NMN is (again) Legal in Dietary Supplements

    At the end of last month, after nearly three years of discussions, the U.S. Food and Drug Administration (FDA) announced its position that nicotinamide mononucleotide (NMN) is not excluded from the legal definition of a dietary supplement.

    Previously, the FDA had taken the stance that NMN could not be marketed as a dietary supplement because it was initially investigated as a new drug. However, in response to petitions and lawsuits, the FDA recognised that NMN had been marketed as a dietary supplement in the United States as early as 2017.

    As a result, NMN is not excluded from the definition of a dietary supplement and is now allowed back on the market.

FDA’s Proposed Changes to GRAS: A More Stringent Process

    The FDA has introduced a new proposed rule to the Unified Agenda* that would make significant changes to the Generally Recognized as Safe (GRAS) rule.

    The GRAS process was originally established to allow widely used food ingredients, historically proven to be safe, to remain on the market without extensive review. This process entitles food manufacturers to use ingredients that have not undergone a formal safety review by self-determining the ingredients’ safety.

    FDA’s new proposed rule would enforce stricter oversight of the GRAS process in several ways:

        1. It would require mandatory FDA notification of GRAS submissions for most substances; exemptions will be authorised only for substances that are:

              • Already listed by the FDA;

              • Granted with a “no questions letter” already;

              • Subject to a regulation.

        2. The FDA will need to have, maintain and update a public inventory of GRAS notifications, along with the respective conditions of intended use.

        3. Clarify the process by which the FDA would determine that a substance is not classified as GRAS.

*The Unified Agenda mentioned above details the regulatory and deregulatory actions that federal agencies plan to take over the next year.