FDA and NPA release new strategy for NMN supplements

 

In the recent US health supplement market, the legality of β-Nicotinamide Mononucleotide (NMN) has attracted widespread attention. As a popular longevity supplement ingredient, NMN is favored by consumers for its potential anti-aging effects. However, the US Food and Drug Administration (FDA) said in 2022 that because NMN is being studied as a potential new drug, companies can no longer sell it as a dietary supplement.

In a joint court filing on October 24, the US government, the Natural Products Association (NPA) and the US Department of Justice (DOJ) requested a stay of legal proceedings so that the FDA can fully evaluate citizen petitions related to NMN. According to documents from the District Court for the District of Columbia, the FDA plans to respond to these petitions by July 31, 2025.

During this period, the government revealed that it would not take enforcement action against NMN dietary supplements under certain conditions. The FDA told the NPA that while it considered the arguments raised in the citizen petition, the agency does not intend to prioritize enforcement actions related to the sale and distribution of NMN-containing products labeled as dietary supplements, on the premise that if NMN were not excluded from the definition of "dietary supplement," these products would be considered legally marketed dietary supplements. However, if the FDA becomes aware of new safety issues, the agency will need to reassess its enforcement priorities.

This policy shift has injected new vitality into the future development of the NMN market. According to the latest report from SupplySide Supplement Journal, the FDA's decision not to restrict means that NMN can continue to be legally sold in the U.S. market without direct regulatory intervention. This is undoubtedly a positive signal for participants in the global NMN industry, and it also provides a broader space for the further promotion and application of NMN.

In the lawsuit, the NPA insisted that the FDA had misunderstood the "drug exclusion clause" in DSHEA. The NPA pointed out that NMN did not meet the conditions to be classified as a drug, and therefore should continue to retain its legal sales status as a dietary supplement. NPA emphasized that according to the "Drug Exclusion Clause", if an ingredient is approved as a drug or authorized for research as a new drug and has obtained "substantial clinical research", it cannot be sold on the market as a dietary supplement. However, NMN has been circulating in the US market as a dietary supplement for many years, and there is currently no official recognition that it meets the conditions of the drug exclusion clause.

With the gradual relaxation of the FDA's regulatory attitude towards NMN and the continuous growth of market demand, the NMN industry will usher in a broader development prospect.

*Special note - This article is for informational purposes only and cannot replace a doctor's treatment diagnosis and advice. It should not be regarded as a recommendation or proof of efficacy of the medical products involved. If it involves disease diagnosis, treatment, and rehabilitation, please be sure to go to a professional medical institution to seek professional advice.

by GSHWORLD

GSHWORLD is China Biological API Manufacturer. China NMN Supplements powder suppliers & best NMN benefits raw material Factory.