Is NMN banned in the US? Everything You Need to Know
Last Updated: January 2026
As the founder of NMN Bio, I've dedicated my career to longevity research and supplementation. For years, one of the most common questions I heard was: Is NMN legal in the US?
The answer is now unequivocally YES. On September 29, 2025, the FDA officially reversed its previous position and confirmed that NMN (nicotinamide mononucleotide) is lawful for use in dietary supplements in the United States. This landmark decision ended three years of regulatory uncertainty and represents a monumental victory for the supplement industry and consumers alike.
This article explains what changed, why it matters, and what this means for anyone interested in NMN supplementation for healthy ageing.
The Historic FDA Decision: September 29, 2025
In two letters dated September 29, 2025, the U.S. Food and Drug Administration (FDA) officially confirmed that NMN is not excluded from the definition of a dietary supplement. This decision completely reversed the agency's November 2022 stance that had cast a shadow over the NMN market.
Official FDA Statement: "We now conclude that NMN is not excluded from the definition of dietary supplement under section 201(ff)(3)(B). Specifically, although NMN was authorized for investigation as a new drug, and substantial clinical investigations of NMN have been instituted and made public, NMN was marketed as a dietary supplement in the United States before such authorization."
— Donald Prater, DVM, Principal Deputy Director for Human Foods, FDA
What the FDA Concluded
The FDA acknowledged critical evidence that NMN was marketed as a dietary supplement in the United States as early as 2017, before it was ever authorized for investigation as a new drug. Under the "race to market" provision in federal law, this timing is decisive: because NMN reached consumers as a supplement first, it cannot be excluded from the supplement category simply because it was later investigated as a pharmaceutical.
Crucially, the FDA also clarified that it no longer requires proof that the prior marketing was "lawful" in determining the race-to-market clause. The agency admitted its previous interpretation was not the "best reading" of the statute. What matters is that NMN was marketed in the United States before the drug authorization date, regardless of whether that marketing met all regulatory requirements at the time.
The Industry Response
Daniel Fabricant, Ph.D., president and CEO of the Natural Products Association (NPA), immediately called on e-commerce platforms to restore NMN products:
"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. We will continue pressing Congress, the courts, and the Administration until FDA stops abusing the drug preclusion clause once and for all."
The NPA subsequently filed a notice to voluntarily dismiss its federal lawsuit against the FDA, marking the official end of this regulatory battle.
NMN Is Back on Amazon and Major Retailers
Following the FDA's September 2025 reversal, NMN supplements have returned to Amazon and other major e-commerce platforms. After removing NMN products in early 2023, Amazon began restoring listings in October 2025 once the regulatory situation was resolved.
According to NutraIngredients: "Amazon removed NMN dietary supplements from its virtual shelves at the start of 2023, but several different NMN dietary supplements are now available on Amazon."
This restoration means US consumers can now purchase NMN through multiple channels:
- Direct from trusted brands like NMN Bio (international shipping)
- Amazon US (multiple brands now available)
- Specialty supplement retailers (online and brick-and-mortar)
- Health food stores (select locations)
With the market reopened, consumers should prioritize brands that demonstrate:
- Third-party testing and Certificates of Analysis (COA)
- GMP-certified manufacturing
- Transparent sourcing and production
- Proper NDI (New Dietary Ingredient) compliance
What Is NMN and Why Does This Matter for Longevity?
Nicotinamide mononucleotide (NMN) is a vitamin B3 derivative and a direct precursor to NAD+ (nicotinamide adenine dinucleotide), a molecule essential for energy production in our mitochondria. Without adequate NAD+ levels, our bodies cannot generate ATP, the energy that powers every cell.
NAD+ levels naturally decline with age, contributing to many hallmarks of ageing including reduced energy metabolism, impaired DNA repair, and cellular dysfunction. This is why NMN supplementation has gained significant traction globally among those interested in supporting healthy ageing.
Multiple human clinical studies have demonstrated NMN's potential benefits, including improved insulin sensitivity in prediabetic women (Yoshino et al., Science 2021).
Important: The FDA's 2022 restrictions were never about safety concerns. NMN has maintained a strong safety profile throughout all clinical research. The dispute was purely regulatory, centered on the technical question of whether NMN qualified as a dietary supplement under federal law.
Complete Timeline: NMN's Regulatory Journey in the United States
2016-2021: NMN Enters the Market
NMN was sold in the US as a dietary supplement for anti-aging and healthspan, with no FDA objections. It gained popularity among consumers and researchers as a longevity supplement, amid studies showing it boosts NAD+ levels for potential health benefits. No major safety concerns were reported during this period.
