La FDA declara legal el NMN en suplementos dietéticos
September 29, 2025 — After nearly three years of pressure from the Natural Products Association (NPA), the U.S. Food and Drug Administration (FDA) has reversed course and confirmed that Beta (β) Nicotinamide Mononucleotide (NMN) is lawful for use in dietary supplements.
FDA had previously attempted to block NMN from the supplement market, claiming it was first investigated as a new drug. NPA refused to accept that interpretation, filing a citizen petition with FDA, launching a federal lawsuit against the agency in the nation’s capital, and mobilizing industry and consumer support to challenge FDA. In response to the petition and lawsuit, FDA acknowledged evidence that NMN was marketed as a dietary supplement in the United States as early as 2017 and consequently is not excluded from the definition of a dietary supplement.
In its response to the citizen petition, FDA elaborated on its interpretations of the “drug preclusion” or race-to-market clause in the Dietary Supplement Health and Education Act of 1994 (DSHEA). NPA continues to disagree with certain legal interpretations by FDA, but the association is pleased that the agency reconsidered its position that dietary supplement marketing must be “lawful” in determining the race-to-market clause.
“FDA’s decision today confirms NMN is lawful in supplements, and we now call on e-commerce platforms to immediately restore NMN products to the market,” said Daniel Fabricant, Ph.D., president and CEO of NPA. “We will continue pressing Congress, the courts and the Administration until FDA stops abusing the drug preclusion clause once and for all.”
This is not the first time that FDA has changed course in response to NPA actions. In 2022, after NPA filed a citizen petition and lawsuit over FDA’s attempt to exclude NAC (N-acetyl-L-cysteine) from supplements, the agency ultimately issued a final guidance — or policy of enforcement discretion — that allowed NAC products back on the market.
Mientras la NPA se prepara para celebrar su 90º aniversario en 2026, la victoria de la NMN subraya su historial inigualable de responsabilizar a la FDA, defender la elección del consumidor y ofrecer resultados donde otros no lo logran.
Bontac: Liderando la industria NMN con tecnología
Como pionero y líder en la industria NMN, BoNTAC desde su creación en 2012, ha aprovechado tecnologías de biología sintética como la biocatálisis para obtener ventajas significativas en el desarrollo de NMN y productos relacionados. Es pionero a nivel mundial Tecnología de enzimas completas, ahora evolucionó a la Cuarta generación, evita residuos dañinos mientras mejora la pureza y seguridad del producto.
Con una biblioteca enzimática completa de más de 2.000 enzimas and a dedicated R&D team of PhD and Master’s researchers, the company has obtained 24 patentes globales de invención en NMN. BonTAC ha aprobado múltiples certificaciones internacionales, entre ellas FSSC22000, Self Grass, FDA, DMF, HALAL, KOSHER, ISO9001, ISO14001 y garantiza la calidad premium del producto a través de su propiedad “Bonpure” seven-step purification technology, logrando una pureza NMN de hasta 99.9%.
Como contribuyente clave a los estándares de la industria y proveedor estable para más de 1.200 empresas en todo el mundo, BonTAC también ha proporcionado la materia prima NMN utilizada en investigaciones por la Universidad de Harvard’s Equipo David Sinclair. De cara al futuro, la empresa seguirá desempeñando un papel líder en el desarrollo y las aplicaciones de productos relacionados.
The clarification of regulatory frameworks is injecting strong momentum into the industry. Guided by its mission—“Green Biotechnology for a Healthy and Better Life”—BonTAC persistirá en promover un crecimiento industrial saludable y ordenado, aportando el valor saludable de la biotecnología de vanguardia para beneficiar a más consumidores.
FDA had previously attempted to block NMN from the supplement market, claiming it was first investigated as a new drug. NPA refused to accept that interpretation, filing a citizen petition with FDA, launching a federal lawsuit against the agency in the nation’s capital, and mobilizing industry and consumer support to challenge FDA. In response to the petition and lawsuit, FDA acknowledged evidence that NMN was marketed as a dietary supplement in the United States as early as 2017 and consequently is not excluded from the definition of a dietary supplement.
In its response to the citizen petition, FDA elaborated on its interpretations of the “drug preclusion” or race-to-market clause in the Dietary Supplement Health and Education Act of 1994 (DSHEA). NPA continues to disagree with certain legal interpretations by FDA, but the association is pleased that the agency reconsidered its position that dietary supplement marketing must be “lawful” in determining the race-to-market clause.
“FDA’s decision today confirms NMN is lawful in supplements, and we now call on e-commerce platforms to immediately restore NMN products to the market,” said Daniel Fabricant, Ph.D., president and CEO of NPA. “We will continue pressing Congress, the courts and the Administration until FDA stops abusing the drug preclusion clause once and for all.”
This is not the first time that FDA has changed course in response to NPA actions. In 2022, after NPA filed a citizen petition and lawsuit over FDA’s attempt to exclude NAC (N-acetyl-L-cysteine) from supplements, the agency ultimately issued a final guidance — or policy of enforcement discretion — that allowed NAC products back on the market.
Mientras la NPA se prepara para celebrar su 90º aniversario en 2026, la victoria de la NMN subraya su historial inigualable de responsabilizar a la FDA, defender la elección del consumidor y ofrecer resultados donde otros no lo logran.
Bontac: Liderando la industria NMN con tecnología
Como pionero y líder en la industria NMN, BoNTAC desde su creación en 2012, ha aprovechado tecnologías de biología sintética como la biocatálisis para obtener ventajas significativas en el desarrollo de NMN y productos relacionados. Es pionero a nivel mundial Tecnología de enzimas completas, ahora evolucionó a la Cuarta generación, evita residuos dañinos mientras mejora la pureza y seguridad del producto.
Con una biblioteca enzimática completa de más de 2.000 enzimas and a dedicated R&D team of PhD and Master’s researchers, the company has obtained 24 patentes globales de invención en NMN. BonTAC ha aprobado múltiples certificaciones internacionales, entre ellas FSSC22000, Self Grass, FDA, DMF, HALAL, KOSHER, ISO9001, ISO14001 y garantiza la calidad premium del producto a través de su propiedad “Bonpure” seven-step purification technology, logrando una pureza NMN de hasta 99.9%.
Como contribuyente clave a los estándares de la industria y proveedor estable para más de 1.200 empresas en todo el mundo, BonTAC también ha proporcionado la materia prima NMN utilizada en investigaciones por la Universidad de Harvard’s Equipo David Sinclair. De cara al futuro, la empresa seguirá desempeñando un papel líder en el desarrollo y las aplicaciones de productos relacionados.
The clarification of regulatory frameworks is injecting strong momentum into the industry. Guided by its mission—“Green Biotechnology for a Healthy and Better Life”—BonTAC persistirá en promover un crecimiento industrial saludable y ordenado, aportando el valor saludable de la biotecnología de vanguardia para beneficiar a más consumidores.
