Regulatory explainer
Is NMN legal? FDA status and what changed in 2025
Quick answer
FDA now concludes that NMN is not excluded from the definition of a dietary supplement. That means NMN can be used in dietary supplements in the United States, subject to the usual rules on safety, labeling, claims, and manufacturing. This change reflects FDA’s revised reading of the “race to market” clause and evidence that NMN was marketed as a supplement in the U.S. before drug investigations began. It does not waive other requirements like NDIN where applicable. This page is educational, not legal advice.
What changed and why it matters
In late 2025, FDA issued responses to citizen petitions on NMN. In those letters, the agency stated it now concludes NMN is not excluded from the dietary supplement definition because it had been marketed as a dietary supplement in the United States before authorization for investigation as a new drug. FDA also said it will no longer consider whether that earlier supplement marketing was “lawful” when applying the race‑to‑market clause. Marketing still must have occurred in the U.S. The bottom line for consumers is that NMN may be sold as a dietary supplement, and for brands that means the usual dietary supplement rules still apply.
What “not excluded” actually means
| Topic | What it means in practice |
|---|---|
| Drug preclusion | FDA’s reversal removes the drug‑preclusion barrier for NMN. NMN may be in supplements because it was marketed as a supplement in the U.S. before drug authorization. |
| “Lawful” marketing | For the race‑to‑market analysis, FDA will not evaluate whether that earlier supplement marketing was “lawful.” The agency will still verify that the product was a supplement or food and that the marketing occurred in the U.S. |
| NDI notifications (NDIN) | NDIN is a separate requirement from drug preclusion. An NDIN is not required if the ingredients were present in the food supply as articles used for food and not chemically altered. Self‑affirmed GRAS does not, by itself, prove that. Many NMN products will still need to address NDIN obligations. |
| Other rules still apply | Labeling, cGMP, substantiated structure‑function claims, and adverse event reporting remain in force. Brands must avoid disease claims. |
If you run a brand or retail site, talk to regulatory counsel and verify your NDIN and labeling posture before launch.
NMN regulatory timeline at a glance
- 2022: FDA communications to several NDIN filers stated NMN was excluded under the drug‑preclusion clause. Brands began to exit some marketplaces.
- 2023–2024: Trade groups filed citizen petitions seeking clarity.
- September 2025: FDA responded, concluding NMN is not excluded because it was marketed as a supplement in the U.S. before drug authorization. Some marketplaces have since allowed NMN again.
What this means if you are a consumer
- NMN supplements may be sold in the U.S. Choose products from companies that publish Certificates of Analysis and follow cGMP.
- Be wary of disease claims. Responsible brands stick to well‑qualified structure‑function language.
- If you have a medical condition, are pregnant or nursing, or take prescription drugs, talk with your clinician first.
Brand and retailer checklist
- Confirm whether your formulation triggers NDIN or qualifies for a food‑supply exemption. Do not rely on self‑affirmed GRAS as proof of food‑supply presence.
- Lock down supplier quality and identity testing. Keep COAs current.
- Align labeling and claims with U.S. regulations. Avoid disease claims in ads and PDP copy.
- Keep adverse event reporting and cGMP documentation in order.
FAQ
- Is NMN legal in the United States
- Yes. FDA now concludes NMN is not excluded from the dietary supplement definition. NMN can be sold as a dietary supplement, subject to all standard rules.
- Does this mean no NDIN is needed
- Not necessarily. Whether an NDIN is required is a separate question. In general, NDIN is not needed if the ingredients have been present in the food supply as articles used for food and not chemically altered. Many NMN products will still need to evaluate NDIN.
- Did marketplaces restore NMN
- Some marketplaces that had removed NMN have begun allowing it again after the FDA responses. Marketplace policies can change, so always confirm current rules.
- Is this page legal advice
- No. This is educational content. If you are making or selling NMN products, consult regulatory counsel.
Continue learning
Let customers speak for us
I have been taking these for almost a month now and already feel healthier and have more energy. This vitamin in particular has everything we need for men in our 50’s. 60 pills per bottle 2 a day = 30 day supply for $56 to $57. I believe they are a bit pricy but well worth it
This supplement is exactly what I was looking for for my son. It tastes good and provides him with the nutrients we were looking for without synthetic ingredients. Great customer service as well. Thank you!
I have been using the blood sugar support for about two weeks now. I have been type two diabetic since 2018.
I have seen a noticeable decline in high blood sugars. With our hot weather this summer I did have some ice cream a couple days in a row and I noticed that my blood sugar still stayed within a healthy range. I can’t guarantee that for everyone, but it did help me.
I had multiple surgeries on my sinuses. I was told that I would have to be on steroids the rest of my life, as the surgeries did not correct the problem. Mt Angel Quercetin Nettle+ has completed cured all my sinus issues! I recommended it to all who struggle seasonal or otherwise.
