NMN Declared a Lawful Supplement Again: The FDA's Landmark Decision Ends Regulatory Uncertainty
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Time to read 5 min
The Outcome Consumers Deserved After a Multi-Year Regulatory Battle
After years of uncertainty and back-and-forth rulings, the U.S. Food and Drug Administration (FDA) has formally declared Nicotinamide Mononucleotide (NMN) a lawful dietary ingredient. This landmark reversal ends the regulatory limbo created in 2022 when the FDA initially excluded NMN from supplement use under a technicality known as the "drug preclusion" clause.
This decision restores confidence for consumers, manufacturers, and the wider longevity industry. Most importantly, it confirms that NMN supplements are once again fully accessible and legal for U.S. consumers.
Following this announcement, For Youth has made its NMN-based NAD⁺ boosters, The Repair and The Base, available for purchase again in the U.S.
“It restores access to what we believe is a more effective pathway for boosting NAD⁺.”
This outcome did not happen in isolation. It followed sustained pressure from the Natural Products Association (NPA) and the Alliance for Natural Health USA (ANH). Their efforts were pivotal in securing this reversal and ensuring NMN’s continued availability for consumers. Their Citizen Petition, followed by a lawsuit, forced the FDA to reconsider its stance and address the contradictions in its interpretation of supplement law.
"After NMN’s exclusion, Americans largely had to rely on NR [Nicotinamide Riboside] as their main NAD⁺ booster. This long-awaited decision marks a historic moment for both the supplement industry and the people we serve," said Jeff Duyvesteijn CEO and Founder of For Youth. "It restores access to what we believe is a more effective pathway for boosting NAD⁺. We’re thrilled to make NMN available again in the U.S., including through our groundbreaking Triple-Action NMN formula, The Repair. Consumers can now access our state-of-the-art solutions without concern over pharmaceutical monopolization."
The FDA’s Reversal: Why the Change?
The crux of the original exclusion rested on the “Race-to-Market” clause in U.S. dietary supplement law. This clause was designed to ensure that an ingredient cannot be marketed both as a drug and a supplement at the same time. The logic is simple: if a substance has already been authorised for drug investigation, it cannot later be introduced as a supplement, unless it can be shown that it was marketed as a supplement before any drug research began.
In 2022, the FDA applied this clause to NMN and concluded that it was not a lawful dietary ingredient. Their position hinged on the idea that NMN had first entered the pipeline for pharmaceutical development, therefore making its use in supplements invalid. This created immediate disruption across the supplement industry and confusion among consumers who had relied on NMN for its longevity benefits. [3]
However, industry groups, researchers, and advocates presented clear evidence that NMN was already being sold as a dietary supplement as early as 2017, well before any drug investigations received authorisation. This historical proof undermined the FDA’s original stance and forced a reassessment of the facts. [4]
After years of petitions, legal challenges, and careful review, the FDA issued its final ruling in September 2025. In its own words: [1]
“We now conclude that NMN is not excluded from the definition of dietary supplement”
This acknowledgment represents not only a legal correction but also a validation of the supplement industry’s position from the beginning. By recognising NMN’s long-standing status as a supplement, the FDA has restored clarity and certainty for consumers, manufacturers, and the broader wellness market. The reversal firmly re-establishes NMN’s rightful place in the dietary supplement category, ending years of ambiguity and speculation.
The Legal Rollercoaster: A Brief Timeline
2022 (Exclusion): FDA announced NMN was not a lawful dietary ingredient. [2]
2023 (Citizen Petition and Lawsuit): NPA and ANH formally challenged the FDA’s interpretation. [2]
2024 (Court Stay): A federal court halted enforcement and forced the FDA to respond. [4]
September 2025 (Resolution): FDA issues its formal reversal, declaring NMN lawful. [1]
Industry Reaction and Future Implications
Daniel Fabricant, PhD, President & CEO of the Natural Products Association, welcomed the FDA reversal with enthusiasm in their press release: “FDA’s decision today confirms NMN is lawful in supplements, and we now call on e-commerce platforms to immediately restore NMN products to the market.”
