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. Responding to citizen petitions filed by the Natural Products Association (NPA), Council for Responsible Nutrition (CRN), and the Alliance for Natural Health (ANH), the FDA revised its interpretation of a clause of Food Drug and Cosmetic Act (FD&C) that states that an ingredient that is first a drug cannot then become a dietary ingredient, according to The National Law Review.
“In light of FDA’s revised interpretation of the race-to-market clause in section 201(ff)(3)(B), we now conclude that NMN is not excluded from the definition of dietary supplement undersection 201(ff)(3)(B),” said Donald Prater, DVM, principal deputy director for human foods, FDA’s Human Foods Program. “Specifically, although NMN was authorized for investigation as a new drug and substantial clinical investigations of NMN have been instituted and made public, NMN was marketed as a dietary supplement in the United States before such authorization.”
In response to the decision, Daniel Fabricant, PhD, NPA president and CEO, said, “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. We will continue pressing Congress, the courts and the Administration until FDA stops abusing the drug preclusion clause once and for all.”
CRN expressed its strong disappointment in the FDA’s decision to deny CRN’s citizen petition urging the agency to correct its flawed interpretation of the drug preclusion provision under Section 201(ff)(3)(B) of the FD&C Act and provide the industry with reasonable, fair guidance regarding the provision’s application to dietary supplements.
“FDA missed a pivotal opportunity to bring clarity and balance to the line between pharmaceuticals and dietary supplements,” said Steve Mister, CRN’s president and CEO. “At every juncture where FDA had the opportunity to choose between two interpretations of the statute, it chose one that favors pharmaceutical development over supplements. Consumer access to affordable and accessible healthcare products will be stymied as a result.”
For more information, visit www.fda.gov, www.npanational.org or www.crnusa.org.
