Regulatory

HealthCo (Bloomingdale, IL), a division of NOW Health Group, has received Generally Recognized as Safe (GRAS) status for its Stevia FSE ingredient. The company contends that its Stevia ingredient is different from most other Stevia ingredients because it is enzymatically treated to remove stevia...s usual bitter aftertaste.

Health Canada has approved phytosterols (or plant sterols) and sterol esters for Novel Food use, according to Cognis Nutrition & Health (Cincinnati). Phytosterols, found naturally in plants, can compete with, and therefore lower, dietary cholesterol in the body.

A new bill introduced today demands that the Food and Drug Administration (FDA; Rockville, MD) implement the regulatory powers provided by the Dietary Supplement Health and Education Act (DSHEA) established in 1994. Called S.3414, the Dietary Supplement Full Implementation and Enforcement Act of 2010, the new bill has been introduced by Senators Orrin Hatch (R-UT), the original author of DSHEA, and Tom Harkin (D-IA). The bill also requires that FDA receive a minimum of $20 million in funding to aid enforcement.

Krill oil manufacturer Aker Biomarine (Oslo, Norway) announced last week that it has been granted permission to use the Marine Stewardship Council...s (MSC; London) sustainability label for the company...s Antarctic krill. Aker Biomarine produces krill oil and ingredients under the brands Superba and Qrill, and the MSC 'ecolabel' implies that the company only uses sustainable fisheries.

Dietary supplement manufacturer Wellington Foods Inc. (Long Beach, CA) is pleased to announce that it has received Good Manufacturing Practices (GMP) certification from the Natural Products Association (NPA; Washington, DC). In the independent, third-party audit, NPA gave the company an 'A' compliance rating in its certification for the dietary supplement industry. The company formulates, manufactures, and packages dietary supplements in both liquid and power forms. For more information on the company, click here.

To assist the dietary supplement industry with Good Manufacturing Practices (GMP) procedures, Blaze Science Industries (Lawndale, CA) and Tampa Bay Analytical Research Laboratories (Largo, FL) will be offering a one-day workshop in July in St. Pete Beach, Florida, according to Verdure Sciences (Noblesville, IN), a sponsor of the event.

The European Food Safety Authority (EFSA; Parma, Italy) published its negative opinion on a health-claims application for beta-glucans on May 26. But the details of Leiber GmbH...s (Bramsche, Germany) Article 13.5 application may be of greater concern.

The USDA Center for Nutrition Policy and Promotion released a draft report for its 2010 Dietary Guidelines for Americans, last week'”a report that will ultimately form the basis for 2010...s Dietary Guidelines for Americans. Within the report...s language, dietary supplements receive mixed approval.

As of today, June 25, all dietary supplement manufacturers are now required by law to follow good manufacturing practices (GMPs). Since the GMP final rule was first inked in 2007, the entire dietary supplement industry has had 36 months to prepare itself for the changes. Now, even companies with fewer than 20 employees are required to be comply with the regulation.

In the case of Monsanto v. Geertson Seed Farms'”the first-ever Supreme Court case to be held on genetically modified (GM) crops'”the Supreme Court has ruled 7 to 1 in favor of lifting an injunction (established previously by a lower court) on planting GM alfalfa. Furthermore, planting and selling of said alfalfa is still prohibited until an environmental review is conducted and considered.

UAS Laboratories (Eden Prairie, MN) has announced that its DDS brand probiotics are now kosher-certified by OK Kosher (Brooklyn, NY). The company...s DDS line of probiotics, including DDS Acidophilus and DDS Junior, is available in 37 countries around the world. OK Kosher currently certifies over 300,000 products from over 1500 companies.

Ever since the European Food Safety Authority (EFSA; Parma, Italy) published its second batch of general health claims in February, much of the industry had been waiting for last week...s stakeholders meeting, where EFSA intended to clarify its procedures and offer advice on claims substantiation.  

A subsidiary of Nestlé S.A., the world...s largest food and nutrition company, has agreed to drop allegedly deceptive advertising claims about the health benefits of its children...s drink BOOST Kid Essentials, as part of a settlement resolving the Federal Trade Commission...s first case challenging advertising for probiotics.

Cyvex Nutrition (Irvine, CA) has received Generally Recognized as Safe (GRAS) status for its BioVin(R) full spectrum grape extract and BioVin(R) 20 grape skin extract, according to a company announcement made yesterday. The successful GRAS status qualifies the extracts for safe used in a wide-range of functional foods and beverages. The process involved an intensive review of safety and toxicology data by an independent panel of qualified experts.

By unanimous vote, the U.S. Senate has passed S.3307, the Healthy, Hunger-Free Kids Act, which is reported to be the biggest financial increase for school lunch programs in recent decades.

Up until July 13, the case for cultivating genetically modified organisms (GMOs) within the European Union (EU) was deadlocked: some member states support the practice (e.g., Spain and Britain), while others (e.g., Austria and France) have made moves against it.

With current Good Manufacturing Practices (cGMPs) for dietary supplements now fully in place, the Food and Drug Administration (FDA) has the authority to conduct cGMP inspections of facilities of all sizes. As FDA inspectors hit the ground, so, too, are inspectors from NSF International (NSF; Ann Arbor, MI).

Originally Published

While writing this issue's State of the Industry report, I recalled the parting line of my editor's page in our November/December issue last year: "Looks like we're headed into an action-packed 2010." And indeed, the dietary supplements industry has certainly seen its share of activity so far this year, positive and negative-from (for some) increasing sales and innovation to tighter regulations and media scrutiny.

Per usual, priorities in Washington are too numerous to count. But major legislation affecting the dietary supplement, food, and beverage industries has been waiting its turn. Here are some of the could-be laws awaiting votes in the Capitol. (As of July 2010)

On March 26, a Food and Drug Administration (FDA) directive on Current Good Manufacturing Practices (cGMP) inspections made its way to agency field offices. Part III of the directive, known as the Dietary Supplement Compliance Program, or the Dietary Supplement-Import and Domestic Compliance Program, offers valuable insight on how inspectors will conduct dietary supplement cGMP inspections at both domestic and foreign dietary supplement firms.

Originally Published <a data-cke-saved-href="/sites/beta.nutritionaloutlook.com/files/articlelist.php?issueid=62" href="/sites/beta.nutritionaloutlook.com/files/articlelist.php?issueid=62" "="">NO July/August 2010IFT HONORS INNOVATION

As dietary supplement companies reported their financial results this year, they seemed to confirm that despite a down economy, things are looking up. This year kicked off with increased business for many-not all, but many-signaling either recovery from 2009, or growing business that had never dropped off, even during the recession. (Read some positive reports in the sidebar.)

A bill to levy tougher regulations on the U.S. cosmetics industry was introduced to Congress in late July. The Safe Cosmetics Act of 2010 (H.R. 5786) calls for a list of ingredients prohibited from use in cosmetics, new recall authority for the Food and Drug Administration (FDA), randomized postmarket cosmetics testing, and new registration fees for companies, among other measures, according to Representative Jan Schakowski (D-IL), who introduced the bill together with Ed Markey (D-MA) and Tammy Baldwin (D-WI).