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FDA official sheds light on dietary supplement working group

In December, FDA announced the formation of a working group to improve oversight of the dietary supplement industry. The industry immediately wondered about the working group’s participants and objectives, including whether it would make substantive changes affecting dietary supplements without outside input.

In an interview, an FDA official explained the internal working group is focused on improving the agency’s internal processes and procedures, and he emphasized FDA would continue to solicit input from stakeholders on substantive policy changes.

The working group is “a simple self-reflection and acknowledgement that we have an obligation as an agency to make the best use of the resources and the authorities that we have,” said Steven Tave, director of FDA’s Office of Dietary Supplement Programs.

Since passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the “market has evolved,” and FDA must ensure it has “evolved appropriately,” Tave added in a phone interview.

He suggested it is time to examine practices and procedures that his agency established long ago. For example, Tave noted, depending on a variety of factors, a product that contains an ingredient FDA has determined doesn’t belong in dietary supplements could fall under the jurisdiction of two different entities at FDA: the Center for Food Safety and Applied Nutrition, or the Center for Drug Evaluation and Research.

“When you have these products that label themselves as dietary supplements but actually contain unlawful drug ingredients … [under the law] that takes them out of the definition of dietary supplement and takes them out of the definition of food,” Tave explained. “Within FDA operationally, that makes them drug products, so what’s happening is we’re splitting up authority internally over the commodity.”

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Supply Chains & The Trust Transparency Paradigm

Transparency has become a reality, not an aspiration, in today’s marketplace. Understandably, customers and consumers in the dietary supplement industry have learned to expect more from companies, and are becoming progressively more demanding.

Ingredient manufacturers are becoming the cultural pivot point for change, and supply chains have been the focus of improvement. Expectations about transparency are eclipsing the rate of change though, as demand for more information increases. While companies seek openness from their supply chain, what they ultimately want is the trust of their consumers. To that end, we present here the paradigm of trust transparency—the intersection point of trust and transparency—which is a proactive and top-of-mind strategic approach to creating a process and value system that aligns organizations and their internal and external partners to develop tangible, quantifiable ROI.

There are many obstacles to overcoming perceived deficiencies in supply chain transparency including:

  • Inertia & Status Quo
  • Culture
  • Competitive Environment
  • Technology/Geography

Inertia & Status Quo
Today’s supply chain is still opaque, but slowly moving toward more transparency and clarity. It’s easy to maintain information privately that hasn’t traditionally been shared. Historically, we’ve been taught that we don’t get in trouble for what we don’t say. Today though, what is not said can be as damaging as what is. Consumers and society are shifting attitudes to require a responsible dialogue of truthful representation at an increasing level of accuracy. It is essential to recognize the shift in expectation and understand the need for both good and bad information to be shared.

Culture
Our supply chains traverse a variety of cultures that offer varying levels of transparency. To excuse misinformation or incomplete information as a product of culture, or translation of words or ideas, is not acceptable in today’s market. It’s our responsibility to educate about the importance of transparency and not enable, excuse, or accommodate a culture that is not open to disclosure. Rather, we should make it a point to reward transparency initiatives.

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Green Power for Future Generations

The world’s population is increasing rapidly. All people need to eat and there is no denying that protein supplies an essential part of a healthy daily diet. However, protein sources can exert an enormous impact on the environment and the world. Scientists around the globe are investigating plant-based alternatives to animal proteins. These alternatives can play a vital role not only in supplying essential nutrients but also doing it in a more environmentally friendly, sustainable way compared to animal proteins.

By the Numbers
While the current global population stands at 7.7 billion, some predictions estimate the number will grow to 9.8 billion by the year 2050. Correspondingly, food production needs to increase. This population growth means higher demand for animal protein; in fact, demand for animal protein might double. While animal proteins supply a full complement of essential amino acids required for human health, they also leave behind a huge environmental footprint. Some concerns, specifically related to increased animal protein, include the required amount of land, water, and feed necessary for its production, as well as emissions of greenhouse gases and potential issues with animal welfare.

The issues with animal-based protein extend beyond the land into the oceans. Researchers at the University of Western Australia and the University of British Columbia, who analyze global fishing trends, found that industrial fishing fleets have dramatically expanded their fishing areas, traveling double the distance to fishing grounds compared to 1950, yet catch rates are a third of what they were 65 years ago per kilometer traveled (Science Advances, 2018).

Plant proteins are certain to play a key role in meeting the protein needs of future generations and the growing population. The need for plant protein alternatives is critical and matching plant sources in the right combination can achieve adequate essential amino acid profiles. Currently, major industrial protein ingredients from plant sources include soy, wheat, rice, corn, peas, canola, and potato. Plant protein utilization can reduce demand for animal protein sources, thereby reducing environmental impact.

One study conducted in 2014 that compared the environmental cost of two plant-based proteins—one from beans and the other from almonds—to the cost of three animal-based proteins found that to produce 1 kg of protein from beans required “approximately 18 times less land, 10 times less water, nine times less fuel, 12 times less fertilizer, and 10 times less pesticide in comparison to producing 1 kg of protein from beef.” Beef also generated five to six times more waste compared to the other animal proteins, namely chickens and eggs (Public Health Nutrition, 2014).

