Washington, D.C.—The Natural Products Association (NPA) has filed a lawsuit against the Food and Drug Administration (FDA) requesting that the agency cease its unlawful retroactive application of the Food, Drug, and Cosmetic Act against Nicotinamide Mononucleotide (NMN).
This lawsuit follows earlier efforts by NPA on NMN, which became necessary after a November 2022 notification by FDA declared that NMN is not a legal dietary ingredient. In 2023, NPA and Alliance for Natural Health (ANH) responded by submitting a citizen petition requesting that 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. In July 2023, FDA rejected a Congressional Request for Public Hearing on NMN.
Now, NPA has taken another approach with the lawsuit. “We are extremely grateful for the leadership shown by our organization’s members in deciding to take this issue head on but also for those within the organization who have financially supported this significant endeavor,” said Daniel Fabricant, Ph.D., NPA President and CEO. "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. NMN is just another iteration of the FDA’s misapplication of the Food Drug and Cosmetic Act. Unfortunately, much like NAC and CBD, the FDA’s negligence has caused significant economic damage to a critical part of the dietary supplement industry."
Dr. Fabricant added: “Equally as important, 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 American consumers. Especially when the Agency claims to have received only about 1,200 NDI notifications since the passage of DSHEA, 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.”
NPA noted that this is the third time it has pursued regulatory clarity through this path. NPA has also filed a citizen’s petition and lawsuit against the FDA on the regulatory status of NAC, and the association stated that those actions established "significant precedent for the dietary supplement industry as the agency rendered enforcement discretion regarding drug preclusion for the first time in the Agency’s history."
