

On the Tuesday that the FDA letter was released, FDA Commissioner Margaret Hamburg held a press conference to discuss the new role FDA is undertaking to oversee FOP labeling. She said that the agency plans to bring standardization to FOP labeling by developing a “single set of science- and nutrition-based criteria” that all FOP labels should abide by. The agency is also launching a consumer research program to determine how consumers are influenced by FOP labels, and how to best convey nutrition information to consumers through FOP labels.

Hamburg said that the agency could make “significant progress” toward its goal by the end of 2010. As a model, FDA will be looking to the United Kingdom’s “traffic light” nutrition labeling approach, for which government defines the nutritional criteria that foods using FOP labels should meet.

The U.K.’s labeling system is voluntary, meaning that many retailers have voluntarily adopted the government’s criteria. FDA hopes that a voluntary program will work in the United States. If it doesn’t, however, the agency is prepared to use its authority “to move toward a mandated approach, should that prove necessary,” said Hamburg.

And the agency is ready to start enforcing against current FOP labels on the market that could be misleading consumers. Hamburg and her staff will begin examining existing FOP labels for violations of current FDA labeling rules, including those rules under FDA’s Nutrition and Education Labeling Act.

Hamburg also called on industry to report any cases of misleading labeling. “If you know of any products in the marketplace in your areas that you think should be brought to our attention, please feel free to do so,” she said.

Hamburg also stressed that FDA is seeking a collaborative approach with the food industry, including manufacturers and retailers, to help devise appropriate labeling criteria. “While we may take enforcement action against manufacturers whose labels are either false or misleading, our primary aim is to work with the food industry to help develop appropriate criteria for FOP labeling that will truly serve American consumers.”

Meanwhile, the announcement that Smart Choices would halt any further growth of its program was surprising, if not welcome, to many. The program’s officials said that while FDA is reviewing nutrition claims, the Smart Choices program will “voluntarily postpone active operations and not encourage wider use of the Smart Choices Program logo.”

Products currently bearing the Smart Choices logo will remain on shelves, however, and food companies already participating in the program can continue to use the logo. Smart Choices officials said that the program’s criteria will be adjusted if necessary to meet any criteria decided on by FDA.
published date: 10-26-2009

Consumer Confidence in Dietary Supplements Remains Stable, Says CRN Survey

In the face of an economic recession and raids on companies selling tainted supplements, dietary supplement use appears to be steady, according to a survey conducted by Ipsos Public Affairs (Ipsos; Washington, DC) for the Council for Responsible Nutrition (CRN; Washington, DC).

The 2009 Consumer Survey on Dietary Supplements found that 84% of Americans surveyed claim to be “confident in the safety, quality, and effectiveness of dietary supplements,” compared with 81% in last year’s survey. This is also the highest recording of consumer confidence since the study’s inception in 2001.

A slight increase was also found in the amount of people who claim to use dietary supplements (65% in 2009, compared with 64% in 2008). These figures are only a few percentage points below 2008 and 2007 figures (68% and 66%, respectively).

CRN claims the 2009 results are hopeful, considering that three quarters of those surveyed claimed that they haven't changed their supplement purchasing habits due to the recession.

“We believe that responsible companies within the industry can take some of the credit for the continued rise in consumer confidence,” says Steve Mister, president and CEO of CRN. “They have embraced new regulatory requirements, such as adverse event reporting and new Good Manufacturing Practices specific to dietary supplements.”

Increased industry regulation is also believed to have been a factor in the 2009 results.

Another high note for the industry came with a reported 78% of surveyed Americans taking daily multivitamins (an increase from 75% in 2008).

“As hard as they may try, many consumers recognize that daily stress and lack of time prohibit them from eating as well as they know they should,” says Judy Blatman, senior vice president of communications for CRN. “They realize that they can’t meet all of their nutritional requirements through diet alone…We’re encouraged that consumers continue to look to the multivitamin to help round out their nutritional habits.”

The 2009 Consumer Survey on Dietary Supplements surveyed 2043 adults from August 26 to September 1. Ipsos claims weighting was used to accurately represent U.S. census data.
published date: 10-23-2009

Natural Products Association Appoints New CEO

The Natural Products Association (NPA; Washington, DC) has announced the hiring of John F. Gay as executive director and CEO, today.

"After conducting a thorough search for someone with an outstanding background in advocacy and trade association leadership, John is the ideal person for the job,” said Pat Sardell, president of NPA. “John has tremendous experience and a widely respected presence on Capitol Hill."

Gay's professional experience includes a number of government relations positions. Most recently, he served as senior vice president of government affairs and public policy for the National Restaurant Association (Washington, DC).

Gay will assume action with NPA in time for the NPA Board of Directors meeting on November 2.
published date: 10-22-2009

Novel Ingredient Services Adds Management Personnel

Novel Ingredient Services (West Caldwell, NJ and Los Angeles), a supplier of botanical and nutraceutical raw materials, has announced the hiring of Gisela Roufs and Yolanda Nargiella as west coast account executive and director of quality control, respectively. Roufs has more than a decade of experience with raw material suppliers, including American Ingredients (Anaheim, CA) and Pharmachem Laboratories (Kearny, NJ). Nargiella comes with eight years of experience in a similar position with Johnson & Johnson (Langhorne, PA). She will oversee quality assurance, quality control, and testing departments with her new company.
published date: 10-21-2009

Melon Juice May Alleviate Stress, Fatigue

Daily intake of a melon juice concentrate may help to lessen stress and fatigue, according to a new study published in Nutrition Journal. A pilot study tested the effects of oral supplementation with a supplement containing Extramel, a proprietary freeze-dried melon juice concentrate that is rich in antioxidant superoxide dismutase (SOD) enzymes. SOD enzymes are thought to fight against oxidative cell damage, which several studies have linked to perceived feelings of stress.

The randomized, double blind, placebo-controlled clinical study was performed on 70 healthy volunteers between the ages of 30 and 55 years old. The subjects took an oral supplement containing 10 mg of Extramel, or a placebo, once daily over the course of four weeks. Feelings of stress and fatigue were measured using four psychometric scales: FARD, PSS-14, SF-12, and the Epworth Sleepiness Scale.

Subjects who took the melon juice concentrate showed decreased symptoms of stress and fatigue, including less physical pain, less trouble sleeping, less trouble concentrating, less weariness, and less irritability. No adverse effects were noted.

Researchers also reported that the placebo effect was very high for the first seven days of supplementation, perhaps because the subjects studied did not have very high levels of fatigue and stress. According to researchers, subjects’ stress and fatigue corresponded with a “normal everyday level of fatigue and stress of working people in developed countries.” They noted that a higher base level of stress and fatigue might lead to a more significant difference between the placebo and the supplemented group.

On a side note, researchers noted that although SOD helped to decrease trouble sleeping, it did not cause sleepiness, which can be a side effect of many sedatives.

Extramel is an ingredient offered by Bionov. High in antioxidants, Extramel contains concentrated melon juice microencapsulated in a vegetal coating, as well as other ingredients that are part of the antioxidants naturally found in melon pulp, such as catalase, glutathione, vitamins, caratenoids, and selenium.

published date: 10-20-2009

Dr. Weil Website Receives First Joint FDA, FTC H1N1 Warning Letter

On October 15, FDA and the Federal Trade Commission together issued their first joint warning letter to www.drweil.com, a website associated with health guru Dr. Andrew Weil, for what the agencies called fraudulent H1N1 marketing claims.

Among other things, the agencies took issue with a page on the website titled “Swine Flu and You,” on which Weil gave advice on how to avoid contracting the H1N1 flu. On the same page, Weil suggested using his Weil Immune Support Formula product to help ward off colds and the flu.

Posted on the web page was this statement from Weil: “[D]uring the flu season, I suggest taking a daily antioxidant, multivitamin-mineral supplement, as well as astragalus, a well-known immune-boosting herb that can help ward off colds and flu. You might also consider…the Weil Immune Support Formula[,] which contains both astragalus and immune-supportive polypore mushrooms…”

The warning letter, the first to be issued jointly by the agencies, gave the website 48 hours to respond. Although Weil denied in a statement that his website aimed to market a fraudulent H1N1 product, he ordered that the content in question be deleted from the website, and issued a press statement saying, “I fully support the FDA/FTC task force in its efforts.”

In the same statement, Weil also added: “The content that was called into question in the warning was primarily educational, including appropriate strategies to avoid getting the flu this season. It included the official recommendations for H1N1 flu vaccination from the Centers for Disease Control.”

He added: “Because these products and the flu (which is a medical diagnosis) were both mentioned in editorial content on the site, and it was suggested that particular traditional herbal ingredients may provide some protection against flu, it was the opinion of the FDA/FTC that the language was in violation of current standards.”

Since May 2009, FDA has issued warning letters to more than 75 websites, to stop the sale of more than 135 products with fraudulent H1N1 claims. This week, FDA enhanced its efforts to warn the public about deceptive H1N1 flu products and encourage reporting of such products by releasing an H1N1 influenza fraud widget. The agency says that the hope is that the widget will “allow the public to play an active role in preventing flu fraud.
published date: 10-20-2009

BioCell Appoints Stanford Scientist

Biocell Technology (Newport Beach, CA) announced the appointment of Joosang Park, PhD, as vice president of scientific affairs, earlier this week.

Park, who has direct research experience at Harvard Medical School and Stanford University, will be responsible for all research and development affairs related to patented and branded nutraceutical ingredients; namely BioCell Collagen II and i-Sabi.

The company has also announced the launch of its new wasabi japonica ingredient, i-Sabi, for brain health support. “[Research data] strongly supports that bioactive compounds, such as isothiocyanates in the wasabi rhizome extract, can exert a diverse range of physiological effects,” says Park. These effects include antioxidant, liver-protective, anti-inflammatory, and neuritogenic activities.

Park will be giving a presentation, “BioCell Collagen II: A Natural Solution for Healthy Joints, Skin, and Aging,” at the upcoming Supply Side West conference at 8am on November, 12.
published date: 10-20-2009

Study Confirms Quick Absorption, Good Retention For Vitamin C Ingredient

A recent clinical study of Fast-C, a vitamin C ingredient, has confirmed the ingredient's quick absorption and retention rates. The study's findings were presented at the American College of Nutrition conference held last week in Orlando, FL.


The clinical trial is the second double-blind, randomized crossover clinical trial performed on Fast-C. The first trial took place in 2007 and likewise showed Fast-C's significantly faster vitamin C absorption time and retention.

The newest double-blind, randomized crossover study enrolled 10 nonsmoking male subjects. Results showed a significantly faster rise of vitamin C in the blood following consumption of Fast-C. The ingredient's bioavailability was compared with a leading vitamin C formulation at a 1000-mg single dose. Moreover, despite the faster entry of vitamin C in the blood, retention rates by body tissues were found to be comparatively better based on urinary excretion.

The trial was conducted at Miami Research Associates, a U.S.-based pharmaceutical and nutrition research lab that employs Good Clinical Practices. The lab also conducted the 2007 test on Fast-C.

Patent-pending Fast-C was developed by Scientific Food Solutions. It is distributed by E.T. Horn, in partnership with Alkemy Partners LLC. The ingredient provides a buffered and 90%+ acid-neutralized vitamin C.
published date: 10-06-2009

One-Third of Lipoic Acid Supplements Fail Quality Test, ConsumerLab.com Reports

In a recent ConsumerLab.com evaluation of alpha-lipoic acid supplements, only two-thirds of the brands tested passed quality review.

Lipoic acid is a natural antioxidant that can help diabetics control blood sugar and reduce symptoms of peripheral neuropathy. In its tests on various brands of lipoic acid supplements, ConsumerLab.com found that two brands' supplements contained less lipoic acid than was promised on their product labels. A third product was called out for making FDA drug-classified claims.

The other seven lipoic acid supplements tested by ConsumerLab.com did meet quality standards, as did five other products that passed ConsumerLab.com's voluntary certification testing.

None of the products tested exceeded contamination limits for lead.

ConsumerLab.com's latest report specifies which lipoic acid supplements failed testing, as well as which passed. For more information, visit www.consumerlab.com.
published date: 10-06-2009

Grain Processing Corporation to Unveil New Fiber and Maltodextrin Products

Grain Processing Corporation (GPC; Muscatine, IA) will showcase brand new products at the upcoming SupplySide West 2009 tradeshow in November.

The company will present its TruBran oat fiber in a breakfast cookie. TruBran products offer high fiber sources in a variety of snacks, cereals, baked goods, and other applications.

In addition to GPC’s fiber-fortified products, the company will also feature an organic chewable tablet base made with Maltrin OR organic rice maltodextrin and rice syrup solids. The formula is intended to serve as a binder with smooth mouthfeel and sweetness control. These new additions are USDA and Quality Assurance International (QAI) certified organic.

GPC’s Maltrin products can be used in various applications, including nutritional beverages and infant formulas. Quick-dispersing versions are also available.

GPC will be at SupplySide West 2009 in booth #24014.

For more information, go to www.grainprocessing.com.
published date: 09-30-2009

CRN Responds to Senate Subcommittee Hearing on Hidden Steroids

In response to Tuesday’s Senate Subcommittee on Crime and Drugs hearing, “Body Building Products and Hidden Steroids: Enforcement Barriers,” the Council for Responsible Nutrition (CRN; Washington, DC) released a statement detailing its position on products containing anabolic steroids and sold as dietary supplements.

CRN maintains its position that “Rogue products that contain anabolic steroids are not dietary supplements, regardless of how the bad actors who manufacture and market these products might position them—they are illegal, unapproved new drugs.”

CRN cites various federal regulatory powers granted to FDA (Rockville, MD) and the Drug Enforcement Administration (DEA; Alexandria, VA) to allow these agencies to actively regulate and enforce penalties upon companies marketing products containing unapproved substances.

For example, for a substance to enter the dietary supplement market, CRN cites the Dietary Supplement Health and Education Act of 1994 (DSHEA), which requires that new dietary ingredients (NDIs) submit to an NDI notification process before being allowed to enter the market. A product that doesn’t submit to this process would be considered adulterated.

Regarding FDA’s ability to control the flow of unapproved products into the consumer marketplace, CRN says, “Enforcement tools available to FDA include seizure of products, and fines and criminal sanctions against companies that ignore the law—FDA just needs the resources and the political will to use them.”

Much of the Senate hearing focused on evaluating the effectiveness of current law enforcement on all “bad actors” in the dietary supplement industry.

The hearing was led by Senate Subcommittee on Crime and Drugs chairman Arlen Specter of Pennsylvania.
published date: 09-29-2009

U.S. Omega Opens Business with Fish Oil Softgels

Fish oil distributor U.S. Omega, Inc. (U.S. Omega; Santa Ana, CA) began operations today with an official press release. The Southern California-based company has launched its premier product, Omega 3 Fish Oil 1000 mg softgels, which will available in retail stores and for medical practitioners in retail-ready bottles or in bulk.

The company's mission is to provide "the most popular and important nutritional products" without the standard high prices, according to managing director Herrie Tantono. "Our plan is to take advantage of additional opportunities where value can be extracted from the traditional distribution chain...Given the current economic environment, it is imperative that our industry offer customers the best possible value in nutritional supplements."

U.S. Omega has established partnerships in South America for fish oil supply and in the U.S. for encapsulation.

For more information, visit www.US-Omega.com.
published date: 09-24-2009

White House Unveils New Food Safety Website at www.foodsafety.gov

This week, HHS (Washington, DC) secretary Kathleen Sebelius and USDA (Washington, DC) secretary Tom Vilsack, announced the launch of a new government website at www.foodsafety.gov, according to the news agency Reuters.

This website is a development of the White House’s Food Safety Working Group, which Sebelius and Vilsack are co-chairs of. The site will provide consumers and businesses with up-to-date information regarding food product recalls with the ability to receive information through email and phone alerts.

The site will also provide advice on how to safely handle foods, and contact information for reporting adverse events related to food. Contact information for reporting food poisoning incidents and other adverse events will be categorized by food types for consumer ease.

“Those reports of illness can help us identify potential outbreaks sooner and strengthen our efforts to protect Americans from unsafe food and food-borne illness,” said Tom Frieden, director of the Centers for Disease Control and Prevention (CDC; Atlanta), in an interview with Reuters.

The site’s overall intention is to provide consumers with a gateway of food safety information from several leading health organizations, including FDA, CDC, and USDA.
published date: 09-11-2009

FDA Issues

Wisdom Natural Brands(Gilbert, AZ) received a “no questions” letter from the U.S. Food and Drug Administration (FDA) in which an FDA expert panel of scientists granted Generally Recognized As Safe (GRAS) status to the whole leaf steviol glycosides (with rebaudioside A and stevioside) in the company’s SweetLeaf Sweetener® extract. SweetLeaf Sweetener is Wisdom’s all-natural, zero-calorie, zero-carb and zero-glycemic index stevia sweetener.

"It is a tremendous victory for Wisdom Natural Brands and SweetLeaf Sweetener," said Wisdom’s founder, Jim May. "Scientists spent more than a year conducting extensive research to assure the safety and quality of our sweetener extract and today’s letter from the FDA authenticates what science has already proven – SweetLeaf Stevia’s high-intensity sweetener extract is a safe and pure alternative to sugar for consumers and food and beverage companies across the globe."

According to May, SweetLeaf Sweetener does not contain chemically altered glycosides. Instead, SweetLeaf Sweetener is produced by isolating and extracting the four sweetest glycosides produced naturally within the stevia leaf, resulting in a purer, sweeter-tasting stevia extract that does not require masking agents or other flavoring compounds.

According to Wisdom Natural Brands, SweetLeaf Sweetener is made entirely with high grade stevia leaves in a proprietary cool, purified water filtration process. No chemicals or alcohols ever touch the stevia leaves and no chemical residues are found in the extract or products made from it.

"It is the only truly 100% natural stevia sweetener available," said May. "And the entire extraction process supports natural and sustainability principles. The leftover leaf material is used to nourish livestock and the post-extraction water is saved and then trucked to agricultural fields to enrich the soil and growing fruits and vegetables. Even our tabletop sweetener packet box is made from 100% recycled material as part of our commitment."

SweetLeaf received GRAS status in March, 2008, when GRAS Associates, an independent panel of scientists, awarded SweetLeaf stevia GRAS status pursuant to FDA regulations. FDA regulations allow companies to independently determine by qualified food science experts, through a self-affirmation process, that an ingredient is generally recognized as safe.

Wisdom obtained a concurring opinion from the Life Science Research Office, which independently agreed with GRAS Associates’ original findings. Wisdom submitted their GRAS notification to the FDA in February, 2009. The submission created two separate and distinct panels of scientists to determine the GRAS status of a product independently of one another and of the company making the product.

For more information on Wisdom Natural Brands™, please visit www.WisdomNaturalBrands.com or www.SweetLeaf.com



published date: 09-02-2009

New Dossier Published For Lactium Stress Relief Ingredient

A new dossier has been released for the product Lactium, according to its exclusive international distributor Pharmachem Laboratories (Pharmachem; Kearny, NJ). Lactium is a milk casein hydrolysate that has been studied for its relaxing properties.

"The dossier contains all the available research and application studies on Lactium, and is the most comprehensive technical document developed for the ingredient to date," said Mitch Skop, director of new product development for Pharmachem.

Lactium works by regulating stress symptoms in the digestive and cardiovascular systems. It has achieved Generally Recognized As Safe (GRAS) status and clinical trials have shown that its use comes without side effects. Lactium can be applied to the human diet as a supplement and a functional food ingredient.

The full dossier can be viewed at www.lactiumusa.com.
published date: 08-25-2009

ConsumerLab.com Finds Natural Vitamin E Products to be Synthetic

In a review of various natural vitamin E products, ConsumerLab.com (White Plains, NY) found "virtually all" of two products to be composed of synthetic vitamin E. The report by ConsumerLab states that natural vitamin E is more expensive than the synthetic option.

Additionally, one product fell short of its claimed amount of vitamin E and one product's tablet took 128 minutes to break down. United States Pharmacopoeia (Rockville, MD) requires that a tablet must break down in 30 minutes or less for proper absorption.

ConsumerLab president Tod Cooperman, M.D, advises consumers of how to find the right vitamin E supplement that is as natural as it claims. If you want natural vitamin E... at a minimum, look for a product that lists 'd-alpha tocopherol' (or 'd-alpha tocopheryl') in the ingredient area," says Cooperman. "Not just the word 'natural.'"

The full report can be viewed by subscribers at www.consumerlab.com/reviews/Vitamin_E_Supplements_and_Skin_Care_Products/vitamine/

-Robby Gardner
published date: 08-04-2009

Study Shows Aloe Vera Fights Cavities

A new study on aloe vera gel confirms that aloe vera can be used in tooth gel to soothe tooth pain and control mouth bacteria, reports Examiner.com. The study, published in the May/June 2009 issue of General Dentistry, compared aloe vera gels to other commercial brand toothpastes and found that aloe vera can be an effective alternative for treating mouth bacteria.

Some manufacturing factors, like heating, can make the gel ineffective; for this reason, gels certified by the International Aloe Science Council (Silver Spring, MD) are recommended for their purity and quality.

"Thankfully, consumers with sensitive teeth or gums have a number of choices when it comes to their oral health, and aloe vera is one of them," said Academy of General Dentistry (Chicago) spokesperson Eric Shapria, MS.

-Robby Gardner
published date: 07-20-2009

Finnish Study Suggests Probiotic Cultures for Treatment of Birch Allergies

For those who suffer from birch pollen allergies, a recent study conducted in Finland may provide new information, according to Danisco Health & Nutrition (Danisco; Copenhagen). Researchers from Turku University Hospital and Turku University (Turku, Finland), and Danisco tested the effects of a dose of two probiotic cultures on children diagnosed with birch allergies.

The study, published in World Journal of Gastroenterology, used 47 children between the ages of 4 and 13 and found an importance related specifically to the ratio of probiotics used.

Previous studies have combined probiotic strains at a ratio of 1:1. The innovative aspect of our study was that we used an adapted ratio in an attempt to find the right probiotic mix, said Dr. Arthur Ouwehand, lead researcher for Danisco.

These new findings are promising for probiotics as a possible alternative to antihistamines, which can cause various side effects like drowsiness and dry mouth.

Danisco's full press release can be read at www.danisco.com/cms/connect/corporate/media%20relations/news/archive/2009/july/businessupdate_300_en.htm.

-Robby Gardner
published date: 07-20-2009

Haloteco Announces Voluntary Nationwide Recall of Libipower Plus

Earlier this week, manufacturer Haloteco (Los Angeles) announced a voluntary nationwide recall of its product Libipower Plus, according to FDA (Rockville, MD). The recall came when FDA reported finding tadalalafil in lab analysis of product samples.

Tadalalafil is the active ingredient in FDA-approved drugs prescribed for erectile dysfunction that may cause various dangerous side effects like low blood pressure and interaction with nitrates found in certain prescription drugs.

-Robby Gardner
published date: 07-16-2009

LiveTheSource Introduces Nano-Encapsulated Liquid Vitamin, Mineral, and Herbal Supplement

The new company LiveTheSource (Ft. Lauderdale, FL) has announced its launch of "daily source," the first ever nano-encapsulated liquid vitamin, mineral, and herbal supplement. The company claims the herbal compounds in daily source will "provide a substantial increase in nutritional value, first, due to their synergy, and second, due to their nano-encapsulation."

LiveTheSource also announces its new president and COO John Neubauer, former COO of Herbalife (Los Angeles).

-Robby Gardner
published date: 07-15-2009

FDA Releases Final Guidance on Serious Adverse Event Reporting

FDA (Rockville, MD) announced in today's Federal Register the release of its final draft of "Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act," according to the American Herbal Products Association (AHPA; Silver Spring, MD).

FDA's final guidance concerns the required submission of written reports to FDA within 15 days by any "responsible person," typically a product marketer, whose product has received report of a serious adverse event. These regulations took full effect in December 2007.

An earlier draft of the guidance was issued in October 2007, and AHPA submitted comments in response to it. The final guidance shows evidence that several of AHPA's comments, including concern with interpretation of official language, were considered and even incorporated into the language of the documents.

