The decision stated the FDA does not intend to prioritize enforcement action related to the sale and distribution of NMN-containing products that are labeled as dietary supplements, provided that they would be lawfully marketed dietary supplements if NMN is not excluded from the definition of “dietary supplement”. The motion added, however, that FDA would reevaluate its enforcement priorities if it became aware of new safety concerns.
In terms of the the Citizen Petition, filed by NPA and the Alliance for Natural Health (ANH) in March 2023, the Court requires the FDA to respond by the end of July 2025.
Speaking with NutraIngredients-USA at SupplySide West last week, Dr. Daniel Fabricant, NPA’s CEO and president, said: “We worked with the government to make some changes to the citizen petition as well as our case, and so the agency can respond to everything.
“Also, it gives us a period of enforcement discretion. Obviously, folks are selling NMN [and they still] have to adhere to the other parts of the Food, Drug and Cosmetic Act, but the government will not be prioritizing any enforcement on NMN as an ingredient during that time period.
“I think that bodes well, considering the history, some shades of NAC too. So, stay tuned.”
NMN and NDI Notifications
NMN is one of the forms of vitamin B3, or niacin, that has been shown to enhance the levels of nicotinamide adenine dinucleotide (NAD+) in the cells of the body. Boosting these levels has in turn demonstrated significant benefits in staving off cellular aging.
Despite issuing an acknowledgement without objection for a New Dietary Ingredient Notification (NDIN) in May 2022, FDA announced in November 2022 that NMN is not allowed as a dietary ingredient because of its prior investigation as a drug. The agency reportedly made this determination after having been made aware of recent drug studies on the ingredient. For more information, please view NDIN 1247.
NPA filed a citizen petition on March 7, 2023 with the Alliance for Natural Health (ANH) requesting the FDA determine NMN is not excluded from the definition of a dietary supplement or commit to exercise enforcement discretion regarding the sale of NMN as a supplement.
FDA stated in September 2023 that it had been unable to reach a decision on the requests made in a citizen petition about NMN due to “competing agency priorities.”
In August of this year, NPA filed a lawsuit against the Agency, but the association and the U.S. Department of Justice (DOJ) recently came together to seek a temporary break in the battle over NMN. As first reported by NutraIngredients-USA on Oct. 30, U.S. District Judge Paul L. Friedman granted the stay of legal proceedings to allow FDA to evaluate the NMN citizen petition.
“This is a monumental victory for NPA, our members, and American consumers,” Dr. Fabricant said. “Fundamentally, FDA’s past decisions have weakened the integrity of the New Dietary Ingredient Notification process for members of the NPA who want to bring twenty-first-century consumer health products to the market. While we believe the FDA could have solved this and other similar cases without litigation, we are pleased with the outcome and will continue to hold the FDA accountable when the agency misapplies the law.”
During the interview in Las Vegas, Dr. Fabricant also discussed ongoing efforts at the State level to restrict access to weight loss products and bodybuilding supplements for people under the age of 18. Watch the video above for the full interview.
