Starting March 13th, 2023, Amazon stated it would require further documentation from all nicotinamide mononucleotide (NMN) suppliers if they wanted to continue selling their product on the site. They must show proof that they have been approved by the U.S. Food and Drug Administration (FDA) for over-the-counter sales.
Amazon has announced about an upcoming NMN product regulation starting on March 13, 2023.
NMN suppliers will have to show proof of FDA approval to remain on the site.
Failure to reinstate products as requested will result in the removal of remaining inventory.
The letter comes in reference to an FDA decision announced in October 2022 that reclassified NMN as a drug or drug ingredient, requiring FDA approval for its sale. The change was triggered after Metro International Biotech submitted a form of proprietary NMN they developed to the FDA for investigation as an investigational new drug (IND) in July 2022.
According to the FDA, once a drug has been submitted for such studies, it can no longer be sold as a dietary supplement and must require FDA approval prior to being marketed.
Found in all life forms, NMN is a molecule commonly used in dietary supplements for its anti-aging potential. It is believed to increase the levels of nicotinamide adenine dinucleotide (NAD+), a compound that plays a crucial role in repairing and protecting DNA and promoting optimal mitochondrial health and cellular energy. However, as we age, NAD+ levels tend to decline.
Amazon requirements for suppliers
NMN suppliers have just a few weeks left to plan their next steps. Amazon listed three supporting documents that suppliers will have to provide in order to reinstate their products:
- Upload the ingredient list for the product to the product detail page.
- Upload labeling with a National Drug Code (NDC) clearly present and legible.
- Request a reinstatement through their standard seller appeal process.
If brands do not apply for reinstatement and have any remaining inventory of these products in Amazon fulfillment centers after March 13, 2023, they will need to create a removal order for return or disposal of their remaining inventory.
If they don’t submit a removal order within 30 days of receiving a removal notice, Amazon may dispose of that inventory in accordance with its Service Terms and Legal Policies.
How suppliers are responding?
ProHealth wrote in a statement that they received the letter from Amazon, but “haven’t received any communication from the FDA, and we plan to continue to sell NMN until the FDA tells us that we have to stop.”
This wasn’t the first time Amazon has taken action to remove a popular dietary supplement that the FDA deemed inappropriate for use in natural products.
In May 2021, Amazon also removed NAC (N-acetyl-L-cysteine) from its platform, which resulted in a lawsuit filed by the Natural Products Association against the FDA in a U.S. District Court in Maryland seeking a permanent injunction against the FDA’s retroactive exclusion of NAC from dietary supplements.
The ruling is yet to be determined, and the lawsuit remains pending. In the meantime, however, in August 2022, the FDA announced its plans “to exercise enforcement discretion”, so NAC supplements were reinstated on Amazon.
We believe this story will eventually end up as the earlier skirmish over NAC, and NMN will be returning to Amazon, but it is not assured. It is possible the FDA will decide to fight harder this time and stop all sales from every platform.Renue By Science, NMN brand
You might be unable to buy NMN supplements from some suppliers on Amazon starting March 13th, 2023. However, you will still be able to make purchases from retailers directly.
Please be aware that from the fall of 2022 NMN is under an investigation as a potential new drug by the FDA. That puts the legality of the product as a dietary supplement in question. It’s a complicated situation that’s not yet solved. However, it is important to note that since we are not a manufacturer or retailer, we do not take any responsibility for the availability of the product as a dietary supplement after having lost its dietary ingredient status.
- U.S. Food and Drug Administration. Investigational New Drug Applications (INDs) for CBER-Regulated Products.
- U.S. Food and Drug Administration. FDA Releases Final Guidance on Enforcement Discretion for Certain NAC Products.