FDA's final guidance can be read here: www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm171383.htm

AHPA's 2007 comments can be read here: www.ahpa.org/Portals/0/pdfs/07_1214_AHPAcomments_DS-SAER.pdf

-Robby Gardner
published date: 07-14-2009

Three Manufacturers Fail to Meet GMP Standards; FDA Intervenes

FDA has requested a court order be issued on Quality Formulation Laboratories, American Sports Nutrition Inc., Sports Nutrition International LLC (Paterson, NJ), and Mohamed S. Desoky, the overseer of operations at all three companies.

The complaint, filed July 1 by the US Department of Justice (Washington, DC) on behalf of FDA, alleges that each of the companies failed to improve its "filthy" conditions of product manufacturing and storing after three investigations. FDA alleges that the companies did not meet GMP standards. Major food allergens in products were not labeled and evidence of live and dead rodents was found.

"This company has consistently failed to correct filthy conditions in their plants and to make sure that allergens are appropriately declared on the labels, despite frequent warnings to do so," said Michael Chappell, FDA's associate commissioner for regulatory affairs. "The FDA will not tolerate companies that fail to provide adequate safeguards."

-Robby Gardner
published date: 07-13-2009

European Food Safety Authority Urges Higher Omega-3 Levels for Recommended Daily Intake

The European Food Safety Authority (EFSA; Parma, Italy) has suggested new levels of recommended daily consumption of omega-3s to the European Commission (EC; Brussels).

EFSAs Panel on Diabetic Products, Nutrition, and Allergies (NDA) issued a recommendation to EC, stating that 250 mg of long-chain omega-3 fatty acids be the minimum level required in products claiming to contain or be high in omega-3s. This intake value is an increase of ECs previously-suggested value of 200 mg. NDAs recommendation also includes daily standards for short-chain fatty acids at 2 mg (the same level suggested by EC) and omega-6s at 10mg.

Cassie France-Kelley, public relations manager at Martek Biosciences (Columbia, MD), stressed her optimism with NutraIngredients.com

While there may be some confusion about how much omega-3 should be included in the daily diet for optimal health, the EFSA proposal will establish minimum levels acceptable for inclusion in food products in order to make specific labelling claims, she said. This is a step in the right direction and will serve to minimise industry and consumer confusion.

EC is due to consider NDAs recommendation this Wednesday.

-Robby Gardner
published date: 07-13-2009

Gaia Herbs Announces Membership in United Natural Products Alliance

Gaia Herbs (Gaia; Brevard, NC) announces today that it is now a member of the United Natural Products Alliance (UNPA; Salt Lake City). Gaia is a grower and manufacturer of natural and organic herbal products and its new membership with UNPA assures proper implementation and enforcement of DSHEA by UNPAs multinational standards.

-Robby Gardner
published date: 07-13-2009

CRN Questions Health Advocacy Group over Selenium Claims

The Center for Science in the Public Interest (CSPI; Washington, DC) issued a press release on June 29 alleging that selenium intake may increase several health risks. These claims have motivated an adverse response from the Council for Responsible Nutrition (CRN; Washington, DC).

CSPI alleges that selenium intake may pose health risks to men suffering from prostate cancer, and that selenium may cause increased risks of diabetes and hypertension. But CRN insisted in a July 7 press release that the studies referenced by CSPI do not support such claims.

The fact is that the researchers involved in the SELECT trial have themselves been very careful to state that any increased risk of diabetes that might have been associated with the SELECT trial was not statistically significant and may have been due to chance, says CRN.

Accor finds fault in CSPIs reference to a study published in this Junes Journal of Clinical Oncology, where researchers admitted to certain limitations in the study.

To state, as CSPI does, that studies suggest selenium leads to increased risk of aggressive prostate cancer isinaccurate, says CRN. As with the SELECT trial, these researchers stated, this finding may be a result of chance and warrants further confirmation in humans.

To read the CSPI press release, visit
www.cspinet.org/new/200906291.html

To read the CRN press release, visit www.crnusa.org/CRNPR09RespondstoCSPIAllegations070709.html

-Robby Gardner
published date: 07-09-2009

BENEO-Group Sees Increase in Clients with New EU Regulations Approaching

With the European Unions (EU) upcoming nutrient profile regulations, BENEO-Group (Morris Plains, NJ) is reporting an increase in prospective clients. BENEO-Group anticipates advising many food producers on how to meet new EU criteria regarding improved labeling, packaging, and wording on food products.

The impending EU standards are meant to encourage consumers to adopt healthy diets. Products will now include quantities of certain nutrients and substances, along with their importance to the human diet. BENEO-Group plans to properly advise its clients on new branding strategies that will allow them to conform to what they call a new era of nutrition and health claims.

-Robby Gardner
published date: 07-07-2009

EFSA Negates Future Health Claims for Probiotics

The European Food Safety Authority (EFSA; Parma, Italy) has no displayed interest in drafting health claims for probiotics, according to accounts from EFSAs June 15 health claims summit reported by NutraIngredients.com.

One hundred and twenty representatives of the probiotics industry met in Brussels for a Q&A session which was the first opportunity for industry leaders to meet with EFSA since the organization enacted new health claims regulations three years ago.

EFSA responded negatively when asked if it would draft guidance for probiotics like those recently produced by the Canadian regulatory authority. The Canadian regulatory authority released health claims guidance for safety, quality, and labeling aspects of foods containing probiotics. EFSA has not issued health claims on any food groups.

Full disclosure of questions and answers posed at the EFSA summit has not been made public, but EFSA reportedly told NutraIngredients.com on July 2 that it would publish an overview and report on the meeting in autumn.

-Robby Gardner
published date: 07-07-2009

Swedish Researchers Link Fish Consumption to Improved Intelligence

Researchers in Sweden may have discovered a connection between fish consumption and higher intelligence scores among teenage males, according to omega-3 ingredient supplier Ocean Nutrition Canada (ONC; Dartmouth, NS).

The study, published in the journal Acta Paediatrica, sampled nearly 4000 Swedish teenage males at age 15 to see if various intelligence scores could be influenced by fish consumption at the age of 18.

Each patient submitted responses about their weekly consumption of fish. According to the study, those who claimed to eat fish at least once a week scored an average of 7% higher in combined intelligence tests than those who did not eat fish at least once a week. The teenagers who claimed to eat fish more than once a week averaged test scores 11% higher than those who did not eat fish at least once a week.

ONC chief sales and marketing officer Jon Getzinger attributes these test results to the consumption of omega-3 EPA/DHA found in oily fish, omega-3 dietary supplements, and omega-3 fortified foods.

-Robby Gardner
published date: 07-06-2009

China Implements New Food Safety Law

Food producers in China are now operating under closer scrutiny due to new quality control and safety regulations, reports European Advisory Services (EAS; Brussels). New legislation applied last month includes a range of regulation procedures including new monitoring and reporting processes, stricter inspections and a farm-to-fork approach for overseeing all chains of production in the food industry.

In the wake of recent food scares in China, this new oversight aims at acting as increased liability for food producers.

There have been a series of food safety scandals in recent years in China that have seriously undermined consumer confidence, and the new law aims to restore confidence from domestic consumers and international trade partners on the safety of the food products made in China, said EAS Asia advisor Jie Hu. The development of the law is a significant step, and improving food safety issues in China will be a long-term process.

-Robby Gardner
published date: 07-02-2009

Central Coast Nutraceuticals Fined $1.3 Million

Supplements firm Central Coast Nutraceuticals (CCN; Phoenix) has been fined $1,375,000 for alleged deceptive online marketing practices in a State of Arizona consumer fraud lawsuit.

The lawsuit was enacted by Arizona attorney general Terry Goddard after he received hundreds of complaints from consumers who made online CCN purchases of risk-free trial offers for health supplements. Consumers complained of being charged for additional products that were pre-selected in the order process for the risk-free trial offers. Consumers also claimed they did not receive responses to their emails and that they were put on telephone holds for over an hour.

Resulting from the lawsuit, CCN must now warn its consumers of the consequences of purchasing CCN trial products.

-Robby Gardner
published date: 07-02-2009

Naturex Earns Spot on Sustainable Businesses List

Natural ingredients supplier Naturex (Avignon, France) announced today that it has earned a spot on the 2009 SB20 List of sustainable businesses. The SB20 List, presented by SustainableBusiness.com, annually recognizes 20 international companies leading in sustainable and environmentally-conscious business practices.

Naturex is a multinational supplier and manufacturer of products for food, nutraceuticals, pharmaceuticals, and cosmetic industries.

Naturex was selected for this years SB20 List in the sustainable food category because it produces products from plant extracts, replacing chemical ingredients, says Rona Fried, PhD, CEO, of SustainableBusiness.com. Besides being plant-based, its flavorings, colorings, antioxidants and preservatives are GMO-free and not tested on animals, providing a much healthier and environmentally responsible alternative for the food industry. Such ingredients are found throughout the food industry; therefore Naturex has the potential to make an important contribution on a large scale.

-Robby Gardner
published date: 07-01-2009

Cerilliant Introduces Certified Reference Standards for Stevia

Cerilliant (Round Rock, TX), a producer and provider of certified reference standards and materials, announced the introduction of two new certified reference standards today, Rebaudioside A (Reb-A) and multi-component Rebaudioside-A Impurities.

These new reference standards will enable producers of Reb-A, a natural sweetener derived from stevia, to meet FDA guidelines for Reb-A ingredients and to attain a consistent flavor profile in the sweetener.

-Robby Gardner
published date: 07-01-2009

Fuji Chemical Focused on Astaxanthin

Researchers at Fuji Chemical Industry (Fuji; Toyama, Japan) are researching the supplement AstaREAL astaxanthin for its potential to cure asthenopia, commonly known as eye fatigue, reports its U.S. subsidiary Fuji Health Science (Burlington, NJ).

Astaxanthin is a natural antioxidant that can be abundantly found in the freshwater microalgae, Haematococcus pluvialis. Fuji scientists believe it can reduce cellular inflammation and improve capillary blood flow for the lens of the eye. The company has sponsored eleven human studies with astaxanthin on patients with symptoms of asthenopia. Fuji also cultivates astaxanthin at locations in Hawaii and Sweden.

-Robby Gardner
published date: 07-01-2009

Gluten Identified as Culprit of Unusual Celiac Disease

Researchers at the Mayo Clinic (Rochester, MN) have determined that celiac disease is four times more common today than it was in the 1950s, according to a Mayo Clinic study published in the June issue of Gastroenterology.

Celiac disease occurs when gluten from wheat, barley, or protein causes an attack on the immune system and nutrient-absorbing villi in the small intestine become damaged. Symptoms of celiac disease include diarrhea, abdominal discomfort, and weight loss. Since these symptoms are typically associated with other more common diseases, celiac disease can be misidentified.

A Mayo Clinic study conducted from 1948 to 1954 at Warren Air Force Base in Wyoming tested blood samples for the antibody produced in celiac disease. A follow-up of 45 years determined that patients who had celiac disease had a mortality rate four times higher than those patients who were celiac-free.

The Mayo Clinic recently conducted two similar blood test sets in Olmsted County, MN. One set was taken from patients matching the birth years of those from the Warren study, and the other with patients matching the ages of the Warren patients at the time of the Warren study. Results indicate that younger people are 4.5 times more likely to have celiac disease, and people as old as the Warren participants are four times more likely to have celiac disease.

"Something has changed in our environment to make [celiac disease] much more common, says Joseph Murray, MD, the lead researcher in the recent studies. Until recently, the standard approach to finding celiac disease has been to wait for people to complain of symptoms and to come to the doctor for investigation. This study suggests that we may need to consider looking for celiac disease in the general population, more like we do in testing for cholesterol or blood pressure."
published date: 06-30-2009

Harvard Report: Two Nutrients are Better than One

New research suggests that some of the daily nutrients we seek are actually influenced by other nutrients, according to reports in Julys Harvard Health Letter.

The reports suggest that certain nutrient levels in our bodies can be increased and decreased by other nutrients. Calcium absorption is said to be assisted by high levels of vitamin D. When sodium levels are too high in the kidneys, potassium can encourage sodium excretion. Vitamin B12 is also cited for its ability to help folate be absorbed, stored, and metabolized, the report says.

-Robby Gardner
published date: 06-30-2009

Fusion Formulations Quadruples Liquid Manufacturing Output

Fusion Formulations (Fusion; Phoenix) has announced an estimated quadrupling of its capacity for liquid manufacturing as a result of recent investments in production equipment that will create higher and faster output of products.

The investments include new Phase Fire heat tunnels and an Axon applicator machine which will yield a fully-automated shrink-labeling process for sleeve labels on any bottle shape. Additionally, a new FTNIR analytical testing instrument will expedite raw material analysis from two weeks to two days.

Thanks to this new equipment, Fusion claims it will be able to increase its daily output from 6000 bottles per day to 22,000 bottles per day. Fusion is a GMP-certified manufacturer working with nutraceutical beverages, vitamin and mineral capsules and powders, and other nutraceutical products.

-Robby Gardner
published date: 06-29-2009

Chemi SpA Passes Inspection of Enhanced Brazilian Facility

Chemi SpA (Chemi; Milan, Italy) has announced that its manufacturing facility, ITF Chemical Ltda, (ITF; Camacari, Bahia, Brazil) has been granted acceptable status after an inspection was conducted by HHS (Washington, DC) on its construction of new R&D and QC facilities.

ITF, which specializes in the production of active pharmaceutical ingredients and nutraceutical ingredients, was notified of the new status on June 16. Its new facilities come as a result of increased production of SerinAid PhosphatidylSerine (PS), which is known in the United States as a product used to enhance skills like memory, concentration, and exercise performance. PS is supplied to the United States through Chemis U.S. supplier, Chemi Nutra (White Bear Lake, MN).

-Robby Gardner
published date: 06-29-2009

Cracking the Mystery of Quercetin

A recent study on the effects of quercetin proves the plant pigment found in red wine and apples is still of scientific interest. Previously researched for its potential to treat health conditions like cancer or child asthma, quercetin is now being evaluated as a potential athletic performance booster, according to U.S. News & World Report.

The International Journal of Sports Nutrition and Exercise metabolism published a study this week that tested the effect quercetin had on cycling performance for 12 patients over seven days. Some performance results (notably endurance times) leaned in favor of those patients who took quercetin, but there is still speculation surrounding its use.

The American Cancer Society states that there is no reliable proof that quercetin can treat or prevent cancer. ConsumerLab.com, involved in a 1999 study of the supplement, acknowledges that it may be helpful for chronic non-bacterial prostatitis, but that it should be avoided by pregnant women and in high doses.

-Robby Gardner
published date: 06-26-2009

Government to Fund Huge Vitamin D Study

In 2010, Boston will be home to a $20 million study on the effects vitamin D and fish oil have in reducing the risks of cancer and cardiovascular disease in humans, reports the Boston Globe. The project is being funded by NIH (Bethesda, MD), and will enroll 20,000 patients starting January of next year.

The intentions of the study are to analyze how vitamin D affects the average person, and specifically how it affects African American. Darker skin does prevent significant vitamin D absorption from the sun, so a quarter of the studys patients will be black to evaluate this factor.

African Americans have a higher risk of vitamin D deficiency and a greater frequency of certain types of cancer, said JoAnn Manson, MD, a lead researcher for the study. I think that it will be of great importance to look at whether something as simple as taking a vitamin D supplement can narrow these health gaps.

The study will use women over 65 and men over 60, all with no history of cancer or cardiovascular disease. Patients will be separated into four groupsone given pills of vitamin D and fish oil, one given placebos, and the other two given one placebo and one supplement.

More information on the study can be found at www.vitalstudy.org.

-Robby Gardner
published date: 06-26-2009

UN Making Food Safer; Smaller Companies Feel at Risk

A new United Nations report may have some small food companies feeling left in the cold. The World Health Organization (WHO; Geneva) and the Food and Agriculture Organization (FAO; Rome) wrote a report that warns of the adverse effects that may occur impending food safety standards put on smaller companies.

The report says that processors and exporters have found it difficult to deal with new and overlapping requirements, with smaller companies having neither the time nor the infrastructure to compete with their richer, more-able counterparts.

The report comes in response to recent U.S. and world food scares involving pistachios, peanuts, and alfalfa sprouts, says the Reuters report.

The report is scheduled to be released next week at a Codex Alimentarius Commission (CODEX, Rome) meeting. CODEX is a joint body of WHO and FAO that establishes international food safety standards.

Various new safety standards of both a regulatory and private nature are expected to impose problems on smaller food companies, especially those in poorer nations, according the report.

"To the extent that there are economies of scale in compliance and/or larger firms are better able to access finance and other resources, compliance processes are likely to induce processes of consolidation and concentration," said the study.

-Robby Gardner
published date: 06-25-2009

Survey Says Grocery Shoppers are Wary

IBM (Armonk, NY) has released a survey indicating significant levels of consumer anxiety in the U.S. surrounding grocery shopping, reports MediaPost News. The survey sampled 1000 Americans who claim to shop for groceries at least once a month.

Among many notable statistics, the survey concluded that less than 20% of adult shoppers trust their food companies to produce safe and healthy products. Out of those surveyed, 60% claimed to feel concerned about the foods they purchase with 77% wanting more information about their foods' contents.

Recent nationwide product recalls may provide this survey with more relevance as 83% of those surveyed were able to name a food product recalled in the past two years.

IBM has not been identified as the studys sponsor.
published date: 06-25-2009

Redpoint Developing a Sweet Alternative

The biotechnology company Redpoint (Ewing, NJ) has announced that it has developed a new all-natural sweetener, RP44. Redpoint claims RP44 demonstrated enhancement results with common sweeteners, including sucrose, fructose, and high-fructose corn syrup. The independent laboratory that conducted taste tests with RP44 also found that the sweetener enables reduction of up to 25% of the caloric sweetener content in product prototypes, according to Redpoint.

Redpoint CEO Ray Salemme has publicized strong interest in further development and marketing of RP44.

We believe that the development of an all-natural sweetness enhancercan permit the development of new food and beverage products that require reduced amounts of [highly caloric] sweeteners, said Salemme. In addition, RP44 has the potential to reduce overall ingredient costs for manufacturers, along with creating healthier products for consumers due to lower calorie content.

According to Redpoint, they expect to develop RP44 by obtaining GRAS status. Ultimately they hope to market the product with food and beverage companies. As a result of research into healthier approaches to food, the company has vested much research into RP44, they said. If proven successful, the sweetener may give stevia a run for its money in the natural sweetener product aisle.

-Robby Gardner
published date: 06-24-2009

Moving and Shaking the Produce Industry

The United Fresh Produce Association (United Fresh; Washington, DC) is urging member companies and the produce sector at large to enact change in what United Fresh thinks can be a transformative year in the industry.

Citing the recent House approval in Congress of the Food Safety Enhancement Act of 2009, United Fresh is pursuing industry activism with high hopes in its recent news. More than ever before, it s important that members of the produce industry actively engage with lawmakers on legislation that would both maximize public health and rebuild consumer confidence in our food safety system, says United Fresh president and CEO Tom Stenzel.

Stenzel suggests this Septembers Washington Public Policy Conference, where 350 industry leaders will meet with policy makers, as an opportunity for groundbreaking legislation around issues like child nutrition and food safety.

-Robby Gardner
published date: 06-24-2009

DSM and Lonza Renew Partnership in Switzerland

DSM (Basel, Switzerland) and Lonza (Basel, Switzerland) have announced an extension of their partnership in Swiss production facilities in the districts of Visp and Lalden, the companies announced today.

The two companies have collaborated for over 40 years.

-Robby Gardner
published date: 06-22-2009

USADA Advocates State Action on Doping

In a conference with attorneys general on June 18, USADA (Colorado Springs, CO) CEO Travis Tygart called for state-level action in dealing with steroid contamination in supplements, according to the Associated Press.

Statistics related to high steroid contamination in consumer supplements were cited at the conference.

Tygart urged attorneys general to use state consumer protection laws to influence federal government interest in steroid use. A possible avenue could be recovering government-paid health care costs for the treatment of people that have become ill from tainted supplements.

"We're a complaint-driven organization and I have to admit, we're not getting a high number of complaints at our office about mislabeled substances," said Colorado Attorney General John Suthers.

"Whether we can muster the will to do something about it, I don't know. But it's a serious issue and I think we've got to look at it."

-Robby Gardner
published date: 06-22-2009

USDA Commits $176 Million to Priority Labs

Agriculture Secretary Tom Vilsack has announced the distribution of $176 million in Recovery Act funding to research laboratories in 29 states, according to the Agricultural Research Service (ARS; Washington, DC). ARS states that the funding will help improve research facilities of the highest priority. The funding will go towards improving safety and health aspects, energy efficiency, and reduced operation and maintenance costs of each facility.

Vilsack says the funding shows President Obamas commitment to ensuring that USDA (Washington, DC) stays on the cutting edge of research in food safety, nutrition, producing food, and preserving the quality of our soil and water, according to ARS. These investments are expected to support continuing scientific research, create new jobs, and help sustain local businesses that conduct business with the labs.

For a list of the selected research projects, visit www.ars.usda.gov/is/pr.

-Robby Gardner
published date: 06-19-2009

BASF Increases Costs of Styropor and Neopor, Again

Effective June 15, 2009, chemical company BASF (Florham Park, NJ) will charge an increase of 5 cents per pound on all of its grades of Styropor and Neopor expandable polystyrene. The price hike follows a previous increase which went into effect this month.

-Robby Gardner
published date: 06-19-2009

Nestl Recalls Cookie Dough as Consumers Fall Ill

A nationwide recall of all Toll House cookie dough products has been announced due to the risk of E. coli infection, according to Nestl USA (Nestl; Glendale, CA).

While Nestl states that it has not detected E. coli in its product, FDA (Rockville, MD) and the Centers for Disease Control (CDC; Atlanta) have released an official warning to consumers not to eat the refrigerated cookie dough. Since March 2009, 66 cases of illness have been reported to FDA from 28 states, with 25 people hospitalized and seven having developed a complication known as hemolytic uremic syndrome (HUS). No fatalities have been reported.

-Robby Gardner
published date: 06-19-2009

Surprise Bacterium Causes Disease in Turkeys

Agricultural Research Service (ARS; Washington, DC) scientists have discovered that an avian bacterium, Bordetella hinzii, has been doing more damage to turkeys than previously assumed.

DNA tests at ARS National Animal Disease Center (NADC; Ames, IA) have concluded that B. hinzii caused respiratory disease in a sample of turkey isolates. The finding came after NADC scientists realized that infected turkeys had been mislabeled as carrying another Bordetella species, B. avium. The confusion is attributed to the difficulty in distinguishing B. avium from B. hinzii.

Results of the tests are published in the March 2009 issue of Avian Diseases.

-Robby Gardner
published date: 06-18-2009

New Study Suggests Rise in Organic Sales

According to a study by the Organic Trade Association (OTA; Greenfield, MA) and Kiwi Magazine, families in the United States are now spending significantly more money on organic products than in years past. The study, to be released this week, examined the consumer behaviors of 1200 families surrounding organic food purchases. Among several key findings, nearly three-quarters of the families sampled claimed they purchase organic products at least occasionally.

For more information, visit OTAs website at www.ota.com.

-Robby Gardner
published date: 06-17-2009

FDA Drafts Reportable Food Registry for Comment

In response to section 1005 of the Food and Drug Administration Amendments Act of 2007, FDA (Rockville, MD) has drafted its Reportable Food Registry (RFR).

RFR now requires a responsible party to file a report through an FDA internet portal whenever a food or dietary supplement regulated by FDA poses a threat of causing serious adverse health consequences or death to humans or animals. A responsible party is any person who submits registration information to FDA from a food facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States.

The draft for RFR details who is responsible for submitting reports, when and where reports must be submitted, and what information must be provided in the reports and through the food supply chain.

Implementation of RFR is scheduled for September 8, 2009 and may also be accessed by federal, state, and local officials for reporting information on adulterated foods.

