30 Aug 2024 — The Natural Products Association (NPA) filed a lawsuit against the US Food and Drug Administration (FDA) requesting it to cease its “unlawful” retroactive application of the Food, Drug, and Cosmetic Act against nicotinamide mononucleotide (NMN).
“This drug preclusion issue is not solely related to NMN, but a greater issue at hand when it comes to misapplication of the law by the FDA and our members have talked the talk and walked the walk,” says Daniel Fabricant, Ph.D., president and CEO of the NPA.
“NMN is just another iteration of the FDA’s misapplication of the Food Drug and Cosmetic Act. Unfortunately, much like NAC (N-acetyl-L-cysteine) and CBD (cannabidiol), the FDA’s negligence has caused significant economic damage to a critical part of the dietary supplement industry.”
Nutrition Insight reached out to the FDA for a response and the spokesperson told us: “The FDA does not comment on pending legislation.”
Meanwhile, many US trade associations representing the supplement industry oppose the recently proposed Dietary Supplement Listing Act of 2024, with reactions ranging from “misguided,” “unnecessary” and “burdensome” to the proposal being “too limited.” The bill, proposed by US Senator Richard Durbin, would introduce mandatory supplement listing in a FDA database.
Definition of dietary supplement
The NPA states that the FDA’s decision has weakened the integrity of the New Dietary Ingredient (NDI) process for manufacturers seeking to bring emerging and innovative ingredients for other dietary supplements to US consumers.
“Especially when the agency claims to have received only about 1,200 NDI notifications since the passage of DSHEA (Dietary Supplement Health and Education Act), representing only a fraction of the total NDIs launched on the market over that time and it estimates that more than 4,600 notifications should have been submitted and were not,” says Fabricant.
In March of 2023, the NPA and the Alliance for Natural Health (ANH) submitted a citizen petition requesting the FDA determine NMN is not excluded from the definition of a dietary supplement or commit to exercise enforcement discretion regarding the sale of NMN as a supplement.
The FDA said in a letter to NPA and ANH that the agency had “not reached a decision on your petition within the first 180 days due to competing agency priorities” and that staff “is evaluating your petition.”
Regulatory clarity requests
In total, the NPA pursued regulatory clarity through citizen petitioning thrice. NPA also filed a citizen’s petition and lawsuit against the FDA on NAC. The agency’s citizens’ petition and lawsuit regarding the regulatory status of NAC “established significant precedent for the dietary supplement industry” as it rendered enforcement discretion regarding drug preclusion for the first time in its history.
In 2022, the FDA sought to exercise enforcement discretion for NAC in products labeled as dietary supplements. After months of legal wrangling, the move was met with many reactions, ranging from deeming it “bittersweet” to disagreeing with the agency’s interpretation.
Earlier that year, the NPA demanded that the FDA assess if CBD qualifies as a dietary supplement.
By Inga de Jong