In a letter recently made public on the federal docket, the FDA has restated the position it announced in October 2022 that NMN does not meet the definition of a dietary supplement because, in the agency’s view, it was studied as a drug before it was ever sold in or as a supplement. The FDA is clearly gearing up for a ban of this critical anti-aging supplement. We need a strong, sustained grassroots response from the natural health community to protect access to this supplement; we also need to support changes in this law that threatens many other natural compounds from being turned into drugs.
The letter, dated January 23, 2023 but made public on March 29, 2023, is in response to a “new dietary ingredient” notification filed by Effepharm, Ltd., in November 2022 with additional information submitted in January 2023. The letter reiterates the FDA’s position that NMN is not a legal supplement due to the back-channel at the FDA that we’ve described many times before.
For supplements that are considered “new” under the law—that is, they weren’t sold “in or as a supplement” before 1994—companies must submit a notification to the FDA with studies to prove that it is safe before that ingredient can be marketed—this is referred to as a “new dietary ingredient” (NDI) notification. But here’s the issue: if a drug company files an investigational new drug application (IND) and studies that ingredient before the FDA receives an NDI notification on it from a supplement company, it can no longer be sold as a supplement.
This back-channel is threatening the existence of a number of important supplements. The pyridoxamine version of vitamin B6 was banned through this mechanism; CBD and NAC are also in jeopardy due to this loophole. We’ve explained previously that this provision inherently favors drug companies. IND applications are confidential. A drug company can file an IND on an ingredient and sit on it for years. Meanwhile, an innovative supplement company could develop that nutrient into a great product, do the studies to comply with the FDA’s ridiculous notification process, and then create a market for that product—and then the drug company can swoop in with their IND, kick the supplements out of the market, and create a monopoly.
Last month, ANH-USA filed a Citizen’s Petition with our allies, the Natural Products Association, calling for the FDA to issue a regulation stating that NMN is a lawful dietary supplement. You can read our previous coverage for more detail on the arguments contained in that submission.