The draft can be read at: www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htm or www.regulations.gov.

-Robby Gardner
published date: 06-17-2009

ChemNutra Pleads Guilty in Toxic Pet Food Case

Matt J. Whitworth, acting U.S Attorney for the Western District of Missouri, announced today that Sally Qing Miller and Stephen S. Miller, owners of pet food supplier ChemNutra, Inc. (Las Vegas), have pleaded guilty on federal charges for selling adulterated and misbranded pet food.

ChemNutra was indicted on February 6, 2008 over several shipments of toxic wheat gluten that were distributed between November 6, 2006 and February 21, 2007 for use in various brands of pet food. The shipments, which were imported from China, all contained the unsafe contaminant, melamine. This culminated in a nationwide pet food recall, and the deaths of thousands of cats and dogs. FDA consumer reports claim that 1950 cats and 2200 dogs died from eating the contaminated products.

Sentencing and fine hearings will be scheduled after all presentence investigations are carried out by the U.S. probation office.

-Robby Gardner
published date: 06-17-2009

Clean Label Products as a Modern Selling Point

Rising consumer interest in eco-friendly productsnot to mention recent food scaresis encouraging food manufacturers to take on more natural approaches when it comes to selling products. From ingredients used, to locations and methods of manufacturing and distributing, a cleaner image is becoming increasingly significant.

BENEO-Remy (Wijgmaal, Belgium), a producer of rice-based ingredients, is taking this trend seriously. Vincent Caluwaerts, sales and marketing manager for BENEO-Remy, says, we have been working closely with leading food and beverage manufacturers to see how our rice derivatives, Remyline (natural waxy rice starch) for example, can best offer innovative solutions. BENEO-Remys approach involves various clean label characteristics, such as oversight of its production sites (i.e. water quality, soil condition, and crop rotation) and relationships with its rice farmers and millers.

Such practices demonstrate a variety of ways many manufacturers are attempting to attract consumers with an inclination towards natural products. BENEO-Remys process is used in the making ingredients for baby foods, breakfast cereals, prepared meals, bakery goods, and other products.

-Robby Gardner
published date: 06-16-2009

Dairy Doesnt Spoil in Economic Crisis

As plenty of markets take spills in the midst of international economic downturn, one industry is managing to thrive: the dairy industry.

The Packaging Machinery Manufacturers Institute (PMMI; Arlington, VA) has released a recent study, "Dairy Industry Market Research Study 2009," in which the industry proves to be making considerable profit. PMMIs study evaluates the perspectives of 34 leading dairy processors, accounting for 68% of the total dairy industry. While some doubt comes with the prospect of raw materials and price fluctuations in the future, the study still bodes well for the industry.

The study affirms that, even with a price increase of 9%, dairy product sales have gone up 2% within the last year. U.S. dairy production is expected to move to the West Coast and to centralize in a greater number of mega dairies, according to PMMI. Production methods are also expected to change, with a greater vested interest in energy sustainability. Such cost-effective moves in production would, in effect, make up the projected capital expenditures (expected from 71% of dairy processors) on packaging and machinery investments that will continue as long as dairy is a thriving industry.

PMMIs full study can be read at www.pmmi.org.

- Robby Gardner
published date: 06-16-2009

The Red Yeast Rice Ride

A new study in the June 16 issue of the Annals of Internal Medicine concluded that nonprescription red yeast rice may have cholesterol-lowering qualities.

The study included 62 people who stopped taking statins because of side effects. All of them followed a lifestyle change program, including education on nutrition, exercise and relaxation techniques. Half also took 1,800 mg twice a day of a red yeast rice product for 24 weeks, while the others took a placebo.

"In the group that took red yeast rice, the average drop in cholesterol was 43 points at 12 weeks," said Ram Y. Gordon, PhD, a cardiologist in private practice who was a member of the research group. "The drop in the placebo group was only 11 points. In the longer run, the drop was 35 versus 15 points. We think the difference narrowed because after 12 weeks we told people to keep on doing it, but maybe some stopped."

There are, however, complications related to the product. Red yeast rice is under a regulatory cloud at the FDA (Rockville, MD) because it contains a natural statin, lovastatin, sold as a prescription drug named Mevacor.

FDA moved against several red yeast rice productsnot the one used in the Pennsylvania studyon the grounds that they were unlicensed pharmaceuticals, a move which was upheld after a court tussle.

The product used in the study does contain lovastatin, Gordon said, but not enough to explain the reduction seen in the trial. Trial participants took three 600-mg vials of red yeast rice twice a day.

"Each vial had one mg of lovastatin. So the total was six mg a day, which is really a tiny amount," Gordon said. "And lovastatin is one of the weaker statins. The cholesterol drop was much more than what you'd expect from that low dose of lovastatin."

Some statin-related side effects, such as muscle pain and liver problems, were reported in the study, by two people who took red yeast rice and one who took the inactive substance, "but they were not severe," Gordon said.
published date: 06-16-2009

Deerland Enzymes Acquires GMP Sport Certification

Enzyme supplier and contract manufacturer Deerland Enzymes (Kennesaw, GA) recently received GMP for Sport certification from NSF International (Ann Arbor, MI).

Deerland Enzymes new GMP for Sport is meant to certify that the companys sports products do not contain any banned substances. The Sport Certification was granted in addition to Deerland Enzymes already existing GMP certification, under NSFs dietary supplements certification program, which approves of the companys facility, processes, and ingredient sourcing.

-Robby Gardner

published date: 06-15-2009

EFSA Issues Health Claims Assistance

The European Food Safety Authority (EFSA; Parma, Italy) has published a Q&A in advance of its stakeholders meeting in Brussels on June 15 to help industry better understand the nutrition and health claims process.

Plausibility between dietary effect and development of disease; the importance of human data; careful wording of claims; the inclusion of the full totality of evidence in regard to a proposed claim were all highlighted by the risk assessor in the seven-page document.

EFSA stated the importance of accurately demonstrating nutritional and physiological effects with appropriate outcome measures of that claimed effect."

The claimed effect needs to be specific enough to be testable and measurable by generally accepted methods, EFSA said. For example, gut health is too general but transit time is specific.

In the preparation of an application, a rationale/evidence should be provided that the claimed effect is beneficial in the context of the specific claim as described in the application.

Risk factors in relation to the development of disease were singled out with EFSA emphasising that reduced risk factors for particular diseases must be biologically plausible.

The risk factor must also be an independent predictor of disease risk, something that can be established via intervention and/or observational studies.

For some risk factors, there is strong evidence that they meet both criteria, EFSA said. For example, elevated serum LDL cholesterol is a risk factor for coronary heart disease (CHD) for which there is strong evidence for the biological basis through which it can contribute to the development of atherosclerosis (one pathway to CHD).

EFSAs document reemphasised the importance of targeted studies carried out on the food/constituent in question; the importance of human data; conditions of use; relevant study groups; usable animal models.

In addition, it is important that the human studies provided represent all available evidence pertinent to the claim, including evidence that supports the relationship as well as equivocal evidence and evidence of no effect or opposing effects.

EFSA said it would propose wording on occasion so that claims matched the available science, but noted it was up to the European Commission to take into account how such wordings may be interpreted by consumers.

It said wording must reflect the scientific evidence, complies with criteria established in the regulation and conditions of use are appropriate.

The meeting in Brussels next month has been double over-subscribed as industry seeks answers from EFSA before January, 2010, when the process is due for completion.
published date: 05-28-2009

Herbal Supplement Sales Experience Slight Increase

According to data supplied by IRI of Chicago, Illinois, sales of herbal dietary supplements in the food, drug, and mass market (FDM) channel increased by 7.16% in 2008 from 2007 sales, for a total figure of $289,248,200.

Although IRI data does not represent the entire FDM channel, as it does not include sales reports from Wal-Mart, Sams Club, and other large warehouse buying clubs, or from convenience stores.

Sales of cranberry (Vaccinium macrocarpon, Ericaceae) supplements, which increased by more than 23% in 2007 from 2006,3 continued to rise in 2008, making cranberry the top-selling herbal supplement product within the FDM channel.
published date: 05-19-2009

NY Times Columnist Calls Vitamin A Supplements A Cost-Effective and "Simple Fix"

In the May 13th edition of The New York Times, columnist Nicholas Kristof paints a very favorable portrait of vitamin A supplements. After visiting a town in northern Guinea, Kristof had this to say about supplementation:

"Americans pretty much take vitamin A for granted, but many of the worlds poorest people lack it," he writes. "And as a result, it is estimated that more than half-a-million children die or go blind each year. Theres a simple fix: vitamin A capsules that cost about 2 cents each.

"[It has been] have found that vitamin A supplements reduce not only blindness, but also death from diarrhea and other diseases. A review by Unicef and Helen Keller International reports that in areas such as West Africa where many children lack the vitamin, child mortality drops by approximately 23% after vitamin A capsules are distributed to children.

"According to the United Nations, half of the children in many African countries are deficient in vitamin A (which comes from liver, mangos, orange-fleshed sweet potatoes and dark, green leafy vegetables), and a disease like measles will quickly deplete their supply further and trigger blindness. The upshot is that vitamin A deficiency is the leading cause of child blindness in the world today.

Addressing vitamin A deficiency may be the most cost-effective intervention you can implement, he quotes a member of Helen Keller International as saying.

To read the full story, click here: http://www.nytimes.com/2009/05/14/opinion/14kristof.html
published date: 05-19-2009

ZMC and Farbest Extend Beta-Carotene Market

ZMC-USA (The Woodlands, TX)and ZMC China have announced a strategic partnership to market ZMCs line of beta carotene products in the United States. Leveraging its national sales and distribution network, Farbest (Montvale, NJ ) will exclusively market these products to the U.S. food and beverage industry. The companies will join forces to market ZMCs beta carotene to the dietary supplement industry, maximizing customer service and penetration.
published date: 05-19-2009

FDA Seizes $1.5 Million Worth of Food from "Filthy" Supplement Ingredients from Warehouse

FDA says federal agents have seized more than $1.5 million worth of herbs, botanicals, and other ingredients used in dietary supplements that were being stored in filthy conditions.

U.S. Marshals, acting at the direction of FDA, targeted the American Mercantile Corporation of Memphis, Tenn. An FDA inspection of the facility in March 2009 uncovered evidence of widespread insect and rodent infestation throughout the warehouse. When the company failed to clean up the mess on its own and comply with FDA orders regarding the cleanliness of the facility, the food stored there was seized under a warrant issued by the United States District Court.

FDA will not tolerate a companys failure to adequately control and prevent filth in its facility, said Michael Chappell, the FDAs acting associate commissioner for regulatory affairs. The FDA is prepared to use whatever legal means are necessary and appropriate to keep potentially contaminated products out of the marketplace.

American Mercantile Corp. stores and processes food ingredients used in dietary supplements and herbal teas made by other companies, FDA said. The products seized include sarsaparilla, spearmint leaves, cornstarch, sweet orange peels powder, licorice powder, sassafras, and salt.
published date: 05-14-2009

U.S. Dept. of Agriculture Offers New Funding & Contracts

The Organic Trade Association has announced that the U.S. Department of Agriculture is offering $50 million in new funding to encourage greater production of organic food in the United States.

A portion of the funding has been allocated for every state and is available exclusively through a special signup under the Environmental Quality Incentives Program, administered by USDA's Natural Resources Conservation Service.

To qualify, a producer must be certified through the National Organic Program or be in the process of transitioning to organic production.

"The Organic Trade Association is pleased to see this support and recognition from USDA that organic farming practices represent positive environmental practices. OTA believes that this funding will further encourage farmers to use such practices and help increase the U.S. production of organic food to meet growing consumer demand," said Christine Bushway, OTA's executive director.

Under the initiative, new contracts for organic production are being offered for six core practices, which include conservation crop rotation, cover crops, nutrient management, pest management, prescribed grazing, and forage harvest management. Funding is capped at $20,000 per year.

The sign-up period for the special organic contracts begins May 11 and ends on May 29.
published date: 05-14-2009

American Companies May Experience Fierce R&D Competition From Asia

Western-origin brands were found to be leading Asia-based products in terms of research and development, according to joint findings by Global Intelligence Alliance Group (GIA) and analyst Fusion Consulting.

The groups tracked 20 multinational food and drink companies.

Although the research found companies like Nestle or Danone to be more advanced in pushing innovative products that rivals such as Yakult, there was still strong potential for certain Asian products.

There are very strong Asian companies in the food and beverage industry that can compete with Western European and US-based multinationals, stated a Fusion spokesperson. In fact, in some domains like probiotic drinks and instant noodles, Asian companies are way ahead than their European or US-based competitors.

In looking at the findings, which were conducted between 2004 and 2007, the consultancy group said that Asia-based companies were in an increasingly strong position to follow the lead of their western counterparts and look to international markets to expand.

In the same way that more Westernized companies had worked to distribute and establish their products in Asia, manufacturers in the region were well positioned to increasingly bring their goods to Europe and the US, according to the analyst.

Fusion Consultancy said that in order to successfully meet seemingly growing Western demand in Asian food and drink products, customizing products and brand identity to meet local tastes was a key challenge.

The challenge on doing this is always the same: customization, stated the analyst. Some companies are very good at it like Unilever, Nestle and Kraft.

The GIA index, that focused on three dimensions innovation, regional presence and revenue performance claims that Anglo-Dutch firm Unilever performed best in class thanks to efforts to appoint chefs and food experts in 18 key markets to research and develop new products customized to the local needs and preferences.
published date: 05-14-2009

Phosphotech and Enzymotec Sign Marketing Agreement

Phosphotech (Saint-Herblain Cedex, France) and Enzymotec (Springfield, NJ) have signed a marketing agreement to target the nutraceutical market in France

Phosphotech specializes in natural ingredient for human and animal health. They will will distribute phosphatidylserine-based products under the Sharp trademark.

We expect that the collaboration with Phosphotech will enable us to deepen our penetration into the French market which is one of leading nutraceutical markets in Europe. The collaboration will cover our proprietary phospholipids based line of cognitive solutions under the brand name Sharp. The French nutraceuticals brands have a very strong presence in other European countries and we expect that working closely with leading French companies will further expand our market share in the European market, said Michal Haim-Bravman, Enzymotec's director of sales and marketing.
published date: 05-11-2009

XSTO Solutions Announces U.S. Distribution of BRUDYS New DHA

XSTO Solutions (Morristown, NJ) and Brudy Technology (Barcelona, Spain) have jointly announced a new sales and marketing distribution agreement between the two companies to market Algatrium, Brudys patented source of DHA. Brudys new Algatrium product is naturally produced and clinically tested.

Using XSTOS experience and relationships in the nutrition industry, we look forward to expanding the presence of our specialty ingredient line stated Francesc Gass, managing director of Brudy.
published date: 05-06-2009

Sale of Organic Products Reached $24.6 Billion in 2008

The sale of U.S organic products, both food and non-food, reached $24.6 billion by the end of 2008, growing 17.1% over 2007 sales, according to the Organic Trade Association (OTA), which yesterday made available final results from its 2009 Organic Industry Survey.

"Organic products represent value to consumers, who have shown continued resilience in seeking out these products," said Christine Bushway, OTA's executive director.

Results show organic food sales grew in 2008 by 15.8% to reach $22.9 billion, while organic non-food sales grew 39.4% to reach $1.648 billion. As a result, organic food sales now account for approximately 3.5% of all food product sales in the United States, according to OTA.
published date: 05-05-2009

Danisco Introduces LysoMax Enzyme

Danisco (Copenhagen, Denmark) is introducing a new enzyme called LysoMax for vegetable oil refiners. The enzyme is claimed to increase yield during refining, and enable more sustainable use of water and energy.

Vegetable oils commonly used in foods, such as soy and oilseed rape, tend to be subject to fluctuations in supply and price on the commodity market. This means that users on the manufacturing side are eager to glean maximum use from their oil.

For refiners, however, the challenge is obtaining the maximum amount of oil during the refining process. The Danish firm is presenting a new tool that it says improves the release of vegetable oil from the gum, the viscous mass that is obtained when the crude oil is treated with hot water.

Called LysoMax, the enzyme solution is added to the water during the first stage of refining the crudely pressed oil.

As well as increasing the yield, the enzyme is said to reduce water use by 50%.

The company says the enzyme has no impact on the quality of the oil, and does not require the refiner to invest in any special equipment.
published date: 05-05-2009

Astaxanthin Launched in Softgel Capsules

The Israeli company Algatechnologies is launching 4 mg softgel astaxanthin capsules at the Vitafoods trade show in Geneva next week.

Usually, we sell our astaxanthin in the form of oleoresin and beadlets to dietary supplement manufacturers, said Efrat Kat, marketing director at Israel-based Algatechnologies.

But due to the increase in demand for our high-value AstaPure astaxanthin line from other manufacturers, who cannot produce the necessary initial quantities of softgels themselves, we decided to provide it in capsules as well.

She said the company would not sell the capsules direct to consumers, only to business partners and would focus on Europe, the US and also in Asia Pacific.

The global astaxanthin market is estimated at about 190m globally, most of which is used in fish coloration.

published date: 05-05-2009

Capsugel Announces Pre/ Probiotic Combo

Capsugel (Peapack, NJ ) has announced the launch of Pre-Pro Combo, which is designed to contain a combination of prebiotic and probiotic ingredients.

Utilizing its Moisture Defense System (MDS) design, which includes the use of capsule-in-a-capsule technology, the capsule offers natural products marketers the opportunity to enter the growing probiotic market "with an innovative edge," according to the company.

As the awareness of digestive health continues to grow, consumers are looking for nutritional products that can improve their digestive health. Prebiotics and probiotics can work together to improve the ultimate nutritional effectiveness of probiotic ingredients. However, prebiotic regimens are less common because they are new to the market and more difficult to find on store shelves. The Pre-Pro Combo gives manufacturers a distinctive way to efficiently offer consumers additional benefits within one unique product, said Mark Vieceli, marketing manager for Capsugel.

The inner capsule of the Pre-Pro Combo contains Lactobacillus acidophilus probiotic, which is then suspended in a liquid-based prebiotic formula containing fructo oligosaccharide. Both capsules are composed of plant-based HPMC (hypromellose), and both are sealed with Capsugels proprietary LEMS sealing process.

The low moisture content of HPMC capsules, as well as the use of excipients with low water activity, means that very little moisture is present.

It acts like an internal desiccant--which means twice the protection from moisture from one innovative system, said Vieceli.
published date: 05-05-2009

CapsCanada Acquires Two New Gelatin Production Facilities

CapsCanada announced today that it has formally acquired two additional bovine hide gelatin production facilities.

The acquisition further consolidates the companys vertically integrated operations with a total of four bovine hide gelatin production facilities.

According to the companys director of business development, Gabriel Eilemberg, We have experienced very strong demand.

He added that CapsCanada is the only vertically-integrated capsule manufacturer. Vertical integration means a secure long-term supply, better traceability and superior quality," Eilemberg noted.
published date: 04-27-2009

Pure Genistein Reduces Menopausal Symptoms, According to DSM Study

According to a new study first presented at the Experimental Biology 2009 meeting in New Orleans today, a form of pure genistein reduces the number and duration of hot flashes in peri- and postmenopausal women. The study was conducted by KGK Synergize, Inc., London, Ontario and sponsored by DSM Nutritional Products, Inc (Basel, Switzerland).

In the randomized, double-blind, placebo-controlled trial, half of the enrolled women were given placebo capsules, while the other half were given capsules of a safe, high purity, non-plant derived, non-allergenic, patent-protected, proprietary genistein branded as geniVida by DSM. Study measurements included daily hot flashes (frequency, duration and intensity), individual-specific safety factors and adverse events.


published date: 04-22-2009

CapsCanada Launches Platinum Caps

CapsCanada (Pompano Beach, FL) has announced the launch of Platinum Caps, two-piece metallic capsules available in gelatin or vegetable HPMC.

The metallic look is obtained with a light-reflecting pigment, Candurin, composed of titanium dioxide and natural mica.

Platinum Caps are available in a wide range of metallic colors or color combinations, and can be printed for increased product differentiation.

Platinum Caps are free of preservatives, allergens, gluten and starches.
published date: 04-17-2009

Packaged Facts Reports Increase in Kosher Food Sales

Packaged Facts estimates that sales of certified kosher foods swelled from nearly $150 billion in 2003 to more than $200 billion in 2008, demonstrating a compound annual growth rate twice that of the overall food market. The increase is largely attributable to the rising number of certified products, as well as a growing number of consumers who deliberately seek out kosher foods. Packaged Facts does not see traditional or "ethnic" kosher foods contributing to market growth.

Packaged Facts forecasts the total market for certified kosher food will approach $260 billion, while sales of products that are purchased because they are kosher will fall between $14 billion (low estimate) and $17 billion (high estimate).

Because the concept of a market for certified halal foods is a fairly new phenomenon, Muslims compose a very small share of the U.S. population, and many of the countries that are home to large Muslim populations have just begun to monitor and quantify sales, hard data are virtually nonexistent.
published date: 04-15-2009

NSF International Launches New Web Site

ANN ARBOR, MIIn response to demands from consumers, athletes and coaches, NSF International has launched a new online resource, www.nsfsport.com, that provides information to help consumers, athletes, and coaches choose safer, quality products. Additional information, such as recent news stories on doping in sports and educational resources, can also be found at nsfsport.com.

published date: 03-13-2009

FDA Continues Weight-Loss Supplement Investigation

In a continuing investigation, FDA (Rockville, MD) has determined that dozens of weight-loss supplements, most of them imported from China, contain hidden and potentially harmful drugs. The agency plans to issue a longer list of brands to avoid that are spiked with drugs in the coming weeks, an FDA spokeswoman said.

Late last year, FDA ruled that StarCaps, papaya-infused weight loss capsules promoted as natural dietary supplements, were potential health hazards. The capsules contained pharmaceutical drug, bumetanide.

So far, the FDA has cited 69 tainted weight-loss supplements.

An in-depth story can be found here: http://www.nytimes.com/2009/02/10/business/10pills.html?_r=1&hp
published date: 02-09-2009

Astaxanthin May Lower Blood Pressure

BURLINGTON, NJ Astaxanthin has the ability to significantly lower systolic blood pressure in rats, according to a new study performed at Georgetown University Medical Center. This study joins three other past studies performed at the Toyama Medical and Pharmaceutical University in Japan which researched astaxanthins ability to reduce hypertension as well mechanism of actions for this benefit.

In the Georgetown University study, tests suggested that the Renin-Angiotensin system was involved in the ability of astaxanthin to lower blood pressure. Also, at higher dosage levels it was shown that astaxanthin influenced circulating TNF-α and MCP-1 and lessened fat oxidation in the liver and kidneys. This is an indication that astaxanthin may help to reduce stress.

The study was sponsored by Fuji Chemical Industry (Japan) and performed using AstaREAL astaxanthin.
published date: 02-03-2009

Pyridoxamine Decision Places More Responsibility on Industry, CRN Says

WASHINGTON, DCIn response to an FDA (Rockville, MD) decision declaring products containing pyridoxamine dihydrochloride are not dietary supplements under DSHE, the Council for Responsible Nutrition issued the following statement:

CRN accepts as established law under DSHEA the requirement that an article that has been authorized for investigation as a new drug and subjected to substantial clinical investigation prior to its being marketed as a dietary supplement or a food may not be marketed as a dietary supplement.

"However, we are disappointed with FDAs response to the recent citizen petition involving pyridoxamine (a form of vitamin B6) that apparently views as inadequate the evidence presented by the industry, including CRN, of the previous marketing of pyridoxamine, even prior to the passage of DSHEA.

"FDAs decision suggests that companies need to produce even more extensive evidence supporting an ingredients marketing as a dietary supplement, including catalog and business records from more than 15 years ago. Demanding that industry maintain these records, but failing to work with industry to develop an agreed-upon list of grandfathered ingredients, places more burden on dietary supplement companies to be sure that they can substantiate that an ingredient has in fact previously been marketed as a dietary supplement.

"The agencys decision on pyridoxamine could set a precedent for the status of other dietary ingredients to be challenged. As such, CRN strongly encourages supplement and food companies to keep careful records of ingredients and marketing materials to ensure that the ingredients that they are using and marketing can continue to be marketed as dietary supplement ingredients under the law.
published date: 01-28-2009

Cyvex Becomes Sole Distributor for Chr. Hansen

MILWAUKEE, WICyvex Nutrition will be the exclusive distributor for Chr. Hansen's (Irvine, CA) line of phytonutrients.

Chr. Hansen is a perfect partner for developing unique phytonutrients for the dietary supplement industry, said Gilbert Gluck, Cyvex CEO.

published date: 01-27-2009

Deerland Invests in Capital Expenditures

KENNESAW, GADeerland Enzymes recently invested in several capital expenditures at its Kennesaw headquarters. These expenditures included improved bulk blending capabilities for both large and small batch sizes, high speed encapsulation capabilities along with a broader spectrum of capsule sizes, a new tableting line to broaden manufacturing capabilities, automated bottling and labeling capacity, and automated inspection equipment.

Deerland must evolve as our industry evolves. In doing so, it is vital that we continually invest in our business to meet or exceed the expectations of the customers who entrust us with their business, said Scott Ravech, CEO.

Deerland has recognized this and to support these needs we invested in additional manufacturing capabilities, which will help us be able to better partner with our customers from concept through to commercialization. This will be offered across the value chain to include product/formulation design, development and finished product.
published date: 01-26-2009

Next Pharmaceuticals Expands Website

SALINAS, CANext Pharmaceuticals has announced their expanded website, www.nextpharmaceuticals.com. Scientific articles that support their branded proprietary raw materials may now be accessed. The site also addresses product manufacturers.

Next Pharmaceuticals has grown significantly since the companys inception into the dietary supplement industry and it was time that our website reflected that growth and loyalty to our customers, said Charles Kosmont, NP CEO.
published date: 01-26-2009

Devansoy Facility Assumes Sole Ownership

ROCK CITY, ILDevansoy has assumed complete ownership of their soy plant previously jointly operated with Berner Foods (Dakota, IL).

This evolutionary step for Devansoy provides an increased ability to address new and exciting opportunities, stated Elmer Schettler, president of Devansoy. Most importantly, this commitment allows Devansoy to provide even greater service to our customers.

The liquid soy base production facility is 94,000 sq ft.
published date: 01-23-2009

Himalaya Plants Trees for the Future in India

HOUSTON In a partnership with Trees for the Future (Silver Spring, MD), Himalaya Herbal Healthcare, makers of LiverCare, planted 49,750 trees in the two states of Andhra Pradesh and Tamil Nadu, the companys home country of India.

These trees, planted in India, will sustainably benefit lands and communities devastated by deforestation and, increasingly, global climate change, said Trees for the Future director, Dave Deppner.

These fast-growing, permanent, multi-purpose trees will protect fragile and eroded lands. They will improve the food and water security of surrounding households and communities, and ensure that families can continue to live in dignity and harmony with the natural resources of the land.

published date: 01-23-2009

Omega Fatty Acids Gaining Prominence in Global Market

NEW YORK In a new report, "Omega Fatty Acids: Trends in the Worldwide Food and Beverage Markets, 2nd Edition," market research publisher, Packaged Facts estimated that the omega fatty acid global market grew 36% between 2007 and 2008.

The market for omega-3 fatty acids alone grew 34% from an estimated $3 billion in 2006 to almost $5 billion in 2007. Packaged Facts projects that the retail market for omega-3 enhanced foods will approach $8 billion by 2012. The projection reflects a compound annual growth rate (CAGR) of 32% between 2003 and 2012.

The upsurge of products enriched with omega fatty acids began in earnest in 2006 and the market is believed to be many years away from saturation. Marketers didnt really start touting the omega-3 content of enhanced foods until late 2004, and even once products entered the retail scene it wasnt until early 2006 that such products appeared in mainstream U.S. supermarkets, said Tatjana Meerman, publisher of Packaged Facts.
published date: 01-22-2009

BI Nutraceuticals Educates Industry on ETO and Irradiation

LONG BEACH, CA BI Nutraceuticals has begun an education program designed to inform the dietary supplement industry about the FDA's (Rockville, MD) ban on the use of both irradiation and ethylene oxide (ETO) as a means of sterilization for raw materials.

As part of this initiative, BI has compiled a four-page consultative guide to help industry members better understand U.S. regulations surrounding the banned use of ETO and irradiation as a means for dietary supplement ingredient sterilization, as well as familiarize them with legal alternatives including steam sterilization.

"What a majority of manufacturers in the industry may not realize that the use of ETO and irradiation for the purpose of reducing or eliminating microbial loads is not permitted right now," stated George Pontaikos, president and CEO, BI Nutraceuticals. "These restrictions are not part of the new cGMPs that are being phased in over a three-year period, they are being enforced currently and companies using ETO or irradiated materials are subject to FDA penalties now."

ETO is considered a pesticide, and according to the Federal Food, Drug and Cosmetic Act, any food that bears or contains a pesticide chemical residue that is unsafe is considered adulterated.
published date: 01-22-2009

Purdue Technology Detects Contaminant in Milk Products

WEST LAFAYETTE, INA research team at Purdue University created an analysis method to detect levels of melamine in the low parts-per-billion in milk and milk powder in about 25 seconds.

FDA (Rockville, MD) issued new guidelines in November limiting melamine in dairy products to 1 part-per-million or less.

"This situation created an immediate need for an analytical method that is highly sensitive, fast, accurate and easy to use," said R. Graham Cooks, professor of chemistry, who led the team that developed the analysis method.

"We took it as a challenge to use simpler instrumentation and to develop a faster method that allows the testing to be done on site and does not require pretreatment of samples."

The new method pairs mass spectrometry with a low-temperature plasma ionization probe technique.

Mass spectrometry is a commonly used analysis method known for its sensitivity and accuracy; however, most available mass spectrometers require that a sample be pretreated and remain in the controlled environment of a vacuum for analysis, Cooks said.

"There is a growing need in our society for detailed chemical information that calls for the special capabilities of mass spectrometers," he said. "Researchers are working to make these devices faster, easier to use and more portable. Perhaps one day everyone will have a mass spectrometer to analyze whatever comes their way."
published date: 01-22-2009

Sabinsa Stages Functional Food Demo at Expo West

PISCATAWAY, NJ Sabinsa will provide dishes including several of Sabinsas GRAS ingredients at Expo West in Anaheim, California on March 6. The products include:

LactoSpore shelf-stable probiotic: Produces only L (+) Lactic Acid, which metabolizes to glycogen

Cococin coconut water solids: Hold a repository of vitamins, minerals and amino acids

Citrin K Garcinia cambogia fruit extract in potassium salt form: Supports satiety

Selenium: Bio-available, a form of selenium supplementation

This demo will take place at 1 PM in the Global Supply Marketplace booth #130 in the Anaheim Convention Center.
published date: 01-21-2009

Vitiva Opens New UK Office

SLOVENIAVitiva has opened a subsidiary office in the UK for its natural rosemary extract formulations used for food and beverage preservation.

I'm very enthusiastic to see the UK market follow the success that natural preservatives based on rosemary extract meet in Europe and the USA, said Steve Sutton-Wild, regional sales manager of Vitiva. The new office will provide local service, superior technical support and after sales support to an extensive customer base.
published date: 01-21-2009

Pycnogenol Wins Frost and Sullivan Award

GENEVAHorphag Research, suppliers of Pycnogenol, has earned the 2008 Frost & Sullivan Health Ingredients Excellence in Research of the Year Award. The antioxidant Pycnogenol is an extract from French maritime pine bark. It is available in more than 600 dietary supplements, cosmeceuticals and functional food and beverage products.

Our pledge is to further strengthen the brand value of Pycnogenol though innovative research, new product development and state of the art communication in order to continue growing consumer demand, said Victor Ferrari, CEO of Horphag Research.

published date: 01-21-2009

AHPA Releases White Paper on Heavy Metals

SILVER SPRING, MDAHPA announced its paper, Heavy metal analysis and interim recommended limits for botanical dietary supplements, on January 20. The paper provides industry with information on successful compliance with current good manufacturing practices (cGMP).

AHPAs white paper presents the associations proposed interim limits for lead, mercury, cadmium and arsenic, which were announced in October 2008, with accompanying explanations as to how these limits were determined. Additionally, the document addresses:

1) Regulations concerning lead, mercury, cadmium and arsenic in products sold in the U.S.
2) Daily limits set for these chemicals by U.S. and international regulatory agencies
3) Available analytical methods for measuring heavy metals guidance on how to determine which analytical methods are most suitable for dietary supplements
4) Selecting a contract lab that can properly conduct heavy metal testing

Heavy metal analysis and interim recommended limits for botanical dietary supplements is available for purchase by non-members at AHPAs online bookstore. If you are an AHPA member, you may login and then download your free copy here: http://www.ahpa.org/Default.aspx?tabid=211>

The paper will also be provided free to registrants of AHPAs upcoming webinar, Setting and Meeting Specifications for Contaminants in Finished Products Under cGMP. Scheduled for Jan. 22 at 1 p.m. EST, the webinar will expand upon the information in the white paper and also address Californias Proposition 65, certificates of analysis, liability concerns and additional contaminants including mycotoxins and pesticides.

AHPAs goal is to help excellent companies of all sizes come into compliance with cGMP and continue producing superior, health-promoting products for consumers, said Michael McGuffin, AHPA president.
published date: 01-20-2009

CortiSlim Re-Launches with Advantra Z

WEST CALDWELL, NJNutratechs bitter orange extract, Advantra Z, will continue as the thermogenic component of the weight loss supplement, CortiSlim (Laguna Niguel, CA).

"By incorporating Advantra Z, CortiSlim offers the thermogenic benefits of all five adrenergic amines that occur naturally in the bitter orange fruit - including the stable p isomer of synephrine - so consumers can enjoy optimal body fat loss as well as an increase in energy expenditure without any negative cardiovascular and central nervous system side effects," said Bob Green, Nutratech president.

"It was important to us to continue the CortiSlim formula that was effective for so many consumers, and that includes Advantra Z," said John Neubauer, chief financial officer of CortiSlim International.
published date: 01-16-2009

EBF Releases Report Detailing Botanical Supplements

BRUSSELSIn light of the popularity of botanical supplements in Europe, the European Botanical Forum (EBF) has released its first fact file detailing the nutritional role of these ingredients.

The file aims to correct some commonly-held misapprehensions, and offers an overview of aspects related to the use of these ingredients in food supplements.

It includes regulatory and practical information on their current use. It also details legislation that covers these products to ensure consumers have safe and useful products to supplement their diet.

Advances in research and technology have meant that the health-promoting benefits of botanicals can be captured, preserved and presented in a convenient form that can be made widely available, said Manfred Ruthsatz, EBF chairman. The development of botanical food supplements enables an ever-growing number of consumers in our increasingly urbanised society to safely and easily use botanicals to both maintain and optimise their health.

Botanical food supplements and herbal medicinal products follow two distinct and separate legal frameworks, hence fully justifying their co-existence side by side, Ruthsatz said.

This fact file clarifies and shows that the extensive regulatory framework for botanical food supplements is fully adequate to ensure their safety and quality, he added.

The EBF was founded in 2004 by the European food supplements sector. Its main goal is to encourage debate among industry, government and the scientific community on issues affecting botanical foods supplements.

To obtain a copy of the fact file, e-mail info@botanical-forum.be or call the EBF at (+32) 2 209 11 50.
published date: 01-15-2009

CRN Questions PEN Report

WASHINGTON, DCIn response to a recent report released by the Project on Emerging Nanotechnologies (PEN; Washington, DC) detailing the regulatory challenges posed by nanomaterials, Andrew Shao of the Council for Responsible Nutrition (CRN), released this statement:

Nanotechnology has been used in various products for decades, including drugs, medical devices, cosmetics, conventional foods and dietary supplements. As the prevalence of nanomaterials continues to rise, FDA (Rockville, MD) is examining how to best address this emerging technology in all regulated industries.

"We question the true motives behind this report from ...PEN which provides a very limited amount of useful information on nanotechnology and paints a misleading picture by implying that only one industry faces questions about nanotechnology. This report masquerades as a legitimate review of the use of nanomaterials in dietary supplements but in reality it seems to be an attempt to explain the authors views on dietary supplement regulations and their suggestions for change.

"As far as we are aware, there are no specific safety issues associated with the use of nanotechnology. There is one area of agreement with the report: that FDA could use more resources to better do its job; however, adequate agency funding and nanotechnology are not specific to dietary supplementsthese issues affect all industries regulated by FDA. We encourage FDA to evolve with emerging technologies, such as nanotechnology, and welcome further dialogue with the agency on how to proceed with reasonable regulation of these new technologiesregulation that is able to be implemented by the industry, enforced by the agency and would benefit consumers.
published date: 01-15-2009

Judge Orders Weight Loss Author to Pay More Than $37 Million

A federal judge has ordered infomercial marketer Kevin Trudeau to pay more than $37 million for violating a 2004 stipulated order by misrepresenting the content of his book, The Weight Loss Cure They Dont Want You to Know About.

In August 2008, Judge Robert W. Gettleman of the U.S. District Court for the Northern District of Illinois had ordered Trudeau to pay more than $5 million and banned him, for three years, from producing or publishing infomercials for products in which he has an interest. The ruling confirmed an earlier contempt finding, the second such finding against Trudeau in the past four years.

Urged by both the FTC (Washington, DC) and Trudeau to reconsider aspects of its August order, on November 4 Judge Gettleman amended the judgment to $37,616,161, the amount consumers paid in response to the deceptive infomercials. The judge also revised the three-year ban to prohibit Trudeau from disseminating or assisting others in disseminating any infomercial for any informational publication in which he has an interest. On December 11, the court denied Trudeaus request to reconsider or stay this ruling.

The FTC filed its first lawsuit against Trudeau in 1998, charging him with making false and misleading claims in infomercials for products he claimed could cause significant weight loss and cure addictions to heroin, alcohol, and cigarettes, as well as enable users to achieve a photographic memory. A stipulated court order resolving that case barred Trudeau from making false claims for products in the future, ordered him to pay $500,000 in consumer redress, and established a $500,000 performance bond to ensure compliance.

In 2003, the Commission charged Trudeau with violating the 1998 order by falsely claiming in infomercials that a product, Coral Calcium Supreme, could cure cancer. The court subsequently entered a preliminary injunction that ordered him not to make such claims. When Trudeau continued to make cancer-cure claims about Coral Calcium, he was found in contempt. In 2004, Trudeau agreed to an order that resolved the Coral Calcium matter. He was directed to pay $2 million in consumer redress and banned from infomercials, except for informational publications such as books, provided that he must not misrepresent the content of those publications.

The 2004 injunction remains in effect.
published date: 01-15-2009

Marketers of Thermalean, Lipodrene, and Spontane-ES Must Pay More Than $15 Million

NORCROSS, GAA federal district court has ordered the marketers of three dietary supplements to pay more than $15 million for deceiving consumers about the products safety and effectiveness. The court imposed the final monetary judgment and permanent prohibitions against the marketers in December 2008, after granting the FTC's (Washington, DC) motion for summary judgment last June.

The court found National Urological Group, Inc. and several other corporate and individual defendants liable for more than $15.8 million in deceptive sales of Thermalean, Lipodrene, and Spontane-ES. Thermalean and Lipodrene are purported weight loss treatments. According to the defendants advertisements, they were clinically proven to cause substantial weight loss, including a 19 percent loss in total body weight. Spontane-ES is a purported treatment for erectile dysfunction. According to the defendants advertisements, it was clinically proven to safely and effectively treat 90 percent of men with erectile dysfunction. The court permanently barred the defendants (except now-dissolved National Institute for Clinical Weight Loss) from engaging in deceptive conduct in the future and also ordered Terrill Mark Wright, MD, to pay $15,454 for his deceptive endorsement of Thermalean.

These defendants are old-fashioned snake oil salesmen who retooled their pitches to cash in on 21st century concerns, said Lydia B. Parnes, director of the FTCs Bureau of Consumer Protection. They led people to believe that the supplements they sold to treat weight loss and erectile dysfunction were safe and effective treatments, when nothing could be further from the truth.

Of note, the court held the three corporate defendants liable based on their operation as a common enterprise, given that the same group of individuals controlled all the companies, shared expenses and advertising for the same products, and worked together to achieve profitability. The court rejected the defendants arguments that the advertising was protected commercial speech under the First Amendment or that it was mere puffery. The court held that the FTCs requirement calling for competent and reliable scientific evidence is not unconstitutionally vague, pointing to the FTCs dietary supplement guides as evidence that an ordinary person could understand the definition of the term as outlined in the guides. The court also rejected the defendants argument that the FTCs challenge to the advertising was precluded by a consent decree that the defendants had entered into with the FDA (Rockville, MD).

The final order imposes a $15.8 million judgment. The final order against medical endorser Terrill Wright imposes a $15,454 judgment. The orders also place restrictions on the defendants future conduct. These orders were issued last month by the U.S. District Court for the Northern District of Georgia. They prohibit the defendants from claiming that their products treat obesity or erectile dysfunction, are clinically tested or scientifically proven to be safe or effective, or have other health or safety benefits, unless the claims, including endorsements, are true, not misleading, and based on reliable scientific evidence. In addition, the defendants are banned from misrepresenting the existence, validity, results, or conclusions of any test or study. The orders also contain standard record-keeping provisions to allow the FTC to monitor compliance.

Copies of the June 2008 decision and December 2008 court orders are available on the FTCs Web site at http://www.ftc.gov
published date: 01-15-2009

Nanomaterials a Regulatory Challenge for FDA, Report Concludes

WASHINGTON, DCFDAs ability to regulate the safety of dietary supplements using nanomaterials is inadequate due to a lack of information, resources and statutory authority in certain areas, according to a new report released by the Project on Emerging Nanotechnologies (PEN).

The report, titled A Hard Pill To Swallow: Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements, details the FDAs chief problems in regulating nano-enabled dietary supplements. The report also offers a host of recommendations for improving oversight of such products.

"Historically, the regulation of dietary supplements has been a significant challenge for FDA, and the fact that some of those products are now being manufactured using nanotechnology creates an additional layer of complexity," said William B. Schultz, report co-author, and a former FDA official.

Supplement manufacturers are required to disclose limited information about their products under current law, and what information is available is a result of nanotechnology marketing by manufacturers, says the report.

"While it is not possible to precisely determine the prevalence of dietary supplements using engineered nanoparticles, it is likely that the public's exposure to these products will grow significantly in the next several years," said Lisa Barclay, also a co-author of the report.

According to an inventory of federal environmental, health and safety research on nanotechnology maintained by PEN, the U.S. government spends less than $1 million annually to study the direct impact of nanoscale materials on the gastrointestinal tract.

"It is not clear that the supplement industry is conducting the rigorous testing needed either to understand the effects of nanoscale ingredients in its products or to back up the product claims. This means that consumers are potentially exposed to unknown risks that should be balanced with the possible benefits of taking these supplements," said David Rejeski, PEN's director.
published date: 01-14-2009

Bright Outlook for European Functional Foods Sector and Heart Health Market

LONDONThe European functional foods market earned $545 million in 2008 and is estimated to earn up to $2 billion in 2014, according to analysis from Frost & Sullivan (Palo Alto, CA), the company reported on January 13.

"A variety of ingredients positioned for heart-health, with their functional benefits, is increasingly used for the fortification of various food and beverage applications," said Frost & Sullivan research analyst Chandrasekhar S. "The preventive cost of cardiovascular disease (CVD) by virtue of these ingredients is much cheaper for the consumers than the cost of its treatment."

Nevertheless, the heart health ingredients market is restrained by a 2000 EU food-labeling directive preventing health claims from being made on products.

Nonetheless, European manufacturers have submitted their dossiers to the European Food Safety Authority (EFSA; Parma, Italy) to place health claims on their ingredients.

"Manufacturers, with the help of industry associations such as GOED (Salt Lake City) are lobbying for the usage of health claims," noted Chandrasekhar.

"They are also involved in extensive branding and promotional activities to increase consumer awareness on CVD and the positive impact of the various ingredients, thereby enhancing the credibility of such awareness campaigns."


published date: 01-13-2009

Vitamin D May Delay or Prevent Diabetes

MAYWOOD, ILA sufficient intake of vitamin D may prevent or delay the onset of diabetes, concluded research from Loyola University Chicago, Marcella Niehoff School of Nursing. The study, appearing in the latest issue of Diabetes Educator, said adequate intake may also reduce complications for those who have already been diagnosed with diabetes.

"Vitamin D has widespread benefits for our health and certain chronic diseases in particular," said study co-author, Sue Penckofer, PhD, RN. "This article further substantiates the role of this nutrient in the prevention and management of glucose intolerance and diabetes."

One study examined for the review article evaluated 3,000 people with type 1 diabetes and found a decreased risk in disease for people who took vitamin D supplements. Observational studies of people with type 2 diabetes also revealed that supplementation may be important in the prevention of this disease.

"Management of vitamin D deficiency may be a simple and cost-effective method to improve blood sugar control and prevent the serious complications associated with diabetes," said study co-author, Joanne Kouba, PhD, RD, LDN.

Diet alone may not be sufficient to manage vitamin D levels. A combination of adequate dietary intake of vitamin D, exposure to sunlight, and treatment with vitamin D2 or D3 supplements can decrease the risk of diabetes and related health concerns. The preferred range in the body is 30 - 60 ng/mL of 25(OH) vitamin D.

An estimated 23 million Americans with diabetes have low vitamin D levels. Vitamin D deficiency may also be associated with hyperglycemia, insulin resistance, hypertension and heart disease.
published date: 01-12-2009

Robinson Pharma Completes Successful CGMP Audit

SANTA ANA, CARobinson Pharma Inc., (RPI) announced its completion of a surveillance audit for cGMP compliant manufacture of dietary supplements on January 9.

The audit was performed by STR (Enfield, CT), a third party testing and auditing firm with a focus on quality systems and analysis.

According to RPI, the company has undergone significant investments in manufacturing systems that feature a hands free constant monitoring approach to all aspects of manufacturing process. These include investing resources in designing systems that support effective ingredient receipt and testing, pharmacy and pre-production processing, manufacturing, post production testing, and packaging.

Last year we committed to the RQP. This year we have demonstrated that we can maintain a high level of quality simultaneous to expanding our production capacity and speeding our pace of delivery to our customers, said RPI president and founder, Tuong Nguyen.

Partnering with STR, along with other key strategic initiatives, has facilitated the transformation of RPI from a contract manufacturer to aprivate label supplier of some of the leading marketers of dietary supplements in the United States and other international markets said Kenn Israel, vice president of marketing.
published date: 01-09-2009

Ecuadorian Rainforest Launches Online Video With Top 2008 Ingredients

BELLEVILLE, NJ Ecuadorian Rainforest has launched an online video titled, Nutraceuticals 2009, the company announced on January 9. The video presents the top ingredients of 2008 based on ER sales figures and showcases new ingredients for 2009. The video can be viewed for free at: http://www.intotherainforest.com/blog/
published date: 01-09-2009

CRN Supports FDA Weight Loss Recall

WASHINGTON, DC In response to the FDAs expansion of a nationwide recall of 69 tainted weight loss products that contain undisclosed ingredients, Steve Mister, president of the Council for Responsible Nutrition (CRN), issued the following statement on January 9:

We applaud FDAs efforts to protect consumers from tainted weight loss products that contain active, undeclared ingredients. It is unfortunate that some of these products have been marketed as dietary supplements. Under the law, what is in the dietary supplement bottle should be listed on the label and products that break the law have no business being on store shelves. CRN supports the Agencys decision to demand removal of these adulterated products from the market.

It is particularly concerning that some of these weight loss products illegally contain pharmaceutical drugs, which can be especially dangerous and put consumers at risk. Regardless of how it is marketed, if a weight loss product contains a drug ingredient, it is a drug under federal law.