May 2022: FDA Issues "No Objection"
The first formal New Dietary Ingredient (NDI) notification for NMN was accepted by the FDA. In May 2022, the FDA issued a "no objection" letter for an NMN ingredient (by SyncoZymes), essentially allowing NMN's use in supplements. This indicated that NMN was considered a lawful dietary ingredient.
November 2022: FDA Reverses Course
The FDA abruptly changed its position. Citing the drug preclusion clause, the agency determined that NMN was "excluded from the definition of a dietary supplement" because it had been investigated as a new drug. A pharmaceutical company (Metro International Biotech, co-founded by Harvard scientist David Sinclair) had filed an Investigational New Drug (IND) application for a proprietary NMN drug (code-named MIB-626).
The FDA claimed that NMN "was not marketed as a dietary supplement... before FDA authorized it for investigation as a new drug." This effectively withdrew the earlier NDI acknowledgment.
February-March 2023: Amazon and Retailers Remove NMN
Following the FDA's stance, Amazon notified sellers that NMN products would be delisted by March 13, 2023. Walmart and iHerb followed suit, creating significant market disruption.
March 2023: Industry Pushback Begins
On March 7, 2023, the Natural Products Association (NPA) and the Alliance for Natural Health (ANH) filed a formal Citizen Petition urging the FDA to reverse its position.
Mid-Late 2023: FDA Delays Response
The FDA failed to act on the petition within the 180-day window, citing "competing agency priorities." This delay left NMN's status in limbo.
August 2024: NPA Files Lawsuit
With the FDA still unresponsive, the NPA escalated the fight by filing a lawsuit against the FDA and the Department of Health & Human Services in U.S. District Court. The lawsuit sought a declaratory judgment that NMN is a lawful dietary supplement.
October-November 2024: Court-Ordered Stay
A federal judge approved a joint motion to stay the lawsuit. The FDA agreed it "does not intend to prioritize enforcement" against NMN supplements while the case was on hold. The court set a deadline for FDA to respond to the citizen petition.
September 29, 2025: FDA Confirms NMN Is Legal ✓
The FDA officially reversed its position. In letters dated September 29, 2025, the agency confirmed that NMN meets the definition of a dietary supplement and is lawful for sale in the United States. The FDA acknowledged evidence that NMN was marketed as a supplement as early as 2017, before the drug investigation began.
October 2025: NMN Returns to Amazon ✓
Multiple NMN brands relisted their products on Amazon US following the FDA's confirmation. The market began stabilizing as consumers regained easy access to their preferred supplements.
December 2, 2025: FDA Reinstates NDI Status ✓
The FDA sent letters to NMN ingredient suppliers (SyncoZymes and Inner Mongolia Kingdomway) reinstating their New Dietary Ingredient notifications, providing additional regulatory clarity for manufacturers.
How NMN Bio Ensures Quality and Compliance
At NMN Bio, we are a UK-based company that manufactures all our products in the UK and ships them globally to over 70 countries, including the United States. Throughout the period of regulatory uncertainty, we continued to legally ship NMN to US customers without interruption.
Now, with the FDA's clear confirmation that NMN is lawful, US consumers can purchase with complete confidence. Our products meet the same quality and compliance standards that NDI-validated suppliers must follow:
- ✓ Third-party tested for purity and potency with published Certificates of Analysis
- ✓ GMP-certified manufacturing facilities
- ✓ Full transparency in sourcing and production
- ✓ Scientifically-backed formulations developed by longevity researchers
- ✓ Compliant labeling following dietary supplement regulations
When you purchase from NMN Bio, you're choosing a brand that maintained its commitment to quality even during the most uncertain regulatory period, and one that now operates in a fully clarified legal environment.
Nutrition and Lifestyle: The Foundation of Longevity
While NMN is a powerful supplement for supporting healthy ageing, true longevity depends on more than one molecule. My personal routine combines nutrition, supplementation, and lifestyle optimization.
1. Nutrition
Since 2019, I've followed low-carbohydrate diets to maintain insulin sensitivity. Insulin resistance, caused by high-carb, processed diets, is a hallmark of aging and a precursor to diabetes, obesity, and cardiovascular disease.
2. Supplements
My daily supplementation protocol includes:
- NMN: Supports NAD+ levels and has been shown to improve insulin sensitivity in prediabetic women
- Berberine with Milk Thistle: Enhances absorption and helps regulate blood sugar levels
- Desiccated Beef Liver Capsules: Nutrient-dense "nature's multivitamin"
- Omega-3 & BCAAs: Support heart health and muscle recovery
- Quercetin: Anti-inflammatory and helps clear senescent "zombie cells"
For a broader scientific context, see the systematic review of NMN clinical studies, which highlights both promising results and the need for longer-term research on optimal NMN dosages.
