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FDA Re-Establishes NMN As A Dietary Supplement

FDA Re-Establishes NMN As A Dietary Supplement

by Gataca Admin in News


In a landmark decision in September 2025, the U.S. Food and Drug Administration (FDA) officially removed restrictions on NMN (Nicotinamide Mononucleotide), restoring its status as a legal dietary supplement. This marks the end of a three-year regulatory saga that has shaped the future of NMN in the wellness and longevity industry.

The journey began in May 2022, when the FDA approved NMN as a New Dietary Ingredient (NDI), paving the way for its legal sale as a dietary supplement. This was a significant moment for companies and consumers interested in NMN’s potential benefits for energy, metabolism, and healthy aging.

However, in November 2022, the FDA reversed its stance. It ruled that NMN could not be sold as a supplement because it was under investigation as a pharmaceutical drug. This decision was based on the “drug preclusion” clause, which gives investigational drugs regulatory priority over supplements. The sudden restriction disrupted the NMN market and drew criticism from both industry stakeholders and consumers.

In March 2023, the Natural Products Association (NPA) filed a formal petition urging the FDA to lift these restrictions, arguing that NMN had been marketed as a supplement well before drug investigations began. When this did not yield results, the NPA escalated the matter by filing a lawsuit in August 2024 against the FDA.

Mounting public and legal pressure led the FDA to pause enforcement in October 2024, allowing NMN products back on shelves. 

Finally, in September 2025, the FDA permanently lifted its restrictions, marking a decisive victory for the supplement industry and NMN consumers.

This resolution brings clarity to NMN’s regulatory status and paves the way for broader access and innovation in the longevity space.

Tags: NAD+ updates

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