FDA NMN Policy - March 2023 Update

In March 2023, two of the largest supplement and natural products trade organizations filed a citizen's petition with the FDA asking that they change their position on NMN. The Natural Products Association (NPA) and the Alliance for Natural Health (ANH) asked the 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.

During a meeting on Friday, Dan Fabricant, the head of the Natural Products Association (the NPA) explained that although everyone hopes the citizen's petition leads to an FDA policy reversal on NMN, the filing is meaningful regardless of the FDA's response because it will ultimately allow the trade organizations the right to sue the FDA. Now that the citizen's petition has been filed the FDA has 180 days to respond. Often, they don't respond to citizen's petitions, but in both the case of a denial of the petition or a non-response the NPA and ANH gain the legal right to sue.

In order to avoid litigation and to encourage the FDA to come to the table to negotiate, the NPA is now asking that everyone who's interested in keeping NMN on the market as a supplement write to their representatives in congress. They'll create form letters next week that we'll forward on to you, but you can always visit your representative's website and write to them now.

FAQs

Q: Why is NMN being pulled from the US market?

A: Until/unless the FDA contacts us or issues a public policy statement, we won’t know for sure what the situation is. Below is the story being shared within the supplement community.

Most people will probably be surprised to learn that the way the FDA determines if a new ingredient should be classified as a drug or as a supplement is simply based on who files the paperwork first. NMN has been sold as a supplement for about 10 years in the US. Over the years, a few supplement companies have sent the necessary paperwork to the FDA to have NMN classified as a supplement, but each time the submission was rejected for unknown reasons. Then, a pharmaceutical company submitted the paperwork to have a refined form of NMN classified as an investigational drug and it was approved. After that, several supplement companies submitted the paperwork to have NMN classified as a supplement and at least one was approved. However, the FDA later retracted that supplement approval and changed the earlier designation of the refined form of NMN as a drug to include all forms of NMN as a drug. 

Hopefully the FDA ultimately limits the drug classification to the refined form of NMN, but we won’t know until the FDA takes any enforcement action. 

Q: Will NMN be pulled from the US market for sure?

A: We don’t know yet. It’s highly likely that NMN will be pulled from the market by the FDA, but the FDA doesn’t always enforce their own policy decisions. In the case of the product NAC, the FDA issued a policy statement that designated NAC as a drug but also issued an official policy statement that they won’t enforce the policy. So NAC is still widely available in the US. The NMN situation is different from NAC though in a material way. No pharmaceutical company had a vested interest in making NAC only available as a drug, whereas there is a pharmaceutical company with a strong financial interest in making NMN only available as a drug.

Q: Will I continue to be able to buy NMN supplements in the US anywhere after it’s pulled from the market?

A: If the FDA enforces their current position, then NMN won’t legally be sold by anyone other than pharmacies, and by prescription only. Even with a prescription, it’s unclear what diseases it would be prescribed for.

Q: Will NMN be available in other countries still?

A: We don’t know of any regulatory changes in any other countries that would cause NMN to be pulled from any foreign markets.

Q: What’s the difference between “normal” NMN & the investigational NMN drug?

A: We don’t know much about the investigational drug version of NMN. Natural NMN found in food is unstable and occurs in such small quantities that it would be impossible to sell an extract made of natural, unrefined NMN. We know that all supplement and drug forms of NMN are manufactured, refined, stabilized, etc… but we don’t know the differences.

Q: How much more effective is the investigational NMN drug than “normal” NMN?

A: We don’t know. David Sinclair has stated in an interview it’s much more effective, but we don’t know exactly what that entails: how much more effective, more effective compared to what baseline, or what it’s effective at doing. 

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