The U.S. Food and Drug Administration (FDA) has responded to multiple petitions and actions from industry regarding the status of nicotinamide mononucleotide (NMN), granting in part and denying in part a petition from the Natural Products Association (NPA) and Alliance for Natural Health (ANH), as well as granting in part and denying in part a petition from the Council for Responsible Nutrition (CRN). 

 

In its responses, FDA now takes the position that NMN is not excluded from the legal definition of a dietary supplement by relevant language of section 201(ff)(3)(B) of the Federal Food, Drug, and Cosmetic Act. Under this clause and in relevant part, products are excluded from the legal definition of "dietary supplement" if they include an article that was subject to certain market or premarket approval or investigations as a drug, antibiotic or biologic product, and which had not previously been "marketed as a dietary supplement or as a food". FDA had previously taken the position that such prior marketing which would prevent an article from being excluded from the dietary supplement definition must be "lawful;" this is no longer the case.

 

In reaching this decision, FDA declines to address or resolve other questions and points of ongoing concern regarding the application of these "drug preclusion" elements of the law. AHPA will continue its work with FDA and other industry stakeholders, seeking greater clarity, certainty, and fairness regarding the path to market for dietary ingredients.