He also added a commitment to further action: “We will continue pressing Congress, the courts and the Administration until FDA stops abusing the drug preclusion clause once and for all.”
Looking ahead, the FDA’s decision on NMN may well serve as a partial blueprint for future ingredient disputes. Compounds like N-acetyl-cysteine (NAC) faced similar “drug preclusion” challenges. In 2022, the FDA attempted to remove it from the dietary supplement market, citing that it was first studied as a pharmaceutical. Following industry pushback, the agency eventually adopted a policy of enforcement discretion, essentially allowing NAC supplements to remain on the market despite its earlier drug-status claim. [5]
By contrast, the NMN ruling goes further: the FDA explicitly revised its interpretation of the race-to-market clause, foregoing its prior requirement that the ingredient be “lawfully marketed” before drug investigations. That shift suggests the agency may now be more open to arguments from supplement manufacturers that historical marketing, even if not fully “lawful” under earlier interpretations, can suffice as a defence against exclusion.
In practical terms, that opens the door for supplement makers to revisit the status of compounds that were once threatened by drug preclusion. Some trade associations have already noted that the NMN case “underscores” the need for a more coherent, consistent framework across ingredients.
But the path is not guaranteed. Critics warn that the core statute (DSHEA) still contains ambiguous language about what constitutes a “substantial clinical investigation,” leaving room for FDA discretion or future legal interpretation. [1]
In sum, NPA sees this as a landmark victory, for NMN in particular, yes, but also for the principle that consumers should retain access to well-documented ingredients, and that regulators must operate with clarity, consistency, and respect for established supplement law.
What This Means for Consumers
Safety Confirmed: NMN’s safety has never been in doubt throughout the legal process.
Availability Restored: U.S. consumers can once again access NMN supplements without risk of regulatory crackdowns.
Trusted Sources Matter: As with all supplements, quality is key. For Youth ensures transparency by using a traceable source of NMN and conducting independent third-party lab testing on every batch.
Conclusion
The FDA’s decision marks the end of years of legal uncertainty. NMN is now firmly recognised as a dietary supplement, clearing the path for innovation and growth in the longevity market. For consumers, it means peace of mind and renewed access to one of the most promising supplements in healthy ageing.
At For Youth, this clarity allows us to do what we do best. Focus on quality, transparency and innovation. With the regulatory cloud lifted, we are proud to once again make The Repair and The Base available for Americans. Every batch is traceable to its source and independently third-party tested, so our customers can trust they are receiving NMN in its purest, most effective form.
References
Natural Products Association. (2025, Sept 29). Amid pressure from NPA, FDA declares NMN lawful in dietary supplements. NPA. https://www.npanational.org/news/amid-pressure-from-npa-fda-declares-nmn-lawful-in-dietary-supplements/
Daniells, S. (2023, Sep 12). NPA’s Fabricant on NMN: ‘Taking FDA to Federal Court is expensive, but I don’t see another option’. https://www.nutraingredients-usa.com/Article/2023/09/12/NPA-s-Fabricant-on-NMN-This-is-not-an-insignificant-ingredient/
Drake, K. (2024, Feb 13). FDA bans NMN as a dietary supplement: Why and what happened?. Healthnews. http://healthnews.com/longevity/longevity-supplements/fda-b-nmn-can-no-longer-be-sold-as-a-dietary-supplement-in-the-us/
Food and Drug Administration. (2022, Nov 8). NDI 1259 - B-Nicotinamide Mononucleotide (NMN) from Inner Mongolia Kingdomway Pharmaceutical Limited. https://www.regulations.gov/document/FDA-2022-S-0023-0051
Daniells, S. (2022, November 2). NPA withdraws FDA lawsuit following final NAC guidance, marketplace stabilization. NutraIngredients-USA. https://www.nutraingredients-usa.com/Article/2022/11/02/npa-withdraws-fda-lawsuit-following-final-nac-guidance-marketplace-stabilization/
