NMN (nicotinamide mononucleotide) has had a rough few years in the US. In 2022 the FDA said it could no longer be sold as a dietary supplement, and many retailers pulled it. In September 2025 the agency reversed that position. Brands are coming back to NMN, and the questions now are practical ones: is the product lawful to sell, and is the powder in the capsule what the label says?
Where NMN stands now
In letters dated September 29, 2025, the FDA concluded that NMN is not excluded from the definition of a dietary supplement, because it was marketed as a supplement in the US before it was authorized for investigation as a drug. That reversed the agency’s 2022 view.
NMN is still treated as a new dietary ingredient. A company marketing it generally needs a New Dietary Ingredient Notification (NDIN) on file with the FDA, unless its NMN comes from a supplier that already has an acknowledged notification covering that ingredient. Before you launch, confirm with your supplier and your regulatory adviser which notification covers your material.
What to check on an NMN raw material
Purity, by HPLC
Good NMN raw material is typically sold at 99% purity or higher, measured by HPLC. Ask for the actual chromatogram-based result on the COA, not just a purity claim on a spec sheet.
The right form
The active form is beta-NMN. Identity testing should confirm that, and the COA should state it.
How it was made
Most NMN is made by enzymatic synthesis or by chemical synthesis. Both can produce high-purity material, but the production route decides which impurities and residual solvents to look for. Ask which route your supplier uses and make sure the COA covers the matching tests.
Contaminants
Heavy metals, microbial limits and, where relevant, residual solvents should all have a number and a limit, as they would for any ingredient. If you are new to reading these documents, see how to read a supplement COA.
Stability: the part samples don’t show
NMN takes up moisture easily and breaks down faster in heat and humidity, with nicotinamide as a main breakdown product. A fresh sample will test well. The question is what the capsule contains after months on a shelf or in a bathroom cabinet.
That makes packaging part of the formula: a tight closure, an induction seal, and often a desiccant. Ask for stability data on the finished product, and set your overage and expiry date from it. The same moisture logic is covered in what looks fine in a sample can still fail in storage.
Watch the claims
NMN is often marketed with anti-aging language. Dietary supplements can’t claim to treat, cure or prevent disease, and structure-function claims need support and the standard FDA disclaimer. Keep the label and the marketing within what the evidence supports.
The takeaway
NMN is back on the table as a supplement ingredient, but it rewards careful sourcing. Confirm the regulatory coverage of your raw material, check purity and identity on the COA, ask how it was made, and plan packaging around moisture from day one.
Sources
- US FDA, responses dated September 29, 2025 to citizen petitions from the Natural Products Association and the Alliance for Natural Health USA regarding NMN, as reported by Venable LLP (October 2025) and the National Law Review.
- US FDA, New Dietary Ingredient Notification requirements, 21 U.S.C. 350b and 21 CFR 190.6.
- US FDA, 21 CFR 101.93, structure/function claims for dietary supplements.