NMN (β-nicotinamide mononucleotide) is a derivative of nicotinic acid, which has been proven to increase the level of coenzyme nicotinamide adenine dinucleotide (NAD+) in human cells and has a certain effect on delaying cell aging benefit.
Recently, the FDA pointed out in a response to a New Dietary Ingredient (NDI) notification from Inner Mongolia Jindawei that β-NMN cannot be sold as a dietary supplement because it has been studied as a new drug.
The development of NMN has once again faced challenges.
This decision has nothing to do with the efficacy and safety of NMN. The FDA is based on the drug exclusion clause of the Food, Drug and Cosmetic Act (FD&C), which states that if the ingredient meets the following three criteria, it cannot be used as a dietary supplement:
1) The ingredient must be authorized as a new drug for research;
2) A large number of clinical studies must be carried out;
3) Clinical studies must be made public. However, this exclusion does not apply if the research was initiated after the ingredient was approved for use in dietary supplements.
In its response to Jindawei’s application, the FDA stated:
According to DSHEA, if an ingredient has been authorized for investigation as a new drug, extensive clinical trials have been conducted, and the trials of such ingredients have been published, the ingredient cannot be used as a dietary supplement unless the ingredient was authorized as a new drug before Already being marketed as a dietary supplement or food.
Simply put, an ingredient should be classified as a drug if it is first clinically studied as a drug. But if it's an ingredient initially marketed as a dietary supplement that can later be developed as a drug, both forms can co-exist in the market.
From approval to prohibition, it took less than half a year for NMN to "legalize".
To sell new ingredients in dietary supplements (referring to ingredients that have not appeared on the market before October 15, 1994), companies must submit an NDI notification to FDA. If FDA raises an objection, the ingredient will not be available for dietary use. supplements. Over the past two years, the FDA has objected to NDI notifications submitted by several companies on the grounds that there is “insufficient evidence that NMN supplementation is safe.”
After continuous efforts, until May 16 this year, SyncoZymes received an official reply from the FDA that the β-NMN produced by the company has passed the NDI approval and can be used as a dietary supplement in the dose.
However, half a year later, the FDA reversed its original stance, banning NMN as a dietary supplement ingredient and prohibiting its sale as a dietary supplement. After reviewing information from relevant sources as well as its own records, the FDA has determined that NMN cannot be marketed as a dietary supplement. Because NMN is an ingredient that has undergone a large number of clinical trials, relevant research results have been published.
In fact, this incident has already begun. Previously, Metro International Biotech, a clinical-stage pharmaceutical company in the United States, raised this issue with the FDA and asked the FDA to take the exclusion clause seriously.
On December 1, 2021, the pharmaceutical company MetroBiotech wrote to the U.S. FDA. The general content was that the company’s independently developed MIB-626 is a "NMN-derived molecule" that has been authorized as a new drug and has entered the clinical stage. It is hoped that the FDA will seriously Deal with the exclusions of Section 201(ff) of the Federal Food, Drug, and Cosmetic Act, removing NMN products that are marketed as dietary supplements but have not applied for a new NDI, thereby protecting the rights of companies that spend time and resources developing drugs.
NMN is prohibited from being sold as a dietary supplement in the United States, and it is unknown whether the FDA will enforce this "rule".
At present, platforms such as Amazon have not removed NMN dietary supplements, and it is unclear whether the FDA will eventually enforce them. Manufacturers of NMN dietary supplements, as well as associations, should continue to pressure FDA to exercise enforcement discretion over NMN as it has over NAC.
In the future, NMN will face three possibilities:
1) Like NAC, NMN can continue to be legally sold as a dietary supplement in the United States, exercising law enforcement discretion;
2) NMN can no longer continue to be produced;
3) NMN can be produced, but only exported.
Based on the information and feedback from all parties, the "NMN Incident" is mainly a preliminary result of the game between pharmaceutical companies, the dietary supplement industry, and the FDA.