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FDA launches tool to ‘quickly alert’ consumers of unlawful ingredients marketed as supplements

Various Dietary Supplements 2019

FDA announced today a new tool designed to quickly alert consumers of ingredients unlawfully marketed as supplements.

Dubbed the Dietary Supplement Ingredient Advisory List, the tool is intended to provide rapid notification to consumers of unlawful ingredients in order to better protect them from potentially dangerous ingredients. Included in the list are ingredients FDA deems not permissible for use in dietary supplements based on its “initial assessment” of an ingredient.

The tool is part of the agency’s efforts announced earlier this year to modernize its regulatory framework over supplements to meet the demands of an industry that has grown significantly over the last 25 years.

“As the dietary supplement marketplace has grown, the introduction of new ingredients often raises complex questions involving science, policy and the law,” said Frank Yiannas, FDA’s deputy commissioner for food policy and response, in a statement announcing the tool. “In the time it takes the FDA to make a final determination, consumers and industry might mistakenly conclude that a lack of action by the FDA indicates that these ingredients are lawful. This list is intended to get information to both consumers and industry more quickly. It also provides an opportunity for stakeholders to share information with us that they think might be relevant to our determination.”

Yiannas also pointed to “bad actors” who “seemingly ignore the legal requirements for dietary supplements” as an issue threatening the safety of consumers.

“While many dietary supplements meet the FDA’s standards, there are some companies who knowingly distribute and sell dangerous or otherwise illegal products that put consumers at risk,” he said. “As the agency entrusted with the oversight of dietary supplements, we will not stand by and allow these companies to compromise the health of the very people who are seeking out supplements to aid in their well-being.”

FDA cited potential reasons for adding an ingredient to the list, including lack of pre-market notification based on regulatory requirements; exclusion from use in a dietary supplement; and/or not fitting FDA’s definition of a dietary ingredient.

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FDA dietary supplement initiatives will continue after Gottlieb’s departure

Scott Gottlieb

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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FDA Commissioner Gottlieb resigns

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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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FDA official sheds light on dietary supplement working group

FDA tainted supplements 2019

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

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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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FDA commissioner announces formation of dietary supplement working group

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FDA’s top official on Wednesday announced the creation of a working group within his agency to improve oversight of the dietary supplement industry, reflecting concerns over FDA’s ability to manage risks in a sector that has grown 10-fold over the last quarter century.

“I’ve formed a dietary supplement working group within FDA to take a hard look at what more the FDA can be doing within our existing authorities, including re-examining our own internal operating structure and procedures—and what new authorities might make sense,” Gottlieb announced during a speech in Washington at the FDLI [Food and Drug Law Institute] Enforcement, Litigation and Compliance Conference. “We have some specific, new policy measures that we plan to pursue when it comes to modernizing our overall approach to dietary supplements.”

Since passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the industry has grown from US$4 billion to more than $40 billion, with more than 50,000 products on the market, Gottlieb observed.

“And while much of this industry is responsible to consumers and the public health, there are also too many bad actors who are not,” he said. “With the growth come new opportunities for consumers to improve their health, but also a lot of new risks.”

Gottlieb added, “I’m concerned that the industry has gotten bigger and riskier faster than our policies and our capacity to manage this risk. That needs to change. And so we plan on advancing new policies that will improve our oversight in this space.”

Gottlieb reported FDA’s success working with its partners at the U.S. Department of Justice (DOJ) on civil and criminal cases involving dietary supplements, an area where he said the agency has “encountered a range of problematic conduct.”

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IP trends in sports nutrition

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Patent filings directed to sports nutrition continue to generally grow year over year. The trend is particularly pronounced on a global scale.

The increase in patent filings (through 2016) of sports nutrition products has been occurring outside the United States, with a large portion of filings in China. Brazil and Russia, which are not usually on the top filer lists, have weighed in with a significant amount of patent filings specifically associated with sports nutrition.

