FDA Declares NMN Lawful in Dietary Supplements
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.
As NPA prepares to celebrate its 90th anniversary in 2026, the NMN victory underscores its unmatched record of holding FDA accountable, defending consumer choice, and delivering results where others fall short.
Bontac: Leading the NMN Industry with Technology
As a pioneer and leader in the NMN industry, Bontac has, since its establishment in 2012, leveraged synthetic biology technologies such as biocatalysis to build significant advantages in the development of NMN and related products. Its globally pioneering full-enzyme technology, now evolved to the fourth generation, avoids harmful residues while improving product purity and safety.
With a comprehensive enzyme library of over 2,000 enzymes and a dedicated R&D team of PhD and Master’s researchers, the company has obtained 24 global invention patents in NMN. Bontac has passed multiple international certifications, including FSSC22000, Self Grass,FDA,DMF,HALAL,Kosher,ISO9001，ISO14001 and ensures premium product quality through its proprietary “Bonpure” seven-step purification technology, achieving NMN purity of up to 99.9%.
As a key contributor to industry standards and a stable supplier to more than 1,200 enterprises worldwide, Bontac has also provided the NMN raw material used in research by Harvard University’s David Sinclair team. Looking ahead, the company will continue to play a leading role in advancing the development and applications of related products.
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 will persist in promoting healthy and orderly industry growth, bringing the health value of cutting-edge biotechnology to benefit more consumers.
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.
As NPA prepares to celebrate its 90th anniversary in 2026, the NMN victory underscores its unmatched record of holding FDA accountable, defending consumer choice, and delivering results where others fall short.
Bontac: Leading the NMN Industry with Technology
As a pioneer and leader in the NMN industry, Bontac has, since its establishment in 2012, leveraged synthetic biology technologies such as biocatalysis to build significant advantages in the development of NMN and related products. Its globally pioneering full-enzyme technology, now evolved to the fourth generation, avoids harmful residues while improving product purity and safety.
With a comprehensive enzyme library of over 2,000 enzymes and a dedicated R&D team of PhD and Master’s researchers, the company has obtained 24 global invention patents in NMN. Bontac has passed multiple international certifications, including FSSC22000, Self Grass,FDA,DMF,HALAL,Kosher,ISO9001，ISO14001 and ensures premium product quality through its proprietary “Bonpure” seven-step purification technology, achieving NMN purity of up to 99.9%.
As a key contributor to industry standards and a stable supplier to more than 1,200 enterprises worldwide, Bontac has also provided the NMN raw material used in research by Harvard University’s David Sinclair team. Looking ahead, the company will continue to play a leading role in advancing the development and applications of related products.
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 will persist in promoting healthy and orderly industry growth, bringing the health value of cutting-edge biotechnology to benefit more consumers.
