Washington, D.C. – Today the Natural Products Association (NPA) 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).
The full lawsuit can be viewed here.
“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. 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,” said Daniel Fabricant, Ph.D. President and CEO of the Natural Products Association.
“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.”
On March 7, 2023, the NPA and 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 (LINK) 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.”
This was the third time the NPA pursued regulatory clarity through this path. NPA has also filed a citizen’s petition and lawsuit against the FDA on NAC, which can be viewed here and here. NPA’s citizens petition and lawsuit regarding the regulatory status of NAC 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. NPA’s citizens petition on CBD can be viewed here.
