Washington, D.C.—The Natural Products Association (NPA) has asked to join a new Dietary Supplement Working Group, according to a press release.
On December 12, Scott Gottlieb, M.D., commissioner of the FDA, delivered a speech at the Food and Drug Legal Institute (FDLI) Enforcement, Litigation, and Compliance Conference. He addressed the necessity of regulations and compliance, and mentioned those who show a “willful disregard for the rights or even the safety of people who’ll be affected by products being put into the marketplace,” including those who intentionally adulterate products, those who sell counterfeit, substandard, or unapproved medical products, or those who fraudulently market their products.
Dr. Gottlieb also said that he has formed a Dietary Supplement Working Group within the FDA to take a look at what else the FDA could be doing within their existing authorities, “including re-examining our own internal operating structure and procedures.” He stated that the FDA has new policy measures that they plan to pursue in modernizing their approach to dietary supplements, which the FDA would be releasing more information on soon.
This all comes after several products masquerading as dietary supplements have been removed from the market.
Daniel Fabricant, Ph.D., president and CEO of NPA, said in the NPA’s press release that, “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 and other promising natural products, not playing catch-up.”
The NPA pointed out that the association has met with the FDA or the Department of Health and Human Services (HHS) 11 times in 2018.
Dr. Fabricant added that, “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 (SAER’s). The latest SAER’s 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 and the Agency in the future.”