3. Lifestyle & Sleep Hygiene
A consistent sleep schedule is just as important as diet and supplements. Without proper recovery, the benefits of nutrition and supplementation are diminished.
Global Markets: NMN Regulation Around the World
While the US has now clearly established NMN's legal status, regulations vary globally. Here's the latest as of January 2026:
United States ✓ LEGAL
As of September 29, 2025, NMN is officially lawful for use in dietary supplements. Products have returned to Amazon and major retailers.
Japan ✓ LEGAL
Japan remains one of the most NMN-friendly markets. NMN is legal and treated as a regular dietary supplement, often marketed as a functional food for anti-aging. Japan was an early adopter, with the first NMN supplements launching around 2015-2016.
Australia ✓ NOW LEGAL (New!)
Breaking news: Australia's Therapeutic Goods Administration (TGA) has approved NMN for use in dietary supplements for the first time in late 2025. Previously, NMN supplements could only be manufactured in Australia for export. This marks a significant regulatory breakthrough for the Australian market.
India ✓ LEGAL
In India, NMN supplements are permitted and not explicitly banned by regulators. Indian companies actively market clinically validated NMN products for healthy aging.
European Union & UK — Novel Food (Pending)
In the EU, NMN is treated as a "Novel Food" requiring pre-approval. As of early 2026, NMN is not yet authorized for sale, though several Novel Food applications are under review with EFSA (European Food Safety Authority). Chinese manufacturers EffePharm and SyncoZymes have applications in risk assessment. If approved, NMN could be sold across Europe. For now, European consumers can obtain NMN via personal imports from international suppliers like NMN Bio. The UK follows a similar approach post-Brexit.
China — Restricted (Cross-Border OK)
Mainland China's stance is restrictive despite high demand. NMN is not approved for supplements, food, or drugs domestically. It's only permitted in cosmetics. However, millions of Chinese consumers purchase NMN via cross-border e-commerce for personal use.
Canada — Under Review
Canada may regulate NMN as a Natural Health Product. Health Canada has proposed steps to expedite approval.
Key Takeaways
| Question | Answer |
|---|---|
| Is NMN legal in the US? | Yes, definitively. The FDA confirmed on September 29, 2025 that NMN is lawful for use in dietary supplements. |
| Was NMN ever banned? | No. The FDA never banned NMN or declared it unsafe. The 2022 decision was purely regulatory, not a safety issue. |
| Can I buy NMN on Amazon? | Yes. NMN products returned to Amazon in October 2025 following the FDA's reversal. |
| Can I buy NMN from international suppliers? | Yes. UK-based companies like NMN Bio have always been able to ship to US customers legally. |
| What changed? | The FDA acknowledged that NMN was marketed as a supplement in the US as early as 2017, before it was investigated as a drug. This satisfied the "race to market" provision. |
Conclusion: A New Era for Longevity in the United States
The FDA's September 2025 reversal marks the end of a period of confusion and the beginning of an era of total transparency for NMN supplementation. For consumers, this means you can now integrate NMN into your health protocol with the certainty that it is fully recognized and authorized by American regulatory authorities.
This decision is more than a regulatory footnote. It validates what the longevity community has known for years: NMN is a safe, science-backed supplement with genuine potential to support healthy aging. The three-year battle waged by the Natural Products Association and industry advocates has resulted in not just a victory for NMN, but greater clarity on how the drug preclusion clause should be interpreted going forward.
At NMN Bio, we never wavered in our commitment to providing high-quality NMN supplements throughout this period of uncertainty. Now, with the regulatory landscape clear, we're proud to serve customers in the United States and over 70 countries worldwide with products that meet the highest standards of purity, potency, and compliance.
True longevity requires a holistic approach combining nutrition, supplementation, and lifestyle optimization. NMN plays a valuable role in this strategy, and now more people than ever can access it legally and with complete confidence.
Ready to start your longevity journey?
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For questions about NMN supplementation or our products, please visit nmnbio.co.uk or contact our support team.
References
- FDA Letters dated September 29, 2025 — Venable LLP Legal Analysis
- Natural Products Association Press Release — September 29, 2025
- NPA: FDA Reinstates NMN as Dietary Supplement — December 10, 2025
- NutraIngredients: FDA declares NMN lawful — September 30, 2025
- NutraIngredients: NMN back on Amazon — October 8, 2025
- NutraIngredients: FDA reinstates NDI status — December 9, 2025
- Yoshino et al., Science 2021 — NMN and insulin sensitivity in prediabetic women
- Systematic review of NMN clinical studies — GeroScience, 2024
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