Sports nutrition ingredients may be formulated into food products, such as modified foods or complete food formulations. Alternatively, specialized ingredients may be incorporated into single or multi-ingredient nutritional supplements. To be patentable, these types of formulations must include a unique non-naturally occurring single ingredient or a previously unknown combination of ingredients, among other innovative features.

Trademarks for sports performance products include some expected terms like “sport,” “perform,” “strong” and “fast.” Since these terms are common, they cannot be registered in trademarks on their own. Common terms and variations thereof must be coupled with more distinctive terms to obtain trademark registration.

Careful consideration is required to determine if a particular combination is available. Trademark availability searches from trademark counsel can help find a potential trademark that does not encroach upon the rights of a third party’s trademark.

Finally, a steady increase in the term “performance” may indicate the sports nutrition performance field is still growing. Opportunities still exist for innovative products and brands to carve out their exclusive rights in an exciting area of nutritional products.

This is an excerpt from the article, “Intellectual property trends in sports nutrition.” To read the complete article, download the Sports nutrition: Performance digital magazine.

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FDA still finding same cGMP deficiencies at dietary supplement facilities

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FDA investigators who inspect dietary supplement manufacturing facilities for compliance with cGMPs (current good manufacturing practices) are still often finding the same deficiencies more than a decade after the regulations were adopted.

In fiscal year 2018 (FY18), 75 inspections—or about 24 percent of firms that received a Form 483 inspection report for “observations,” or alleged cGMP violations—were cited for failing to establish product specifications for the identity, purity, strength and composition of the finished dietary supplement, FDA data revealed. This was the most common cGMP observation in FY18 year as well as in FY17 when 24 percent of firms (89 inspections) were cited for the same infraction, according to FDA data INSIDER obtained through the Freedom of Information Act (FOIA).

Over the years, FDA has repeatedly emphasized the importance of setting and following specifications for the identity and other key attributes of a dietary supplement. Without doing so, FDA and outside cGMP consultants have said, manufacturers have no reliable way to know and verify what is in their products.

Nearly half (274 inspections, or 46 percent) of the 591 inspections in FY18 didn’t receive a Form 483, which suggests those dietary supplement manufacturing facilities are fully compliant with the cGMPs.

Warning Letters

There may be another silver lining. Data analyzed by the Natural Products Association(NPA) suggested an increasing number of firms cited in Form 483s for failing to establish product specs make the necessary corrections without requiring an admonishment from FDA in a subsequent warning letter.

NPA, a trade association founded in 1936 and led by former FDA officials, reviewed FDA warning letters to analyze alleged infractions of the cGMPs.

In reviewing the data dating back to 2010, NPA identified a change in the most cited cGMP violation. Through the first nine months of 2018, FDA most commonly cited dietary supplement firms in warning letters for failing to establish and follow written procedures for the responsibilities of quality control operations. In FY18 Form 483s, the latter cGMP infraction was the second most cited cGMP observation (52 inspections, representing around 16 percent of all Form 483s).

In the previous three years, the most common cGMP violation reported in FDA warning letters was related to specifications to establish when devising a production and process control system, NPA reported this week in a chart within a news release. The above infraction dropped to the third most-cited cGMP violation in 2018 warning letters, while the second most commonly cited infraction related to recordkeeping requirements for production and process control systems.

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FDA’s new nutrition label regulation for fat-soluble vitamins

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The international unit (IU) has been used to measure fat-soluble vitamins—vitamin A, D and E—for decades. The IU is an arbitrary amount based on the amount of a given nutrient needed to produce a biological effect. Different than milligram or microgram, the IU measurement describes something that we cannot see; the potency or biological activity of a product. While IU seemed to be an innovative idea during the time it was introduced, many would agree that this IU system is now outdated.

