The FDA cited “competing agency priorities” in a recent letter describing why it hasn’t reached a substantive decision pertaining to a citizen petition about NMN in dietary supplement products.
In March 2023, the Natural Products Association (NPA) and Alliance for Natural Health USA submitted a request to the Food and Drug Administration (FDA). In their request, the organizations asked the FDA not to exclude NMN under the definition of a dietary supplement and commit to not enforcing their existing ban on the sale of NMN as a supplement.
“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,” wrote Cara Welch, PhD, director of FDA’s Office of Dietary Supplement Programs (ODSP), to the NPA and the Alliance for Natural Health USA according to a press release. “However, be advised that our staff is evaluating your petition.”
The citizen petition was filed after the FDA concluded in November 2022 that NMN cannot be lawfully marketed in dietary supplement products. The FDA went on to say that their decision was based on NMN being authorized for investigation as a new drug and being the subject of substantial clinical investigations.
Prior to this conclusion from the FDA, the FDA had acknowledged NMN as a new dietary ingredient (NDI) — an additive to dietary supplement products. Regarding their NDI, the FDA later went on to say that it had not immediately made the connection between NMN and MIB-626 — a proprietary form of NMN under investigation as a new drug from the company Metro International Biotech.
The NPA President and CEO Daniel Fabricant, PhD, said that the NMN petition should be an agency priority because it is a public health matter relating to the NDI notification process. This process is a requirement of the Dietary Supplement Health and Education Act of 1994 (DSHEA) to demonstrate the safety of novel ingredients.
Dr. Fabricant has criticized the FDA’s reversal of their NDI acknowledgement in the form of a so-called “good day” letter they sent in May of 2022 to a Chinese NMN manufacturer, SyncoZymes (Shanghai) Co. Ltd. As such, he has characterized the FDA’s decision reversal as “basically taking the NDI process and throwing it out.”
The FDA’s decision to exclude NMN from being defined as a supplement has had an enormously adverse effect on the NMN market, valued at an estimated $280.2 million in the US in 2022. Along those lines, Amazon, the world’s largest sales platform, prohibited retailers from selling NMN beginning in March 2023.
Dr. Fabricant has predicted that the FDA “is just going to run clock” on the citizen petition. The consequence will be that other sales platforms will eventually ban the sale of NMN. He went on to say that the FDA may go several years without responding substantively to such a petition.
“If I’m in the NMN business or new ingredient business, this is where the industry has to stand tall and probably pursue … some form of litigation, because you’re not going to get relief otherwise,” he said in a press release. “FDA’s just going to wait you out.”
The executive and scientific director of the Alliance for Natural Health USA, Rob Verkerk, PhD, said his organization “is disappointed, but not surprised, by the FDA’s continued inaction on NMN.”
“The FDA knows perfectly well that the IND [investigational new drug] rubber stamp gives preferential treatment to its paymasters, the drug companies, while working against wider, low-cost access to highly effective dietary supplements like NMN,” Verkerk said in a press release. “Without congressional intervention, it looks likely that we’ll need a lawsuit if we’re going to successfully rein in the FDA’s bias against natural products through the use of IND submissions.”