FDA responds to citizen petitions on NMN, amending its position on the ingredient's status as a dietary ingredient

The U.S. Food and Drug Administration (FDA) has responded to citizen petitions filed by the Natural Products Association (NPA, Washington, D.C.), Alliance for Natural Health USA (ANH; Edinburg, VA) and The Council for Responsible Nutrition (CRN; Washington, D.C.), regarding the status of Beta (β) Nicotinamide Mononucleotide (NMN). Previously, the agency concluded that NMN was not a dietary ingredient, citing the drug preclusion clause of the Food, Drug, and Cosmetics Act (FD&C), even retroactively rejecting an acknowledged new dietary ingredient notification for the ingredient.

NPA’s citizen petition requested that FDA reverse its decision on NMN, explain its interpretation of the clause, as well as reveal the date it relied on to reach the conclusion that NMN was authorized for investigation as a new drug. FDA granted the petition in part and denied in part. Notably, FDA amended its conclusion that NMN was not a dietary ingredient, but did not reveal the date of the IND authorization. FDA did not agree on a number of arguments set forth in NPA’s citizen petition, but did ultimately reach the decision that “the best reading of the race-to-market clause is that Congress intended the sole focus to be the timing of specific events, such as the first approval of the article as a new drug under section 505 of the FD&C Act and the first marketing of the article as a dietary supplement or as a food in the United States. Congress did not intend for FDA to examine whether the first marketing of the article as a dietary supplement or as a food was lawful.”

As such, FDA now concludes that NMN is not excluded from the definition of dietary supplement under section 201(ff)(3)(B) because NMN was marketed as a dietary supplement in the U.S. prior to any IND authorization.

“FDA’s decision today confirms NMN is lawful in supplements, and we now call on e-commerce platforms to immediately restore NMN products to the market,” said Daniel Fabricant, PhD, president and CEO of NPA, in a press release. “We will continue pressing Congress, the courts and the Administration until FDA stops abusing the drug preclusion clause once and for all.”

CRN’s citizen petition urged FDA to revise its interpretation of the drug preclusion clause. Just as it did in its response to NPA, FDA’s only concession was that the marketingof a dietary ingredient prior to an IND did not have to be lawful. Otherwise, FDA continues to limit marketing evidence to the U.S., rejecting foreign marketing of an ingredient as relevant evidence to the race-to-market. Nor did FDA clearly delineate what constitutes “substantial” clinical investigation, or provide guidance or rulemaking to create reasonable exceptions.

While the decision is a win for industry, its impact is limited, and therefore CRN expressed disappointment in the response from FDA. “The agency’s reliance on non-public IND dates and an expansive view of ‘substantial clinical investigations’ creates a moving target that businesses cannot reliably plan around,” said Megan Olsen, senior vice president and general counsel for CRN in a press release. “Yes, FDA now says that NMN is not drug precluded. But the same unstable framework remains in place for the next ingredient, inviting repeat uncertainty.”

“Collectively, FDA’s response does one thing: it allows FDA to dodge the bullet with respect to NMN and escape a potential legal battle over its status,” added Steve Mister, president and CEO of CRN. “But FDA has aggressively declined to provide any real guidance to the supplement or pharmaceutical industries. Without transparent, publicly knowable triggers and workable guidance, companies will continue to face unnecessary conflict with drug development rather than a coherent policy that advances public health.”