NMN Banned by the FDA? What You Need to Know!

The FDA has recently stated that NMN, specifically beta-NMN, is excluded from being classified as a supplement due to being investigated as a potential prescription drug. This beta-NMN is the same NMN that most U.S. companies are selling. I'm going to link to all of my sources and everything down below in the description box so that you can look into this further. If you weren't aware of this, Dr. David Sinclair and his team at Metro Biotech International They've been working on getting NMN classified as a prescription medication. Their version of NMN is called MIB-626. It's a proprietary formulation and a version of beta-NMN, and Sinclair refers to it as a super-NAD booster. Sinclair was interviewed in a YouTube video in 2021, and he stated, So the question is, if MIB-626 is being investigated as a new drug in the U.S., does that mean it is suddenly no longer considered a dietary supplement? According to the FDA, if three criteria are met with the Federal Food, Drug, and Cosmetic Act, FDCA, then the FDA can ban NMN as a supplement. Number one, the ingredient must be authorized for investigation as a new drug. Two, substantial clinical investigations must have been instituted. Three, the clinical investigations must have been publicized. But, even if they meet that criteria, it does not cause an exclusion. If it was previously marketed as a supplement or as a food prior to authorization for investigation as a new drug, the current problem is that no one is disclosing the date of the new drug application submitted by Metro International Biotech. So it is not known when Metro International Biotech received authorization for beta-NMN or MIB-626 as being a new drug. The FDA doesn't disclose when a company submits an IND or investigational new drug application. So if it's the case that NMN was sold as a supplement prior to Metro International Biotech's FDA new drug request, then it cannot be excluded as a supplement. So we are waiting for an update on that situation. So in 2020, the FDA attempted to ban the supplement NAC or N-acetylcysteine. They claimed it was not a dietary supplement because it was first authorized for investigation as a drug prior to being marketed as a supplement. Citizen petitions were then filed against the FDA and several organizations fought this situation. The Natural Products Association, or NPA, filed a lawsuit against the FDA. The NPA stated that the FDA was attempting to retroactively apply a drug exclusion clause in order to ban NAC. NAC was sold as a supplement prior to the FD&C Act was ever enacted into law. So in the end, NAC was briefly taken off of Amazon and some other websites, but it's now being sold again. Although companies can legally sell it in the U.S., the FDA never formalized the exemption in writing, which kind of leaves things up in the air. The CEO of the NPA was interviewed and asked about the NMN ban, and he said, There's no reason why the agency couldn't begin a policy of enforcement discretion here on NMN immediately, even if it's a draft or interim. If the FDA does what they did with NAC, then NMN could remain available as a supplement in the U.S. I will keep you all updated on the situation, but so you know, almost all of the companies that I'm aware of are continuing to sell NMN in the U.S. at this time. The situation needs some updating and clarification which should happen later in the month, so I'm going to keep you posted as I'm following it very closely. Please also take a look at Richard's video from the Modern Healthspan channel because he does a really great job of summarizing the situation. What are your thoughts on this situation? Please feel free to share them down below in the comments section. If you found this video helpful, please subscribe. Thanks for watching and take care.