"The FDA had previously accepted NMN as a New Dietary Ingredient (NDI), which allowed supplement manufacturers to market it. But, on October 11, 2022, they revoked the NDI, so companies can no longer sell it in the United States."
Representative Jeff Duncan (R-S.C.) has made a formal request for the Food and Drug Administration (FDA) to conduct a public hearing addressing the use of Nicotinamide Mononucleotide (NMN) in dietary supplements. NMN has gained attention in recent years for its potential benefits related to healthy aging.
In a letter to the FDA Commissioner, Rep. Duncan emphasized the importance of holding a public hearing to provide clarity on the agency's stance regarding NMN. He posed several questions, including whether the FDA plans to remove NMN-containing supplement products listed in the National Institutes of Health (NIH) database from the market.
Rep. Duncan expressed concern over what he perceives as the FDA's arbitrary restrictions on a supplement that has been used safely by millions of Americans for their health. He believes that a public hearing would be instrumental in understanding the FDA's motivations behind these actions.
The FDA is currently reviewing Rep. Duncan's letter and is expected to respond directly to him. The Natural Products Association (NPA) has expressed support for Rep. Duncan's efforts, highlighting his advocacy for consumer access to safe and effective supplements.
Criticism has been directed at the FDA from industry groups following the agency's shift in stance regarding the regulatory status of NMN in dietary supplements. While the FDA had previously permitted the inclusion of NMN as an ingredient in such products, it later determined that NMN falls under the category of a new drug authorized for investigation, which has prompted further scrutiny.
This change in FDA policy has raised concerns among finished product brands and ingredient manufacturers who had previously received acknowledgment letters from the FDA, assuming permission to market NMN in supplements.
The FDA cited its discovery of an association between NMN and an article called MIB-626, which is being studied as a new drug, as the basis for revising its position. The agency communicated this information to companies that had submitted notifications for NMN as a dietary ingredient.
Rep. Duncan has set a deadline of May 11 for the FDA to respond to his inquiries. He has also expressed concerns about e-commerce platforms restricting the sale of NMN and requested clarification on whether the FDA has engaged with platforms like Amazon regarding the regulatory status of NMN.
While the FDA's Office of Dietary Supplement Programs (ODSP) Director, Cara Welch, has stated that the agency does not directly communicate with retailers about the compliance status of specific products, Rep. Duncan seeks clarification on whether the FDA has informed platforms like Amazon about the regulatory status of NMN.
In March, the NPA and the Alliance for Natural Health USA filed a citizen petition requesting that the FDA determine that NMN is not excluded from the definition of a dietary supplement or exercise enforcement discretion for its marketing and sale. The petition also proposed rulemaking to permit the sale of NMN in dietary supplements.
The response from the FDA to Rep. Duncan's request, along with ongoing discussions surrounding the regulatory status of NMN, will be crucial in providing clarity and establishing a regulatory framework for NMN-containing dietary supplements.
DUNCAN-FDA-Letter-NMN.pdf