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	The Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, makes significant amendments to the Federal Food, Drug & Cosmetic Act (FDCA). It requires FDA to implement a sweeping array of new regulations and enforcement policies, intended to better ensure the safety of food products marketed in the United States, including dietary supplements.

Dietary Supplements and the Food Safety Modernization Act: Today and Tomorrow

OmniActive Health Technologies (Bridgewater, NJ and Mumbai, India) has announced a partnership with the Council for Responsible Nutrition (CRN; Washington, D.C.) to educate and raise awareness about the role of lutein and zeaxanthin in supporting maternal and fetal health during pregnancy among obstetricians, gynecologists, and other maternal healthcare practitioners. This knowledge will be shared at The American College of Obstetrics and Gynecology’s (ACOG) Annual Clinical & Scientific Meeting. OmniActive is 

one of six companies CRN has partnered with

 to showcase the latest research and developments in prenatal nutrition through a specially designed “Prenatal Nutrition Center” at the conference. 

“It’s wonderful to have OmniActive as one of our featured partners during the ACOG annual event to help spread the word on the importance of prenatal nutrition,” said Andrea Wong, PhD, senior vice president, Scientific & Regulatory Affairs for CRN, in a press release. “CRN continues our efforts in supporting supplement manufacturers and ingredient suppliers in bringing clinically studied products to consumers to help meet their nutritional needs. Advancing awareness at the physician’s level is a huge part of this equation and this meeting is an effective way of reaching them.”

Citing market research from SkyQuest Technology, OmniActive explains in its press release that prenatal supplement sales were estimated to be at $740 million in 2023 and projected to rise to $1.4 billion by 2031. Similarly, a recent 

 found that about 60% of gynecologists think that 80-100% of their pregnant patients take dietary supplements. There is therefore a great deal of opportunity to grow and advance this category. Lutein and zeaxanthin are known for their support of eye health, but these benefits are relevant during pregnancy as well, says Deshanie Rai, PhD, FACN, vice president of Global Science, Regulatory and Advocacy at OmniActive Health Technologies.

“Current evidence supports the preferential accumulation of lutein and zeaxanthin in the human eye and neural tissues during pregnancy, especially during the third trimester. This suggests that lutein may play a functional and protective role in infant visual and cognitive development. As part of our Lutein for Every Age campaign, our goal is to help educate healthcare practitioners on this latest nutritional science research and the benefits of achieving adequate dietary lutein during pregnancy,” said Rai, in a press release. “OmniActive is proud to partner with the CRN Foundation’s Prenatal Nutrition Centre to promote awareness among healthcare practitioners on the nutritional relevance of lutein for both mom and baby.”

The educational initiative, “Lutein for Every Age,” focuses on raising awareness of early and consistent lutein and zeaxanthin intake to help support eye, cognitive, and general health throughout life, explains OmniActive. The AOCG meeting is taking place from May 17-19, 2024 in San Francisco, CA.

OmniActive Health Technologies has announced a partnership with the Council for Responsible Nutrition to educate and raise awareness about the role of lutein and zeaxanthin in supporting maternal and fetal health during pregnancy among obstetricians, gynecologists, and other maternal healthcare practitioners. 

Topic

OmniActive partners with CRN to raise awareness about macular carotenoids for prenatal health

Chondractiv™ Plus, New Collagen-based Solution for Joint Health & Mobility

Dietary fiber is an important nutrient that is well-recognized and sought after by consumers. According to the International Food Information Council’s (IFIC) 2024 Food & Health Survey,

 fiber was among the most desirable nutrients in the U.S. Dietary Guidelines, just behind protein. In the survey, 64% of American consumers said that they were actively trying to consume fiber. Additionally, 92% of people actively trying to consume fiber do so from food. “Good source of fiber” was also cited by 24% of consumers as a way to signify a food as healthy.

According to data from Innova Market Insights,

 the perceived importance of fiber grows with age. For consumers between the ages of 18 and 24, 51% accept fiber in their food, while 59% of consumers between 25 and 24 accept fiber in their food. After the age of 55, this percentage goes up to 71%. It should be no surprise that fiber consumption is a higher priority with advanced age, considering its benefits in reducing one’s risk of cardiovascular disease and type II diabetes.

