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The FDA Prolongs Its Inaction Regarding NMN
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The FDA Prolongs Its Inaction Regarding NMN
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. Get more news about NMN supplements,you can vist our website!
Inaction and No Substantive Response from the FDA Regarding NMN
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.”