The Food and Drug Administration (FDA) finally responded to a citizen petition submitted on March 7, 2023, by the Natural Products Association (NPA) and Alliance for Natural Health (ANH)...well, sort of responded. The petition from NPA and ANH had requested that FDA either determine that 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.
FDA’s response? “We are advising you, in accordance with 21 CFR 10.30(e)(2), that we have not reached a decision on your petition within the first 180 days due to competing agency priorities. However, be advised that our staff is evaluating your petition.”
That’s “woefully inadequate” said Daniel Fabricant, Ph.D., President and CEO of NPA. “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 Backstory
Following letters sent on October 11, 2022 and November 4, 2022, a notification by the FDA posted on November 8, 2022 stated NMN is not a legal dietary ingredient. As the Council for Responsible Nutrition (CRN) President and CEO Steve Mister pointed out at the time, prior to those letters the agency had acknowledged a New Dietary Ingredient Notification for β-NMN without objection. Additionally, FDA has not previously raised any concerns publicly about the ingredient being used in dietary supplements.
In July 2023, NPA shared the news that FDA rejected a request by Rep. Jeff Duncan (R-SC) to hold a public hearing on FDA’s position on NMN. FDA’s stance: A public comment period would be sufficient on the matter.
Rolling Back DSHEA?
Dr. Fabricant noted a key concern: “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.”
So what’s keeping FDA so busy that the agency can’t deal with the NMN matter in a timely manner? Dr. Fabricant pointed to the proposed reorganization and creation of a unified Human Foods Program (HFP). The proposal includes relocating the Office of Dietary Supplement Programs (ODSP) and a new model for the Office of Regulatory Affairs (ORA). FDA said the move will “further enhance coordination, prevention and response activities across the FDA, enabling the agency to better support its public health mission.”
NPA said FDA’s proposed reorganization of ODSP has been met with “staunch opposition from powerful corners.” That includes NPA, Senate Majority Whip Richard Durbin (D-IL) and Senator Richard Blumenthal (D-CT). The senators said: “ODSP is the lead office at FDA responsible for oversight of the $50 billion supplement market in the United States. With a little more than $13 million in funding, it sets strategic priorities, and ensures that limited resources are used in the best manner possible to protect the health and well-being of consumers. According to the June 27, 2023, announcement, ODSP will be merged into the ‘Office of Food Chemical Safety, Dietary Supplements, and Innovation.’ We are concerned that these changes could divert resources, funding, and attention from the supplement market at a time when it is needed more than ever.”
The American Herbal Products Association (AHPA) also weighed in. “AHPA shares the concerns expressed by Senators Durbin and Blumenthal about the potential impact on the regulation of dietary supplements of placing ODSP within a larger office,” said AHPA President Michael McGuffin. “We too have expressed our concerns to FDA directly, and we await with interest the agency’s answers to the senators’ discerning questions.”
NPA added that Representative Duncan, a senior member of the House Energy and Commerce Committee, called the proposal “backward” and said ODSP should “remain free-standing, as was established, consistent with the statute.”
Dr. Fabricant’s take: “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.”
