Representative Jeff Duncan, a republican congressman representing South Carolina’s 3rd District, has sent a letter to the U.S. Food and Drug Administration’s Commissioner, Robert M. Califf, MD, asking the Agency to hold public hearing on NMN decision.
Representative Jeff Duncan, a republican congressman representing South Carolina’s 3rd District, has sent a letter to the U.S. Food and Drug Administration’s (FDA) Commissioner, Robert M. Califf, MD, with regard to the agency’s decision that beta-nicotinamide mononucleotide (NMN) did not meet the definition of a dietary ingredient, citing drug preclusion. The letter, first reported on by Natural Products Insider and published by the Natural Products Association (NPA; Washington, D.C.), requests that FDA hold a public hearing to clarify its position given the Agency’s “sudden change of policy.”
The letter also asked FDA to respond to a number of questions, including whether the Agency has been in contact with e-commerce platforms regarding the sale of NMN, given the restrictions platforms such as Amazon have implemented against the sale of said products. Additionally, Duncan is asking for information that would help determine the timeline between NMN’s presence in the marketplace as a dietary ingredient and its investigation as a new drug, as well as the differences between drug and dietary supplement product composition.
Duncan is giving FDA until May 11, 2023 to respond to the letter.