The new good manufacturing practices (GMPs) specific to dietary supplements, published in 2007, provide even more quality assurance throughout the entire manufacturing process to reduce the risk of accidental adulteration and cross-contamination, so that incidences like this are rare.

The majority of companies in the dietary supplement industry abide by the law and work hard to provide the more than 150 million Americans who take vitamins and other dietary supplements with safe, high quality, and beneficial products. We encourage consumers to be savvy when it comes to their supplementsalways buy from reputable companies that you know and trust.

published date: 01-09-2009

AHPA Supports FDAs Recall of Tainted Dietary Supplements

SILVER SPRING, MD The American Herbal Products Association supported the FDAs efforts to recall products marketed as dietary supplements that contained undeclared, active pharmaceutical ingredients, AHPA said on January 9.

We applaud this good work by FDA, said AHPA president, Michael McGuffin. AHPAs mission to promote the responsible commerce of herbal products can only be accomplished when FDA and other government agencies actively enforce the law against outliers.

Under the Food, Drug & Cosmetics Act (FDCA), products marketed as dietary supplements that contain pharmaceutical ingredients not specified on the label are illegal, and must be removed from the marketplace.
published date: 01-09-2009

NPA Advocates Strength of DSHEA

WASHINGTON DC Responding to recent statements regarding dietary supplement regulation, the Natural Products Associations CEO, David Seckman, released this statement on January 8:

Increased scrutiny by professional sports leagues on steroid usage, which the NPA commends, has unfortunately also led to increased and unsubstantiated allegations that a "tainted" or mislabeled dietary supplement is to blame when an athlete tests positive for a banned substance.

As (DSHEA) mandates, all ingredients must be listed on product labels and product claims must be substantiated. If this is not the case, the FDA (Silver Spring, MD)-- along with the FTC (Washington DC)-- have the authority under DSHEA to act promptly. These federal enforcement powers include, but are not limited to, removing any dietary supplements deemed adulterated from the marketplace and imposing substantial penalties on those who violate the law. Additional regulations authorized by DSHEA require that makers of dietary supplements have manufacturing practices in place that ensure their products meet high standards for quality and purity.

Finally, it is important to remember that substances that are banned by various sports leagues as performance enhancers are not necessarily dangerous or illegal and include caffeine, commonly used over-the-counter cold remedies and prescription medications. Athletes have the right and responsibility to avoid their use. However, the consuming public who benefits from legitimate medications or dietary supplements -- as well as a trip to the local coffee house -- should not be denied their use if an athlete is unwilling or unable to follow the rules established by their sport.
published date: 01-08-2009

Astaxanthin Detected in the Iris/Ciliary Body of the Eye, Fuji Says

BURLINGTON, NJIn a new study, Fuji Healths brand of natural astaxanthin extract (AstaREAL) derived from Haematococcus microalgae was detected in the iris/ciliary body of New Zealand albino rabbit eyes 24 hours after ingestion, the company announced on January 6.

Astaxanthin has been reported to have benefits in the eye such as the alleviation of eye fatigue in visual display terminal (VDT) workers after oral supplementation. However, up to now there has been no intraocular kinetic information available.

Researchers at Kanazawa Medical University (Ishikawa, Japan) and Fuji investigated the ocular and blood serum levels of astaxanthin in 24 NZW albino rabbits. After administering a 100 mg/kg single oral dose, astaxanthin was determined by extraction followed by HPLC analysis over a period of 168 hours.

Further human study is necessary.
published date: 01-06-2009

Aloha Medicinals Announces Construction of Second Nanoparticle Device

CARSON CITY, NVAloha Medicinals announced the construction of a second proprietary nanoparticle manufacturing device, the company said on January 6. Aloha first introduced nano-sized medicinal mushroom products in early 2008.

Nanoparticles, sometimes called sub-micronized particles, those of 1 microns or less in size, demonstrate remarkable ability to increase the bodys ability to absorb nutrients and medicines, said John Holliday, president and chief scientific officer of Aloha Medicinals.

The smaller the particle size, the more efficient the nutrient or drug becomes. That means that ultimately less of the drug is required to obtain a therapeutic affect, which in turn means that medicines not only cost less, but absorption is quicker and the potential for side-effects is minimized.

The technology uses jets of high pressure gas to grind the particles down to sizes small enough to pass through the skin. In order to prevent heat from building up, the gas jets are fed through a specially designed nozzle that creates cold rather than heat. The gas jets stream into the manufacturing chamber at temperatures of 30 degrees below zero.

Roger Scott, the Alohas CEO said that the new technology opens opportunities in the areas of dietary supplements, OTC and prescription drugs, cosmetics and liquids.

The micronized particles of insoluble material are so fine they appear to become soluble, allowing them to be inserted in liquids and not fall to the bottom of the bottle, said Scott.

This technology gives us the ability to produce novel new dosage forms that will make it more convenient and less expensive for people to stay well.
published date: 01-06-2009

New Standard for Stevia to Assue Products Quality

ROCKVILLE, MD Responding to the growing popularity of a plant-based sweetener, the U.S. Pharmacopeial (USP) Convention today announced it is developing a new standard to be included in the Food Chemicals Codex (FCC) that will help food and beverage manufacturers assure the products quality for consumers. USP is seeking comments from the food and beverage industry as well as all other interested parties on the proposed new standard for Rebaudioside A.

As U.S. manufacturers begin to incorporate this new ingredient into their products, it is important for these companies and, ultimately, consumers to have some sort of assurance that the Rebaudioside A being used is of high quality, is free of harmful contaminants and is consistent in its contents from one batch to the next, said Darrell Abernethy, MD, PhD, chief science officer for USP.

By proposing a standard that all manufacturersin the United States and around the worldcan participate in the development of and subsequently choose to adhere to, USP and food and beverage manufacturers can partner to assure the quality of this ingredient. Consumers also are able to participate in this process. We believe such a quality standard is critical given that Rebaudioside As use as a sweetener is relatively new in the United States.

The proposed monograph standard became available in the FCC Forum section of USPs website on December 31, 2008, for 90 days. After this comment period, USPs Food Ingredients Expert Committee, which comprises a group of independent, scientific experts, will approve the final monograph to be included in the 2009 FCC supplement.
published date: 01-05-2009

DSM Blood Pressure Management Product Wins at HIE

PARSIPPANY, NJ TensGuard, an odorless, water soluble blood pressure management ingredient from DSM Nutritional Products, was recently awarded first prize at this years Health Ingredients Europe exhibition by a judging panel of retailers, manufacturers, scientists, and industry leaders.

TensGuard demonstrates an innovative heart health solution that creates exciting opportunities for food and beverage manufacturers to open up a completely new market, said Luc van der Heyden, the business manager for DSMs functional food marketing division. Were delighted to have won.

published date: 01-05-2009

Sabinsa Receives GRAS status for LactoSpore

PISCATAWAY, NJ Sabinsas probiotic ingredient, LactoSpore, received GRAS status after a review of safety and toxicology data by an independent panel of scientists.

LactoSpore is particularly valued by our customers for its convenient storage and handling attributes. The fact that this clinically validated probiotic culture does not need refrigeration to help retain its healthful properties is attractive to formulators and consumers alike, said Lakshmi Prakash, PhD, vice president of innovation and business development.

LacotSpore, formerly known as Lactobacillus sporogenes is a shelf stable (at room temperature) probiotic, originally isolated from a food source (green malt) in Japan.

It can be used in baked goods to milk products, soups, snacks, candy, and non-alcoholic beverages, among other products.
published date: 01-05-2009

Scientia Forecasts Sunny Future for Functional Foods

PALO ALTO, CAIn a study released on December 18, Scientia predicts an annual compound growth rate of 7% through 2012, averaged across all segments of the industry. The rapid rise will bring global sales of functional foods to $195 billiona 52% gain over 2006 sales of $128 billion.

Functional foods, also called medicinal foods or nutraceuticals, are those fortified with naturally occurring ingredients that provide health benefits beyond basic nutrition.

Functional foods may include probiotics, omega-3 extracts, phytonutrients, or other natural substances. Some of these ingredients can reduce the risk of certain diseases or help manage chronic conditions such as diabetes or heart disease. Others can enhance physical and athletic performance, memory, or cognitive performance.

The expected growth in the functional foods marketplace will come as a result of a constellation of factors, according to Bob Jones, a principal consultant at Scientia, who led the study. Factors include: increasing scientific evidence of functional foods effectiveness; increased media publicity encouraging consumer adoption; an aging population with growing chronic health needs, and food companies ability to work in a regulatory environment that increasingly requires scientific substantiation of claims being made.

Both large and small companies are developing efficacious new ingredients, Jones said. Currently, there are clinical trials underway to test the role of omega-3 fatty acids in slowing the progression of Alzheimers disease. There is also work supporting the role of probiotics in enhancing immune systems. Equally important, companies are making commercially successfully products that taste good, are affordable, and can be found in the supermarket.

Not all functional food products enjoy equal success, the study found. For example, yogurts fortified with probiotics have enjoyed great success, where margarines fortified with a cholesterol-lowering sterol have largely failed in the United States. The study identifies several factors responsible for the commercial success of some functional food products and the disappointing sales of others.
published date: 12-18-2008

BASF to Close North Carolina Manufacturing Site

WILMINGTON, NCBASF Corp. announced on December 18 that it will close its Wilmington, NC, vitamins manufacturing site by March 31, 2009.

The facility, a part of BASFs Care Chemicals Division, manufactures formulated vitamin C products for the dietary supplement industry.

Employees were notified that the approximately 33 positions at the site will be eliminated over the next three months.

We wanted employees to be aware of this decision as soon it was made. We regret the impact this decision may have on these employees and their families, especially at this time of year, said Simon Medley, vice president of BASFs Care Chemicals and Formulators Regional Business Unit.

The decision is in no way a reflection of the hard work, dedication, and professionalism of the colleagues at this facility.
published date: 12-18-2008

Omniactive Launches Capsimax, New Hot Pepper Weight Loss Ingredient

SHORT HILLS, NJOmniActive Health Technologies announced the launch of a proprietary blend of Capsimax Plus, its capsicum, or hot red pepper, ingredient, on December 18.

"In the weight-loss and athletic performance categories, products containing ingredients with no science to support their calorie-burning claims are all-too-common," stated Jayant Deshpande, PhD, vice president of research and development for OmniActive Health Technologies.

"OmniActive is pleased to offer manufacturers a high-quality, clinically researched ingredient like Capsimax Plus Blend to help their customers achieve their diet or weight-management goals."
published date: 12-18-2008

FDA Issues No Objection Letter to GRAS Status of Reb A; Companies Unveil New Products

PURCHASE, NYFDA issued a no objection letter to the GRAS status of rebaudioside A (Reb A), the stevia extract used in PureVia, PepsiCos all-natural, zero-calorie sweetener, PepsiCo announced on December 17.

This response indicates FDA has no objection to the conclusion that Reb A is generally recognized as safe.
"We are delighted to bring PureVia to consumers," said Paul Block, CEO of Merisant and Whole Earth Sweetener Co.

PepsiCo will launch two new products featuring PureVia. Zero-calorie SoBe Lifewater, a line of naturally sweetened waters, will hit store shelves soon in three flavors: black and blue berry, Fuji apple pear, and yumberry pomegranate. Tropicana will introduce Trop50, a light orange juice product with 50%less sugar and calories using PureVia, in March.

For consumers who are demanding more natural foods and beverages and counting calories but don't want to compromise on taste, PureVia hits the sweet spot," said Massimo d'Amore, CEO of PepsiCo Americas Beverages.

"The new flavors of SoBe Lifewater and Trop50 will continue the transformation of our product portfolio into a wider variety of healthy products, and we also believe they can help revitalize interest in our North American beverage business.

Cargill (Minneapolis), which partnered with Coca-Cola to help pioneer Truvia, said of the news, "Given the extensive research conducted to assure the safety of Truvia, Cargill has tremendous confidence in the product. The FDA letter further validates what the science has concludedthat Truvia rebiana is safe for use for all consumers," said Marcelo Montero, president of Cargill Health & Nutrition. "FDA brought the appropriate rigor to the process and we are extremely pleased with the news."

As a result of this news:

*Coca-Cola announced the launch of its new product, Sprite Green, naturally sweetened with Truvia sweetener. The beverage has 50 calories per 8.5-ounce serving and 5% lemon juice.

The Sprite brand has a rich history of setting trends and breaking new ground in sparkling beverages, and we think consumers will be excited to try Sprite Green, said Santiago Blanco, vice president of Sprite and Flavors at Coca-Cola North America. Sprite Green with Truvia natural sweetener is a significant step in our ongoing efforts to apply the latest breakthrough innovations to our expanding array of beverages.

*Odwalla Inc. is also adding reduced-calorie juice drinks sweetened with Truvia to its product portfolio.
The drinks, Mojito Mambo natural juice drink with vitamins C and E, and pomegranate strawberry natural juice drink from concentrate with vitamins C and E, will be on retailer shelves this month.

Each has 50 calories per 8-oz. serving.
published date: 12-17-2008

BIO-tract Awarded Third Patent

REDMOND, WANutraceutix received a patent for BIO-tract from the Australian Patent Office. BIO-tract tablets form a protective layer in the body, shielding probiotic organisms from the acidic conditions of the stomach. After passing from the stomach to the intestinal tract, the tablets release the organisms at rates determined by formulation.

Many years ago, we recognized the need for an effective probiotic and nutraceutical delivery technologyone that draws from proven pharmaceutical principals, but does so in a fashion that is economically feasible in the nutritional supplement marketplace. With BIO-tract, we have addressed this need," said Steve Moger, president of Nutraceutix.
In the case of probiotics, three barriers must be fulfilled:

1) Survival of these beneficial, but fragile organisms through the manufacturing process.
2) Survival on the store shelf.
3) Safe passage through the harsh stomach acids that may denature the organisms.
This is BIO-tracts third international patent.
published date: 12-16-2008

Airborne Reaches Largest Ever Dietary Supplement Settlement

TALLAHASSEE, FLA $7 million settlement has been reached between Airborne Health Inc., Florida, and 31 other states, said Florida Attorney General Bill McCollum on December 16. Under the settlement, the Florida-based company and owners Victoria Knight-McDowell and Thomas John McDowell will modify marketing practices in order to alleviate allegations against unsubstantiated claims concerning Airborne products.

The lawsuit alleged that the company marketed a cold prevention remedy, a sore throat remedy, a germ fighter, and an allergy remedy without adequate proof the products could perform as advertised at the time the claims were made.

The lawsuit also alleged the defendants failed to adequately warn consumers about potential health risks to select populations, including pregnant women, caused by old formulations of Airborne that contained potentially elevated levels of vitamin A. The company has since significantly reduced the vitamin A levels.
The $7 million payment is the largest payment to date in a multistate settlement with a dietary supplement producer. Floridas share of the $7 million is $460,000, which will go toward future monitoring and enforcement in this area.

Under the settlement, the company and the McDowells have agreed not to make any express or implied claims concerning the health benefit, performance, efficacy, or safety of their products, unless the claim can be substantiated by competent and reliable scientific evidence.

The settlement is the last of three settlements involving similar claims regarding the older advertising and labeling of Airborne dietary supplements.
published date: 12-16-2008

AHPA Urges USP to Adopt Guidelines on Heavy Metals

SILVER SPRING, MDThe American Herbal Products Association (AHPA) has petitioned U.S. Pharmacopeia (USP; Rockville, MD) to adopt AHPAs guidance limits for heavy metals in orally consumed botanical-containing finished products, AHPA announced on December 16.

The setting of specification limits for heavy metals should be risk-based, which does not confer a testing requirement unless the risk is likely to be present. USP has provided no justification that additional testing is required, or that initial testing is needed to provide safety assurance that would not otherwise already be handled under CGMP, said AHPA chief science officer and USP metal impurities ad hoc advisory panel member, Steven Dentali, PhD.

AHPA also requested that USP communicate that the listing of limits for metal impurities does not present an implied need to employ analytical testing.
USP is an official public standardssetting authority for all prescription and overthecounter medicines and other health care products manufactured or sold in the United States.
published date: 12-16-2008

NCCAM Study Reveals 38% of Americans Have Tried CAM

About 38 percent of American adults 18 years and over and about 12 percent of U.S. children 17 years and under use some form of complementary and alternative medicine (CAM), according to the 2007 National Health Interview Survey. The study was developed by the National Center for Complementary and Alternative Medicine (NCCAM; Bethesda, MD), a part of the National Institutes of Health (NIH; Washington DC.) and the National Center for Health Statistics (NCHS; Hyattsville, MD), a part of the Centers for Disease Control and Prevention (CDC; Atlanta, GA).

"The 2007 NHIS provides the most current, comprehensive, and reliable source of information on Americans' use of CAM," said Josephine P. Briggs, MD, director of NCCAM.

"These statistics confirm that CAM practices are a frequently used component of Americans' health care regimens, and reinforce the need for rigorous research to study the safety and effectiveness of these therapies. The data also point out the need for patients and health care providers to openly discuss CAM use to ensure safe and coordinated care."

The results are based on data from more than 23,300 interviews with American adults.

Comparison of the data from the 2002 and 2007 surveys suggests that overall use of CAM among adults has remained relatively steady36 percent in 2002 and 38 percent in 2007.

The most commonly used CAM therapies among U.S. adults were:

* Nonvitamin, nonmineral, natural products (17.7 %) Most common: fish oil/omega 3/DHA, glucosamine, echinacea, flaxseed oil or pills, and ginseng3
* Deep breathing exercises (12.7 %)
* Meditation (9.4 %)
* Chiropractic or osteopathic manipulation (8.6 %)
* Massage (8.3 %)
* Yoga (6.1 %)

The most commonly used CAM therapies among children were:

* Nonvitamin, nonmineral, natural products (3.9 %)
Most common: echinacea, fish oil/omega 3/DHA, combination herb pill, flaxseed oil or pills, and prebiotics or probiotics
* Chiropractic or osteopathic manipulation (2.8 %)
* Deep breathing exercises (2.2 %)
* Yoga (2.1 %)

"Future analyses of these data may help explain some of the observed variation in the use of individual CAM therapies and provide greater insights into CAM use patterns among Americans," said Richard L. Nahin PhD.


published date: 12-11-2008

Lifesupplemented Study Reveals Doctor's Supplement Choices

The results of the 2008 Lifesupplemented Healthcare Professionals Impact Study show that orthopedic specialists, cardiologists and dermatologists both consume and give dietary supplements to their patients for nuanced diseases as well as overall wellness.

We learned from the 2007 HCP Impact Study that physicians and nurses are taking supplements as part of a proactive wellness regimen that also includes healthy diet and regular exercise, said Judy Blatman, senior vice president of communications at the Council for Responsible Nutrition (CRN; Washington DC.), that heads the study.

With the second year of this study, we were able to dive into specific specialties and find similar trends, further demonstrating the important role for doctors in incorporating dietary supplements as an integral part of wellness.

The highest dietary supplement use was among dermatologist with 75 percent of dermatologists using dietary supplements and 60 percent believing the use of dietary supplements among consumers is mainstream. About 73 percent of orthopaedic specialists use dietary supplements and 63 percent believe the use of dietary supplements among consumers is mainstream. The number among cardiologists is 57 percent to 53 percent.

The study surveyed 1,177 healthcare professionals (300 primary care physicians, 301 OB/GYNs, 299 other physician specialists and 277 registered nurses and nurse practitioners).
published date: 12-11-2008

Naturex Receives Organic Certification

TALLAHASSEE, FLA $7 million settlement has been reached between Airborne Health Inc., Florida, and 31 other states, said Florida Attorney General Bill McCollum on December 16. Under the settlement, the Florida-based company and owners Victoria Knight-McDowell and Thomas John McDowell will modify marketing practices in order to alleviate allegations against unsubstantiated claims concerning Airborne products.

The lawsuit alleged that the company marketed a cold prevention remedy, a sore throat remedy, a germ fighter, and an allergy remedy without adequate proof the products could perform as advertised at the time the claims were made.

The lawsuit also alleged the defendants failed to adequately warn consumers about potential health risks to select populations, including pregnant women, caused by old formulations of Airborne that contained potentially elevated levels of vitamin A. The company has since significantly reduced the vitamin A levels.

The $7 million payment is the largest payment to date in a multistate settlement with a dietary supplement producer. Floridas share of the $7 million is $460,000, which will go toward future monitoring and enforcement in this area.

Under the settlement, the company and the McDowells have agreed not to make any express or implied claims concerning the health benefit, performance, efficacy, or safety of their products, unless the claim can be substantiated by competent and reliable scientific evidence.

The settlement is the last of three settlements involving similar claims regarding the older advertising and labeling of Airborne dietary supplements.
published date: 12-09-2008

Nordic Naturals Defends Cod Liver Oil In Light of Vitamin A Study

WATSONVILLE, CANordic Naturals defended its cod liver oil products as posing no threat to consumers, the company said on December 1, in light of a report suggesting cod liver oil may be detrimental to humans due to its high vitamin A content.

The initial report, titled: Cod Liver Oil, Vitamin A Toxicity, Frequent Respiratory Infections, and the Vitamin D Deficiency Epidemic was published on November 11 in the Annals of Otology, Rhinology & Larynology by 16 members of the supplement fraternity.

The issue that is cited by this group is based on the fact that almost all cod liver oil in the market is being supplemented with synthetic or natural vitamin A, standardized to certain levels, which is why it is assumed that all cod liver oil has high levels of vitamin A," said Karin Yien, MD, Nordic Naturals chief medical adviser.

"This is not true for the Nordic Naturals brand. We have always had low, healthy levels of natural vitamin A in our cod liver oil; consequently, we do not add Vitamin A to any of our cod liver oil products.
published date: 12-04-2008

Vitamin D Intake to Come from Diet & Supplements, Advises AAD

SCHAUMBURG, IL The American Academy of Dermatology issued a statement on December 4 advising the public to obtain vitamin D from their diet and dietary supplements, rather than exposing themselves to UV radiation from the sun.

"Vitamin D is essential for optimal health, and the medical literature supports safe ways to get it -- a healthy diet which incorporates foods naturally rich in vitamin D, vitamin D-fortified foods and beverages, and vitamin D supplements," stated dermatologist C. William Hanke, MD, president of the American Academy of Dermatology.

"And, according to the medical literature, unprotected exposure to UV radiation from sunlight (natural) or indoor tanning devices (artificial) is not safe. Individuals who intentionally expose themselves to UV radiation for vitamin D are putting their health at risk for developing skin cancer."
published date: 12-04-2008

FDA Definition of Whole Grains Limits Support for Heart Disease Claims

BETHESDA, MD (November, 2008) Since 2005, FDA has allowed manufacturers to make health claims tying heart disease reduction to a diet rich in whole grains. Yet it was not until 2006 that FDA defined whole grains as the the intact, ground, cracked or flaked fruit of the grains whose principal componentsthe starchy endosperm, germ and branpresent in the same relative proportions as they exist in the intact grain.

A new study by the Life Science Research Office announced on November 24, found that:

The FDA definition for whole grains as a selection criterion to evaluate the scientific literature is limiting because most of the studies use a broader concept of whole grains.

The few studies that meet the FDA whole grains definition provide insufficient scientific evidence to support a CVD health claim.

A whole grains and CVD health claim is supported when a larger number of studies that use a broader concept of whole grain that includes isolated bran, germ or fiber in their analysis of whole grains are also considered.

The scientific evidence on risk reduction of diabetes and whole grain consumption is suggestive, but not conclusive, whether or not the study meets the FDA definition of whole grains.

This type of analysis is complicated by the diversity in nutrients and bioactive components of different types of whole grains.


The results of the study are part of an LSRO report titled, Whole Grain Intake and Cardiovascular Disease and Whole Grain Intake and Diabetes: A Review.
published date: 11-25-2008

Silliker Receives NIH/NCCAM Grant

HOMEWOOD, ILSilliker, Inc. has received a grant to study the allicin bioavailability of garlic products, the company announced on November 24.

