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The U.S. Food and Drug Administration (FDA) has officially declared nicotinamide mononucleotide (NMN) lawful for use in dietary supplements, reversing its earlier decision that had effectively banned the ingredient. NMN, a compound related to vitamin B3 that supports cellular energy by boosting NAD+ levels, has been popular in the wellness industry for its potential anti-aging benefits. The FDA’s reversal followed a citizen petition by the Natural Products Association and the Alliance for Natural Health USA, which argued that NMN had been sold as a supplement before it was investigated as a drug — making it eligible under federal supplement law.
The central issue was the “race-to-market” clause in the Dietary Supplement Health and Education Act (DSHEA). Previously, the FDA ruled in 2022 that NMN could not be classified as a dietary ingredient because it had been the subject of clinical drug studies. However, in its new decision, the agency acknowledged that NMN had already been marketed as a supplement in the U.S. as early as 2017. This meant that its earlier interpretation was overly restrictive, and NMN did not fall under the drug exclusion rule.
The decision was widely welcomed by the supplement industry. The Natural Products Association called it a major win for consumer choice and science-based regulation, while the Alliance for Natural Health described it as a landmark ruling for natural health products. However, the Council for Responsible Nutrition cautioned that regulatory uncertainty remains, as the FDA has yet to clarify the broader framework surrounding when an ingredient is considered a drug versus a supplement.
This ruling is expected to reshape the supplement market by allowing companies to legally sell NMN products once again, particularly those targeting longevity and metabolic health. While the decision may boost consumer access and innovation in the healthy-aging sector, experts note that ambiguity in FDA policy could still create hurdles for future novel ingredients seeking approval.
