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FDA delays decision on NMN citing other agency priorities

FDA Delays Decision on NMN, Citing Other Agency Priorities

The FDA recently highlighted “competing agency priorities” as the reason behind its ongoing delay in making a significant decision concerning a citizen petition about NMN in dietary supplement products, as stated in a recent letter.

In March 2023, the Natural Products Association (NPA) and Alliance for Natural Health USA approached the Food and Drug Administration (FDA) with a plea. They requested the FDA to consider NMN as a dietary supplement and to refrain from enforcing the existing ban on NMN sales as a supplement.

In response, Cara Welch, PhD, the director of FDA’s Office of Dietary Supplement Programs (ODSP), informed the NPA and the Alliance for Natural Health USA, in line with 21 CFR 10.30(e)(2), that a decision on their petition has not been reached within the initial 180 days due to other agency priorities. Nonetheless, she assured them that their petition is under evaluation by the staff.

Lack of Tangible Action from FDA on NMN

This citizen petition emerged after the FDA’s November 2022 conclusion that NMN could not be legally marketed in dietary supplement products. The FDA justified this stance based on NMN’s authorisation for new drug investigation and substantial clinical investigations surrounding it.

Before this determination, the FDA recognised NMN as a new dietary ingredient (NDI), a component in dietary supplement products. Later, it acknowledged not immediately recognising the link between NMN and MIB-626—a proprietary NMN form from Metro International Biotech under new drug investigation.

NPA’s President and CEO, Daniel Fabricant, PhD, emphasised that the NMN petition should be prioritised by the agency as it’s a public health matter concerning the NDI notification process, crucial for demonstrating the safety of new ingredients as per the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Dr. Fabricant criticised the FDA for retracting their NDI acknowledgment, sent in a “good day” letter in May 2022 to Chinese NMN manufacturer SyncoZymes (Shanghai) Co. Ltd. He described this retraction as undermining the NDI process.

Wide-Reaching Implications of FDA’s NMN Decision Reversal

The FDA’s choice to omit NMN from the supplement category significantly impacted the NMN market, which was estimated to be worth $280.2 million in the US in 2022. Subsequently, Amazon banned NMN sales on its platform in March 2023.

Dr. Fabricant fears that the FDA will merely delay the citizen petition, leading other sales platforms to ban NMN sales. He suggested that without proactive litigation, relief is unlikely as the FDA might take several years to respond to such petitions.

Rob Verkerk, PhD, the executive and scientific director of the Alliance for Natural Health USA, expressed disappointment but not surprise over the FDA’s continued delay on NMN. He criticised the FDA’s favor towards pharmaceutical companies through the IND (investigational new drug) approval process, hindering broader, cost-effective access to supplements like NMN. Verkerk stressed the potential necessity of a lawsuit or congressional intervention to challenge the FDA’s bias against natural products via IND submissions.

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