Allicin is the main, active compound of garlic that is known to provide the most health benefits.

The $599,500 award was been granted by the National Institute of Health and the National Center for Complementary and Alternative Medicine (NIH/NCCAM; Bethesda, MD), and will cover a minimum two-year period.

Most garlic supplements have allicin levels of about 3-15 percent, compared to 100 percent in raw garlic. Without clinical research, however, it is difficult to make advancements in the field.

The conclusions of the study, Silliker stated, will address three main goals:

1) An understanding of what type of supplements should be used in a clinical trial and in what form it should be consumed.

2) How results can be extrapolated to crushed raw garlic.

3) Provide supplement manufacturers with a correct standard for the design and evaluation of garlic supplements."

This is the third grant Silliker has received from NIH and NCCAM.
published date: 11-25-2008

Gencor Receives Frost & Sullivan Award for Slimaluma

HONG KONGGencor Pacific received a Frost & Sullivan (Palo Alto, CA) award for its weight management supplement, Slimaluma, the company announced on November 21.

Gencor received the Global Appetite Suppressant and Satiety Ingredients Product Innovation of the Year award.

Gencor Pacific Groups Slimaluma is a unique ingredient that has been scientifically validated for its efficacy and safety in human consumption, said Frost & Sullivan analyst Natalie Watt.

A weight management ingredient like Slimaluma is critical for the success of the weight management industry, which seeks to control the ever-increasing global obesity epidemic.
published date: 11-21-2008

Omega-3 Content Confuses Consumers, Says GOED

SALT LAKE CITYConsumers knows omega-3s are good for them, but thats about all they know on the topic, said the Global Organization for EPA and DHA Omega-3 (GOED; Salt Lake City).

"Omega-3" is too broad to a term, GOED said, because it refers to three separate fatty acids -- EPA, DHA and ALA -- which do not perform in the same way.

"Consumers don't understand what it is," said Vivian Tysse, sales manager of Denomega (Norway).

ALA (alpha-linolenic acid), derived from plant sources such as flaxseed, can be labeled "omega-3", although it does not have the same nutritional content as EPA and DHA.

"Consumers don't really get the difference...it's EPA and DHA that your body really needs," said Ian Lucas, vice president of innovation and strategy at Ocean Nutrition Canada (Nova Scotia).

"Consumers need to be informed and make their own choice," said Philip Fass, executive director of industry and commercial relations at Martek Biosciences (Columbia, MD).
published date: 11-20-2008

Martek Reach 100 DHA Products

Columbia, MDMartek Biosciences Corporation announced the launch of two new products containing "life'sDHA," a polyunsaturated omega-3 fatty acid found in the body. The company subsequently reached 100 products containg DHA, Martek announced on November 18.

A growing number of experts around the world are recognizing the importance of DHA for healthy brains, eyes and hearts. They are also recognizing that most people's diets do not include adequate amounts of DHA," said Steve Dubin, Martek's CEO.

Fish are often incorrectly thought to be the only source of DHA omega-3. However, life'sDHA offers a vegetarian form of DHA containing no known toxins.

"By looking for the life'sDHA logo on food and beverage packages, consumers can be sure they are buying products with a trusted, sustainable, vegetarian source of DHA," Dubin said.
published date: 11-19-2008

PRI Expands Warehouse Space

CITY OF INDUSTRY, CA Pacific Rainbow International (PRI) will double its warehouse and office space, the company announced on November 18.

This expansion will enable us to dramatically increase on-site inventory of our most popular ingredients, said Herman Zhang, PRI president.

In addition, it will give us the capability to inventory new ingredients we dont normally stock.
published date: 11-18-2008

Ecuadorian Rainforest to Host Webinar

BELLEVILLE, NJ Ecuadorian Rainforests vice president of marketing, Steve Siegel, will conduct a Nutraceuticals 2009 webinar on December 11th, 2008 at 2:00pm. The seminar will look at a new year full of new ingredients, new trends and an ever changing economy, the company said.

The event is free; register by clicking the link below: http://www.intotherainforest.com/webinar
published date: 11-18-2008

Soy Link to Lower Cholesterol Confirmed, Says Solae

NEW ORLEANS Solae, a soy ingredient supplier, presented a study confirming soy consumptions link to lower cholesterol at the American Heart Association 2008 Scientific Sessions on November 10.

These findings build on the body of evidence that continues to strongly justify maintaining the currently approved health claim for the role of soy protein in lowering heart disease risk, said Priscilla Samuel, PhD, director of Nutrition at Solae, and lead researcher of the study.

According to the American Heart Association, at a population level for every 1 percent reduction in blood cholesterol there is a 2-3 percent reduction in the rate of coronary heart disease which is still the leading cause of death in the United States. Our research confirms that consuming soy protein is one way to reduce total cholesterol.

Solaes research team reviewed over 150 studies using the FDAs 2007 evidence-based guidance for scientific evaluation of health claims, the company said.

The meta-analysis found reductions in total blood cholesterol of 9.54 mg/dL and reductions in LDL cholesterol of 7.12 mg/dL. Results showed consuming 25 grams of soy protein per day results in significant reduction in total cholesterol and LDL cholesterol.
published date: 11-18-2008

Ginkgo Biloba Does Not Prevent Dementia, Study Concludes

Ginkgo biloba does not eliminate or prevent the progression of dementia or Alzheimer's, according to a new study published in the Journal of the American Medical Association (Chicago).

The study enrolled 3,069 people between the ages of 75 and 96; half took a placebo while the other half took 240 milligrams a day of the ginkgo extract EGb 761, the extract used in products sold by Nature's Way (Springville, Utah).

At the end of the study, 277 people who took ginkgo were diagnosed with dementia, compared with 246 in the placebo group. The study also says the ginkgo group had 257 cases of Alzheimer's, compared to 220 in the placebo group.

"No one is more disappointed that we didn't have any traction in slowing down the disease than the group that did the study," said Steven T. DeKosky MD, the neurologist who led the trial.

"We did show it was fairly safe -- that is of some reassurance," said DeKosky, also dean of the University of Virginia Medical School. He said the only harm from gingko could be "spending money on something that may not be useful."

French researchers are currently using a much larger study pool-- 2,854 people over the age of 70 already suffering from memory problems. The results of that clinical trial will be available in 2010.

"That may show an effect that was missed in this study," said Maria C. Carrillo, director of medical and scientific relations for the Alzheimer Association (Chicago).

But Lon S. Schneider MD, a geriatric psychiatrist at USC (Los Angeles) said theres no doubt that antioxidants protect neurons, however we can make it work in animals, but we can't seem to make this work in humans."
published date: 11-18-2008

Long-Term Use of Vitamins C, E Do Not Prevent Cancer, Study Concludes

PHILADELPHIA Long-term use of Vitamins C and E do not prevent cancer, concluded the Physicians' Health Study II, the American Association for Cancer Research (Philadelphia) announced on November 16.

The study included 14,641 physicians, who were given either a placebo or 400 IU of vitamin E every other day; or 500 mg of vitamin C daily or its placebo.

Researchers followed these patients for up to 10 years.

"After nearly 10 years of supplementation with either vitamin E or vitamin C, we found no evidence supporting the use of either supplement in the prevention of cancer," said Howard D. Sesso, MPH., an assistant professor of medicine at Brigham and Women's Hospital.

"While vitamin E and C supplement use did not produce any protective benefits, they also did not cause any harm," he added.

Study co-author J. Michael Gaziano, MD, associate professor of medicine at Brigham and Women's Hospital and VA Boston, said, "Individual vitamin supplements such as vitamin E and C do not appear to provide the same potential advantages as vitamins included as part of a healthy, balanced diet."

"Our results represent one of only a few clinical trials that have tested this idea, Sesso said.

The final component of the Physicians' Health Study II, testing daily multivitamin supplementation, remains ongoing."
published date: 11-17-2008

InterHealth Receives ISO Certification

BENICIA,CA - InterHealth Nutraceuticals has received its ISO 9001:2000 certification, the company announced on November 14.

An ISO certification provides assurance on good management practice by an independent body.

"Our customers see a real benefit in the quality of our products and services and ability to respond efficiently to their need," said Paul Dijkstra, InterHealth CEO.

InterHealth's ingredients are used in over 600 nutritional supplements, functional foods and beverages distributed in more than 30 countries worldwide.
published date: 11-14-2008

Jarrow Formulas Donates to AIDS Project

LOS ANGELES Jarrow Formulas has given about 1,650 bottles of vitamins to the Necessities of Life Program, a part of AIDS Project Los Angeles, the company announced on November 13.

The bottles included the company's ToxGuard Colon PF and Hemp Seeds prouduct.

Jarrow Formulas and its associates have really opened their hearts to the people that have suffered so much, said Mark Becker, communications director for Jarrow.

"We want to do everything in our power to help.

The company has previously donated to the 2005 earthquake in Pakistan and Hurricanes Katrina, Rita and Wilma.
published date: 11-13-2008

Vitamins C and E Not Beneficial in Heart Disease Prevention, Study Concludes

BOSTONVitamins C and E were not effective in preventing cardiovascular disease in males, concluded the Physicians Health Study II that will be published in the November 12 issue of the Journal of the American Medical Association.

"(The vitamins) showed no trends that reached significance, except for an increase in hemorrhagic stroke among vitamin E users that was only marginally significant at p=.02, said J. Michael Gaziano, MD, associate professor of medicine at Harvard Medical School (Boston).

The study included 14,641 physicians, with a mean age of 64. This was a very healthy population, Gaziano noted. Participants received a placebo or 400 IU vitamin E every other day. While the studys participants only included Caucasian men, smaller vitamin E trials did not show a gender difference.

Effects of the study will continue for an additional 3 years, Gaziano reported.

This was a high-quality, long-term nutritional trial, and we dont have many of these, said Barbara V. Howard, PhD, Medstar Research Institute (Hyattsville, MD).

We do need data in other racial groups, but it is very unlikely there will be differences. The other issue that will be raised is the type of formulation, Howard said.

I think most nutritionists would feel that it is highly unlikely that you could suddenly find a specific vitamin formulation that would be beneficial.

In response to the study, Andrew Shao of the Council for Responsible Nutrition (CRN; Washington DC.) released this statement:

Although the results did not demonstrate an overall benefit, the results also do not discount the earlier epidemiological data showing that people with high intakes of vitamins E and C may have a lower risk of cardiovascular disease. Nutrition research is extremely complex, and doesnt always provide clear cut answers. This study raises an interesting set of scientific challenges as to why the benefits found in observational studies have not been confirmed in this kind of trial.

Annette Dickinson, PhD past president of CRN, said, These results do not of course negate other evidence of benefits for vitamin E and vitamin C for other conditions, including immune function, mental acuity, and eye health. Consumers would be well advised to ensure adequate intakes of all essential nutrients through a good diet plus use of a multivitamin, and selected other nutrients including vitamins E and C, vitamin D, calcium, and EPA and DHA omega-3 fatty acids.

Dickinson added that the possible effect of vitamin E on increased risk of hemorrhagic stroke may have been a matter of chance.
published date: 11-10-2008

Chromadex, Cargill Partner for Stevia Quality-Control

IRVINE, CAChromaDex and Cargill (Wayzata, MN) have partnered to standardize the quality of stevia-related products, ChromaDex announced on November 10.

Since there was previously no standard to evaluate stevia-based products, new analytical reference methods will provide industry standards set for rebiana, the company said.

Not all stevia sweeteners are created equal, and it will be important for companies using stevia ingredients to select the right standards and analytical methods in differentiating products that meet requirements for food use, said Frank Jaksch, co-founder of ChromaDex.

For rebiana, we not only developed the specifications for this new sweetener, but we also created the methods and systems to insure that our product is consistent said Zanna McFerson, business director of Truvia, Cargills new rebiana sweetener.
published date: 11-10-2008

SourceOne Partners with Nutri Pharmaceuticals in Powder Technology

LAS VEGAS SourceOne (Chicago) has partnered with Nutri Pharmaceuticals Research to develop powder forms of Sources products with the hopes to broaden the companys appeal in the nutritional market.

Both companies share the same vision for delivering greater value and broader functionality of exceptional health and wellness ingredients and formulas through innovative application technology. We like to say that we transform good ingredients into great ingredients, said NPRI CEO, Godfrey Yew.

This new partnership will allow SourceOne to alter the form of products like CoQsource Coenzyme Q10 and OmegaChoice Concentrated Omega-3 Essential Fatty Acids (EFAs) in free-flowing powders, using NPRIs oil-to-powder technology, according to Jesse Lopez, SourceOne CEO.

The synergies created by these partnerships are directly and immediately applicable to SourceOne ingredients and formulas in various forms and concentrations, said Lopez.
published date: 11-06-2008

MGP Ingredients Decrease Protein and Starch Production

ATCHISON, KNMGP Ingredients will reduce wheat and starch production at its facility in Atchison, effective Nov. 12. As a result, MGP will discontinue manufacturing operations in Pekin, Illinois, the company said.

We have been very straightforward about our strategy to strengthen MGP Ingredients by becoming a more customer-centric, and therefore less production-driven supplier of value-added products , said Tim Newkirk, MGP CEO.

Our decision to exit our protein and starch operations in Pekin and concentrate our efforts on the production of value-added ingredient solutions at our Atchison, Kansas plant represents another critical step toward achieving this goal.

The closure of operations will result in lay-offs and early retirement offers, the company said.
ConAgra Mills will supply the companys protein and starch ingredients, MGP previously announced on October 20.

Although recent economic conditions have caused us to accelerate some of these decisions, they all stem from an exhaustive business analysis spanning our entire enterprise...even though we anticipate an operating loss for the year, every facet of our organization will aim to return the company to profitable operations in the fourth quarter while ensuring proper alignment with our strategic focus going forward, Newkirk added.
published date: 11-06-2008

WCFN Winners Announced

VANCOUVER, BCWinners of the Western Canadian Functional Food & Natural Health Product Networkk (WCFN) were announced on November 3.

Recipients are Kelley Fitzpatrick, President of NutriTech Consulting and Director of Nutrition at Flax Canada 2015, Solo GI Nutrition (Edmonton, AB), Manitoba Food Processors Association (Winnipeg, Ontario), and Advanced Foods and Materials Network (AFMNet; Guelph, Ontario).

Awards will be presented during the WCFN Conference in Winnipeg on November 24.
published date: 11-05-2008

Kemin Health Wins Award

BARCELONA Slendesta won the award for Most
Innovative Slimming Ingredient" at the Ingredientes Adelgazantes Espaa 2008 conference held from October 2-3 in Spain.

Isabel Farinha, marketing manager of the company, said, "Receiving this award is recognition of the innovative properties of Kemin Healths new ingredient. It opens a wealth of opportunities for Slendesta, not only in Spain, but all over the world. For many, this will be the first glimpse of Slendesta's amazing potential as a health ingredient."
published date: 11-05-2008

Dow to Introduce Weight Care Technology at HiE

MIDLAND, MICHDow will introduce new weight care technology at the Health Ingredients Europe (HiE) show in Paris, the company said on November 4.

SATISFITTM Weight Care Technology promoted healthy fat metabolism and reduced weight gain in pre-clinical studies, the company said.

SATISFIT is targeted to aid in the development of foods that can satisfy in taste and texture, while also being compatible with consumers goals for fitness and healthy eating, said Stephanie Lynch, global marketing manager for Food & Nutrition.

The new technology is fully soluble, process-tolerant, and does not add calories.
published date: 11-05-2008

Fortitech Launches New Initiative to Battle Malnutrition

SCHENECTADY, NY Helping support the battle against global malnutrition, Fortitech announced the launch of the World Initiative for Nutrition (WIN) on November 4. WIN will work with governmental and non-governmental organizations, ingredient suppliers, local food mills and manufacturers to develop and deliver tailored nutritional solutions.

"The message we want to convey through WIN is that nutrition is not the problem, it is the solution, said Franoise Chom, director of WIN. "Food fortification not only impacts the health of the individual, but the health and economic wellbeing of the nations and communities to which they belong.

"I think one of WIN's greatest strengths is its ability to deliver innovative, cutting-edge solutions that may not be apparent upon first glance of a project, said Walt Borisenok, president and CEO of Fortitech. "We make it our responsibility to look at an application from every angle to determine the optimum mix of nutrients and market forms, along with the best method to integrate them to achieve a successful end product.

"As a responsible corporate citizen, we take the point of view as to what we can do to help reduce the number of people affected by malnutrition and the health conditions that manifest themselves due to inadequate nutrition, continued Borisenok. "We have worked on many fortification programs aimed at decreasing the incidence of malnutrition in the past, but to effectively address this, we needed to establish dedicated resources with the sole purpose of fighting malnutrition. WIN is a solution to this issue.
published date: 11-04-2008

ProCaps Labs Donates Prenatal Vitamins

HENDERSON, NVProCaps Laboratories has partnered with Vitamin Angels (Santa Barbara, CA) to produce prenatal vitamins which will be donated to Vitamin Angels' Maternal Health Program for distribution worldwide, the company announced on November 4.

"Every year more than 500,000 women die during childbirth...complications from childbirth are a leading cause of death and disability among women of reproductive age in developing countries," said Howard Schiffer, founder of Vitamin Angels, a 14-year nonprofit with the aim to fight vitamin A deficiency worldwide.

"There is likely no vitamin that can have a greater impact on life than a prenatal vitamin in the hands of a expectant mother," said Andrew Lessman,founder of ProCaps Labs.

"With Vitamins Angels' help we will be able to provide the essential nutrition an expectant mother needs to be better equipped for pregnancy, delivery and nursing, as well as, providing the vital nutrients necessary to increase birth weights and help babies resist common childhood diseases and infections."

ProCaps Laboratories donated over 650,000 bottles (58 million capsules) this year.
published date: 11-04-2008

ZMC-USA Wins Frost & Sullivan Award

THE WOODLANDS, TX Raw ingredient manufacturer ZMC-USA received the Frost & Sullivan (Palo Alto, CA) award for Best Practices, representing the North American Coenzyme Q10 Emerging Company of the Year award.

ZMC-USA strategically altered the landscape of the marketplace and brought quality, affordability and value to a market which had suffered extreme pressures in the years prior to the companys formation, said Frost & Sullivan food products technical researcher, Linda Gomez.

By changing the typical market distribution channel to include transparency, ZMC-USA allowed both the customer and the parent manufacturing company to more efficiently realize the needs and demands of the US marketplace.
published date: 10-30-2008

Carnipure Supplementation May Help Aging Process

BASEL, SWITZERLAND A new study released in the October issue of the Journal of Gerontology showed supplementation with Carnipure may support healthy aging.

Researchers at the University of Dijon, France found that L-Carnitine levels in the muscle cells of aging rats restored muscle oxidative capacity and induced positive changes in body composition. Without any change in food intake, the study showed that the old rodents demonstrated a decrease in abdominal fat mass and an increase in muscle capabilities.

With the worlds elderly population predicted to nearly triple by 2050, it is not surprising that the market for anti-aging foods and supplements will see increased levels of activity and opportunity for manufacturers. Carnipure may help support functions that seniors need to stay fit and healthy in both mind and body, said Professor Jean Demarquoy, leading researcher of the study.

In the elderly, both dietary intake of L-Carnitine, an ammonium compound required for the transport of fatty acids, are generally reduced. This may lead to reduced levels in the body, resulting in a reduction in energy metabolism. The new study found a 34% differences in muscle L-Carnitine content between young and old rats. The capacity for energy generation from fatty acids as measured via β-oxidation rates is generally reduced in the elderly. Supplementation with Carnipure increased the β-oxidation rate and thus muscle oxidative capacity in old rats by 55%. The study found one months treatment with L-Carnitine in subjects aged from 70 to 92 showed an increase in total muscle mass, compared with placebo, with thee total fat mass reduced at the same time.

Carnipure is crystalline, white, water-soluble and heat stable, according to Lonza, manufacturer of the supplement.
published date: 10-30-2008

FDA Issues Warning Letters to Bayer HealthCare


ROCKVILLE, MD On October 28, two of Bayer HealthCares (Leverkusen, Germany) over-the-counter products were met with warning letters from FDA. Two of the companys OTC aspirin products Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage) require new drug application in order to be marketed legally.

Both products, containing aspirin with either phytosterols or calcium, are intended for use in heart disease risk reduction. Bayer Women's is also labeled for use in "fighting" osteoporosis, although neither product has been approved by the FDA for such uses.

"The marketing of these unapproved drugs is troubling," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research. "Because OTC drugs are widely used by consumers, without supervision by a doctor or other health care professional, the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events. It is essential that companies obtain FDA approval and fully comply with FDA regulations."

While FDA allows some drugs to be marketed without first obtaining agency approval, the products must comply with regulations that set requirements for the drugs' labeling, formulation and use. OTC drugs that do not meet these requirements and that lack FDA approval are considered illegal, unapproved drugs. According to FDA, Bayer Heart Advantage and Bayer Women's do not meet the conditions in any applicable OTC monograph, and do not have FDA approval. In addition, the products have been called misbranded because their labeling lacks sufficient directions for consumer use.

Effects of the two products are unknown, although FDA is concerned because neither product has been approved by the agency for consumer use. Companies failing to comply to FDA warning letters risk enforcement action, such as injunctions and/or seizure of illegal products.

Steve Mister, of the Council for Responsible Nutrition (CRN; Washington DC.), defended the dietary supplement industry by releasing this statement: Dietary supplement-OTC drug products have a useful and important role to play in integrated healthcare and wellness. Our hope is that FDA will assist companies attempting to maneuver the regulatory challenges of developing products that combine these ingredients and meet the labeling and formulation requirements of both drugs and dietary supplements, as required by the law.

In a statement released by Bayer, the company reinforced its claim that all our communications on product benefits prominently feature information for consumers to check with their physicians to determine if the product is right for them.
published date: 10-29-2008

GSK Petition Met With Mixed Feelings at SupplySide West

LAS VEGASOn October 23, Sabinsa Corp. (Piscataway, NJ) hosted a meeting at SupplySide West to discuss a citizens petition that seeks to classify weight-loss claims on dietary supplements as disease claims. The petition was filed by the American Dietetic Association (Chicago), GlaxoSmithKline (GSK; London), the Obesity Society (Silver Spring, MD), and Shaping Americas Health (Alexandria, VA).

The four petitioners asked FDA in April to treat weight-loss claims as disease claims, because such statements purport to prevent or treat an abnormal or unhealthy condition that, while not itself a disease, is a significant risk factor for disease.

While many dismiss the petition as inconsequential, some attendees at the meeting asserted that the supplement community must be closer-knit in dealing with threats to the industry.

The point of the meeting at SupplySide was to alert the industry to ways in which the supplement industry can be blocked in, in which case everyones affected, supplement industry regulatory attorney Marc Ullman, one of the meetings speakers, said after the event.
The discussion, expected to draw some 130 people, according to Jeff Lind, CEO of Sabinsa, however, garnered about 30. Lind later said that he was disappointed in the gross lack of industry support in discussing the petition.

Speakers at the meeting included Michael McGuffin, president of the American Herbal Products Association (Silver Spring, MD); David Seckman, CEO of the Natural Products Association (Washington, DC.); Loren Israelsen, director of the Utah Natural Products Alliance (Salt Lake City); Steven Mister, executive director of the Council for Responsible Nutrition (Washington DC.), and Ullman.

There is a long-standing problem in the supplement business with a few, select companies consistently expected to step up and challenge much larger problems, said Ullman, who works with Sabinsa. He called for more active support within the industry.

Yet AHPA president McGuffin dismissed claims that supplement companies were not responsive to potential dangers to the market.

This is not a bold call to industry, he said. I would not judge active support by numbers, mostly because companies rely on trade associations such as CRN and AHPA to act on their behalf. Thats why they become members.

According to the Council for Responsible Nutrition (CRN; Washington DC.), they feel FDA decided in 2000 that weight loss claims should be filed under DSHEA. They said that the intended use of many dietary supplements and other weight loss plans are for cosmetic reasons and immediate health benefits such as feeling better and having more energy, not primarily to manage their risk of disease.

