On March 7th, the NPA, in conjunction with the Alliance for Natural Health, submitted a citizen's petition to the Food and Drug Administration (FDA) requesting the FDA:
- Determine nicotinamide mononucleotide (NMN) is not excluded from the definition of a dietary supplement under 21 U.S.C. §321(ff)(3)(B);
- Commit to exercising enforcement discretion in connection with the marketing and selling of NMN in or as a dietary supplement; or
- In the alternative, recommend the Secretary of Health and Human Services (HHS) issue a regulation after notice comment, finding NMN would be lawful.
The agency’s reversal on NMN NDIs is without statutory authority. The secrecy behind the IND dates, the evidence of a GRAS notice predating any IND on NMN, and NMN’s presence in the food supply all could’ve been rectified. Just like the case with NAC, the citizen’s petition gives the industry a platform to move towards a resolution concerning the ability to market NMN in or as a dietary supplement. In the case of NAC, NPA’s Citizen’s Petition was the vehicle that made its return to commerce on all platforms possible.
Now, we are calling on all health and wellness advocates to protect NMN supplements by writing to their members of congress, demanding they hold FDA accountable. The issues surrounding NAC and NMN are glaring examples of the FDA fundamentally failing American consumers and industry. Our Citizen’s Petition on NMN positions NPA to have all available options needed to rectify NMN’s unwarranted regulatory uncertainty. However, we still need your help, so please write to your members of congress today.
Thank you,
Daniel Fabricant, Ph.D.
President and CEO
Natural Products Association