Similar to NAC, the NMN Citizen’s Petition requires FDA action and requests for a reevaluation by FDA or exercising Enforcement Discretion on Drug Exclusion Clause for NMN, consistent with the Law
Washington, D.C. – The Natural Products Association (NPA) along with the Alliance for Natural Health (ANH) today in a Citizen’s Petition to the Food and Drug Administration (FDA) requested 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.
NPA and ANH’s full Citizen’s Petition can be viewed here.
“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 possible its return to commerce on all platforms,” said Daniel Fabricant, Ph.D., President, and CEO of NPA.
“Our system is broken. The FDA is allowing pharmaceutical companies to ransack nature by monopolizing nutrients that can and should be dietary supplements,” said Gretchen DuBeau, Executive and Legal Director of the Alliance for Natural Health USA. “NMN is found in foods like broccoli, avocado, and cucumbers. This life-extending substance should be widely available, but the FDA is creating a situation in which only those who can afford to pay exorbitant drug prices will be able to enjoy NMN’s many benefits.”
“Issues surrounding NAC and NMN are glaring examples of the FDA fundamentally failing American consumers and industry. Today’s Citizen’s Petition on NMN positions NPA to have all options available needed to ensure NMN’s unwarranted regulatory uncertainty is rectified,” said Fabricant.