US House Member Has Questions On FDA’s Policy On NMN, Also Asks For Public Hearing
Because FDA “suddenly changed its position and advised companies of its determination that NMN is excluded from the definition of a dietary supplement,” Rep. Jeff Duncan states, a public hearing “would be incredibly beneficial as the dietary supplement industry seeks clarity on the FDA’s actions.”
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FDA explains thinking in a letter to Inner Mongolia Kingdomway Pharmaceutical after rejecting Chinese firm’s NDI notification for N-acetyl-L-cystein. Prior to its investigation as a drug, NMN wasn’t used in supplements available in US, “except unlawfully without an NDI notification.”
Natural Products Association and Alliance for Natural Health USA petition FDA to reconsider its stance on beta-nicotinamide mononucleotide. Excluding NMN from use in supplements “adversely affects the entire dietary supplement stakeholder community,” petition says.
Draft guidance states enforcement discretion allowing sales of N-acetyl-L-cysteine supplements which FDA in 2020 ordered firms to halt selling due to its use as a drug ingredient. However, NAC supplements, as they have remained since 2020, were available to US consumers when draft was published.