FDA to Strengthen Regulation of Dietary Supplements in Collaboration with Industry

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Washington, D.C.—FDA Commissioner Scott Gottlieb, M.D., released a statement regarding the agency’s new efforts to strengthen regulation of dietary supplements, promising continued focus on safety and availability.

The statement was largely positive. “I’ve personally benefited from the use of dietary supplements and, as a physician, recognize the benefits of certain supplements as part of a comprehensive care plan,” Dr. Gottlieb said. His goal, he said, is fully in line with that of most in the dietary supplements industry: “We know that most players in this industry act responsibly. But there are opportunities for bad actors to exploit the halo created by quality work of legitimate manufacturers to instead distribute and see dangerous products. One of my top goals is ensuring that we achieve the right balance between preserving consumers’ access to lawful supplements, while still upholding our solemn obligation to protect the public from unsafe and unlawful products.”

Dr. Gottlieb noted that supplements are growing more common: Three out of every four American consumers take a dietary supplement, including one in three children. When the Dietary Supplement Health and Education Act (DSHEA) was passed, he said, the industry was comprised of around 4,000 unique products, and was worth $4 billion. Now, it’s more than 10 times the size—anywhere from 50,000 to 80,000 products are available, and the industry is worth more than $40 billion.

With this growth, Dr. Gottlieb said, the number of entities marketing potentially dangerous products or making claims about the health benefits of their products has also grown, hindering consumers’ ability to make good choices: “To be able to make healthy choices with respect to dietary supplements, consumers need to have access to safe, well-manufactured, and appropriately labeled products.”

The FDA, Dr. Gottlieb said, has three priorities: to protect consumers from harmful products; to ensure that dietary supplement contents match their labels and are produced according to quality standards; and to foster an environment wherein consumers and health care professionals can make informed decisions regarding dietary supplements.

With regards to the steps he’s taking to achieve his goals, Dr. Gottlieb mentioned the Dietary Supplement Working Group he announced in December, saying that it is led out of his office and comprised of representatives from multiple offices across the agency. “I’ve tasked this group with taking a close look at our organizational structures, processes, procedures, and practices in order to identify opportunities to modernize our oversight of dietary supplements.” This is in an effort to ensure that the FDA is acting efficiently and sensibly.

The FDA also issued 12 warning letters and five online advisory letters to companies marketing products as dietary supplements capable of preventing, treating, or curing Alzheimer’s disease, in an ongoing effort to remove unsafe or illegally marketed products from store shelves.

Dr. Gottlieb said that the FDA is developing a new rapid-response tool to alert the public to dangerous or unlawful ingredients. He said that the FDA is looking to foster the submission of new dietary ingredient notifications, allowing the FDA to evaluate the safety of more ingredients. He also announced that the FDA recently created the Botanical Safety Consortium, a public-private partnership that will gather leading scientific minds to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements. He also intends to engage a public dialogue around whether or not it is necessary to modernize DSHEA itself.

“I’m confident that these efforts, and the ones that we’ll continue to advance in the future, will help us achieve these goals on behalf of consumers. We are eager to continue our work with both our industry partners and dietary supplement consumers.”

Dr. Gottlieb tweeted, “We’ll hold a public meeting this spring on new steps we can consider to help advance responsible innovation in the dietary supplement industry. We’ll address challenges that may be barriers to innovation, including incentives like exclusivity as a way to promote safe innovation.” To this, twitter user SanDiegoSunshine replied: “Keep in mind the intent of DSHEA and the Americans: we want to make our own decisions about dietary supplements. FDA has tried to impose unnecessary restrictions and hold supplements to the standard of drugs for over 100 years. We don’t want that and will fight against it.”

Industry Response

The industry response was largely positive, with industry leaders universally expressing enthusiasm for collaborating with the FDA to improve the safety and usefulness of the dietary supplements industry. The one place the FDA seemed to fall short? CBD.

Daniel Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA), said in a press release: “We welcome the need to look ahead, but FDA cannot ignore today’s challenges in the meantime: their inaction on one of the hottest products, CBDs, is a case in point. We look forward to working with FDA on modernization, but what consumers need is action.” He added, “The U.S. has the safest nutritional supplements in the world because of collaborative efforts between our industry and federal regulators, and we are confident that collaboration will continue.”

Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), said in a statement: “CRN appreciates the commitment of FDA Commissioner Dr. Scott Gottlieb to strengthen the dietary supplement industry and modernize FDA’s oversight of these products. He clearly shares our respect, both as a doctor and as a consumer, for the power of dietary supplements to improve the lives and health of all Americans. His statement shares our vision to further develop the thriving, innovative and safe marketplace for dietary supplements.”

Mister further applauded Dr. Gottlieb’s commitment for rooting out those who produce spiked products or unapproved ingredients. “We welcome additional enforcement actions to bring justice to those who would cynically trade on the halo effect of responsible industry to make a quick buck while ignoring the safety and health of consumers.” He called on Congress to allocate more funding to FDA for this purpose, and expressed enthusiasm for future engagement with the FDA to learn more about specific initiatives. “FDA will have a willing and enthusiastic partner in CRN and its member companies. The time is right to dream of an even more vibrant future.”

Loren Israelsen, president of United Natural Products Alliance (UNPA), said in a member brief, “We note that this important announcement falls on the 25th anniversary of DSHEA. We recognize that the world has changed. We will work closely with FDA on each of the stated objectives and the new ideas they propose, and to participate actively in the dietary supplement working group once that becomes more public, as well as the Botanical Safety Consortium. The prospect of amendments to DSHEA has long been discussed as a non-starter. We, of course, will listen closely to FDA’s ideas regarding DSHEA amendments and will work in close consultation with our members to that end.”

Michael McGuffin, president of the American Herbal Products Association (AHPA), said in a press release, “AHPA shares Commissioner Gottlieb’s vision of finding the right balance between preserving consumers’ access to lawful supplements, while also protecting the public from unsafe and unlawful products. AHPA has previously communicated specific suggestions for regulatory improvements to FDA and we look forward to a robust and transparent discussion on how best to serve Americans who include supplement products in their families’ health care choices.”

McGuffin added that AHPA has submitted comments to FDA regarding prior draft NDI guidance documents, and that they will continue to provide input, “so that any eventual guidance is both useful to the trade and does not stray from FDA’s statutory authority.”

The Consumer Healthcare Products Association (CHPA) issued a press release, too: “CHPA and our member companies strongly support FDA’s efforts to identify bad actors selling adulterated or misbranded dietary supplement products. We also look forward to collaborating with FDA on proposals to enhance quality and promote informed decision making as well as to discussing with the agency new policies which would promote innovation in the industry.”

CHPA noted in the release that it’s been 25 years since DSHEA was passed, making this “an excellent time to examine processes aimed at ensuring that the products consumers purchase are safe and carry claims backed by evidence.” CHPA added: “We look forward to ongoing discussion with the agency to ensure that the goals outlined in Dr. Gottlieb’s statement come to fruition.”

Mainstream Response

NBC, Medscape Psychiatry, and Medtech Dive all stayed neutral on the topic. The Washington Post, however, took a more negative view, focusing more on the increased risks to consumers than the fact that, according to Dr. Gottlieb himself, most of the industry acts responsibly. The Post also compared supplements to drugs: “dietary supplements are regulated as food and, therefore, are not subject to premarket approval or the kind of safety and effectiveness testing required for drugs.” The Post cited a 2015 study published in the New England Journal of Medicine, which estimated that 23,000 emergency department visits in the United States every year were attributable to adverse events related to dietary supplements. “According to the study,” the Post said, “many such visits involve cardiovascular problems arising from weight-loss or energy products.”

The Chicago Tribune reposted the Post’s article, under the headline “Unlisted ingredients, false claims, and $50 billion a year: The FDA says it’s ready to crack down on dietary supplements.”

However, Douglas McKay, N.D., senior VP of scientific and regulatory affairs at CRN, told WholeFoods recently that drugs and dietary supplements can’t be compared. “It’s like comparing apples to oranges,” he said, pointing out that while drugs have a risk-reward ratio, dietary supplements are supposed to be like food. And, according to the 2019 study he co-authored, they mostly are: “Your multivitamins and echinacea supplements aren’t causing adverse effects,” he said. Rather, it’s the aggressively formulated ones—the thermogenic weight-loss products and pre-workout products—that tend to have adverse effects. And even then, he notes, correlation is not causation: It’s not always possible to get the kind of data necessary to establish that the supplement is the cause of the concern.

Overall, however, this news escaped most mainstream outlets; it warranted a mention by CNN, but didn’t even get that in most other papers.

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