Disclosure: I work for a company that sells NMN, Renue By Science. With that said, all of my research on this topic, this post and all of the content on my site and on my Youtube channel are my own. These are topics which I am personally very interested in.
FDA States that NMN is Excluded from Supplements
An article released on November 10, 2022, revealed that the FDA has excluded NMN from being classified as a supplement, due to being investigated as a potential prescription drug. Dr. David Sinclair is a co-founder of Metro International Biotech LLC, a company striving to get their proprietary version of NMN classified as a prescription medication, known as MIB-626. An update to the situation is expected near the end of November 2022. There are reasons to remain somewhat hopeful in this situation.
FDA Attempted to Ban NAC in the U.S.
The FDA attempted a similar ban on a supplement called N-acetyl-L-cysteine (NAC), around July of 2020. The FDA sent warning letters to companies which sold the supplement, telling them it is not a lawful dietary ingredient, according to the FD&C Act’s drug-exclusion clause because the ingredient was first authorized for investigation as a new drug before it was marketed as a dietary supplement.
As a result, the Natural Products Association (NPA), along with the Council for Responsible Nutrition (CRN) and the American Herbal Products Association (AHPA), fought back. They filed citizen petitions and NPA filed a suit against the FDA on December 6, 2020. They stated that the FDA attempting to “retroactively” apply the drug-exclusion clause of the FD&C Act in order to ban NAC, was unlawful. They said that NAC meets the definition of a dietary supplement because it was marketed in the U.S. food supply since 1991, before the FD&C Act was ever enacted into law. In addition, NAC drugs that were approved in 1963 were not administered orally, so it’s not clear if the FD&C Act even applies to them.
When this situation was being disputed, in December of 2020, corporate counsel to Metro International Biotech, asked the FDA to “protect the right of companies that have spent significant time and research to develop drug products from competition from dietary supplements that are clearly new dietary ingredients that have never filed a new dietary ingredient notification prior to the institution of substantial clinical trials.” His statement was submitted to an FDA docket in response to a citizen petition filed by NPA.
The Outcome of the NAC Situation
Although the FDA has stated that NAC is excluded from the definition of a dietary supplement, the FDA later adopted a policy of enforcement discretion in a final guidance, which basically allows companies the ability to legally sell NAC in the U.S. Although it’s somewhat positive news that NAC can be sold, the FDA never formalized in writing that NAC is exempt, so that situation is not fully settled.
On November 4th, 2022, the NPA NAC lawsuit was dismissed without prejudice, after they provided a notice of voluntary dismissal. Interestingly, this was the same day that the FDA issued new letters regarding banning NMN from being sold in the U.S.
More Details About the Current NMN Ban
Between the summer of 2020 and the spring of 2022, five companies submitted notifications for new dietary ingredient notifications (NDINs) for NMN. Four of the five were rejected, but the rejections were unrelated to NMN being under investigation for use as a drug. One company which received approval of its NDIN for NMN was SyncoZymes. In June of 2022, SyncoZymes officially received a confirmation letter from the FDA, confirming that their NMN ingredients have successfully passed the NDI (New Dietary Ingredient) approval. The acknowledgement letter to SyncoZymes confirmed that β-NMN could be lawfully sold as a dietary supplement in the U.S. But, that all changed recently.
I will keep you posted whenever meetings take place & whenever updates are available.visit this page: updates on the fda nmn ban
FDA Backtracks Suddenly Due to New Information
But, in early November, an FDA official told SyncoZymes that β-NMN is now excluded from the definition of a dietary supplement.
“Based on new information that came to light when we were reviewing another notification, FDA initiated a review of past notification responses for NMN and concluded that NMN is excluded from the definition of a dietary supplement,” an FDA official, R. Philip Yeager, Ph.D.
He continued on to state, “FDA has carefully reviewed the information available to us and has determined that NMN was not marketed as a dietary supplement, except unlawfully without an NDI notification, or as a food before FDA authorized it for investigation as a new drug,” Yeager wrote in the letter to SyncoZymes.
“Further, FDA has carefully considered the information available to us and has determined that NMN is an article for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,” Yeager added. “Accordingly, we conclude that NMN is excluded from the dietary supplement definition under 21 U.S.C. § 321(ff)(3)(B)(ii) and may not be marketed as or in a dietary supplement.”
