FDA reverses course on NMN — lawful as a supplement again

A completed regulatory event (not pending). Basis is FDA's two NMN letters dated September 29, 2025, reported via legal and trade analysis.

What is happening

FDA's position on NMN (nicotinamide mononucleotide) as a dietary supplement reversed. In November 2022 the agency declared NMN excluded from the dietary-supplement definition because it had first been investigated as a drug; in two letters dated September 29, 2025 — following a citizen petition and litigation involving the Natural Products Association — it reversed that position, concluding under the "race-to-market" provision that NMN was marketed as a supplement before that drug investigation.S1S2

What was decided

NMN is lawful as a dietary supplement in the US, but remains a New Dietary Ingredient — marketers must still file NDI notifications.S2 The action does not approve NMN (or NAD+) as a drug, and it does not address IV / injectable NAD+, which remains a non-approved compounding / clinic product.S1

Why it matters

The reversal removes the cloud over a large consumer supplement category, but "lawful supplement" is not "proven" or "FDA-approved drug" — the evidence questions about anti-aging benefit are unchanged.S1

What's next

Watch whether the same reasoning extends to other NAD+ precursors, and whether the IV NAD+ market — on separate, weaker footing — draws regulatory attention.S1