The 47-page lawsuit, which can be viewed HERE, was filed this week in the U.S. District Court for the District of Columbia. A potential lawsuit was first mooted by NPA after it filed a citizen petition with the Alliance for Natural Health (ANH) in March 2023 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 has still not provided a final response to the petitioners, noting in a letter in September 2023 (180 days after the petition was filed) that it had been unable to reach a decision on the requests made in a Citizen Petition about NMN due to “competing agency priorities”.
NPA’s patience on the issue has now run out, with the association filing a lawsuit this week and Daniel Fabricant, PhD, NPA’s president and CEO, telling NutraIngredients-USA: “The industry is showing that we've got to take a stand on these things.”
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, the Agency 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.
“Enough is enough,” said Kevin Bell, partner at Arnall Golden Gregory and NPA Counsel. “When this agency does these things, they cause these random acts of disruption. They're going to have to be called on it and challenged on it. You have a situation where we have these AKL letters [Good Day letters] on NDIs coming out, and then just unilaterally yanked back and said, sorry about that. That can't stand.”
Dr. Fabricant called NMN another iteration of the FDA’s misapplication of the Food Drug, and Cosmetic Act, causing significant economic damage to a critical part of the dietary supplement industry. He added that the FDA’s stance “completely guts the NDI process.
“We want on our members, and Kevin's clients are rule followers, right? They want to go through the process the same way as with every other government around the planet. They need to have the safety data. They need to present that to the government or have something like a self-GRAS. And so you're basically going, ‘Hey, even if you do that, we're going to get you on a technicality’. So who cares?”
Watch the video for the full interview.
