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Ensuring supply chain integrity before beginning supplement operations

In this remarkable age of international supply chains, instant transmissions of electronic information and voice communications, and the varied impositions of tariffs by different governments, the need for supply “country of origin” transparency has never been greater.

Recent statements from FDA Commissioner Scott Gottlieb, M.D., showed the agency believes it needs to step up its enforcement of the abuses of the dietary supplement industry that have been exposed in recent years. Concerns associated with imported goods remain, including the undisclosed presence of active pharmaceutical ingredients or their analogs, which have been identified by agency laboratories. The agency realizes to safeguard the consumers, it needs to step up enforcement of quality checks for imported materials.

One mechanism of this guardianship is the policing of new dietary ingredient (NDI) submissions by issuing timely acknowledgements of notification acceptance and better managing import alerts to customs and border officials to prevent adulteration, misbranding and potential harm to the consumer. This mandates transparency in the supply chain and honesty in disclosure documents.

Supply chain integrity rests squarely with the finished brand, which is tasked with the selection, handling, testing and processing of ingredients and components, as well as the composition, dose and shelf life of the finished product, whether it be a powder, liquid, tablet or capsule or in confectionery form. This elevation of responsibility was defined in statute with the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the subsequent imposition of the cGMP (current good manufacturing practice) requirements.

What remains a mystery is why almost half of the cGMP inspections conducted annually by FDA still result in either official or voluntary actions being taken by the firms inspected to correct deficiencies in some of the most basic components of a cGMP system, according to information obtained in a Freedom of Information Act (FOIA) request.

Supply chain transparency, or lack thereof, can contribute to significant problems with the agency and the products intended for commerce. Either producers of products in our industry are naïve, or they are willfully ignorant of their responsibilities. In certain circumstances, importers are willfully ignorant of what is in their products. Those that engage in such deception should be met with the full force of federal law, and the offending products should be subject to immediate seizure, no matter where or how the products are being sold in the United States.

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FDA dietary supplement initiatives will continue after Gottlieb’s departure

Despite the recent departure of Scott Gottlieb from FDA, the dietary supplement initiatives he set in motion are expected to continue under his successor. But it remains to be seen whether any substantive changes to supplement regulations or policies will be adopted under the current interim FDA commissioner.

Gottlieb, a physician who served as commissioner of FDA for two years and left the agency in early April, was widely regarded as a competent leader who spearheaded myriad initiatives and worked collaboratively.

National media reported the 46-year-old Gottlieb wanted to spend more time with his family after commuting weekly to Washington from his home in Connecticut. Gottlieb is currently listed as a resident fellow at the American Enterprise Institute (AEI), a conservative think tank, where he focuses on pharmaceutical policy, the cost of prescription drugs, FDA and other issues.

Under Gottlieb’s tenure in recent months, the agency announced plans to strengthen its regulation of dietary supplements and examine a potential legal pathway for the use of cannabidiol (CBD) in conventional food and dietary supplements. He also recently revealed the agency’s enforcement strategy related to CBD, which is widely sold in dietary supplements, cosmetics and other products.

“For supplements, Dr. Gottlieb’s tenure represents an era of FDA-industry collaboration that has never been observed before,” said Andrew Shao, interim senior vice president of scientific and regulatory affairs with the Council for Responsible Nutrition (CRN), in an email. “Under Dr. Gottlieb’s leadership, the agency recognized for the first time the importance of dietary supplements for public health and the great impact the industry has had.”

Outside the dietary supplement industry, the physician and former venture capitalist built a reputation for leading many initiatives focused on tackling high drug prices, strengthening food safety, preventing the use of e-cigarettes by minors and other public health issues.

“Commissioner Gottlieb’s resignation is a loss for the consumer products industry because he has shown a willingness to give industry guidance in areas that you often don’t see from agencies,” Raqiyyah Pippins, a lawyer in Washington with Arnold & Porter Kaye Scholer LLP, who focuses on FDA regulatory issues, said in an email.

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Finished product innovation give sports nutrition consumers more options

The global sports nutrition market is, in a word, massive. And it’s only going to continue to grow.

Different research firms will give you different dollar figures, but the consensus is the market is huge and only getting bigger. Grand View Research predicted the global sports nutrition market will reach US$24.43 billion by 2025, growing at a compound annual growth rate (CAGR) of 9.7 percent. Market Research Future is even more bullish, predicting the global market to reach $39 billion by 2020; Zion Market Research predictions go even further, estimating the market will reach $45.27 billion by 2022.