In the new regulation for the nutrition facts label, FDA is replacing the unit “IU” for vitamin A, vitamin D and vitamin E with the metric unit. The unit for vitamin A will be changed to micrograms of retinol activity equivalents (mcg RAE), milligram of alpha-tocopherol (mg) for vitamin E while Vitamin D will be changed to microgram, while the IU reading for Vitamin D could be displayed in parentheses. This regulation will come into effect on Jan. 1, 2020 for companies with US$10 million or more in annual sales; and Jan 1, 2021 for companies with less than $10 million in annual sales. It is expected that other countries will follow this new regulation as well to standardize the labelling system. This new supplement/ nutrition facts label hopefully will help consumers to make a better decision in terms of choosing the right vitamin A and vitamin E for their daily consumption.

Vitamin A

Vitamin A is essential vitamin for healthy vision and cellular communication. There are two main ways to obtain vitamin A in the diet, through:

(1)         retinols from animal sources and dairy products;

(2)         pro-vitamin A carotenoid from plant.

Both retinols and pro-vitamin A carotenoid are metabolized in the body into the active form of vitamin A, retinoic acid. However, retinols and pro-vitamin A carotenoid differ in their bioactivities. As an example, it takes different amount of IU from retinol, beta-carotene from food, beta-carotene from supplement or alpha-carotene to make 1 microgram of retinoic acid.

Therefore, it is vital for consumers to check the source and forms of vitamin A to ensure they get sufficient vitamin A according to the recommended dietary intake (RDI). The RDI of the vitamin A has also changed from 5,000 IU (equivalent to 1,500 mcg RAE) to 900 mcg RAE for males and 700 mcg RAE for females respectively.

The conversion of unit of vitamin A from IU to the metric unit, mcg RAE, will take into account the differences in vitamin A activity between retinols and pro-vitamin A carotenoid. In the new unit, 1 RAE will equal to 1 mcg retinol, 12 mcg beta-carotene, 24 mcg alpha-carotene or 24 mcg beta-cryptoxanthin. Hence, the change of IU to mcg RAE for vitamin A is welcomed as this will reflect the actual or reality of vitamin A activity of its different forms—retinol and pro-vitamin A carotenoid.

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Probiotics provide a competitive edge in sports nutrition

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The gut flora performs a variety of functions that are important for health. In fact, 70 percent of the body’s immune cells are located in the digestive tract, making gut health critical to overall health. A healthy and well-balanced gut flora facilitates digestion, protects against pathogens, provides vitamins and nutrients, and helps form the immune system. For athletes and fitness enthusiasts, optimizing digestion and immunity are major factors as they strive to improve performance. As research advances, probiotics will play a leading role in shaping the sports nutrition supplements of tomorrow.

Athletes and active individuals have high nutrient needs, which are best met when digestion is well-functioning. Healthy bacteria in the gut aid in the digestion of macronutrients, allowing for optimized nutrient uptake from an athlete’s diet. They also aid in the digestion of macronutrients, allowing for optimized nutrient uptake from the diet. Some probiotic strains can play a role in the use of protein for muscle growth and human recovery by promoting the absorption of key amino acids. Being able to absorb more of the amino acids from protein can help increase muscle growth. In addition, probiotics can support immune health by adhering to the gut epithelium, thereby enhancing the “gut barrier” function of those cells by preventing the adhesion of pathogens.

Working out is all about breaking down and rebuilding muscles to become stronger and faster. With such activity, inflammation and free radical production are normal, expected and necessary—but the body’s response to these reactions will determine how quickly an athlete can recover and get back to his or her regimen. The two main areas of focus while doing strenuous activity are providing the right nutrients to build muscle (protein) and recovery (reduced inflammation). Probiotics can help in both of those areas; for example, the strain Bacillus subtilis DE111® (from Deerland) produces many enzymes to help break down protein, and recent research supported its role in reducing markers of inflammatory compounds that arise during exercise (Sports. 2018;6[3]:70).

According to the National Collegiate Athletic Association (NCAA), there are more than 480,000 NCAA student athletes who compete in 24 sports every year. And of course, this is only a slice of the physical-competition pie. Add professional sports, athletic trainers and serious fitness enthusiasts like marathoners and cyclists, and the number of individuals who could benefit from probiotic supplementation is significantly higher.

Read The Full Article HERE

 

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