Meetings were held last week between the FDA and NMN manufacturers and retailers, lead by Dan Fabricant of NPA and Matt Anania of Cellmark.
Some progress was made as new information was presented to the FDA regarding the history of NMN sales, but there was no resolution.
So far, the FDA has not informed retailers to stop selling NMN products. The process could be quick, or long and drawn out.
We will continually update this page with new information, so check back for updates.
We will inform everyone on our mailing list of any notable changes, so if you are not already subscribed, sign up here.
******************** Updated Dec 7th, 2022 ********************
Manufacturers have received letters from the FDA directing that they stop production of NMN dietary supplements.
If not resolved soon, expect to see more products showing out of stock on our website and others.
Retailers have not been directed to stop selling yet, and we will ship any orders received before that happens.
(This does not apply to our new NMN Pets product, as it is not a dietary supplement)
The FDA may move to stop sales of NMN as a dietary supplement.
The issue is, a product that is already being investigated for use as a drug, cannot then be sold as a dietary supplement (natural product).
New Dietary Ingredient
A New Dietary Ingredient (NDI), allows a natural product to be sold as a dietary supplement. The FDA had previously approved an NDI for NMN, allowing it to be sold as a dietary supplement. But, in an unprecedented action, they revoked the NDI on October 11, 2022.
A quote from that notice: “NMN is excluded from the dietary supplement definition under section 201(ff(3)(B)(ii) of the FD&C Act (21 U.S.C. § 321(ff)(3)(B)(ii)) and may not be marketed as or in a dietary supplement.”
NMN Being Investigated For Use As A Prescription Drug
The FDA stated their reason for excluding NMN from being classified as a dietary supplement is due to it being investigated as a drug. Dr. David Sinclair is a co-founder of Metro International Biotech LLC, a pharmaceutical company that has been trying to get MIB-626 classified as a drug.
MIB-626 is a proprietary formulation and a version of β-NMN Beta-Nicotinamide Mononucleotide (Beta NMN). Beta NMN is the form of NMN that is commonly sold by companies in the U.S. and abroad.
Situation Similar to Recent Rulings on NAC
A similar ban was enacted by the FDA on a supplement called N-acetyl-L-cysteine (NAC), around July of 2020. The FDA deemed that it was no longer a supplement or dietary ingredient because it was first authorized for investigation as a new drug before it was sold as a supplement.
Manufacturers, Citizens and Nonprofits Fought Back
Numerous groups, nonprofits and manufacturers fought back and also filed citizen petitions and a lawsuit against the FDA. The Natural Products Association (NPA), the Council for Responsible Nutrition (CRN) and the American Herbal Products Association (AHPA), all fought back against the FDA’s NAC ruling. Citizen petitions were filed, along with a lawsuit filed by the NPA, December 6, 2020. The groups stated:
- they believed that banning NAC was unlawful because they were said to be attempting to “retroactively” apply the FD&C’s Drug Exclusion Clause
- they said NAC was marketed in the U.S. food supply since 1991, before the FD&C Act was enacted into law, therefore it meets the definition of a dietary supplement
- they said that NAC drugs that were approved in 1963 were not administered orally, so they called into question as to whether or not the FD&C Act even applied to this situation
Outcome of the FDA Banning NAC
On November 4th, 2022, the lawsuit was dismissed without prejudice. And, although the FDA said NAC does not meet the definition of a dietary supplement, they adopted a policy of “enforcement discretion” in a final guidance, essentially allowing companies to continue selling NAC in the U.S.
We Hope For A Similar Outcome with NMN
We may receive a similar “discretionary exclusion” as happened with NAC, which could allow NMN to continue being sold as a dietary supplement in the U.S.
Metro International Biotech’s Letter to the FDA
Corporate counsel with Metro International Biotech sent a letter to the FDA on December 1st, 2021, regarding the FDA’s ban on NAC.
Food, Drug & Cosmetic Act and Supplement Bans
If three criteria are met with the Federal Food, Drug and Cosmetic Act (FDCA), then they can exclude NMN from being used as a supplement in the U.S.
- 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.
If the product was previously marketed as a supplement or food prior to authorization for investigation as a new drug, then it does not cause an exclusion, even if the three criteria are met.
Investigational New Drug Mystery Dates & Lack of Transparency
The FDA does not disclose the actual date of when a company submits an investigational new drug application (IND). The date is not disclosable until there is approval of the new drug application (NDA), which references the IND.
According to the FDA, it may take 30 days after they receive the application for an IND to take effect. Or, it can occur earlier if the FDA notifies the company that clinical investigations may begin.
At this time, it is unknown as to when Metro International Biotech submitted their IND application.
NMN Is Still Available For Sale At This Time
Although we believe this is likely to turn out ok and everyone can continue to benefit from NMN products, this has caused a massive disturbance since news started to leak out about this on Nov 11th.
We have been hit with a flood of orders from customers concerned they might not be able to purchase NMN in the future.
As a result, we have now run out of our Liposomal NMN that we received a shipment of just last week.
We have good supplies of other NMN products, but can’t say how long those will last if the panic buying continues or accelerates.