While fiber is well accepted and recognized for its health benefits, it is still a nutrient of public health concern according to the U.S. Department of Agriculture’s 2020-2025 Dietary Guidelines for Americans.

 Based on research from USDA, Economic Research Service, and an external collaborator, dietary fiber density, measured as grams of fiber per 1,000 calories in food consumed, did not vary much across race and ethnicity in the 1977-1978 and 1989-1991 survey periods, but the gap has been widening over time. Since the 1994-1998 survey period, the diets of non-Hispanic black people have been significantly lower in fiber density compared to non-black people. For example, in the 2017-2018 survey period, Hispanic populations and people of other races and ethnicities had 9.2 grams of fiber per 1000 calories, which is significantly higher to the 7.7 and 7 grams of fiber per 1000 calories that were consumed by non-Hispanic white people and black people, respectively.

Clearly, fiber continues to have opportunity for growth as attempts are made to correct these disparities in fiber consumption. What’s interesting, however, is that according to Innova Market Insights, younger generations are more interested in prebiotics, and as a result, product launches between 2019 and 2023 with fiber claims have decreased while launches with prebiotic claims have increased. Part of the problem may be that fiber and prebiotic are used almost interchangeably. Terms like prebiotic fiber add to the confusion when you consider that not all fibers meet the definition of a prebiotic.

, called “Demystifying the Prebiotic and Postbiotic Markets,” Sandra Saville, RD, director of education and communication for the International Probiotics Association (IPA), said that in a survey commissioned by IPA and conducted by FMCG Gurus, many respondents had poor knowledge of what was and was not a prebiotic. For example, fibers that did not meet the criteria of fermentability were listed as prebiotics, as well as omega-3s, minerals, and polyphenols.

There’s therefore a need to educate consumers so that they can properly distinguish between fiber and prebiotics. This may be easier for fiber ingredients than prebiotics, as the latter does not have a standardized definition from regulators. By contrast, the U.S. Food and Drug Administration has an approved list of ingredients that meet the criteria of fiber, namely, “certain naturally occurring fibers that are ‘intrinsic and intact’ in plants, and added isolated or synthetic non-digestible soluble and insoluble carbohydrates that FDA has determined have beneficial physiological effects to human health. These effects include lowering blood glucose and blood cholesterol, reducing calorie intake, and increasing the frequency of bowel movements.”

Fiber continues to have a great deal of potential as an ingredient, but more work needs to be done to educate the public about its nutritional importance and what constitutes something as dietary fiber.

The International Food Information Council (IFIC) Releases Annual Food & Health Survey Revealing Rising Consumer Stress, Lagging Consumer Confidence In The U.S. Food Supply. IFIC. June 20, 2024. 

https://ific.org/media-information/press-releases/2024-food-health-survey/

https://www.innovamarketinsights.com/trends/fiber-and-prebiotic-trends-in-the-us/

Over time, racial and ethnic gaps in dietary fiber consumption per 1,000 calories have widened. USDA. March 28, 2023. 

https://www.ers.usda.gov/data-products/chart-gallery/gallery/chart-detail/?chartId=106189#

Questions and Answers on Dietary Fiber. FDA. July 15, 2024. 

https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/questions-and-answers-dietary-fiber#define_dietary_fiber

Manufacturers could benefit from leveraging fiber to give their products a "healthy halo."

Fiber forward

During SupplySide West, held in Las Vegas, Nevada from October 29-31, 2024, 

 spoke with Jennifer Clancy, Nutriventia’s head of global marketing, on the technology platforms for five ingredients: Melotime, Prolanza, C-Fence, CaffXtend, and TurmXTRA.

At this event, Nutriventia focused on showcasing the Art of Delivery, their philosophy of combining ingredients, technology, and innovation to deliver health solutions. “Our ingredients are obviously science-backed, but without these unique delivery solutions, it really is leaving the consumer or formulators out there unable to move to the next stage,” explained Clancy. “Our cutting-edge delivery platforms solve formulation challenges, ensuring products are easy to absorb, taste great, and deliver results.”

“Consumers just want to step away from the traditional capsules,” she added. “I think they're inconvenienced. You need water, they’re hard to swallow, and they are quite large, so everyone is really looking for alternatives. What we're highlighting here is our ingredients designed for gummy format, sustained or modified release. We're truly one of the only ones that are able to provide sustained release in the gummy format, dispersible solution, ensuring efficient absorption and maximum bioavailability.” Clancy also noted that there is no sugar added to the gummies and natural flavor is added in.

Melotime, a melatonin ingredient, is one of the time-released ingredients that comes in a gummy format, as well as tablets, capsules, stick packs (powder). It is designed to support 8-hour, restorative sleep and mimic the body’s natural sleep pattern. The release profile ensures up to 50% release in the first hour with a periodic release in a 6-hour interval for maintenance. Clancy also highlighted Nutriventia’s taste masking technology, their solution to melatonin’s bitter taste. Melotime was nominated for the 2024 Nutra Ingredients Awards.

Additionally, the Prolanza ingredient, also known as ashwanova, is an ashwagandha root extract designed for stress management. “It’s sustained release, so over time it's giving you that all-day stress support,” Clancy explained. Practical applications for Prolanza include capsules and stick packs (powder). The ingredient was rebranded as ashwanova and trademarked in New Zealand and Australia to offer better name recognition with regard to ashwagandha. The company is also working on global trademarks to rebrand the ingredient in multiple other jurisdictions. 

Their C-Fence ingredient, a direct compressible granular system, is another example of sustained release technology. “It provides 24-hour immune protection and antioxidant support with 12-hour sustained release for vitamin C. Nutriventia is the only one that is able to provide the sustained release of vitamin C,” Clancy stated. The findings were supported in a pharmacokinetic study, and other health benefits include brain health, cardiovascular health, and skin health.

Nutriventia’s CaffXtend product offers a solution to the diminished effects of caffeine due to its quick absorption in the body, plus caffeine tolerance effects from repeated dosing, known as ‘caffeine crash.’ The one-a-day single dose CaffXtend comes in stick packs (powder), hard capsules, chocolates, with gummies under consideration. CaffXtend is designed to last up to 12 hours, and is reported to reduce consumers’ perception of tiredness, fatigue, and jitters, according to a 2023 clinical study.

TurmXTRA, low dose curcuminoids for supporting joint and muscle health, is a 250mg one-a-day dose with a versatile range of applications, including powdered beverages, stick packs, capsules, tablets, gummies and chews, shots, and RTDs. “That's really what makes us different than the industry, that it’s not 500mg, it's 250mg,” explained Clancy. “You'll see TurmXTRA in a lot of ready to drink sports and active nutrition. We actually just met with the owner of Gold's Gym, and they're introducing two new pre-workout products, both contained through TurmXTRA, and two after workout products.” The ingredient also won NIE New Ingredient Award in 2023 in the Sports Nutrition category and was a finalist for 2023 NutraIngredients USA Awards in the Sports Nutrition category.

A recently published study found that TurmXTRA at 250 mg taken once per day had better absorption compared to a turmeric extract capsules with 500 mg curcuminoids and 5 mg of piperine taken three times per day for a 500 mg daily dosage. The comparison is apt because piperine is often used in combination with curcuminoids to support absorption.

“The heartbeat of our group this year is all around our innovation lab,” Clancy stated. “So we're really able to showcase our ingredients, but in various application formulas to be able to take it one step further and not just be a supplier of ingredients, but really to show at SupplySide West that we can take it one step further and offer concepts and solutions beyond just the brand of ingredient.”

Thanawala, S.; Shah, R.; Doyle, L.; Upadhyay, V. Comparative Pharmacokinetics of Curcuminoids from Water-Dispersible Turmeric Extract Against a Curcuminoids-Piperine Combination: An Open-Label, Randomized, Balanced, 2-Treatment, 2-Sequence, 2-Period Crossover Study. 

At SupplySide West 2024, Nutriventia showcased their innovations for five ingredients. These technologies offer consumers alternatives to traditional supplement forms.

Nutriventia showcases innovative ingredient delivery at SupplySide West 2024

Supplement launches featuring 5-MTHF are on the rise with double digit growth. In this episode of Nutritional Outlook’s podcast, we explore Optifolin⁺, a new ingredient in the market that offers essential nutrition from prenatal through adulthood. Join us as we uncover the potential impact of the next evolution in folate, setting the stage for a healthier future.  

Sarah Roller

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