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The petition asks FDA to reverse its decision that NMN is not a dietary ingredient, and to exercise enforcement discrection.
The Natural Products Association (NPA; Washington, D.C.) and the Alliance for Natural Health (ANH; Edinburg, VA) have filed a Citizen’s Petition with FDA requesting that the Agency reevaluate its position on nicotinamide mononucleotide (NMN). Recently, FDA determined that NMN was not a dietary ingredient, citing the drug preclusion clause of the Food, Drug and Cosmetics Act (FD&C Act), which was later amended in the Dietary Supplement Health and Education Act (DSHEA). According to FDA, the drug preclusion clause prevents ingredients from being marketed as dietary supplements if the same ingredient has been filed as an investigational new drug (IND) or approved as a drug.
In the citizen petition, NPA and ANH criticized the U.S. Food and Drug Administration’s interpretation of the drug preclusion clause, which as written states that an article is not a dietary supplement if it was “authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigation has been instituted and for which the existence of such investigation has been made public.”
According to the petition, FDA’s interpretation is troubling because “(1) INDs are not authorized by FDA, and (2) to Petitioners’ knowledge, there is no public access to a database or list of current articles that are subject to an IND. In fact FDA’s regulations prevent it from publicly revealing the effective date of an IND or the source of an IND.” The petition questions why Congress would set up a regulatory “race-to-market” between drug and dietary supplement companies without giving them access to the relevant information to determine the marketability of their products.
With regard to NMN, because of its interpretation of DSHEA and regulations, the agency is unable to identify the date when NMN was allegedly authorized as an IND. Even though the ingredient was on the market as early as 2016 in Japan, on sale in the U.S. no later than 2018, and the Agency acknowledged without objection a new dietary ingredient notification (NDIN) filed by SyncoZymes Co. Ltd. (Shanghai) in 2022, FDA retracted its acknowledgement, citing drug preclusion and objected to NDINs submitted by other companies.
Further, the petition contends that FDA’s interpretation of section 201(ff)(3) of DSHEA is too narrow. FDA argues that section 201(ff)(3) requires manufacturers to prove an article was marketed as a dietary supplement or food in the U.S. prior to drug investigation or approval, while the petitioners argue that there is nothing in the plain language of the statutes that requires prior marketing only in the U.S. “FDA is improperly trying to import a limitation into the statute that does not exist,” the petitioners write. “In fact, the 2016 Draft Guidance on NDINs provides (at page 68) that the data and information to substantiate a history of safe use is not limited to the United States.”
“The agency’s reversal on NMN NDIs is without statutory authority,” stated Daniel Fabricant, PhD, president and CEO of NPA, in a press release. “The secrecy behind the IND dates, the evidence of a GRAS notice predating any IND on NMN, and NMS’s presence in the food supply all could’ve been rectified. Just like the case with NAC, the citizen’s petition gives the industry a platform to move towards a resolution concerning the ability to market NMN in or as a dietary supplement. In the case of NAC, NPA’s Citizen’s Petition was the vehicle that made possible its return to commerce on all platforms.”
Specifically, the Citizen’s Petition is asking FDA to 1) determine that NMN is not excluded from the definition of a dietary supplement, 2) commit to exercising enforcement discretion on dietary supplement products marketed as containing NMN, and 3) in the alternative, recommend the Secretary of Health and Human Services issue a regulation following notice comment, finding NMN to be lawful.