Steve Mister, president of CRN commented, Contrary to the petitioners assertions, if FDA were to grant this petition, it would result in sweeping implications for weight-related claims for the entire category of food, and create a slippery slope for other structure/function claims that would essentially disease-ify many health conditions not currently considered to be diseases or surrogate endpoints for disease.

This would cripple the dietary supplement category as envisioned by Congress with the passage of DSHEA.

McGuffin said most supplement companies know the petition will most likely fail.

A similar petition GSK filed in 2002 asked the administration to deny approval of any generic product containing ingredients used in its own antibiotic, Ceftin. The request was denied.
For this reason, the supplement industry seems to remain unruffled by the new petition.

Its an overreaction to amass the industry. Theres no need for an emergency press conference, said McGuffin.

published date: 10-29-2008

No Benefit from Selenium and Vitamin E Supplements, Concludes Prostate Cancer Prevention Study

ROCKVILLE, MD Selenium and vitamin E supplements, used together or separately, did not prevent prostate cancer, concluded a review of data from the Selenium and Vitamin E Cancer Prevention Trial (SELECT), funded by the National Cancer Institute (NCI; Rockville, MD).

In addition to this finding, data showed a small increase in the number of prostate cancer cases among the over 35,000 men age 50 and older in the trial taking only vitamin E and a small increase in the number of cases of adult onset diabetes in men taking only selenium. Neither of these findings proves an increased risk from the supplements, as findings are premature and could be coincidental, the study's authors concluded.

(The study) was always designed (to) answer more than a single question about prostate cancer, said Eric Klein, MD, study co-chair for SELECT. As we continue to monitor the health of these 35,000 men, this information may help us understand why two nutrients that showed strong initial evidence to be able to prevent prostate cancer did not do so.

Participants are receiving letters telling them to seize using the studys supplements, and will continue to have their health monitored by study staff, SELECT said. Investigators intend to follow the participants for about three years to determine the long-term effects of having taken either a supplement or placebo.

SELECT was undertaken to validate a 1998 study of 29,133 male smokers in Finland who took vitamin E to prevent lung cancer. The study showed 32 percent fewer prostate cancers in men taking the supplement, and a 1996 study of 1,312 men and women with skin cancer who took selenium for prevention of the disease showed men who taking the supplement had 52 percent fewer prostate cancers than men who did not.

Men were recruited to participate in SELECT based on these findings. Participants were randomly assigned to take one of four sets of supplements or placebos, with more than 8,000 men in each group. One group took both selenium and vitamin E; one took selenium and a vitamin E placebo; one took vitamin E and a selenium placebo; and the final group received placebos of both supplements.

Prostate cancer is the most common type of cancer in men in the United States next to skin cancer. According to estimates, there will be approximately 186,320 new cases of prostate cancer and 28,660 deaths from this disease in the United States this year.

published date: 10-27-2008

BASF to Present S.E.T. Initiative at Supply Side West

FLORHAM PARK, NJ BASF Corporation, the American base of the German-based chemical company, will present the S.E.T. (Sustainability, Eco-Efficiency, and Traceability) Initiative, in a VendorWorks session at the Supply Side West Conference.

Leonardo Mendez, of the Human Nutrition and Pharmaceutical Ingredients and Services section of BASF, will present a lecture titled, BASF presents the S.E.T. Initiative: Proven and Measurable Sustainability Throughout the Entire Value Chain on Thursday, Oct. 23 at 4:30 p.m.

Sustainability, Eco-Efficiency, Traceabilityresponds to the needs of increased quality requirements, sustainability and traceability throughout the global supply chain, said Mendez. Consumers want to know exactly what they are buying and eating, especially when it comes to food and beverages. Where does the salmon fillet in the cooler come from? They want to know the level of quality control over the manufacture of individual products and ingredients.

Since a FDA-estimate says that 84 million people suffer from sensitivity or intolerance to certain foods, BASF says they features vegetarian and allergen-free formulations for dietary supplements.

The S.E.T. initiative allows suppliers to differentiate in the value chain and ensures high quality products, said Mendez.
published date: 10-20-2008

Deal Signed Between Frutarom USA, BLIS K12

NEW ZEALAND, NEW JERSEY- BLIS Technologies Ltd. (Dunedin, New Zealand), developer of BLIS K12, a probiotic for upper airways infection prevention such as bacterial sore throats, tooth and gum disease and chronic bad breath, announced on October 17 that it had signed a distribution agreement with Frutarom, USA (North Bergen, NJ).

Frutarom USA will take reign of all sales and marketing, warehousing and distribution activities in North America, while BLIS Technologies will focus on product development efforts and activities with its research partner, The University of Otago (Dunedin, NZ).

The BLIS K12 advanced probiotic will be unveiled on the Frutarom stand at the Supply Side West show in Las Vegas on Oct 23.

This is a significant opportunity for us to expand our business around a product with both an exceptional safety profile and excellent record of clinical validation for its effectiveness in preventing many common infections of the upper airways and oral cavity, said Laurent Leduc, vice president of the health division of Frutarom USA.

Frutarom is a very proactive company and have already secured orders for BLIS K12, even before the ink was dry(the merger) represents further expansion of our commercial development for BLIS Technologies and it builds on our existing research relationships with Nestle Nutrition in Switzerland, said Barry Richardson, chief executive of BLIS Technologies Ltd.
published date: 10-17-2008

Alzheimers Not Significantly Helped By Vitamin B Supplementation

CHICAGO A new study in the October 15 issue of the Journal of the American Medical Association (JAMA; Chicago) shows that high-doses of vitamin B supplementation do little to reduce the speed of cognitive decline in Alzheimer patients.

Evidence of homocysteine (an amino acid produced by the body) elevation in Alzheimer disease (AD) and the involvement of homocysteine in neuropathological mechanisms suggest that reduction of homocysteine may offer an approach to altering the disease, according to the study.

According to the authors, prior studies of B vitamins to reduce homocysteine in AD have not had sufficient size or duration to assess their effect on cognitive decline.

Paul S. Aisen, M.D., of the University of California, San Diego, and colleagues conducted a clinical trial to determine if reduction of homocysteine levels with high-dose supplementation with folic acid and vitamins B6 and B12 for 18 months would slow the rate of cognitive decline in 409 individuals with mild to moderate AD.

Participants were randomly assigned to two groups of unequal size to increase enrollment (60 percent treated with high-dose supplements [5 mg/d of folate, 25 mg/d of vitamin B6, 1 mg/d of vitamin B12] and 40 percent treated with identical placebo). A total of 340 participants completed the trial while taking study medication. Cognitive abilities were measured via testing with the Alzheimer Disease Assessment Scale (ADAS-cog).

The researchers found that even though the vitamin supplement regimen was effective in reducing homocysteine levels, it had no beneficial effect on the primary cognitive measure: the rate of change in ADAS-cog score did not differ significantly between treatment groups. The authors did find that symptoms of depression were more common in the high-dose supplement group.

Many studies suggest that relative elevation of homocysteine is characteristic of AD, and laboratory research implicates homocysteine in neurodegenerative mechanisms. High-dose B vitamin supplementation in individuals with normal levels of B vitamins was effective in reducing homocysteine levels. However, our study does not support the treatment of individuals with mild to moderate AD and normal vitamin levels with B vitamin supplements, the authors concluded.

***************

Editorial: B Vitamins for Prevention of Cognitive Decline - Insufficient Evidence to Justify Treatment

In an accompanying editorial, Robert J. Clarke, M.D., F.R.C.P., and Derrick A. Bennett, Ph.D., of the University of Oxford, England, commented on the UCSD vitamin B findings:

The precise reasons the [study by Aisen and colleagues] failed to detect any beneficial effect of B vitamins on the rate of cognitive decline remain unclear, they write.

However, until and unless new data suggest otherwise, there is insufficient evidence to justify routine use of homocysteine-lowering vitamin supplements for the prevention of Alzheimer disease and cognitive decline among individuals with normal vitamin status.

published date: 10-09-2008

German Study Supports St. John's Wort Depression Claim

Munich, Germany- The plant extract of Hypericum perforatum, or St. Johns wort, is grown on nearly every continent in the world, but has only recently been scientifically cited as a potential gatekeeper for depression. The study, reported in the Cochrane Systematic Review (United Kingdom) in October, included reviews of 29 trials with a total of 5,489 patients prescribed with symptoms of major depression.

"Overall, we found that the St. John's wort extracts tested in the trials were superior to placebos and as effective as standard antidepressants, with fewer side effects," said lead researcher, Klaus Linde of the Centre for Complementary Medicine in Munich, Germany.

While researchers applauded the effects of St. Johns wort in depression patients, they were quick to note that the plant should not be labeled as an anti-depressant, especially since the effects of its fusion with other drugs is not yet known.

"Using a St. Johns wort extract might be justified, but products on the market vary considerably, so these results only apply to the preparations tested," said Linde.

The report comes in light of a 2002 NCCAM (Bethesda, Maryland) sponsored study that showed that the herb was no more effective than placebo in treating major depression of moderate severity.

"Overall, we found that patients taking either St. John's wort or placebo had similar rates of response according to scales commonly used for measuring depression," concluded the 2002 NCCAM report.

The new Cochrane report noted that results were more favorable in German-speaking countries where doctors regularly prescribe St. Johns wort as an herbal treatment.
published date: 10-09-2008

CRN Celebrates Industry Leaders at Symposium

WASHINGTON, DC.Adrianne Bendich, Ph.D., of GlaxoSmithKline (GSK; UK) and Byron Johnson of Amway/Nutrilite (Ada, Michigan) were awarded CRN (Steuben) Apple awards by the Council for Responsible Nutrition (CRN; Washington DC.) at its annual symposium for the dietary supplement industry on October 6.

Dr. Bendich, the clinical director of medical affairs at GSK, is the only person to serve continuously as a dietary supplement industry reviewer for the National Institute of Healths Office of Dietary Supplements (Bethesda, MD) annual bibliography since its creations. Bendich is an authority in womens health issues involving nutrition, and for the past decade led the GSK research team that provided calcium and Vitamin D to the Womens Health Initiative (Bethesda, MD). Bendich serves on editorial board of The Journal of Nutrition (Bethesda, MD), the Journal of Womens Health (New Rochelle, NY) and the Journal of Nutritional Immunology (Binghamton, NY).

Mr. Johnson has been with Amway/Nutrilite for 25 years, where he is now its nutrition regulatory policy director. Previously, he has served as the nutrition and wellness industry relations director for the company, as well as vice president and general counsel. In his current position, Earlier this year, Mr. Johnson was elected the chairman of the International Alliance of Food/Dietary Supplement Associations (Brussels), where he has been a participant in the organizations regulatory, scientific and advocacy affairs since its inception in 1998. Mr. Johnson served as the Chairman of CRN from 2003-2004, and currently remains an active member on the CRN Board of Directors.
published date: 10-06-2008

Study Shows UC-II Ability in Reducing Osteoarthritic Pain

Arlington, VA - Results of a new clinical study on UC-II, InterHealth Nutraceuticals' (Santa Rosa, CA) Type II collagen product were presented at the American College of Nutrition (Clearwater, FL) on October 3.

The study tested an older arthritic population experiencing joint pain from osteoarthritis. In a sample size of 52 American patients, one group took 40mg UC-II, and the other, a combination of glucosamine (1500mg)+ chondroitin (1200mg). Both treatments reduced their WOMAC index score, which measures stiffness, difficulty in physical function, and pain in the knee. With UC-II, however, the WOMAC score decreased by 33% compared to 14% in glucosamine plus chondroitin-treated groups after 90 days.

"This research shows the power of InterHealth's UC-II product," stated InterHealth CEO Paul Dijkstra. " What is most significant is that UC-II shows better efficacy with a smaller, once daily, 40mg dose than the larger 2700mg dose of the glucosamine + chondroitin combination...Our hope is that major supplement companies will want to bring this ingredient to their consumers and promote its effectiveness over glucosamine and chondroitin in joint health."

The study was conducted at KGK Synergize Inc. (Ontario, Canada) with funding from InterHealth Nutraceuticals Inc.
published date: 10-06-2008

BENEO-Orafti Will Reveal Findings at Health Ingredients Europe

BENEO-Orafti, a producer of inulin and oligofructose, will be exhibiting new findings on continuing research on consumer conscience in health and wellness at this years Health Ingredients Europe (HIE) show in France. This is the 15th study they have commissioned in the past five years. Preliminary results will be announced from research conducted in the US and UK with other European findings being revealed at a later date. The study program examines knowledge and awareness levels of consumers on health concepts like 'the prebiotic effect' and 'digestive well-being.' It also sheds light on consumers understanding on satiety and calcium absorption claims.

Dominic Speleers, Managing Director of BENEO-Orafti, said, "This latest study is just another example of BENEO-Orafti's commitment to investing in consumer research to provide the highest possible level of support to our partners."

"Science, consumer understanding, applications know-how and regulatory expertise have always been key focuses for our business. This depth of knowledge is what allows us to effectively work in partnership with food manufacturers to successfully launch functional products into the marketplace. We invite existing and potential new partners to visit the
BENEO-Orafti booth at HIE to allow us to share our know-how with them," he added.

published date: 10-01-2008

In Brief

--Ecuadorian Rainforest LLC (Belleville, NJ) relaunched its Web site on August 1. The Web site, located at www.intotherainforest.com, includes a monthly video blog, interactive polls, and real-time news.

--Improve USA Inc. (Desoto, TX) completed an expansion of its Proeza processing facility in Jaumave, Mexico. The expansion, Improves third in four years, creates a 67,000-sq-ft facility dedicated to processing the companys DaltonMax700 dehyrated Aloe vera powder. In addition to providing the capacity to process 80 tons of leaves per day, the facility also houses R&D and microbiology labs, along with 10 stainless-steel low-vacuum drying units.

--Farbest Brands (Montvale, NJ) and BioGin Biochemicals (Chengdu, China) formed an alliance to leverage their national sales and distribution networks to market omega-3s in North America. The BioGin line of omega-3 fatty acids contain a broad range of docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) and alpha linolenic acid (ALA) from fish and flax seed oils, while AlaLife ingredients contain concentrated amounts of omega-3s.

--Fenchem (Chino, CA) achieved a 10% sales increase in the United States market from January to June, compared with the same period in 2007. To accommodate increasing demand, Fenchem is expanding its China factorys production capacities, focusing on the production of Tocovet vitamin E and Cholevel phytosterols.

--Gencor Pacific Inc. (Anaheim, CA) received U.S. patent 7,390,516 for its Slimaluma Caralluma fimbriata extract. The patent covers caralluma extract products and processes for making the same.

--Sensus (Roosendall, The Netherlands) launched a new Web site that describes the latest information about inulin and chicory, as well as their use in various applications. The Web site is located at www.sensus.nl .

--Lonza (Allendale, NJ) appointed Seltzer Ingredients (Carlsbad, CA) and Pharmachem Laboratories (Kearny, NJ) as distributors for its Carnipure brand of L-carnitine. The appointments will enable Lonza to reduce shipping time and provide regional technical support.
published date: 09-29-2008

Aminogen Multiplies Rate of Whey Protein Absorption

WAYNE, NJAdding a specific enzyme system to processed whey protein can double or triple the rate at which the protein is absorbed, according to a new study published in the July issue of the Journal of the International Society of Sports Nutrition.

in the study, researchers analyzed the serum blood levels of free and branched-chain amino acids (BCAAs) in 21 healthy males who consumed 50 g of whey protein. Some of the subjects consumed the protein with Aminogen, a patented, generally recognized as safe (GRAS) plant-based enzyme system supplied by Triarco Industries Inc.

The researchers found that the Aminogen-supplemented group experienced a 220350% increase in the rate of protein absorption compared to the control group. That translated into a 100% increase in the amount of free amino acids and a more than 250% increase in the amount of BCAAs. The researchers also found that Aminogen boosted nitrogen retention by 32%.

Increasing the absorption rate is key for whey protein consumers who are concerned about the effects processing may have on bioavailability and want to maximize the benefits of their protein intake, said Triarco director of research and development Mark Anderson, PhD, one of the studys authors.

Our results confirm that what Aminogen does is allow your body to absorb more amino acids and retain more nitrogen from whey protein concentrate, Anderson added. It does this by accelerating absorption before the protein moves farther along the digestive tract, where nutrient absorption does not occur.
published date: 09-29-2008

Cognis Achieves NSF Certification

LA GRANGE, ILCognis Nutrition & Health received goMod manufacturing practices (GMPs) registration for its Covtiol vitamin E, Vegapure phytosterol, and Tonalin conjugated linoleic acid ingredients, the company announced on August 4.

NSF International (Ann Arbor, MI) awarded the certification to Cognis production facilities in Kankakee, IL, and Illertissen, Germany, after conducting an intensive plant audit. NSF also will conduct periodic audits in the future.

The registration provides an invaluable benefit for our dietary supplement customers, said David Hessler, quality assurance leader for Cognis Nutrition & Health. As a world leader in supplying the finest health-enhancing ingredients, Cognis has taken the initiative to complete this rigorous process to ultimately make GMP conformance easier for dietary supplement manufacturers by making sure were in compliance so they are as well. As a result of our affirmed compliance, this certification will help our customers eliminate the need for costly and time-consuming plant audits.
published date: 09-29-2008

Alkemists Offsets CO2 Emissions

COSTA MESA, CAAlkemists Pharmaceuticals is on its way to becoming a carbon-neutral analytical laboratory by offsetting 100% of its CO2 emissions, the company said on July 30.

Today, it is difficult not to be aware of the imbalances we have inadvertently created for our planet, said Alkemists Pharmaceuticals lab manager Elan Sudberg. As a contributing factor in the various environmental issues, I feel that it is our responsibility to be accountable in some way.

Sudberg said that by working with Green Mountain Energy Co. (Austin), Alkemists has been able to calculate a CO2 emissions footprint of 31 metric tons for the labs annual electricity, refrigerant, and natural gas usage, along with emissions caused by employee commuting and corporate air travel.

The company will offset all of its 2007 and 2008 electricity- and refrigerant-related CO2 emissions by purchasing renewable energy credits from wind sources. It also plans to offset 100% of the emissions created during those years by natural gas usage, employee commuting, and corporate air travel by purchasing forest sequestration offsets.

Going carbon neutral is a great and incredibly simple way to move forward in a meaningful attempt to undo the harmful byproducts of operating an analytical laboratory, said Sudberg. In fact, we are going above and beyond our calculated emissions by working with the Arbor Day Foundation and their Rain Forest Rescue and Reforestation Program.
published date: 09-29-2008

Study Shows Lonza Ingredient Lowers Hypoxic Stress

BASEL, SWITZERLANDSupplementation with Carnipure tartrate boosts muscle oxygen consumption, potentially countering hypoxic stress, according to a new study published in the July issue of the Journal of Strength and Conditioning Research.

Hypoxic stress caused by resistance exercise can lead to muscle soreness and hinder athletic performance.

In the study, which was supported by Carnipure tartrate manufacturer Lonza, researchers found that resistance athletes who took the supplement had higher muscle oxygen consumption than other athletes. Carnipure tartrate, a patented, generally recognized as safe (GRAS) ingredient, consists of 68% L-carnitine and 32% L-tartaric acid.

Were pleased with this new evidence, since it further strengthens the story behind the benefits of Carnipure tartrate on exercise recovery, said Lonzas head of technical marketing and scientific affairs for North America, Kevin Owen, PhD.

published date: 09-29-2008

Capsugel Now TGA Certified

GREENWOOD, SCAustralias Therapeutic Goods Administration (TGA) has certified Capsugels Licaps liquid-fill production facility meets its regulatory requirements, the company announced on August 7.

The Australian GMP code is very thorough because it covers all medicines and is highly respected by many regulatory authorities around the world, said Robert Whitelaw, director of sales, marketing, and business development for Capsugels Americas region.

To obtain the certification, the company demonstrated its compliance with Australian good manufacturing practices for medicinal products, Whitelaw said. The certification should enable marketers to expand into the Australian market and in other regions that recognize TGA certification.

In conjunction with the growing demand for products that utilize the Licaps delivery system, our customers can now more readily access important global markets, added Whitelaw. Certainly, our experience is that the important benefits of the Licaps delivery system, which include heightened consumer preference and improved bioavailability, address global needs.

published date: 09-29-2008

ChromaDex Obtains Additional Working Capital

IRVINE, CAChromaDex Corp. raised $4.2 million through a private placement stock offering that began in March, the company said on August 8.

New Castle Financial Services (New York City) acted as the private placement agent for the transaction, which yielded gross proceeds of $4.67 million.

Subsequent to our recent emergence as a publicly traded company through completion of a reverse merger, today we are pleased to announce the closing of this private placement to provide ChromaDex with additional working capital to support our business expansion plans, said ChromaDex cofounder and CEO Frank Jaksch. We are pleased with the amount raised and confident this financing will help position ChromaDex to support the next phase of our growth in our quest to become the premier provider of phytochemical and botanical reference standards to the functional food, cosmetic, dietary supplement, pharmaceutical, life sciences, and other industries.
published date: 09-29-2008

NAI Sells Catalog and Internet Business

SAN MARCOS, CANatural Alternatives International (NAI) sold its As We Change catalog and Internet business for $2 million in cash, the company announced on August 5.

The sale of the catalog business, operated by NAIs wholly owned subsidiary Real Health Laboratories Inc., will enable NAI to concentrate on its private label and contract manufacturing clients.

The sale of this business should allow us to better maintain focus on our core business, private label contract manufacturing, and will provide liquidity that should allow us to make additional investments in our core business while maintaining our strong balance sheet, said NAI president Randall Weaver.

NAI generated $20.7 million in contract manufacturing revenues during the fourth quarter of 2008, compared with $18 million during the third quarter. The companys total revenues for the fourth quarter, including the catalog and Internet business, were $25.2 million.

We are extremely pleased with the growth in our fourth quarter revenues, particularly the contract manufacturing revenues, added NAI chairman and CEO Mark LeDoux. We believe our commitment to good manufacturing practices has paid dividends, as we have seen revenues from new customers grow. We are also pleased we have been able to attract top-tier customers and potential customers who recognize the value in our state-of-the-art facilities and our commitment to quality manufacturing.

published date: 09-29-2008

AHCC Symposium Highlights Research Findings

PURCHASE, NYMore than 300 doctors and researchers discussed the latest research findigns concerning active hexose correlated compound (AHCC) at the 16th International AHCC Symposium, held July 2627 in Sapporo, Japan.

AHCC is an immune-enhancing supplement derived from the hybridization of several species of mushrooms cultivated in Japan. Amino Up Chemical Co. (Sapporo, Japan) manufactures the supplement, which is distributed by Maypro Industries Inc. (Purchase, NY) in the United States.

In two keynote presentations, Masuo Hosokawa, professor emeritus of Hokkaido University (Sapporo, Japan), and Yasuo Kamiyama, professor emeritus of Kansai Medical University (Osaka, Japan), discussed research detailing AHCCs effects on reducing the side effects of chemotherapy and its use as a complementary therapy for postoperative cancer patients, respectively.

In addition, Yale University (New Haven, CT) researchers described the results of a study examining how AHCC affects the production of interferon and tumor necrosis factor alpha, two cytokines involved in immune health.

Drexel University researcher Barry Ritz, PhD, also gave an overview of an article on AHCC that will be published in an a future issue of Nutritional Reviews describing the supplements effects on several viral organisms.

AHCC continues to demonstrate its essential role for healthy immune function, said Fred Pescatore, MD, medical director of the AHCC research association.
published date: 09-29-2008

USP Opens New Brazilian Facility

SAO PAULO, BRAZILThe U.S. Pharmacopeia (Rockville, MD) opened a new, 1800-sq-meter facility in the Wtorre Technology Park in Sao Paulo, Brazil, on August 18.

The facility, situated close to several of USPs pharmaceutical clients, contains state-of-the-art office and laboratory space that the organization will use to dispense its publications and reference standards to local manufacturers.

