Explained: NMN and the FDA

Explained: NMN and the FDA

There has been a lot of talk, and confusion, about how the FDA has changed it's stance on Nicotinamide Mononucleotide (NMN) in late 2022. This has created a lot of fear and uncertainty in the market, and hopefully we can help set the record straight. 

On May 16th, 2022 the US Food and Drug Administration (FDA) issued an acknowledgment (AKL) letter in response to a new dietary ingredient notification (NDIN) for NMN - which is the FDA's formal process for acknowledging the NMN ingredient notification without an objection, paving the way for NMN to be lawfully marketed in dietary supplements in the U.S.

On November 4th, 2022 an unprecedented move by the FDA revoked the acknowledgement letter for NMN and effectively said they 'changed their mind'. The agency’s reversal on NMN NDIs is without statutory authority. The secrecy behind the IND (Investigational New Drug for NMN, a pharmaceutical classification) dates, the evidence of a GRAS (Generally recognized as safe) notice predating any IND on NMN, and NMN’s presence in the food supply all could’ve been rectified. This puts NMN back to where it was before it received an NDI, however the FDA has not yet to issued a ban on sales, nor has the FDA made a formal ruling on NMN.

Our system is broken, and 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 potentially 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 the potential benefits of NMN.

If this sounds familiar, it's because it is. In 2020 warning letters from the FDA concluded that N-acetyl-L-cysteine (NAC) was excluded from the definition of a dietary supplement due to its earlier approval as a drug in 1963. That prompted industry trade associations to challenge the agency in citizen petitions, and file a lawsuit with the U.S. District Court. In comprehensive responses to the citizen petitions, FDA reaffirmed its position that NAC is excluded from the definition of a dietary supplement. The FDA subsequently adopted a policy of enforcement discretion in a final guidance, which essentially grants dietary supplement marketers a legal avenue to market NAC in the U.S.

Issues surrounding NAC and NMN are glaring examples of the FDA fundamentally failing American consumers and industry. 

If you want to learn more, listen to Dr. Daniel Fabricant, Ph.D. of the NPA (Natural Products Association) on Koncrete Podcast:

Take Action! (US Citizens): Tell your representative how you feel about this 📢


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Further reading and sources:

FDA says ingredient studied as drug—β-NMN—is excluded from supplements

NPA and ANH File Citizen’s Petition with FDA on Specific NMN Relief

ANH, NPA ask FDA to reverse position on NMN supplements

Amazon bans NMN in dietary supplements

FDA sticking to its guns on NMN in dietary supplements

FDA official concedes, ‘We didn’t connect those dots’ in reviews of NMN


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