Not long ago, this market consisted mainly of two things: electrolyte-filled sports drinks and ready-to-mix protein powders. And while these products still make up the largest parts of the sports nutrition market—Euromonitor International expects those two subgroups to account for more than $7 billion each in 2020—they are hardly alone in today’s sports nutrition market. Supplements, bars, sweet and savory snacks, spreads, baking mixes and more now inundate the sports nutrition market as consumers seek new and innovative ways to obtain the benefits they seek.

With an ever-growing consumer base, the key for brands who wish to take advantage is to be sure they have a product for everyone.

Brands like Kodiak, IDF, Natural Force and others all understand this changing landscape. As the sports nutrition market continues to expand from athletes and body builders to the population at large, supplementation should continue to take new forms.

As Grand View researchers put it, “[A] growing consumer base…[and] widening base of health-conscious population are anticipated to foster the growth of the market over the coming years.”

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Personalized nutrition for the supplement industry

Personalized nutrition is the future. Currently, the model for pharmaceutical companies is treatment that will work for most patients, while modern wellness is moving toward a model that determines if a treatment works for an individual patient. Personalized nutrition equips consumers with the knowledge and power to make choices about desired actions as it relates to customized individual health and wellness; the making of “the citizen doctor.”

Major disruptors exist in every industry. Firms such as Uber, Spotify and AirBnB have turned age-old industries on their heads. We should expect the same in the health space. However, the health industry faces unique challenges. For one, the market is highly regulated, making it slow to change. Second, the lack of shared data hinders growth. Third, quality assurance (QA) is key. These roadblocks to progress are set to ensure the highest level of care and privacy for consumers.

This empowerment to the patient is now occurring because consumers can analyze their DNA at a reasonable cost, which was unheard of a few years ago. The tools of personalized nutrition can be evaluated in five major areas that can be innovated using data:

  • Gene sequencing
  • Brain mapping
  • Vitals tracking
  • Big data
  • Genetic customization

These tools rely on the advancement of technology and the complexity of computers to lead the charge. On the surface, taking this approach to developing new ingredients is costly and time consuming. However, it quickly becomes clear that personalized nutrition is not only better for consumers, but is also great for nutrition brands’ returns on investments (ROIs). Personalized nutrition allows patients to be treated to their own specifications, rather than in a generalized way, which may not be effective. Imagine being able to use exactly the right amount of a nutrient, and thereby reducing the amount of waste and ensuring efficacy.

An example is with curcuminoid as a personalized supplement. First, one’s personal situation is analyzed. Then, genome sequencing adds additional information. DNA-based variations in the genes or enzymes impact different consumers in a variety of ways. Knowing ahead of time if a patient will have an adverse reaction to treatment allows doctors and consumers to make a better-informed decision on the optimal dose or treatment. The curcuminoid is analyzed using rapid separation liquid chromatography (RSLC) technology, and other fingerprinting technology. This step is key. Rather than assuming each each plant is perfectly uniform, it assumes imperfections are in the system. This testing allows for quality control (QC) at the end product, not at the origin. The end game is efficient and cost-efficacy. Both the consumer and the supplier will see the upside of this.

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Antioxidant botanicals for joint support

According to the Centers for Disease Control and Prevention (CDC), more than 52 million Americans suffer from some form of arthritis—that’s 23 percent of the entire adult population. The joint nutraceuticals glucosamine, chondroitin and hyaluronic acid (HA) are agents that work well for joint support, but sometimes more intensive support is needed. Many herbs and botanical extracts have shown great promise in supporting joint health. Studies show a potent blend of these herbal extracts can provide tissue support benefits and relief from minor pain while supporting healthy joints and muscle tissue.

Botanicals can aid in the relief of muscular pain following intense exercise and provide antioxidants to help protect connective tissue from the damaging effect of free radicals. Devils claw extract, Boswellia serrata extract, turmeric root extract, bromelain, green tea, quercitin, grape seed extract, ginger and phellodendron have all been shown to exert a powerful influence for joint support.

Antioxidants are substances that fight free radicals—compounds in the body that can damage cells, DNA and cause cell death.

Green tea contains a high concentration of powerful antioxidants called polyphenols, which can neutralize free radicals and may reduce or even help prevent some of the damage they cause (Cell Biophys. 1989 Apr;14(2):175-85).

Quercetin belongs to a group of plant pigments called flavonoids, antioxidants that give many fruits, flowers and vegetables their color. In combination with other joint botanicals, it has been shown to impact muscle recovery and joint inflammation on tissues compromised by inflammation and its impact on muscle recovery (Nutr J. 2011 Sep 7;10:90. DOI: 10.1186/1475-2891-10-90).