This new site demonstrates USPs commitment to ensuring the quality and safety of pharmaceuticals, dietary supplements, and food ingredients for everyone, regardless of geographic, economic, or political borders, said USP executive vice president and CEO Roger Williams, MD. As the world continues to focus on these issues, it is even more important for standard-setting bodies and governments to collaborate. This office and laboratory facility will help USP work with Brazilian regulators and manufacturers to move toward that goal.

Flavio Vormittag, MD, vice president of USP Brazil, added that the company will work closely with the National Health Surveillance Agency (Brasilia, Brazil), the Brazilian Federation of the Pharmaceutical Industry (Brasilia, Brazil), and other organizations to ensure the quality of medicines and food ingredients.

Our presence will benefit Brazilian manufacturers, government agencies, and ultimately patients in Brazil, the United States, and the many countries to which Brazil exports, Vormittag said.
published date: 09-29-2008

Arnold Bread Launches Grains & More Double Omega Bread with the MEG-3 Ingredient

NOVA SCOTIA, CANADA--- Ocean Nutrition Canada Limited (ONC) announced that Arnold Bread has launched Grains & More Double Omega, a new bread formulated to improve heart health.

The Grains & More Double Omega bread serves up 50 mg of the MEG-3 Omega-3 EPA/DHA ingredient made from fish oil per two slices. In addition to including MEG-3 for heart health benefits, each slice also contains 20 grams of whole grains per slice and provides a good source of fiber and protein. This new bread product is available in supermarkets and mass retail locations in Northeast United States under the Arnold brand name, and under the Brownberry brand name in the Midwest United States.

This bread offers the added value of the MEG-3 ingredient which provides the complete health benefits of Omega-3 EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) from fish oil which are essential fatty acids that have been scientifically linked to supporting cardiovascular health, healthy brain function, and overall good health, according to the company.

We are very excited to be working with Arnold Bread to provide a bread product that is loaded with Omega-3. If consumers are not eating at least two 4 oz servings of oily fish per week then they are not consuming adequate levels of Omega-3 according to the U.S. Dietary Guidelines. With Double Omega, consumers can get the goodness of fish, while enjoying the great taste of Arnolds Bread, said Lori Covert, Vice President of Marketing & Communications at ONC.

published date: 09-18-2008

New JAMA Study Raises Research Questions

WASHINGTON, DC. A study published in the December 5 issue of the Journal of the American Medical Association (JAMA aised important philosophical issues regarding nutrient research and demonstrated the confusion when new research contradicts earlier work.

The scientific communityfrom scientists to journalists to consumerswants conclusive answers, consequently were always looking at what the study du jour tells us and trying to make it answer all questions, said Andrew Shao, Ph.D., vice president, scientific and regulatory affairs, Council for Responsible Nutrition. But the reality is that science doesnt always move forwardthere is some back and forthand while research may seem to contradict itself, that should not be interpreted to mean one type of study trumps another, particularly when different studies ask and answer different questions.

The JAMA review set out to evaluate the change over time in the quantity and content of citations for two observational studies. One concerned the major cardiovascular benefits associated with vitamin E supplementation. The other examined the protective effects of beta-carotene on cancer and estrogen on Alzheimers disease. Subsequent articles citing the studies were analyzed. The researchers gathered and reviewed 172 articles on vitamin E and cardiovascular health, 16 articles on beta-carotene and cancer prevention and 47 articles on estrogen for dementia prevention, rating them as favorable, equivocal and unfavorable. The sampled articles were published in 1997, 2001 and 2005 (before, early and late after publication of refuting RCTs) related to vitamin E and cardiovascular health and in 2006, which referenced highly cited articles proposing benefits associated with beta-carotene and cancer.

Pertaining to vitamin E the researchers found that, despite the large RCTs that received a great deal of media attention, more than half of the articles that cited the observational studies were favorable towards a beneficial effect of supplemental vitamin E. The study authors write, Even among articles that cited the contradicting HOPE [RCT] trial, rather than the positive epidemiological studies, the majority in 2005 still could not conclude that vitamin E was ineffective.

This suggests that researchers interpret research differently, depending on their bias and expertise, said Shao. For pure scientific purposes, heres a valid hypothesis to test: conduct a trial on secondary prevention in heart patients with a lifetime of bad habits that likely contributed to their heart disease to determine if a nutrient might provide some benefit. But its not valid to conclude from the results of that study that the nutrient doesnt work. We cant expect a simple vitamin supplement to reverse heart disease. So if that doesnt happen, we must interpret the results appropriately by placing the study in the proper context and acknowledge that the results dont answer the question of whether supplemental amounts of vitamin E in a healthy population could have prevented heart disease had it been used consistently over time in combination with other antioxidants.

The findings from the JAMA literature review related to beta-carotene and cancer and estrogen and dementia were similar, with the researchers finding that more than 62% of the articles in each of the subsets were favorable.

The RCTs with negative results attempted to answer the question, can a supplemental nutrient treat or reverse a disease or a lifetime of unhealthy habits in patients who are also taking prescription medications? said Shao. The observational studies with positive results attempted to answer the question, if we start with a mostly healthy population generally free of disease, can we identify various diet/nutrient and lifestyle factors that make them more or less prone to disease? These are very different questions, making the studies incompatible for direct comparison and demonstrating that one type of study cant necessarily be used to refute the other. We firmly believe that RCTs should not be thought of as the only rigorous research approach. As the study authors point out, when randomized and observational studies disagree, it is incorrect to assume that nonrandomized studies are always wrong. Rather, we should put studies into the appropriate context and evaluate the total body of evidence, which includes RCTs and observational studies, and other types of research. We hope that the publication of this analysis will encourage all of those within the scientific community to become more involved in this discussion.
published date: 12-04-2007

FDA Encouraged to Review EPA and DHA Omega-3 Science

SALT LAKE CITY, UT --In response to the US Food and Drug Administrations (FDA) notice of proposed rulemaking prohibiting nutrient content claims on products with EPA and DHA omega-3 fatty acids, the Global Organization for EPA and DHA Omega-3s (GOED) has urged the FDA and/or the Institute of Medicine to review the clinical science on omega-3s and make an authoritative statement on a recommended intake for EPA and DHA.

The FDAs proposed rule would ban nutrient content claims for products containing EPA and DHA on the basis that the IOM has made no authoritative statement that identifies a daily required or recommended nutrient level for EPA and DHA. The proposed rule was published in the November 27 2007 Federal Register (pages 66103 to 66118).

Rather than prohibiting nutrient content claims on EPA and DHA because an old review of the science set no daily requirement, we believe there should be a proper examination of the current clinical science to set a level for EPA and DHA as vital nutrients for chronic disease prevention and nutrient deficiencies, said Adam Ismail, GOED executive director.

The last review by the IOM of clinical science on EPA and DHA for the establishment of dietary reference intakes cited clinical studies and reviews through 2001. According to GOED, the PubMed database has 260 randomized, controlled clinical trials on humans and 347 reviews and meta-analyses published since 2002 that have not been assessed as part of the body of evidence for establishing a reference intake for EPA and DHA.

The IOM has only considered scientific findings related to nutrient deficiencies in the general population with regard to omega-3 fatty acids; however, GOED believes the FDA should consider an approach more akin to nutrient content claims on macronutrients like fiber, where chronic disease prevention was a criterion in establishing nutrient content claims rather than just nutrient deficiencies.

EPA and DHA are believed by many medical specialists to play a major role in preventing cardiovascular disease, one of the leading causes of death in the US, and a growing body of evidence indicates they may help in preventing many other chronic diseases. By allowing credible information to appear on products, the FDA will contribute to the education of consumers in making healthy dietary choices.

The market for EPA and DHA omega-3 products is very dynamic in the US, and in this case we believe the regulatory environment needs to catch up to the market, added Ismail. According to the Nutrition Business Journal, the US market for dietary supplements with EPA and DHA has grown from $100 million in 2001 to $489 million in 2006, while Packaged Facts estimates the US market for food products fortified with EPA and DHA has grown from nothing in 2001 to $600 million in 2006. This means the industry has gone from being a small emerging industry when the science was last reviewed, to exceeding $1 billion in sales today.

GOED strongly believes the best path forward, and to allow consumers to make the informed choices intended under NLEA, is for the FDA and/or the IOM make a determination about the required levels of these two vital nutrients for consumers to help prevent chronic diseases. We believe the time is right to re-examine the science, given the growth in consumers and health professionals interest in omega-3s and the FDAs recent request for comment on adding new nutrients to the Nutrition Facts panel, added Ismail, and in fact GOED has engaged the Life Sciences Research Office to hold a workshop in early 2008 that will explore the issues related to developing a recommended daily intake for EPA and DHA as a means of furthering discourse on the topic.

For more information, contact Lindsay Wright at 801/746-1413 or visit www.goedomega3.com.
published date: 11-29-2007

Natraceutical Group Acquires Viscofiber from Cevena Bioproducts Inc.

EDMONTON, ALBERTA Natraceutical Group, a biotech multinational holding company based in Europe, has agreed to purchase the assets and operations of Cevena Bioproducts Inc. Natraceutical Canada will manufacture and distribute Viscofiber, Cevenas high-viscosity and high-concentration oat beta-glucan soluble fiber. Natraceutical Canada Inc. is a wholly owned subsidiary of Natraceutical Group. The team that manufactured and marketed Viscofiber at Cevena will remain in place at Natraceutical Canada.

Beta-glucan is a natural grain-based soluble fiber mainly from oat and barley. The viscosity of beta-glucan is believed to be extremely important for its physiological efficacy. Today Viscofiber is the only viscous and high concentration beta-glucan commercially available in a multi-functional ingredient. Dietary fiber is collectively acknowledged to be one of the key factors in a health promoting diet as the link between intake of dietary fiber and the reduced risk of many diseases is established in several studies.

With an enhanced concentration of soluble fiber up to 12 times more than oat bran Viscofiber offers a new solution for heart healthy consumers. In fact, Viscofiber delivers a multitude of health benefits, including improved cholesterol, improved glycemic response, glucose management and increased satiety for weight loss formulations.

The need to incorporate fiber into our diets has never been higher, said Mr. Jos Vicente Pons Andreu, CEO of Natraceutical Group. Food manufacturers are scrambling to respond consumer demand for healthier, minimally processed food products.

Viscofibers high concentration and superior viscosity is ideal for dietary supplement manufacturers, while its great flexibility in product formulations is appropriate for functional food products. The ingredient can be incorporated into breads, drinks, nutritional bars, yogurts, ice cream, soups, pasta and breakfast cereals. According to Andreu, Viscofiber also offers great potential for introduction in the beauty and pet food sectors.

After the launch of soluble cocoa fiber last year, the purchase of Viscofiber is a further step for Natraceutical Group to lead the global functional food sector by developing and manufacturing healthy ingredients and services to help their customers to achieve optimal performance in the market-place.
For more information, visit www.natraceuticalgroup.com

published date: 11-16-2007

Three out of Four Physicians, Nurses Take And Recommend Supplements

WASHINGTON, DC. The Lifesupplemented Healthcare Professionals (HCP) Impact Study found that 79% of physicians and 82% of nurses recommend dietary supplements to their patients. The study also showed that 72% of physicians and 89% of nurses personally use vitamin, mineral, herbal and other supplements either regularly, occasionally or seasonally. In comparison, 68% of adults regularly take nutritional or dietary supplements.

The 2007 Lifesupplemented HCP Impact Study on dietary supplements was designed to evaluate the personal attitudes and use of dietary supplements by physicians and nurses and to determine if those factors impact whether they recommend supplements for their patients. The study was sponsored by the Lifesupplemented consumer wellness campaign, which is managed by the Council for Responsible Nutrition (CRN).

This survey, which is a first for our industry, shows that healthcare professionals believe that dietary supplements are part of a healthy lifestyle, said Steve Mister, president and CEO, CRN. Not only are they taking supplements for their own benefit, but theyre also recommending them to their patients. The approval of our products from reputable, respectable healthcare professionals, such as doctors and nurses, should be encouraging to consumers who already incorporate supplements into their wellness routine, and a wake-up call to those who havent yet started to do so.

Of the 72% of physicians who use supplements, 85% also recommend them to their patients. Of the 28% of physicians who do not use supplements, three out of five (62%) still recommend them.

It is common sense that physicians who personally take supplements also recommend them to their patients, said Donnica Moore, M.D., president of the Sapphire Womens Health Group and a member of the studys physician advisor team. Its interesting that the majority of physicians who dont use supplements still recognize their patients may benefit from them. Although the study doesnt provide an explanation, it may simply be that physicians recommend supplements to their patients for specific conditions that dont apply to the physicians own personal health.

The number of physicians recommending dietary supplements to their patients is highest among obstetrician/gynecologists (OB/GYNs) (91%), followed by primary care physicians (84%). In addition, the study shows that almost three quarters of physicians (72%) and more than three quarters of nurses (88%) say it is a good idea for patients to take a multivitamin.

The study found that almost half of physicians and nurses who take supplements most often do so for overall health/wellness benefits, while 41% of physicians and 62% of nurses who recommend supplements most often do so for the same reasons. Primary care physicians, OB/GYNs and nurses recommend supplements as often for general well-being/prevention as they do for special conditions, while other specialists recommend supplements more often for special conditions.

According to Dr. Moore, It makes sense to me that OB/GYNs are the group most likely to recommend supplements, although I am concerned that not all OB/GYNs reported they recommend them for their prenatal patients, given that womens healthespecially prenatalis one arena where the data supporting supplement use is overwhelmingly positive.

Among the physicians surveyed, 51% use dietary supplements regularly, 19% use them occasionally and two% use them seasonally. Among nurses, 59% use them regularly, 27% use them occasionally and 3% use them seasonally.

"Given the current state of the science, it is not surprising that increasing numbers of healthcare professionals are incorporating dietary supplements into their personal health routines. However, the fact that only 25% of physicians actively counsel patients regarding their dietary supplement use demonstrates an on-going and concerning problem that requires more outreach and education, said Tieraona Low Dog, M.D, director of education, Program in Integrative Medicine, and clinical assistant professor, Department of Medicine, University of Arizona Health Sciences.

Paula Gardiner, M.D., an assistant professor at Boston University Medical Center, who has conducted several surveys on the use of dietary supplements by physicians and is a member of the studys physician advisor team, cites the need for additional research, saying: It is critical to better understand how healthcare professionals recommend dietary supplements to their patients and how we can support educational initiatives to encourage dialogue between HCPs and their patients about the proper use of dietary supplements.

Almost three quarters of physicians (72%) and even more nurses (87%) reported they personally ask their patients about their use of dietary supplements. Also, 40% of physicians and 43% of nurses report that when discussing supplements with their patients, they, not their patients, are the ones who bring up the subject most often. Only 13% of physicians and one% of nurses agreed with the statement that no one in my practice inquires about which dietary supplements patients are taking.

Our industry needs to continue this type of research, said Judy Blatman, vice president, communications, CRN. Its important that we use this as benchmark data, continuing to do these types of surveys to see what trends develop in the upcoming years. But in order to do that, we need more companies to step up and support the Lifesupplemented program. Healthcare professionals are an important audience for our industry and for our consumers and we must continue to be proactive in this area.

For more information, visit www.lifesupplemented.org.

published date: 11-16-2007

Acrylamide-Free Biscuits Launched in Germany

DELFT, THE NETHERLANDSGerman consumers will soon be the first in Europe to be able to buy low acrylamide baked goods, according to DSM Food Specialities. A German manufacturer of Speculatius Christmas biscuits will launch the biscuits in October in time for the Christmas.

The biscuits incorporate PreventASe, an enzyme that reduces acrylamide in food by up to 90% through the asparaginase process. The enzyme converts asparagine, one of the precursors of acrylamide, into asparatate, a naturally occurring amino acid. As a result, asparagine is not available for the chemical reaction that forms acrylamide when carbohydrate-containing foods, such as bread, cake, cookies, potato chips and cereals are heated.

Our enzyme has been available for a couple of months for food manufacturers and we see that actual uptake is picking up now, said Judith Heikoop from DSM Food Specialties. The launch in Germany is indeed a breakthrough. It is the first time that asparaginase is being applied commercially, anywhere in the world.

Frito-Lay and Procter & Gamble recently announced that they have reached agreements with DSM Food Specialities on the Intellectual Property rights to apply asparaginase in food products.

Various institutions have identified asparaginase as a way to reduce acrylamide in food products. The list includes the CIAA (Acrylamide Toolbox of 29 September 2006), and the joint FAO/WAO Codex Alimentarius Commission on contaminants in Foods.

In the United States, PreventASe was granted GRAS status by the FDA. In France, the enzymes dossier approval by the French food health safety agency (AFSSA) means the enzyme can be applied as a processing aid. France and Denmark are the only countries in the EU where such approval is needed. DSM has filed for approval in Denmark and expects a positive decision soon.

For more information, visit www.dsmfoodspecialities.com
published date: 08-31-2007

Dr Edouard Brochu, A Probiotics Pioneer

MONTREAL Edouard Brochu, a pioneer in probiotics and cofounder of Institut Rosell, passed away on July 25, 2007, at the age of 96.

An agronomist and microbiologist born in Saint-Isidore-de-Dorchester, Quebec, Dr. Brochu dedicated his career to the development of lactic acid and probiotic bacteria, and the investigation of their health benefits. Emeritus professor for over 36 years, he taught at the Oka Agricultural Institute, the Universit de Montreal, and later at Saint-Hyacinthes Agricultural Technology Institute. During his career, Edouard Brochu received numerous honours and distinctions, among others: Commandeur of the Ordre du Mrite Agronomique, and the Chevalier de lOrdre National, Quebecs highest honor.As an additional and fitting recognition of his long and brilliant career dedicated to the development and the advancement of scientific knowledge on probiotics, he received a doctorate honoris causa from Laval University. His exemplary career development, his expertise in microbiology, his numerous scientific contributions as well as his sustained commitment towards the promotion of nutrition and health gained Professor Brochu respect from his peers and recognition beyond the boundaries of Canada.

In 1932, Edouard Brochu co-founded the Institut Rosell, an enterprise initially dedicated to research in lactic bacteria. Since then he never stopped devoting time and energy to the Institute, acting as its President or General Manager between 1944 and 1988. True to his reputation of exemplary commitment and perseverance, he continued to take an active part in its development after his partial retirement until his full retirement in 2002, and even then later to follow its evolution and share his valuable experience and knowledge with his successors.

The business he co-founded and nurtured, Institut Rosell, is today the Human Health and Nutrition Division of Lallemand, which has established a global reputation with active customers on all 5 continents for its probiotics and other health and nutritional yeasts and bacteria related ingredients .

Dr Brochu was a remarkable man, a highly regarded scientist, a very human businessman, teacher and mentor who has dedicated his entire professional life to the advancement of knowledge in lactic acid bacteria and particularly their use as probiotics. His insatiable curiosity, his relentless work, his perseverance, his willingness to listen and help all who called on him, his humanity, and his vision have inspired and will continue to inspire all those who have had the good fortune to have worked with him. Lallemand is immensely grateful for his contribution.
published date: 08-08-2007

FDA Issues Good Manufacturing Practices for Supplements

FDA will issue a final rule next week in the Federal Register that describes official good manufacturing practices (GMPs) for dietary supplements.

The rule is intended to ensure the quality of dietary supplements and prevent them from containing contaminated, impure, or adulterated materials. The GMPs set requirements for creating quality control procedures, designing and manufacturing plants, and identity testing of both individual ingredients and finished products. The rule also imposes procedures for recordkeeping and handling consumer complaints.

The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling, Robert Brackett, PhD, director of FDAs Center for Food Safety and Applied Nutrition, said on June 22.

Large companies with at least 500 employees have until June 2008 to comply with the new GMPs, while smaller companies with fewer than 500 employees will need to meet the requirements by June 2009. The GMPs will go into effect for companies with fewer than 20 employees in June 2010.

Under the final GMPs, manufacturers may use a certificate of analysis for specifications other than the identity of dietary ingredients, but they must monitor in-process controls and store batch production records. Manufacturers must maintain records for at least one year beyond a products shelf life or expiration date when such dates are used, or for at least two years beyond the date of distribution of the last batch of supplements associated with those records.

FDA will also issue a second interim rule that describes a process that manufacturers can use to request an exemption from some ingredient testing. Under the interim rule, only manufacturers that provide documentation that reduced frequency of testing would still ensure the identity of dietary ingredients would receive the exemption. FDA opened a 90-day comment period on the interim rule and will accept comments until September 24.

Several dietary supplement trade associations expressed optimism about the rules but said it will take days or weeks to read through the 815-page document.

It is too soon to know how well FDA incorporated the comments submitted by industry to the 2003 proposed rule, or to completely understand the economic implications of the final rule, said Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD). I encourage all AHPA members to review the rule promptly and to communicate your thoughts to me at your earliest opportunity.

We applaud FDA for bringing closure to this long, arduous process, said Steve Mister, CEO of the Council for Responsible Nutrition (Washington, DC.). We are now eager to dive into the details of this important regulation to determine both its appropriateness for our industry and to determine how companies can best implement it.

FDA was authorized to establish the GMPs under the Dietary Supplement Health and Education Act of 1994 (DSHEA).

To read the GMPs, click here.
published date: 06-22-2007

NIH-Supported Researchers Launch Nationwide Omega-3 Trial

BETHESDA,MD--Researchers supported by the National Institute on Aging (NIA), part of the National Institutes of Health, will conduct a nationwide clinical trial to invesigate whether omega-3 fatty acids slows Alzeimer's disease.

The study will be conducted by the Alzheimers Disease Cooperative Study (ADCS), a consortium of leading researchers supported by NIA and coordinated by the University of California, San Diego. The trial will take place at 51 sites across the United States and seeks 400 participants age 50 and older who have mild to moderate Alzheimers disease. Joseph Quinn, M.D., associate professor of neurology at Oregon Health and Science University, will direct the study.

Researchers will be evaluating primarily whether the omega-3 fatty acid DHA (docosahexaenoic acid), taken over many months, slows the progression of both cognitive and functional decline in people with mild to moderate Alzheimers. During the 18-month clinical trial, investigators will measure the progress of the disease using standard tests for functional and cognitive change.

The trial will use DHA donated by Martek Biosciences Corporation (Columbia, MD). Participants will receive either two grams of DHA per day or an inactive placebo pill. About 60 percent of participants will receive DHA, and 40 percent will get the placebo. Doctors and nurses at the 51 research clinic sites will monitor the participants in regular visits throughout the trial. To ensure unbiased results, neither the researchers conducting the trial nor the participants will know who is getting DHA and who is getting the placebo.

The evidence to date in observational and animal studies on omega-3 fatty acids and Alzheimers disease warrants further evaluation in a rigorous clinical trial, says NIA Director Richard J. Hodes, M.D. This study is one of a number we are undertaking in the next few years through the ADCS to test compounds that might play a role in preventing or delaying the symptoms of this devastating disease.

By participating in this study, volunteers will make an invaluable contribution to Alzheimers disease research progress, says Quinn, the studys principal investigator. We are indebted to those who graciously volunteer to participate in clinical studies.

In addition to monitoring disease progression through cognitive tests, researchers will also evaluate whether taking DHA supplements has a positive effect on physical and biological markers of Alzheimers, such as brain atrophy and proteins in blood and spinal fluid.

To learn how to participate in the study, contact NIAs Alzheimers Disease Education and Referral (ADEAR) Center at 1-800-438-4380 or by email to adear@nia.nih.gov. To view a list of the research sites, visit www.nia.nih.gov/Alzeimers.

NIA leads the federal effort supporting and conducting research on aging and the medical, social and behavioral issues of older people, including Alzheimer's disease and age-related cognitive decline. For information on dementia and aging, please visit the NIA's ADEAR Center at www.nia.nih.gov/alzheimers, or call 1-800-438-4380. For more general information on research and aging, go to www.nia.nih.gov.

The National Institutes of Health (NIH) The Nation's Medical Research Agency includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit For more information, visit www.nih.gov.
published date: 06-06-2007


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