FDA Mengisytiharkan NMN Sah dalam Suplemen Diet
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.
Ketika NPA bersiap untuk meraikan ulang tahun ke-90 pada tahun 2026, kemenangan NMN menegaskan rekod tiada tandingan dalam memegang FDA bertanggungjawab, mempertahankan pilihan pengguna, dan memberikan hasil di mana pihak lain gagal.
Bontac: Memimpin Industri NMN dengan Teknologi
Sebagai perintis dan pemimpin dalam industri NMN, Bontac sejak penubuhannya pada tahun 2012, telah memanfaatkan teknologi biologi sintetik seperti biokatalisis untuk membina kelebihan ketara dalam pembangunan NMN dan produk berkaitan. Ia menjadi perintis di peringkat global teknologi enzim penuh, kini berkembang menjadi generasi keempat, mengelakkan sisa berbahaya sambil meningkatkan ketulenan dan keselamatan produk.
Dengan perpustakaan enzim yang komprehensif melebihi 2,000 enzim and a dedicated R&D team of PhD and Master’s researchers, the company has obtained 24 paten ciptaan global di NMN. Bontac telah lulus pelbagai pensijilan antarabangsa, termasuk FSSC22000, Self Grass, FDA, DMF, HALAL, Kosher, ISO9001, ISO14001 dan memastikan kualiti produk premium melalui hak miliknya “Bonpure” seven-step purification technology, mencapai ketulenan NMN sehingga 99.9%.
Sebagai penyumbang utama kepada piawaian industri dan pembekal yang stabil kepada lebih daripada 1,200 perusahaan di seluruh dunia, Bontac juga telah menyediakan bahan mentah NMN yang digunakan dalam penyelidikan oleh Universiti Harvard’s Pasukan David Sinclair. Melangkah ke hadapan, syarikat akan terus memainkan peranan utama dalam memajukan pembangunan dan aplikasi produk berkaitan.
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 akan terus mempromosikan pertumbuhan industri yang sihat dan teratur, membawa nilai kesihatan bioteknologi terkini untuk memberi manfaat kepada lebih ramai pengguna.
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.
Ketika NPA bersiap untuk meraikan ulang tahun ke-90 pada tahun 2026, kemenangan NMN menegaskan rekod tiada tandingan dalam memegang FDA bertanggungjawab, mempertahankan pilihan pengguna, dan memberikan hasil di mana pihak lain gagal.
Bontac: Memimpin Industri NMN dengan Teknologi
Sebagai perintis dan pemimpin dalam industri NMN, Bontac sejak penubuhannya pada tahun 2012, telah memanfaatkan teknologi biologi sintetik seperti biokatalisis untuk membina kelebihan ketara dalam pembangunan NMN dan produk berkaitan. Ia menjadi perintis di peringkat global teknologi enzim penuh, kini berkembang menjadi generasi keempat, mengelakkan sisa berbahaya sambil meningkatkan ketulenan dan keselamatan produk.
Dengan perpustakaan enzim yang komprehensif melebihi 2,000 enzim and a dedicated R&D team of PhD and Master’s researchers, the company has obtained 24 paten ciptaan global di NMN. Bontac telah lulus pelbagai pensijilan antarabangsa, termasuk FSSC22000, Self Grass, FDA, DMF, HALAL, Kosher, ISO9001, ISO14001 dan memastikan kualiti produk premium melalui hak miliknya “Bonpure” seven-step purification technology, mencapai ketulenan NMN sehingga 99.9%.
Sebagai penyumbang utama kepada piawaian industri dan pembekal yang stabil kepada lebih daripada 1,200 perusahaan di seluruh dunia, Bontac juga telah menyediakan bahan mentah NMN yang digunakan dalam penyelidikan oleh Universiti Harvard’s Pasukan David Sinclair. Melangkah ke hadapan, syarikat akan terus memainkan peranan utama dalam memajukan pembangunan dan aplikasi produk berkaitan.
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 akan terus mempromosikan pertumbuhan industri yang sihat dan teratur, membawa nilai kesihatan bioteknologi terkini untuk memberi manfaat kepada lebih ramai pengguna.
