Representatives of the Natural Products Association (NPA) recently met FDA officials in response to a recent determination by regulators that an anti-aging ingredient, β-NMN (beta-nicotinamide mononucleotide), cannot be marketed in dietary supplements due to its earlier investigation as a pharmaceutical drug.
NPA CEO and President Dan Fabricant requested the FDA open a docket on NMN to allow stakeholders to submit information and comments to the agency on the presence of the natural ingredients in food and supplements.
Cara Welch, who oversees FDA’s Office of Dietary Supplement Programs (ODSP), advised Fabricant in an email that her agency would review and respond to NPA’s request.
In an interview, following the meeting, Fabricant said he and NPA’s outside counsel, Kevin Bell, made a few key points during the 50-minute conference call with FDA officials, who included Welch and two other representatives from ODSP, as well as a lawyer from the Office of Chief Counsel, Louisa Nickerson. Several industry stakeholders also joined the conference call, including Now Health Group CEO Jim Emme, an NPA board member.
During the meeting, Fabricant recollected, he said NMN poses no safety issues, and he challenged FDA on its legal interpretation of a section in U.S. law that prohibits ingredients in dietary supplements if they have been authorized for investigation as a new drug and the subject of substantial clinical investigations that have been instituted and made public.
According to the FDA, the prohibition doesn’t apply if the ingredient or ‘article’ was lawfully marketed as a natural food or dietary supplement before it was authorized for investigation as a new drug.
NPA has shared documents with FDA that may have relevance to the analysis above. The materials include a few patents related to NMN in food and supplements, as well as a company’s announcement four years ago that its ingredient was self-affirmed GRAS (generally recognized as safe).