FDA erklærer NMN lovligt i kosttilskud
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.
Mens NPA forbereder sig på at fejre sit 90-års jubilæum i 2026, understreger NMN's sejr dets enestående rekord med at holde FDA ansvarlig, forsvare forbrugernes valg og levere resultater, hvor andre ikke lever op.
Bontac: At lede NMN-industrien med teknologi
Som pioner og leder i NMN-industrien er BoNTAC har siden etableringen i 2012 udnyttet syntetiske biologiteknologier såsom biokatalyse til at opbygge betydelige fordele i udviklingen af NMN og relaterede produkter. Det er globalt banebrydende fuld-enzymteknologi, nu udviklet til Fjerde generation, undgår skadelige rester, samtidig med at produktets renhed og sikkerhed forbedres.
Med et omfattende enzymbibliotek på over 2.000 enzymer and a dedicated R&D team of PhD and Master’s researchers, the company has obtained 24 globale opfindelsespatenter i NMN. VelbevisningTAC har bestået flere internationale certificeringer, herunder FSSC22000, Selvgræs, FDA, DMF, HALAL, Kosher, ISO9001, ISO14001 og sikrer premium produktkvalitet gennem sin proprietære “Bonpure” seven-step purification technology, hvilket opnår NMN-renhed op til 99.9%.
Som en nøglebidragyder til industristandarder og en stabil leverandør til mere end 1.200 virksomheder verden over, Velbekomme.TAC har også leveret NMN-råmaterialet, der bruges i forskning ved Harvard University’s David Sinclair-holdet. Fremadrettet vil virksomheden fortsat spille en ledende rolle i udviklingen og anvendelsen af relaterede produkter.
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 vil fortsætte med at fremme sund og ordnet industriudvikling og bringe sundhedsværdien af banebrydende bioteknologi til fordel for flere forbrugere.