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Fiber Revisited: Closing the Gap

On May 27, 2016, the U.S. Food and Drug Administration (FDA) published a definition of “dietary fiber” and created a pre-approval system for various isolated and synthetic non-digestible carbohydrates (NDCs). For all food labeled on or after Jan. 1, 2020, the isolated or synthetic NDCs must be determined by FDA to have a physiological effect that is beneficial to human health before they can be counted as dietary fiber for nutrition labeling purposes.

Dietary fiber is now defined by FDA as “non-digestible soluble and insoluble carbohydrates (with three or more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic non-digestible carbohydrates (with three or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health.”

This change has impacted product development in some significant ways.

According to Aouatef Bellamine, PhD, senior science manager, Lonza Consumer Health & Nutrition, Morristown, NJ, the new fiber definition means dietary supplement formulators and manufacturers will need to either adhere to this list of ingredients if they want to make a fiber claim, or petition for their fiber source to be added to the definition.

One company doing just that is Somerville, NJ-based Nexira, which along with representatives of the gum acacia industry, is conducting additional studies to strengthen the evidence supporting the beneficial effects of gum acacia on blood glucose attenuation and energy intake, noted Julie Impérato, marketing manager. After completion of the studies, Nexira is expected to submit a Citizen Petition to FDA in the spring of 2019 to request that gum acacia be recognized as a dietary fiber for nutrition labeling and claims on foods and beverages. “We are hopeful to receive a positive response from FDA by the summer of 2019,” said Ms. Impérato.

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FDA’s willingness to explore reform of DSHEA draws mixed reactions

Consumer advocates, some Democratic lawmakers and industry trade organizations reacted differently to FDA’s willingness to examine possible reform of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

The divergent reactions reflect stark differences of opinion over the reputation of the dietary supplement industry and its 25-year-old regulatory regime.

Peter Lurie, M.D., a former FDA associate commissioner who leads the nonprofit Center for Science in the Public Interest (CSPI), described DSHEA in a statement as a “deeply flawed law that has long handcuffed the FDA’s regulatory efforts and has produced the sprawling, largely unregulated and often reckless industry we have today.”

Industry trade groups weighed in with a radically different perspective. DSHEA offered consumers wide access to supplements while protecting the safety of the public, according to Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN).

“We are intrigued and enthusiastic to hear what FDA has in mind, but we will be very careful to protect that balance between access and safety,” Mister said in an interview.

FDA’s top official supported the notion that most companies in the industry are responsible. The remarks by FDA Commissioner Scott Gottlieb, M.D., also underscored the need for FDA to rigorously enforce its authority to target “bad actors” who spike products with undeclared prescription drugs or otherwise endanger the public health.

“We know that most of players in this industry act responsibly,” Gottlieb said in a statement, revealing his plans to strengthen regulation of dietary supplements. “But there are opportunities for bad actors to exploit the halo created by quality work of legitimate manufacturers to instead distribute and sell dangerous products that put consumers at risk. As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver.”

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CBD concentration matters

t’s true cannabidiol (CBD) is a drug. GW Pharmaceuticals went to great effort and expense to determine the clinical benefits of CBD. The specific, single-entity chemical is considered a drug because FDA approved it as one, and that is how the U.S. regulatory system operates. The regulatory system also renders items as drugs based exclusively on what is said about them. Cognitive dissonance occurs with different interpretations of the law, and this dissonance, while remaining unresolved, affords opportunity.

Harvesting CBD from hemp raw material (the botanical that was so much the focus of the passage of the Agriculture Improvement Act of 2018, otherwise known as the Farm Bill) is acceptable from a statutory perspective. Hemp products have recently passed through FDA review with a few specific new ingredients (not all) being considered GRAS (generally recognized as safe) for use in foods. The presence of CBD in hemp products additionally renders it consumed in conventional foods. The lack of objection to these hemp product GRAS notifications affirms FDA’s current determination regarding the safety of CBD and tetrahydrocannabinol (THC).

The question of whether this lack of objection extends to use in dietary supplements is a separate, open issue. Proper notification of CBD products as new dietary ingredients (NDIs) for use in dietary supplements is mandatory unless the article of food (hemp) has not been “chemically altered.” The current thinking from FDA is that just about anything is considered chemical alteration. The draft guidance on NDI notifications, issued in August 2016, clarifies this thinking regarding what results in chemical alteration.

Peak cognitive dissonance occurred when FDA Commissioner Scott Gottlieb, M.D., said in a Dec. 20, 2018 statement, “. . . it’s unlawful under the Federal Food, Drug and Cosmetic Act (FD&C) to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.” While FDA did not recently object to three GRAS notices for hemp products that contain trace amounts of both CBD and THC, it simultaneously stated its conclusions do not affect its position in an FDA Q&A on marijuana: It is a prohibited act under federal law “to introduce into interstate commerce a food to which CBD or THC has been added.” This is reminiscent of the similar agency view on the presence of lovastatin in products marketed as red yeast rice supplements and the related regulatory challenges it posed from years past.

