Elementos clave
- As of September 2025, the FDA has confirmed that NMN can be legally marketed as a dietary supplement in the U.S.
- NMN was never banned or considered unsafe, but the FDA revoked its status as a dietary supplement as part of the drug preclusion rule (classic case of pharma first?). as a potential drug.
- With a citizen petition, lawsuit, and never-ending pressure, the Natural Products Association (NPA) pushed the FDA to reconsider.
- NMN supplements can now be purchased with full confidence, and major retailers are likely going to reintroduce products.
Big news! The Food and Drug Administration (FDA) reversed course on its November 2022 decision to revoke NMN’s status as a dietary supplement. The agency confirmed that nicotinamide mononucleotide, or NMN, is officially considered lawful for use in dietary supplements. It’s been a bumpy ride with a lot of confusion for consumers and retailers alike, so let’s break this down.
What changed in the FDA’s NMN decision?
Three years ago, the FDA threw a wrench in the works when it revoked NMN’s previously recognized status as a dietary supplement in what would become a very controversial letter. The agency cited an ongoing investigation into NMN as a new drug, which triggered the FDA’s drug preclusion rule. Basically, that rule means that if a substance is already being developed and studied as a drug, it can’t también be marketed as a dietary supplement—even if it’s safe and already on the shelves. NMN was already being sold as a supplement before the FDA applied this rule, which is why the 2022 decision was so controversial.
The reversal on NMN caused a veritable uproar. Not only was it a technicality—a regulatory interpretation, to be exact, and not a safety issue—NMN had already become enormously popular as one of the most promising NAD precursors. When the FDA issued its letter, retailers like Amazon reacted by pulling NMN from its shelves entirely. The National Products Association (NPA) leapt into action, arguing that NMN had a clear history of safe use in supplements and filing a citizen petition and later a formal lawsuit challenging the FDA’s interpretation. After months (and months and months) of dialogue and petitions and court motions, the FDA finally clarified that NMN is indeed lawful for use in dietary supplements.
Does this mean NMN is legal in the U.S. right now?
Well, NMN wasn’t actually illegal in the U.S to begin with. The FDA’s 2022 decision really muddied the water, but it didn’t actually make NMN unlawful to possess or buy or use. In 2024, in response to the NPA’s lawsuit, a court granted a joint motion to stay the case. That temporarily prevented the FDA from enforcing actions against NMN products. In other words, NMN supplements remained legal and accessible. Consumers could still buy NMN online from brands like Wonderfeel, but the uncertainty really cast a big cloud over the market as a whole. It was a downright shame for something as beneficial and beneficial as NMN!
Now, with the FDA’s 2025 clarification, it’s like the sun has come out. NMN is officially recognized as lawful for use in dietary supplements, which means brands, retailers, and consumers alike can enjoy a little peace of mind. It’s the green light the industry needed all along, and it’s officially here!
A handy timeline (2019–2025)
Interested in exactly how this all played out? We love a good timeline ourselves!
May 2022: NDIN acknowledgement
The FDA acknowledges a New Dietary Ingredient Notification, or NDIN, for NMN, signaling it could be sold as a dietary supplement.
November 2022: FDA reversal letter
The now-infamous letter is issued, stating that NMN might be excluded from dietary supplements under the drug preclusion rule because it’s being investigated as a pharmaceutical (MIB-626). Cue the confusion, retailer pullbacks, general panic.
March 2023: Citizen petition filed
The NPA swings into action, formally petitioning the FDA and requesting confirmation that NMN can remain a supplement o that the agency exercises a little discretion to enforcement as the issue is reviewed. Thumb twiddling ensues.
September 2023: FDA signals delay
The FDA indicates it’s in no hurry and really, it’s busy with other priorities. More confusion, more uncertainly, an entire industry in limbo.
November 2024: Court stay granted
As part of the NPA’s lawsuit, a federal court grants a joint motion to stay the case. That pauses FDA enforcement against NMN products until the matter is resolved, bringing a little relief to retailers and consumers.
September 2025: FDA confirms NMN is lawful in supplements
In a major reversal, the FDA officially confirms that NMN is lawful for use in dietary supplements. In one fell swoop, it lifts years of uncertainty and restores clarity to the market. Retailers weep with relief.
What does this mean for NMN consumers and retailers?
For consumers, the FDA’s clarification is a major relief—no more second guessing whether your favorite longevity booster exists in a weird legal gray area. Plus, with the FDA’s green light, access to NMN will likely become easier and more consistent across trusted brands like yours truly.
For retailers and manufacturers, this is even better news. The last three years have been a time of uncertainty and confusion and the decision provides what the industry needs most—clarity!
Does it change anything for Wonderfeel?
Nope! For Wonderfeel subscribers and new customers, this decision changes less than you might think—because we never stopped. Wonderfeel continued offering clinically tested, GMP-certified NMN formulations throughout the uncertainty. Now, with the FDA’s clarification, you can enjoy even greater peace of mind knowing your trusted supplement is firmly on solid legal ground.
Preguntas frecuentes
Is NMN legal in the U.S. right now?
Yes! The FDA’s September 2025 clarification confirms that NMN is lawful for use in dietary supplements. While NMN was never illegal, the FDA’s decision lifts the cloud of uncertainty for consumers and retailers alike.
What exactly did the FDA change in 2025?
The FDA reversed its 2022 stance that NMN couldn’t be marketed as a supplement because it was under investigation as a drug (MIB-626, to be precise). In 2025, the agency clarified that NMN es lawful for use in dietary supplements, so there’s no more confusion.
Was NMN ever banned by the FDA?
No, the FDA never banned NMN or even declared it unsafe. The 2022 decision was purely regulatory—not a safety issue. People could still buy NMN, but some retailers chose to stop selling it to avoid regulatory risk.
What’s the timeline behind the decision?
In May 2022, the FDA acknowledged an NMN NDIN (New Dietary Ingredient Notification). In November 2022, the FDA issued its reversal letter invoking the drug preclusion rule. In March 2023, the NPA filed a citizen petition. In November 2024, a court stay paused the FDA’s enforcement while the petition was under review. In September 2025, the FDA clarified that NM is lawful in supplements.
How NPA influenced the FDA’s decision
The NPA led the charge against the FDA’s reclassification of NMN by filing a citizen report, organizing industry support, and ultimately suing the FDA over its interpretation of the law. The group did an excellent job of keeping pressure on the agency and played a significant role in pushing for clarity.
Does this mean brands can make medical claims?
Nope. NMN is lawful as a supplement, and brands are still required to follow the same strict rules that apply to any supplement. That means no medical claims, only general function or structure claims when they’re supported by evidence.
Will marketplaces (e.g., Amazon) restore NMN listings?
Probably. Amazon yanked NMN off its shelves in late 2022 after the FDA’s reversal letter. With the agency’s 2025 reversal, major marketplaces have the green light to carry NMN again. Once the dust clears, Amazon will likely be one of them. But reputable manufacturers like Wonderfeel have made NMN available all along.
