FDA Determines NMN is Lawful in Dietary Supplements
- FDA has revised its previous interpretation of a clause of the Federal Food, Drug, and Cosmetic Act (FDCA) that states an ingredient that is first a drug cannot then become a dietary ingredient. In 2022, FDA had reiterated that the definition of a new dietary supplement excludes articles “authorized for investigation as a new drug . . . for which substantial clinical investigation have been instituted and for which the existence of such investigations have been made public,” unless the article was previously marketed as a food or dietary supplement, in its determination that β-Nicotinamide Mononucleotide (NMN) is not a dietary supplement, as we previously blogged.
- Now, FDA has determined that NMN may be lawfully used in dietary supplements in response to Citizen Petitions from the Natural Products Association, the Alliance for Natural Health USA, and the Council for Responsible Nutrition (CRN). The Agency has determined that the “race-to-market” framework in which a dietary supplement or food must have been lawfully marketed before the approval of a new drug is not the “best reading” of the statute. Thus, FDA will no longer evaluate whether the supplement or food was lawfully marketed when determining its status, but any marketing—legal or not—must have occurred in the U.S.
- In reevaluating its position on NMN, FDA noted that there is evidence that the substance was marketed in the U.S. as a dietary supplement as early as 2017 (before NMN was authorized for investigation as a new drug and substantial clinical investigations had been made public). As a result, it is not precluded from the dietary supplement definition.
- While FDA’s decision states clearly that NMN may be legally used in dietary supplements, the Agency left open questions about the wider race-to-market clause. According to CRN, FDA’s response to its petition “fail[ed] to address the core structural problems that sparked the NMN confusion to begin with.”