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Takeaways: Sports nutrition for female athletes

The world is half female. At least half of the sporting world is female; however, most products are formulated for men or based on research conducted mostly on men.

Women are not small men. They are different anatomically, physiologically, biologically and biochemically. The biggest difference, and one of the primary reasons given for lack of female-specific sports nutrition research, is the menstrual cycle. During certain phases of their cycle, women can experience hormone fluctuations that affect muscles, energy and bone health.

There is tremendous opportunity for companies to capture part of this growing category, but it will require an approach that considers and respects the uniqueness of active females.

Research, Research, Research. It is up to brands and manufacturers to request, fund and support increased research on female athletes. Accept and account for challenges from menstrual cycle influences. “The inane idea that women are more difficult or more expensive to study is pure laziness, in my opinion,” said Susan Kleiner, Ph.D., R.D., owner of High Performance Nutrition LLC and nutritionist for many elite female sports teams.

For instance, researchers like Bill Campbell, Ph.D., associate professor of exercise science at the University of South Florida, purposefully does not plan trials around menstrual cycles. “The reason I do not consider the menstrual cycle in my studies is that I like to be able to extrapolate my results by saying that the outcomes were irrespective of the female’s menstrual cycle,” he explained.

More companies, such as sports nutrition brand Dymatize and ingredient supplier Bergstrom Nurition, are funding studies on females. Abbie Smith-Ryan, Ph.D., associate professor of exercise physiology and director of the Applied Physiology Lab at University of North Carolina, Chapel Hill, who also conducts studies on females, reported NIH now requires researchers to justify why they are or are not including women in their research proposals.

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Essential fatty acids health benefits

Fatty acids belong to a category of biological molecules called lipids (or fats), which are generally water-insoluble but highly soluble in organic solvents. Chemically, a fatty acid is a non-polar long aliphatic hydrocarbon molecule chain that has an acidic carboxylic acid group (COOH) at one end of its molecule, and a methyl group (CH3) at the other end, which is designated omega or ω. The COOH being at one end is what makes these molecules acids. Most naturally occurring fatty acids have an unbranched chain of an even number of carbon atoms (from four to 28). They have the general structure of CH3(CH2)nCOOH.

Fatty acids are derived from both animal and vegetable fats and oils. They are a necessary part of nutrition, and have uses outside the body (such as lubricants, cooking, soaps, detergents and cosmetics).

Fatty acids can be categorized in various ways, although they are primarily categorized through the degree of saturation or variation of chain length.

A saturated fatty acid has no double bonds. Saturated fatty acids are solid at room temperature, have high melting points and are common in animal and plant fats.

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The plant-based protein market — deep dive

In the past decade, products made with plant proteins have evolved to include a wide variety of flavors, textures and formats for every eating occasion. A broader range of consumers now seeks plant-based protein goods, particularly consumers under age 40 who eat meat but are incorporating other options. Dairy alternative, sports nutrition and snacks are some of the top categories for plant-protein products, drawing from sources such as soy, pea, lentil and ancient grains.

Takeaways for your business

• Taste is the top reason for eating plant proteins, far outranking concerns about environment or diet.
• 46% of consumers surveyed believe plant-based proteins are healthier than animal-based counterparts.
• Convenience foods, prepared breakfast items, frozen prepared foods and entrées show great potential.

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New research on curcumin’s health benefits

The big question about turmeric and curcumin asks how long its explosive growth will last. Will this superstar spice ingredient sustain its popularity and reach omega-3 status or fade into the background as a once-hot natural product trend? Thanks to the wide body of data generated in recent years, curcumin’s benefits categories have broadened substantially.

Sports nutrition is an up-and-coming benefit sector for curcumin, especially in light of its potential to reduce inflammation and soreness caused by strenuous exercise. The antioxidant benefits of curcumin and its ability to modulate inflammatory pathways underscores its potential as an adjunct to recovery.1

In a recent randomized, double-blind, placebo-controlled study, curcumin was shown to be an effective supplement for recovery after strenuous exercise.2 An additional study also reported a reduction in 24-hour pain scores as well as increased muscle performance after a muscle-damaging exercise.3

Curcumin is also finding potential in heart health, where the effects of its anti-inflammatory properties are being researched. Recently, a highly bioavailable form of curcumin was studied in a healthy population to examine its role in endothelial function, which plays a critical role in cardiovascular health.4 Curcumin’s direct impact on healthy circulation was measured using flow mediated dilation (FMD).

The randomized, double-blind, placebo-controlled study showed supplementing with 200 mg of curcumin had a clinically meaningful impact on potentially reducing cardiovascular disease by up to 50 percent in healthy individuals.

As the buzz around turmeric and its active component, curcumin, continues to spread, market opportunities for these popular ingredients are expanding.

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