NPA Files Lawsuit Against FDA’s “Unlawful Application” of Food, Drug and Cosmetic Act – Vitamin Retailer Magazine

The Natural Products Association (NPA) filed a lawsuit on August 28 against the U.S. Food and Drug Administration (FDA), requesting the agency cease its “unlawful retroactive application” of the Food, Drug and Cosmetic Act against nicotinamide mononucleotide (NMN).

“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,” said Daniel Fabricant, PhD, president and CEO of NPA. “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.”

On March 7, 2023, NPA and Alliance for Natural Health (ANH) submitted a citizen petition requesting 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. FDA told NPA and ANH it had “not reached a decision on the petition within the first 180 days due to competing agency priorities” and staff “is evaluating the petition.”

“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,” Fabricant said. “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.”

For more information, visit www.npanational.org.