Grape seed extract is one of the richest sources of antioxidants, including proanthocyanidins, that reduces the toxic effects of oxidative stress. Grape seed extract may be as much as 50 times more potent that vitamin E and 20 times more potent than vitamin C as an antioxidant (Int J Mol Sci. 2010;11(2):622-646).

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Coming soon to a supplement label near you

Food and dietary supplement labels will be changing right in front of consumers’ eyes. Some already are. And that’s a good thing—but brands must be ready.

In 2016, FDA announced its Final Rule requiring both the Nutrition Facts and Supplement Facts boxes on product labels get updated to reflect new scientific information and to help consumers make more informed choices. It subsequently extended the compliance deadline, mandating that most manufacturers complete these changes by January 2020, although small producers get an extra year to comply. The labels on store shelves already are changing as manufacturers begin phasing in these new requirements.

Some of these revisions were welcomed by the industry. One of the primary changes is new percent Daily Value (%DV) for some essential nutrients to replace outdated science that was 20 to 30 years old. These updated values reflect what we know now about how much average consumers need of these nutrients and what their daily diets are likely to provide. It turns out, we need more of some nutrients than previously thought and less of others.

In some cases, the new label requirements have led brands to reformulate rather than relabel. Some brands want to be able to declare 100 percent of the DV or continue to market their products as “good” or “excellent” sources of a particular nutrient (terms that are tied to the Daily Values). So rather than change labels, manufacturers chose to change ingredient levels. New formulations mean new safety analyses and new stability tests to keep the claimed percentages constant.

FDA also is mandating additional label information and changing the required vitamins and minerals that must be disclosed on the label. For example, the amount and percent Daily Value of sugars added to a product must be disclosed. Vitamins A and C will no longer be mandatory on the label, but vitamin D and potassium will be declared along with calcium and iron. Still other changes include changing units of measurement for vitamins A, D and E from International Units, or IU, to more common measures of milligrams and micrograms. And folic acid—an important nutrient before and during pregnancy—will be listed as folate and be measured in micrograms of dietary folate equivalents (DFE).

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Demand for natural sweeteners continues to rise

More consumers are embracing health and wellness and seeking out better-for-you products, resulting in tremendous innovation in the food, beverage and supplement industries that deliver novel products to feed and fuel the mind, body and soul.

This new paradigm in consumerism also includes a desire for products formulated with ingredients consumers can pronounce, as well as products with shortened ingredient lists. Nowhere is this more apparent the food and beverage industry, where increased numbers of consumers are demanding transparency about how ingredients are sourced and how products are manufactured.

According to the 2018 Food & Health Survey from the International Food Information Council (IFIC) Foundation, most Americans think about the healthfulness of the foods and beverages they consume. When asked to choose between two versions of the same product—an older one with artificial ingredients and a newer version without—69 percent chose the product with no artificial ingredients, while 32 percent opted for the one containing artificial ingredients.

When asked to identify the healthier of two products with the same Nutrition Facts Panel, 40 percent perceived one labeled “non-GMO” (genetically modified organism) as healthier versus 15 percent for one with genetically engineered ingredients, and 33 percent believed a product with a shorter ingredient list was healthier than one with more ingredients (15 percent). What’s more, 62 percent of consumers said they would pay up to 10 percent more for a product without artificial ingredients, while 42 percent said they would pay 50 percent more.

IFIC data also revealed consumption of and opinions regarding sugars have shifted over the years, with 33 percent of Americans pointing to sugar as the most likely calorie source responsible for weight gain. The findings aren’t surprising given sugar content in foods and beverages has been a politicized issue because of its association with several chronic illnesses, chief of which include obesity, diabetes, cancer and heart disease.

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CBD in packaged food and beverages

Alcoholic drinks are by far the most embedded industry in the cannabis sector. At least three leading corporate players have a stake in cannabis producers, the most notable being U.S.-based Constellation Brands and its 38 percent share in leading Canadian cannabis producer Canopy Growth. With the spirits and beer categories already headed in a low- or non-alcoholic direction, a future where tetrahydrocannabinol (THC) replaces alcohol is on the horizon. Cannabis beverages, with specific THC dosing and controlled onset-of-effects, will become more common in places that have legalized recreational use, ultimately providing the equivalent effect of a glass of wine or beer. These would be calorie-free, non-alcoholic or alcoholic recreational beverages with an intoxicating buzz.

Health and wellness trends are driving the global soft drinks industry, fueled by sugar reduction. The functional health and wellness trend is thus a natural bedfellow for cannabidiol (CBD)-infused products. In soft drinks, CBD launches have become prevalent over the last two to three years, particularly in bottled water, juices, ready-to-drink (RTD) tea, RTD coffee and energy drinks, as well as THC inclusions where recreational use of cannabis is legal.

Tea is currently the most popular application for CBD products in hot drinks, particularly green tea and herbal tea, related as they are to health and wellness. As low- and non-alcoholic beverages grow in popularity, and sugary soft drinks continue to decline, a consumer trend confluence occurs between alcoholic drinks and soft drinks. These blurring lines are creating a fertile ground for adult recreational soft drinks, where cannabis (more specifically THC in the long term) fits in as a social lubricant with a health and wellness halo.

Within packaged food, Euromonitor International expects sales of CBD products to double over the next two years, as consumer awareness grows. CBD and THC are the superpower holistic food ingredients of the future—think turmeric (anti-inflammatory) crossed with coconut oil (essential fatty acids). CBD/THC falls within the naturally functional and mindful consumption trends, tapping into the vegan, plant-based and free-from movements. Given hemp is grown sustainably, it is also spurred by the ethical living megatrend and back-to-basics move. THC-combined CBD products are chiefly prevalent in sweet categories, such as confectionery (chocolate and sugar), protein bars and ice cream, with potential for savory snacks, pasta and soups, among others.

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FDA Commissioner Gottlieb resigns

FDA Commissioner Scott Gottlieb, M.D., has resigned and will leave his post next month after almost two years at the helm. The move was a surprise, given he tweeted just two months ago that rumors of his departure were not true and he was determined to lead the agency through challenging regulatory issues.

The public health agency has taken aim at the opioid crisis, teen vaping and, most recently, dietary supplement regulation.

“I want to be very clear – I’m not leaving,” he tweeted, on Jan. 3, 2019. “We’ve got a lot important policy we’ll advance this year. I look forward to sharing my 2019 strategic roadmap soon.”

However, Gottlieb tweeted this afternoon, “I’m immensely grateful for the opportunity to help lead this wonderful agency, for the support of my colleagues, for the public health goals we advanced together, and the strong support of @SecAzar and @realDonaldTrump – This has been a wonderful journey and parting is very hard.”

Gottlieb only said he was leaving, effective one month from today, to spend more time with family, whom reside in Connecticut, while Gottlieb works at FDA in the Washington D.C. area. According to the Washington Post, which broke the story, White House officials assured the move was not initiated by President Trump.

In a statement released online, Department of Health and Human Services Secretary Alex Azar praised Gottlieb as a “public health leader, aggressive advocate for American patients, and passionate promoter of innovation.” Azar said he would personally miss working with Gottlieb on policy. “The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years.”

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Curcumin: Still on the climb

According to SPINS, 2017 sales of turmeric were more than US$4.8 million in U.S. conventional multioutlet stores—a 31 percent year-over-year increase compared to 2016. Additionally, the global curcumin market is expected to reach $110.5 million by 2024, a 137 percent increase from 2016, based on Global Market Insights data. Curcumin continues to climb, though several factors have the potential to impact the success of curcumin products. Consider these key market dynamics affecting the curcumin market.

Popularity & potential. Curcumin is enjoying a nod of approval from consumers seeking its health benefits, namely its anti-inflammatory effects. Natural Marketing Institute (NMI) reported mainstream consumer interest in using nutritional supplements to treat inflammation is on the rise; 30 percent of U.S. consumers were very interested in a supplement to manage or prevent inflammation in the body in 2017 vs. 19 percent in 2009. The anti-inflammatory effects of curcumin translate to several areas of health, with research supporting beneficial effects in cognition, mood and sports nutrition, furthering the reach of this powerful compound.

Ensuring efficacy & quality. Curcumin is challenged with poor bioavailability, which has led ingredient manufacturers and product developers to create solutions that ensure effective curcumin products. Though there are proprietary ingredients and formulation solutions—such as adding piperine to curcumin products—to address curcumin’s bioavailability issues, concern remains surrounding the efficacy of curcumin products. Some researchers, for example, question whether the supporting compounds in turmeric are necessary for curcumin bioavailability. Another challenge for curcumin is the threat of adulteration. The Botanical Adulteration Program reported curcumin has been adulterated with other Curcuma species, starches and dyes. More recently, the addition of undeclared synthetic curcumin or mixtures of synthetic curcuminoids to turmeric extracts has been reported.

Beyond supplements. Turmeric, from which the curcumin compound derives, is an increasingly popular ingredient in foods and beverages. However, food and beverage brands must use caution, as turmeric (and therefore curcumin) has only been approved by FDA as a food colorant and is not recognized for its medicinal properties. Therefore, turmeric should be listed as a coloring agent and not a functional ingredient, which seems like a bit of a grey area considering the many functional products using turmeric on the market.

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