By Mike Montemarano, Associate Editor11.15.22
FDA declared that beta nicotinamide-mononucleotide (NMN) may not be sold or marketed as a dietary supplement in the U.S. because it was first authorized for investigation as a new drug.
NMN has been sold as a dietary supplement ingredient for several years, often marketed for anti-aging as an NAD+ booster (nicotinamide adenine dinucleotide).
Inner Mongolia Kingdomway Pharmaceutical Limited (Kingdomway) had filed a New Dietary Ingredient Notification (NDIN) for its NMN ingredient, which FDA rejected on the drug preclusion grounds.
“FDA has carefully reviewed the information provided […] and other relevant sources, including our own records, and has determined that NMN was not marketed as a dietary supplement, except unlawfully without an NDI notification, or as a food before FDA authorized it for investigation as a new drug,” Philip Yeager, director of the division of research and evaluation at Office of Dietary Supplement Programs (ODSP) Center for Food Safety and Applied Nutrition (CFSAN), wrote on Nov. 4. “NMN is an article for which substa
NMN has been sold as a dietary supplement ingredient for several years, often marketed for anti-aging as an NAD+ booster (nicotinamide adenine dinucleotide).
Inner Mongolia Kingdomway Pharmaceutical Limited (Kingdomway) had filed a New Dietary Ingredient Notification (NDIN) for its NMN ingredient, which FDA rejected on the drug preclusion grounds.
“FDA has carefully reviewed the information provided […] and other relevant sources, including our own records, and has determined that NMN was not marketed as a dietary supplement, except unlawfully without an NDI notification, or as a food before FDA authorized it for investigation as a new drug,” Philip Yeager, director of the division of research and evaluation at Office of Dietary Supplement Programs (ODSP) Center for Food Safety and Applied Nutrition (CFSAN), wrote on Nov. 4. “NMN is an article for which substa
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