NPA files lawsuit against FDA for its decision on NMN

Photo © iStockphoto.com/KLH49

The Natural Products Association (NPA; Washington, D.C.) has announced that they filed a lawsuit against the U.S. Food and Drug Administration (FDA) for its retroactive application of the Food, Drug, and Cosmetic Act (FD&C) against Nicotinamide Mononucleotide (NMN). The agency claims that NMN does not qualify as a dietary ingredient, citing drug preclusion. The agency’s decision was in response to a new dietary ingredient notification (NDIN) submitted by Inner Mongolia Kingdomway Pharmaceutical Limited (Kingdomway). However, prior to this, FDA acknowledged without objection an NDIN for an NMN ingredient from SyncoZymes (Shanghai) Co. Ltd. (SyncoZymes). As such, the agency subsequently retracted its acknowledgment.

The lawsuit is asking that the “court enter a declaratory judgment holding that ß Nicotinamide Mononucleotide (“NMN”) should not be excluded from the definition of a dietary supplement.” NPA alleges that FDA improperly interpreted the drug preclusion clause. “FDA’s misinterpretation of DSHEA harms NPA members who cannot sell dietary supplements, and the public, who are denied the benefits of dietary supplements. Under this misapplication of the law, FDA has created an unprecedented power for itself to reverse the status of dietary supplement ingredients that were previously reviewed by the agency,” states 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. 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, PhD, president and CEO of NPA, in a press release.

“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,” added Fabricant. “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.”

Prior to this, NPA, along with the Alliance for Natural Health (ANH) submitted a citizen petition requesting that the agency to reverse its decision on NMN, or commit to enforcing enforcement discretion regarding NMN supplements. FDA failed to reach a decision on the citizen petition within the 180 deadline and claims that it continues to evaluate the petition. In the meantime, Amazon has banned the sale of NMN supplements on the website.