‘Here we go again’: NPA and ANH file Citizen’s Petition with FDA for NMN relief

07-Mar-2023 - Last updated on 07-Mar-2023 at 17:50 GMT

A new Citizen’s Petition is requesting the FDA reevaluate the status of NMN or exercise Enforcement Discretion on the Drug Exclusion Clause for the ingredient.

Filed jointly today by the Natural Products Association (NPA) along with the Alliance for Natural Health (ANH), the petition asks FDA to

- 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.

NMN is one of the forms of vitamin B3, or niacin, that has been shown to enhance the levels of nicotinamide adenine dinucleotide (NAD+) in the cells of the body. Boosting these levels has in turn demonstrated significant benefits in staving off cellular senescence.

FDA announced at the end of 2022 that NMN is not allowed as a dietary ingredient because of its prior investigation as a drug. The agency made this determination after having been made aware of recent drug studies on the ingredient. This reportedly came while doing due diligence on a recent New Dietary Ingredient Notification.

In response to the FDA actions, Amazon announced it was removing all NMN-containing dietary supplements from its online marketplace.

Similarities to NAC

Talking to NutraIngredients-USA, Daniel Fabricant, PhD, CEO and President of NPA, said that while the petition is not 100% identical to the one that the association submitted for NAC, it is similar and targets the same type of relief.

“Here we go again!” he said. “I think there are sound arguments [in the petition]. There are a lot of gaps here: A lack of transparency around the IND submission, questions why the GRAS affirmation isn’t evidence of marketing predating the IND, questions about why its availability in other countries is not evidence of being in the food supply.

“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 Dr Fabricant.

Gretchen DuBeau, Executive and Legal Director of the Alliance for Natural Health USA, commented: “Our system is broken. The FDA is allowing pharmaceutical companies to ransack nature by monopolizing nutrients that can and should be dietary supplements.

“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.”

The Agency has 180 days to respond, which would put the deadline in early September.

The citizen’s petition can be read here: