The Natural Products Association (NPA), a trade association representing the nutraceuticals industry, has filed a lawsuit against the U.S. Food and Drug Administration (FDA), after the agency determined that nicotinamide mononucleotide (NMN) is precluded from being sold as a dietary supplement because it was first investigated as a drug.
 
The lawsuit requests that the agency “cease its unlawful retroactive application of the Food, Drug, and Cosmetic Act against nicotine mononucleotide,” NPA reported.
 
Per the Dietary Supplement Health and Education Act (DSHEA), a given ingredient can’t be approved for use in dietary supplements through the New Dietary Ingredient Notification (NDIN) process if public notice has been made that the “article” was the subject of substantial clinical investigations as an investigational new drug. “Articles” which were already marketed as food ingredients prior to 1994 are exempt from this so-called “drug preclusion.”
 
In several decisions, FDA’s determinations about what constitutes “public notice” and “substantial clinical investigations” have been met with significant criticism from the dietary supplements industry. Critics also argue that FDA hasn’t been transparent in its determinations, and has blindsided the industry in its decisions on other ingredients as well, including NAC and CBD. 
 
The agency first made its position on NMN known in 2022, when it rejected an NDIN for NMN filed by Kingdomway.
 
NPA: Lawsuit Seeks to Correct FDA’s Broader Misapplication of the Law
 
Daniel Fabricant, PhD, president and CEO of NPA, said that FDA’s process on NMN, NAC, and CBD detracts from the intent of the drug preclusion rule found in DSHEA. Companies are disincentivized from introducing new dietary ingredients into the supplements marketplace through the proper NDIN pathway, instead opting to self-affirm their ingredients as Generally Recognized as Safe (GRAS) when it’s not appropriate.
 
“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,” Fabricant said. “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 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 damage to a critical part of the dietary supplement industry.”
 
“Equally as important, the FDA’s decision has weakened the integrity of the New Dietary Ingredient 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.”
 
NAP and the Alliance for Natural Health (ANH) jointly filed a citizen petition requesting that FDA reverse its decision precluding the sale of NMN as a dietary supplement. FDA responded by stating that it had “not reached a decision on your (sic) petition within the first 180 days due to competing agency priorities,” and that staff was still evaluating the trade associations’ position.
 
NPA has pursued regulatory clarity on drug preclusion through this path before. NPA also filed a citizen’s petition and lawsuit against FDA on its decision regarding NAC, which eventually led FDA to issue enforcement discretion guidance on the issue of drug preclusion for the first time in its history. NPA also filed a citizen petition on CBD.