Metro International Biotech’s Role In the Situation
Dr. David Sinclair and his team at Metro International Biotech, have been working on getting NMN classified as a prescription medication. Their version of NMN is called MIB-626. This is a version of β-NMN beta-nicotinamide mononucleotide. Beta NMN is a common form of NMN being sold worldwide as a supplement, for years now.
MIB-626 is a proprietary formulation of NMN and Sinclair refers to it as a super NAD+ booster. Sinclair was interviewed in a youtube video in 2021 and he stated, “We hope to get on the market in about 3 years from now, for diseases, FDA approved.”
So the question is – If MIB-626 is being investigated as a new drug in the U.S., does that mean it’s suddenly no longer considered a a dietary supplement?
Federal Food, Drug & Cosmetic Act
According to the FDA, if three criteria are met with the Federal Food, Drug & Cosmetic Act (FDCA), then the FDA can ban NMN as a supplement.
- The ingredient must be authorized for investigation as a new drug.
- Substantial clinical investigations must have been instituted.
- The clinical investigations must have been publicized.
But, even if they meet the 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 investigational new drug application (IND) submitted by Metro International Biotech .
Metro International Biotech’s Request to the FDA
Although we don’t know the date of their new drug application, corporate counsel with Metro International Biotech sent a letter to the FDA on December 1st, 2021, which corresponded with the FDA attempting to ban NAC.
The Potential Outcomes of the FDA NMN Situation
As previously mentioned, the NPA filed a lawsuit against the FDA when they attempted to ban NAC sales in the U.S. The President and CEO of the NPA is Dan Fabricant. He is an industry expert and according to his bio “Most recently, Dr. Fabricant served as the Director of the Division of Dietary Supplement Programs at the U.S. Food and Drug Administration (FDA), where he directed agency policy, public affairs and regulatory action regarding regulation of the dietary supplement industry for more than three years.”
Fabricant issued a statement regarding the FDA NMN ban. “Most importantly, the discussion can and should advance swiftly to some form of relief without any red tape, moving more expeditiously than was the case on NAC. There’s no reason why the agency couldn’t begin a policy of enforcement discretion here on NMN immediately, even if it is draft or interim.”
If the FDA provides an enforcement discretion like they did with NAC, then it could keep NMN available as a dietary supplement for sale in the U.S. The NPA fought against the ban on NAC and maybe they can do the same for NMN, if it gets to that point. In addition, the Council for Responsible Nutrition (CRN) has also made a statement on this FDA NMN situation. Here is an excerpt-
“CRN is alarmed that, once again, FDA changed its position on whether an ingredient—in this case, beta-nicotinamide mononucleotide (β-NMN)—can be used in a dietary supplement based on drug preclusion. Prior to the release of its October 11 and November 4 letters, the agency had acknowledged a New Dietary Ingredient Notification for β-NMN without objection. Additionally, FDA has not previously raised any concerns publicly about the ingredient being used in dietary supplements.”
“We’ve already seen FDA’s use of drug preclusion to deny marketing of CBD in dietary supplements and to stop sales of N-acetyl-L cysteine (NAC). Rather than provide clarity to the drug preclusion situation or establish a transparent process for obtaining exceptions to that rule, FDA has invoked enforcement discretion narrowly to NAC more than two years after concluding that it is not a dietary ingredient. The industry is still waiting on the promised formal exemption for NAC. This is precisely why we didn’t offer FDA an easy way out in our citizen petition on NAC. The announcement this week on β-NMN just perpetuates the uncertainty around the drug preclusion issue and furthers FDA’s course of plucking individual ingredients out of the supplement marketplace without warning. Manufacturers, retailers, and consumers are left in limbo each time this happens. CRN is evaluating its options in response.”
I think it’s good to know there are organizations out there willing to stand up against this. It makes more sense to me that MIB-626 is its own proprietary product and should be differentiated from commonly sold NMN supplements.
But, that’s just my view on it. There are numerous possibilities and much more will be known near the end of the month. I’ll keep you posted.
Supplements are still available and for sale online, as this FDA situation is ongoing. For more information on the topic, please read: