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FDA Commissioner Gottlieb resigns

NutraCap Admin

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

NutraCap Admin

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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Alpha lipoic acid for healthy aging

NutraCap Admin

In a time where antioxidants are essential, consumers are looking for the right ingredient to combat free radicals. Known as thioctic acid, alpha lipoic acid is generated through small amounts in the mitochondria—otherwise known as “the powerhouse of the cell.” One study found that “As an antioxidant, [alpha lipoic acid] directly terminates free radicals, chelates transition metal ions (e.g., iron and copper), increases cytosolic glutathione and vitamin C levels, and prevents toxicities associated with their loss.”1 Also known to help with the aging process, another study found ALA helps lower oxidative stress associated with aging.2

In addition, according to Clinical Nutrition, ALA plays a key part in boosting energy production, as it helps the physiological responses to stress.3 As aging occurs, the body is not capable of maintaining the same level of cellular energy production. The Clinical Nutrition study evaluated the efficacy of carnitine, a mitochondrial metabolite, and lipoic acid. The research indicated that an age-dependent decrement in the levels of the TCA cycle enzymes and electron transport chain complexes, in which supplementation of carnitine (300 mg/kg bw/d) and lipoic acid (100 mg/kg bw/d) for 30 days brought the activities close to normal levels. This suggested that alpha lipoic acid helped reverse the age-related decline.

An additional study found that added with L-carnitine, alpha lipoic acid reduced oxidative stress and improved mitochondrial function.4 In the double blind, crossover study, researchers examined the effects of alpha lipoic acid with acetyle L-carnitine treatment on vasodilator function and blood pressure in 36 subjects for eight weeks compared to placebo. The results indicated that active treatment increased brachial artery diameter by 2.3 percent and reduced systolic blood pressure for the entire group. Moreover, there was a dramatic effect in the subgroup with blood pressure above the median, and in the subgroup with the metabolic syndrome. This strongly indicated alpha lipoic acid’s effect on blood pressure and endothelia function in the brachial artery.

As an important part of cellular production, alpha lipoic acid plays a profound impact on oxidative stress. Indeed, the right ingredient to combat free radicals could be Alpha lipoic acid—and helpful ingredient to provide consumers a long and healthy life.

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FDA official sheds light on dietary supplement working group

NutraCap Admin

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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USDA announces time frame for adopting hemp regulations

NutraCap Admin

USDA on Wednesday announced its plans to promulgate regulations in fall 2019 regarding the commercial production of industrial hemp in the United States.

Under the Agricultural Improvement Act of 2018—otherwise known as the 2018 Farm Bill—states and Indian tribes have the option to primarily regulate the production of hemp. That’s provided USDA approves their plans. But states and Indian tribes don’t need to submit plans until the agency adopts its regulations, according to USDA’s Agricultural Marketing Service in a notice to industry.

USDA will hold onto a submission if a state happens to submit a plan before the regulations are promulged. The notice proclaimed: “USDA is committed to completing its review of plans within 60 days once regulations are effective.”

At least one state acted immediately in response to the 2018 Farm Bill. The Kentucky Department of Agriculture submitted its regulatory plan for hemp production the same day President Donald Trump signed the bill.

“Kentucky is emerging as an epicenter for the American rapidly-growing hemp industry,” Ryan Quarles, Commissioner of the Kentucky Department of Agriculture, wrote in a letter to U.S. Agriculture Secretary Sonny Perdue.

For the 2019 planting season, states, tribes and institutions of higher education can continue operating under the 2014 Farm Bill, USDA said.

The 2014 Farm Bill authorized institutions of higher education and state agricultural departments to grow or cultivate industrial hemp under certain conditions. The scope of that bill—including whether it authorized commercial production and sale of hemp and hemp-based products—was long debated.

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Supply Chains & The Trust Transparency Paradigm

NutraCap Admin

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

NutraCap Admin

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

NutraCap Admin

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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Takeaways: Power for powder innovation

NutraCap Admin

Powdered supplements are projected to experience a 10.8 percent compound annual growth rate (CAGR) from 2016 to 2024, according to a 2018 report from Grand View Research. Succeeding in a thriving market with anticipated double-digit growth requires fine-tuned product development and formulation to ensure powdered supplements not only meet consumer expectations for quality, but also stand out on the shelf (or on a web page).

To achieve success in the powdered supplements category, consider these market dynamics:

Telling trends: As the category for powders grows, innovative products will steal the sought-after spotlight. Understanding consumer and category trends is critical to creating products that meet the needs of the market. Some trends impacting the powder category include clean labels, flavor innovation and packaging. Contract manufacturers with global presence can help to identify global and ingredient trends.

Quality considerations: Quality is essential in every category of dietary supplements. But powdered supplements have unique considerations such as taste, texture and solubility. If consumer expectations around quality aren’t met, consumers won’t repurchase the product, regardless how innovative the product is.

Partnership power: Whether a brand wants to test the waters of a trending market with a seasonal flavor or to see what a concept product may look, feel or taste like, a contract manufacturer may be the best resource. This is especially true when a brand is in a growing category like powders. Contract manufacturers can help brand owners to identify market trends, navigate quality considerations and improve time to market, among other benefits.

In the coming year, innovation will drive interest in the powders category. Longtime staples such as collagen and protein powders will remain strong players. Within these key product segments, innovation will take place in the form of packaging, flavor concepts and improved quality in areas such as taste. For example, sports nutrition brand BSN launched in March, in collaboration with Cold Stone Creamery, three new flavors—birthday cake remix, germanchokolatekake and mint mint chocolate chocolate chip—while Sparta Nutrition announced in January the launch of five new protein flavors, including loopy fruits (a take on Kellogg’s Froot Loops cereal) and blueberry muffin. Newcomers to the category will offer trending ingredients as a way to approach innovation. One example is the growth and interest in medium-chain triglyceride (MCT) oil powders to support ketogenic diet trends.

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

NutraCap Admin

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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