Washington- The Food and Drug Administration (FDA) has finally responded to a citizen petition submitted on March 7th, 2023, by the Natural Products Association (NPA) and Alliance for Natural Health (ANH) requesting the FDA determine Nicotinamide Mononucleotide (NMN) is not excluded from the definition of a dietary supplement or commit to exercise enforcement discretion regarding the selling of NMN as a supplement. The FDA said in a letter 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.”
Daniel Fabricant, Ph.D., president, and CEO of NPA, said the response was woefully inadequate:
“The FDA’s negligence has and will continue to cause severe economic damage to a growing sector of the dietary supplement industry. This decision to kick the can down the road after six months of deliberation will absolutely threaten the NMN sector, but also weakens the New Dietary Ingredient (NDI) process for manufacturers seeking to bring emerging and innovative ingredients for other dietary supplements to American consumers.”
The NMN citizen’s petition is an extraordinary measure and is the third time the NPA has 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 citizen’s petition on CBD can be viewed here.
“A recent response to an NDI filing highlights the FDA is using the NDI process as de facto pre-market approval. They get 75 days, no more/no less, to determine whether something is a dietary ingredient and understand the company’s safety data, not forever. Even in the unlikely occurrence where they find a problem after that window, they have appropriate authorities for action. However, the FDA is avoiding that work here all in the name of rolling back DSHEA to protect the pharmaceutical industry’s intellectual property.”
“FDA has literally left the building when it comes to regulating dietary supplements. Instead of protecting Americans and working with stakeholders to bring more products to consumers safely and efficiently, it is wasting time, effort, and taxpayer money pushing a reorganization plan that is dead on arrival. But NPA is determined to devote whatever resources and means necessary to address this problem and hold this dysfunctional bureaucracy accountable,” said Fabricant.
In late July, the FDA proposed a reorganization of the Office of Dietary Supplement Programs (ODSP), but the plan has been met with staunch opposition from powerful corners, including NPA. Senate Majority Whip Richard Durbin (D-IL) and Senator Richard Blumenthal (D-CT) said they were “concerned that these changes could divert resources, funding, and attention from the supplement market at a time when it is needed more than ever.”
This followed similar comments by Representative Jeff Duncan (R-SC), a senior member of the House Energy and Commerce Committee, who said the proposal was “backward,” and that ODSP should “remain free-standing, as was established, consistent with the statute.”