Consumer Access & Industry Advocacy
What is NMN?
Nicotinamide mononucleotide (NMN) is a nucleotide derived from vitamin B3 that serves as a precursor to nicotinamide adenine dinucleotide (NAD⁺), a vital coenzyme involved in cellular energy production, metabolism and aging pathways. NMN has drawn considerable interest as a dietary supplement ingredient due to its role in supporting healthy aging and cellular health through NAD⁺ biosynthesis.
Regulatory Background
Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, which amended the Federal Food, Drug & Cosmetic Act, dietary supplements are regulated as foods and not pre-approved as pharmaceutical drugs. However, DSHEA’s drug preclusion clause can exclude an ingredient from being marketed as a dietary supplement if it has been first authorized for investigation as a new drug or approved as a new drug.
In the fall of 2022, the U.S. Food and Drug Administration (FDA) determined that NMN was excluded from the dietary supplement definition and could not be marketed in or as a dietary supplement. This decision reflected a change in FDA’s position “based on new information that came to light when” FDA was reviewing a regulatory submission called a new dietary ingredient notification.
FDA’s new position sparked immediate criticisms from industry stakeholders since the agency had previously acknowledged NMN as an ingredient suitable for use in dietary supplement products.
NPA’s Advocacy on NMN
The Natural Products Association has successfully spearheaded actions to defend consumer access to NMN-containing dietary supplements:
- Citizen Petition: In March 2023, NPA and the Alliance for Natural Health USA (ANH) filed a formal citizen petition, urging FDA to reverse its determination that NMN is excluded from the definition of a dietary supplement.
- Legal Action: In August 2024, NPA filed a lawsuit against FDA in U.S. District Court, challenging its regulatory interpretation on NMN. The association requested a declaratory judgment that the drug preclusion clause does not apply to NMN.
- Industry Engagement: NPA convened industry stakeholders to coordinate scientific and legal strategies, mobilized grassroots support among consumers and members, and amplified messaging on the importance of protecting lawful ingredient access under DSHEA.
- FDA Reverses Position Again — A Major Advocacy Win
In September 2025, in a 26-page letter to NPA and ANH, following sustained pressure from NPA, FDA reversed its previous interpretation and confirmed that NMN is not excluded from the definition of a dietary supplement. FDA ultimately cited evidence that NMN was marketed as a dietary supplement in the U.S. as early as 2017, which preceded its authorization for investigation as a new drug.
The FDA determination restores NMN’s lawful status in supplements in the U.S. marketplace.
NPA hailed the decision as a significant victory for consumer access, regulatory integrity and industry innovation, and called on retailers and e-commerce platforms to immediately restore NMN products to shelves nationwide.
Why NMN Matters
NMN plays an important role in supporting cellular health and energy metabolism:
- NAD⁺ Biosynthesis: NMN is a direct precursor to NAD⁺, a molecule critical for metabolic pathways, DNA repair and cellular aging processes.
- Cellular Function: By promoting higher intracellular NAD⁺ levels, NMN supplementation has been associated with metabolic, mitochondrial and potentially longevity-related benefits in preclinical and emerging clinical research.
Protecting Consumer Access
NPA’s advocacy around NMN underscores a broader commitment to ensuring that lawful dietary supplement ingredients remain accessible when backed by science and lawful market history. Regulatory clarity not only preserves consumer choice, but also fosters a fair, predictable environment for innovation across the natural products industry.
NPA continues to engage with FDA, Congress and industry partners to ensure that DSHEA’s drug preclusion clause protects lawful access and does not disincentivize innovation in the dietary supplement marketplace.
Press Clippings — NPA’s Work on NMN
Major Coverage
FDA ‘Didn’t Connect Those Dots’— An FDA official acknowledged in an interview that her office didn’t immediately “connect the dots” in its evaluation of NMN. SupplySide Supplement Journal
FDA Provides Update on NMN; Industry Reacts — Industry news outlet detailed FDA’s reversal on NMN’s supplement status, outlining the timeline of regulatory actions and NPA’s role in shaping the outcome. Whole Foods Magazine
FDA Responds to Citizen Petitions on NMN, Amends Position on Ingredient Status — Coverage summarized FDA’s response to petitions, reversing its position and recognizing NMN as a dietary ingredient. Nutritional Outlook
Industry Reacts to FDA NMN Decision — Trade press highlighted mixed industry reactions, including support for NMN’s restored status and broader concerns about ongoing regulatory uncertainty around drug preclusion interpretations. SupplySide Supplement Journal
NMN Confirmed Lawful in Supplements; Regulatory Landscape Evolving — Legal and industry analyses described FDA’s reversal and the implications for future dietary ingredients under DSHEA. National Law Review
FDA Issues Reinstatement Letters — Coverage reported on FDA letters issued in December 2025 to ingredient companies, acknowledging their new dietary ingredient notifications for NMN, following its letter to NPA and ANH. NutraIngredients
