According to the latest international information, recently, the FDA (US Food and Drug Administration) has a new change in the regulatory attitude of NMN, announced that it will not restrict the sale of NMN, and will make the latest ruling on the regulatory status quo of NMN before July 31, 2025.
This decision provides a temporary grace period for NMN's legal sales status in the United States.
In a joint court filing on October 24, the NPA (American Natural Products Association), the FDA and the DOJ (U.S. Department of Justice) requested a stay of the legal proceedings to allow the FDA to evaluate the citizen petition related to NMN.
According to documents filed in the U.S. District Court for the District of Columbia, the FDA said that while considering the petition, it will not prioritize enforcement actions related to the lawful sale and distribution of dietary supplement products containing NMN, and will issue an updated ruling on the NPA's petition by July 31, 2025.
The FDA also stressed that if new safety issues arise, it will need to re-evaluate its enforcement priorities.
This news tentatively confirms that NMN can continue to be sold in the US market without direct intervention by the FDA, which will be positive news for manufacturers, retailers and consumers worldwide.
The outcome of the NPA lawsuit is not only about the future of NMN as a dietary supplement, it could also have far-reaching implications for the entire pharmaceutical and natural products industry.
A key issue in the case is the Drug Exclusion provision of the Dietary Supplement Health and Education Act of 1994 (DSHEA), which states that if an ingredient is approved as a drug or authorized for research as a new drug, and "substantial clinical studies" have been conducted, then it cannot be marketed as a dietary supplement.
The NPA contends that the FDA misinterpreted the "drug exclusion clause" in DSHEA, arguing that NMN does not meet the conditions to be classified as a drug and should continue to retain its legal marketing status as a dietary supplement.
The NPA states that NMN is eligible for the Drug Exclusion Clause if it is not marketed as a dietary supplement before it is authorized for new drug research.
NMN, which has been on the market as a dietary supplement in the United States for many years, clearly does not meet this prerequisite and NMN should not be restricted by this provision.
There is also a lack of a clear and objective standard for the definition of "substantial clinical research", which further adds ambiguity to the application of the provisions.
In evaluating whether NMN should be subject to the Drug Exclusion Clause, the FDA should consider the historical sale of NMN in the market as a dietary supplement, current consumer use, and scientific research on the safety and efficacy of NMN.
The NPA calls on the FDA to fully listen to industry experts, consumers and stakeholders before making a final ruling to ensure transparency and fairness in the decision-making process.
With the grace period announced by the FDA, market participants have been given more time to respond to possible regulatory changes.
The global health industry is also closely watching this development to assess its possible impact on the development of the NMN industry.
Original quote: 《FDA telegraphs enforcement strategy against NMN supplements amid NPA lawsuit》
