WASHINGTON – A [federal] court today issued a significant ruling in a lawsuit brought by the Natural Products Association (NPA) against the Food and Drug Administration (FDA) requesting that the agency cease its unlawful retroactive application of the Food, Drug, and Cosmetic Act against Nicotinamide Mononucleotide (NMN). The Court granted NPA’s request and issued a joint motion to stay the case, meaning the FDA will not be permitted to pursue unauthorized punitive and disciplinary measures of NMN products during the stay [better way to say this? – we don’t want to look like NMN won’t be regulated]. Additionally, the Court requires the FDA to respond to the NPA’s citizen petition.
“This is a monumental victory for NPA, our members, and American consumers. The court said plainly that FDA vastly exceeded their authorities and need to go back to the enforcement regime that follows the letter of the law. Hopefully FDA will get the message and start focusing on using the clear and expansive powers that it has instead of constantly seeking additional authorities that they don’t need,” said Daniel Fabricant Ph.D., president, and CEO of the NPA.
“Fundamentally, FDA’s past decisions have weakened the integrity of the New Dietary Ingredient Notification (NDI) 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.”
On March 7, 2023, the NPA and Alliance for Natural Health (ANH) submitted a citizen petition 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. The FDA said in a letter to NPA and ANH that the agency had “not reached a decision on your petition within the first 180 days due to competing agency priorities” and that staff “is evaluating your petition.”
This was the third time the NPA pursued regulatory clarity through this path. NPA has also filed a citizen’s petition and lawsuit against the FDA on NAC, which can be viewed here and here. NPA’s citizens petition on CBD can be viewed here.
