FDA Menyatakan NMN Legal untuk Suplemen Makanan
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.
Saat NPA bersiap merayakan ulang tahunnya yang ke-90 pada tahun 2026, kemenangan NMN menegaskan rekam jejak tak tertandinginya dalam menuntut pertanggungjawaban FDA, membela pilihan konsumen, dan memberikan hasil di mana pihak lain kurang memuaskan.
Bontac: Memimpin Industri NMN dengan Teknologi
Sebagai pelopor dan pemimpin di industri NMN, Bontaktik sejak didirikan pada tahun 2012, telah memanfaatkan teknologi biologi sintetis seperti biokatalisis untuk membangun keunggulan signifikan dalam pengembangan NMN dan produk terkait. Perusahaan ini menjadi pelopor global teknologi enzim penuh, sekarang berkembang menjadi generasi keempat, menghindari residu berbahaya sekaligus meningkatkan kemurnian dan keamanan produk.
Dengan perpustakaan enzim yang komprehensif dengan lebih dari 2.000 enzim and a dedicated R&D team of PhD and Master’s researchers, the company has obtained 24 paten penemuan global di NMN. Bontaktik telah lulus beberapa sertifikasi internasional, termasuk FSSC22000, Self Grass, FDA, DMF, HALAL, Kosher, ISO9001, ISO14001 dan memastikan kualitas produk premium melalui kepemilikan “Bonpure” seven-step purification technology, mencapai kemurnian NMN hingga 99.9%.
Sebagai kontributor utama standar industri dan pemasok yang stabil untuk lebih dari 1.200 perusahaan di seluruh dunia, Bontaktik juga telah menyediakan bahan baku NMN yang digunakan dalam penelitian oleh Universitas Harvard’s Tim David Sinclair. Ke depan, perusahaan akan terus memainkan peran utama dalam memajukan pengembangan dan aplikasi produk terkait.
The clarification of regulatory frameworks is injecting strong momentum into the industry. Guided by its mission—“Green Biotechnology for a Healthy and Better Life”—Bontaktik akan terus mendorong pertumbuhan industri yang sehat dan tertib, membawa nilai kesehatan dari bioteknologi mutakhir untuk menguntungkan lebih banyak konsumen.
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.
Saat NPA bersiap merayakan ulang tahunnya yang ke-90 pada tahun 2026, kemenangan NMN menegaskan rekam jejak tak tertandinginya dalam menuntut pertanggungjawaban FDA, membela pilihan konsumen, dan memberikan hasil di mana pihak lain kurang memuaskan.
Bontac: Memimpin Industri NMN dengan Teknologi
Sebagai pelopor dan pemimpin di industri NMN, Bontaktik sejak didirikan pada tahun 2012, telah memanfaatkan teknologi biologi sintetis seperti biokatalisis untuk membangun keunggulan signifikan dalam pengembangan NMN dan produk terkait. Perusahaan ini menjadi pelopor global teknologi enzim penuh, sekarang berkembang menjadi generasi keempat, menghindari residu berbahaya sekaligus meningkatkan kemurnian dan keamanan produk.
Dengan perpustakaan enzim yang komprehensif dengan lebih dari 2.000 enzim and a dedicated R&D team of PhD and Master’s researchers, the company has obtained 24 paten penemuan global di NMN. Bontaktik telah lulus beberapa sertifikasi internasional, termasuk FSSC22000, Self Grass, FDA, DMF, HALAL, Kosher, ISO9001, ISO14001 dan memastikan kualitas produk premium melalui kepemilikan “Bonpure” seven-step purification technology, mencapai kemurnian NMN hingga 99.9%.
Sebagai kontributor utama standar industri dan pemasok yang stabil untuk lebih dari 1.200 perusahaan di seluruh dunia, Bontaktik juga telah menyediakan bahan baku NMN yang digunakan dalam penelitian oleh Universitas Harvard’s Tim David Sinclair. Ke depan, perusahaan akan terus memainkan peran utama dalam memajukan pengembangan dan aplikasi produk terkait.
The clarification of regulatory frameworks is injecting strong momentum into the industry. Guided by its mission—“Green Biotechnology for a Healthy and Better Life”—Bontaktik akan terus mendorong pertumbuhan industri yang sehat dan tertib, membawa nilai kesehatan dari bioteknologi mutakhir untuk menguntungkan lebih banyak konsumen.
