NMN FDA Update: What Supplement Founders Need to Know
[Update Sept 23 2025: FDA has since stated that they’ll be delaying their response to the citizen’s petition due to resource constraints.]
Few ingredients have stirred as much controversy as nicotinamide mononucleotide (NMN). Once considered one of the hottest longevity ingredients, NMN ran into regulatory turbulence when the FDA concluded it was excluded from use in dietary supplements under the investigational new drug (IND) exclusion rule.
Now, with industry lawsuits, petitions, and regulatory negotiations in play, brands are left asking: Can I use NMN in my supplement formula today? Here’s the latest status, what the FDA has said, and how startups should think about the ingredient moving forward.
Why FDA Said “No” to NMN
Under U.S. law, if an ingredient is authorized for investigation as a new drug (IND) before it is marketed as a supplement, it is locked out of the supplement category. The FDA determined that NMN fell into this scenario.
This decision was not about safety or efficacy. Instead, it was a technical exclusion under the Dietary Supplement Health and Education Act (DSHEA).
The Industry Pushback
The Natural Products Association (NPA) sued the FDA and also filed a formal citizen petition requesting that NMN be allowed in supplements. In response:
The lawsuit has been paused while FDA reviews the petition.
FDA agreed to provide an official response by July 2025.
Until then, FDA has said it will not prioritize enforcement against brands currently selling NMN—so long as they are otherwise compliant (proper testing, no egregious claims, GMP standards in place).
Current Status of NMN
Here’s where things stand today (late 2025):
Technically not permitted: NMN remains excluded under FDA’s IND interpretation.
Enforcement pause: FDA has stated it will not pursue brands selling NMN pending its July 2025 decision.
Platform movement: LegitScript recently removed NMN from its “problematic ingredients” list, and NPA is working with Amazon to revisit its ban.
This means NMN is in a regulatory gray zone: available for sale but not fully greenlit.
Why Manufacturers Are Hesitant
Even with FDA pausing enforcement, many manufacturers are avoiding NMN for now. Reasons include:
Fear of liability if FDA doubles down in 2025.
Retailer reluctance (Amazon still restricts NMN).
Risk tolerance: smaller or newer facilities may not want to be first movers.
For startup brands, this means fewer reputable options for sourcing and more scrutiny around due diligence.
Q&A: NMN Regulatory Landscape
Q: Is NMN legal to sell right now?
Technically, FDA considers it excluded from supplements. But enforcement is paused until July 2025, meaning brands are not currently being targeted.
Q: What happens in July 2025?
FDA will issue its formal response to the NPA petition. It could reverse course, allow NMN, or reaffirm its exclusion.
Q: Can I launch with NMN today?
It’s possible, but risky. If FDA reaffirms its position in 2025, your brand could face recalls or re-formulation.
Q: What about selling on Amazon?
Amazon still bans NMN, though NPA is in discussions to change this. Don’t assume reinstatement until official confirmation.
Final Thoughts
NMN sits in a regulatory limbo: technically excluded, practically tolerated. The FDA’s July 2025 response will determine whether the ingredient has a future in supplements—or remains locked as a “drug-only” compound.
For startups, the key is risk management. If NMN is central to your concept, build contingency plans. If it’s one ingredient among many, consider whether waiting until FDA clarity is safer than launching into uncertainty.
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