FDA faces new lawsuit from NPA over anti-aging ingredient NMN
news article · 2024
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SUMMARY
Trade-press report on the Natural Products Association's lawsuit against the FDA over its determination that NMN is excluded from the legal definition of a dietary supplement. Quotes the FDA's 4 November 2022 letter directly: 'After carefully reviewing the information provided in your amended notification and other relevant sources, including our own records, we also concluded that NMN was not marketed as a dietary supplement, except unlawfully without an NDI notification, or as a food before FDA authorized it for investigation as a new drug.' Reports that the exclusion followed Metro International Biotech's active Investigational New Drug filing for its proprietary NMN formulation, MIB-626, and that the determination 'blindsided and incensed the industry.' Byline, date, and publisher confirmed directly on the fetched page; the FDA-letter quote above is verbatim from the fetched article text.
NOTES
Regulatory-history source for the case: documents that a company David Sinclair co-founded (MetroBiotech) held the specific investigational-drug filing on which the FDA based a determination that excluded NMN generally from the dietary-supplement market — a regulatory outcome in which Sinclair had a direct financial interest via his stake in MetroBiotech.