New FDA Dietary Supplement Working Group to examine how effective agency’s existing authority is for regulating supplement industry

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FDA has created a new Dietary Supplement Working Group whose goal is “to take a hard look at what more the FDA can be doing with our existing authorities” to regulate dietary supplements, said FDA Commissioner Scott Gottlieb, MD, this week. Gottlieb made the announcement during a speech he gave on December 12 at the Food and Drug Law Institute Enforcement, Litigation, and Compliance Conference hosted in Washington, DC, by the nonprofit organization the Food and Drug Law Institute.

Gottlieb said the new FDA Dietary Supplement Working Group will be examining FDA’s current, existing powers of authority for regulating dietary supplements, as well as “what new authorities make sense” in the agency's effort to effectively police the growing dietary supplement industry. He said the working group would also be examining the agency’s own internal operating processes and structure as part of this effort.

Gottlieb also hinted that there is more to come in terms of “specific, new policy measures.” At the conference, he said: “We have some specific, new policy measures that we plan to pursue when it comes to modernizing our overall approach to dietary supplements. You’ll be hearing more from us on that front very soon.”

Gottlieb also noted the existence of some products of concern in the dietary supplement industry. “Some products marketed as dietary supplements contain dangerous and illegal ingredients, often without identifying them to consumers. Some contain lawful ingredients, but their manufacturing processes fall far short of GMPs [current Good Manufacturing Practices] that are needed to assure a quality product. And others make illegal and unproven claims about their ability to treat serious diseases. We take seriously our obligation to protect consumers from all of these dangerous products,” he said.

He also noted the growing size of the supplement market, part of why FDA has formed the FDA Dietary Supplement Working Group to examine how the agency oversees this burgeoning category. “The dietary supplement industry has grown significantly from where it was 25 years ago,” Gottlieb said. “What was once a $4 billion industry of about 400 products is now an industry of over $40 billion and more than 50,000 products. And while much of this industry is responsible to consumers and the public health, there are also too many bad actors who are not. With the growth come new opportunities for consumers to improve their health, but also a lot of new risks. And 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.”

Dietary supplement industry associations the Natural Products Association (NPA; Washington, DC) and the Council for Responsible Nutrition (CRN; Washington, DC) commented on the news of the formation of the FDA Dietary Supplement Working Group and expressed some concern about Gottlieb’s mention of the notion of new FDA authorities to regulate supplements.

NPA’s president and CEO, Daniel Fabricant, PhD, said his association has put in a request to the agency to join the FDA Dietary Supplement Working Group. In a press statement, Fabricant said: “While we share the commissioner’s concerns and hope FDA gets serious about bad actors who illegally sell drugs under a dietary supplement label or make false claims, we disagree with his suggestion that more or different rules are needed or that the industry’s outstanding safety record has changed. We’ve urged FDA to get tougher on bad actors and we hope they do that, but in the meantime, they should also lead the discussion on new areas like cannabidiol (CBD) and other promising natural products, not playing catch-up.”

He continued: “NPA does disagree with the Commissioner’s characterization that the supplement industry is riskier. Dietary supplements remain the only food commodity for which there is a mandatory reporting requirement for serious adverse events (SAERs). The latest SAERs for supplements are still very low-consistent with prior years and still pale in comparison to prescription drugs. NPA is pleased FDA appears poised to act on our repeated calls for stronger enforcement and is eager to participate in the new working group to make sure Americans have continued access to safe, natural, and affordable supplements and natural products. NPA looks forward to working with HHS [U.S. Department of Health & Human Services] and the Agency in the future.”

Steve Mister, CRN’s president and CEO, released this statement:

“CRN welcomes the announcement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to reexamine its policies and approaches for dietary supplements. He’s correct that the dietary supplement industry has grown tremendously since the enactment of the Dietary Supplement Health & Education Act (DSHEA) in 1994 due to the emerging science that further supports the health benefits of these products and the continued growth in consumers’ interest to take more active roles in their health and wellness. We look forward to learning more about the recommendations of FDA’s Dietary Supplement Working Group and to working with the agency in evaluating these approaches.

Since Dr. Gottlieb’s arrival at FDA, we have seen increased enforcement against bad actors that mismarket drug ingredients as dietary supplements, the implementation of the Program Alignment initiative to make FDA inspectors stronger experts in the product facilities they inspect, and a willingness to work with the industry on Supplement Facts label changes. We applaud these efforts.

It is appropriate that FDA periodically reevaluate its regulatory tools and procedures. CRN has encouraged FDA to engage in more enforcement and to make use of the Supplement OWL, the dietary supplement industry’s online registry of products that provides the agency with new transparency. CRN will analyze any new proposals from the Working Group through the lens of DSHEA and the critical balance it strikes to protect public health while assuring consumer access to a wide range of healthful and safe products marketed as dietary supplements.”