Is NMN banned in the US? Everything You Need to Know

By Dr. Elena Seranova, Founder of NMN Bio

As the founder of NMN Bio, I’ve dedicated my career to longevity research and supplementation. One of the most common questions I hear is: Is NMN legal in the US?

Confusion around NMN (nicotinamide mononucleotide, NMN) has grown in recent years due to mixed Food and Drug Administration (FDA) communications. This article will clarify the legal status of NMN in the United States, explain why it matters for cellular processes and energy metabolism, and share how I personally use it within a broader longevity lifestyle to support healthy ageing.

What Is NMN and Why Is It Important for Longevity?

Nicotinamide mononucleotide (NMN) is a vitamin B3 derivative and a direct precursor to NAD (nicotinamide adenine dinucleotide), a molecule that fuels energy production in our mitochondria. Without NAD, our bodies cannot generate ATP, the energy that powers every cell. Its importance for the aging process and DNA repair has been highlighted in both preclinical and human clinical studies.

This is why NMN supplementation is gaining traction globally—not just in the US but also with regulators like the European Food Safety Authority, who classify it under the broader dietary supplement definition and evaluates its safety profile.

Is NMN Legal in the US? Understanding the FDA Position

Is NMN legal in the US currently? The answer is yes, NMN is legal, but its regulatory status is in a gray zone.

• No official FDA ban on NMN: The drug administration FDA has not prohibited the sale of NMN as a dietary supplement. However, questions around the drug exclusion clause and whether pharmaceutical companies such as Metro International Biotech LLC sought earlier approval complicated the issue.

• Private FDA letters: Some companies received notices advising caution, but private correspondence does not equal law.

• Historical precedent: A similar case with NAC (N-acetylcysteine) shows supplements can remain accessible despite FDA ambiguity.

• Court ruling: In 2024, a federal court delivered a substantial legal victory when it ordered the FDA not to enforce its position against NMN supplements while evaluating an industry petition (NPA filed a petition challenging the FDA’s decision).

• FDA jurisdiction: FDA rules only apply to US interstate commerce. International companies like NMN Bio can still ship to US customers.

This means US consumers can still legally buy NMN, especially from reputable international NMN suppliers like NMN Bio.

How NMN Bio Ensures Supply to the US

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. Because the Food and Drug Administration (FDA) has no authority outside US borders, we continue to legally ship NMN to customers in the United States without interruption.

Some companies have used regulatory uncertainty to spread fear about potential shortages. But the reality is: there is no global shortage of NMN, and supply remains stable. Although some pharmaceutical interests have pushed the FDA to exclude NMN under the drug exclusion clause, the legal process is ongoing, and federal food and drug laws permit continued importation.

Nutrition and Lifestyle: The Foundation of Longevity

While NMN is a powerful health supplement, longevity depends on more than one molecule. My personal routine combines nutrition, supplementation, and lifestyle.

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

• NMN intake: Improves insulin sensitivity in prediabetic women (Yoshino et al., Science 2021).

• 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 clears 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 NMN safe 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.

Is NMN Legal in the US?

Yes. NMN is legal in the US. While the FDA has created regulatory uncertainty, there is no federal ban preventing its sale or import. US consumers can continue purchasing NMN from international suppliers like NMN Bio, with confidence in both legality and product quality.

Ultimately, true longevity requires a three-layered approach: nutrition, supplementation, and lifestyle optimization. NMN plays a decisive role, but it works best as part of a holistic strategy for aging well.

FDA Concluded: What We Know So Far

The FDA concluded in its preliminary review that NMN falls under the new dietary ingredient notification process, rather than being automatically allowed as a supplement. This doesn’t mean NMN is unsafe—multiple clinical studies highlight its potential benefits for longevity and energy metabolism. Instead, it means the agency wants more data before making a permanent decision. For now, NMN continues to be legally available from international suppliers, while the legal process unfolds in the US.

FDA Ban: Fact or Misunderstanding?

There is currently no official FDA ban on NMN. Much of the confusion stems from private FDA letters sent to companies and speculation about whether pharmaceutical interests influenced the process. The FDA has raised questions around the drug exclusion clause, but unlike banned substances, NMN has not been prohibited from the US market. Consumers can still legally buy NMN from reputable suppliers, though the regulatory environment remains uncertain.

FDA’s Decision and the Path Forward

The future of NMN depends on FDA’s decision, which is still pending. While the agency evaluates industry petitions—including one filed by the Natural Products Association (NPA)—a federal court already granted a huge legal victory by halting enforcement against NMN supplements. This ensures US consumers maintain access while the debate continues. Whether the FDA ultimately approves NMN as a dietary supplement, or restricts it under pharmaceutical pathways, will set the tone for how this promising compound is regulated moving forward.

Key takeaway: If you’re asking “Is NMN legal in the US?” the answer is yes. You can safely and legally buy NMN today, even while the FDA’s decision process around the new dietary ingredient notification and drug exclusion clause continues. With Health and Human Services overseeing the legal process, consumers can rest assured that NMN remains available to support natural longevity solutions such as those promoted by Natural Health USA.

Timeline of NMN’s Regulatory Journey in the United States

• 2016–2021: NMN was sold in the US as a novel dietary supplement for anti-aging and healthspan, with no FDA objections during those years. It gained popularity among consumers and researchers as a longevity supplement, amid studies showing it boosts NAD+ levels for potential health benefits (PMC study). No major safety concerns were reported in this period.

• Mid-2022: 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, a supplier), essentially allowing NMN’s use in supplements at that time (NutraIngredients report). This indicated that NMN was considered a lawful dietary ingredient as of mid-2022.

• November 2022: The FDA abruptly reversed course. Citing a legal technicality, the agency determined that NMN is “excluded from the definition of a dietary supplement” because it was first investigated as a new drug before being marketed as a supplement (FDA communication). Notably, 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), and clinical trials were already public (SupplySide SJ report). Under US law’s “drug preclusion” clause, if a substance was publicly part of substantial clinical trials as a drug before it was legally sold as a supplement, it cannot be marketed as a supplement. In a November 4, 2022, FDA letter, officials stated that after reviewing records, “NMN was not marketed as a dietary supplement... before FDA authorized it for investigation as a new drug”, meaning NMN could no longer be sold as a supplement. This effectively withdrew the earlier NDI acknowledgment – the FDA rescinded the May 2022 “no objection” letter once it connected the dots between NMN and the drug trials.

• Early 2023: FDA communications in January 2023 reinforced this stance. The agency responded to new NDI submissions from NMN manufacturers (e.g. Effepharm and an amended SyncoZymes filing) with letters reaffirming that NMN may not be marketed as a dietary supplement (DecodeAge article). These FDA letters emphasized that because of the prior drug investigations, NMN could no longer be sold in or as a supplement in the US.

• March 2023: The supplement industry began pushing back. On March 7, 2023, the Natural Products Association (NPA) and the Alliance for Natural Health (ANH) filed a formal Citizen Petition to the FDA, urging the agency to reverse its position (NutraIngredients coverage). The petition asked FDA to affirm that NMN is not excluded from the supplement definition or, at minimum, to exercise “enforcement discretion” (i.e. allow NMN sales without enforcement) until the matter is resolved. Industry stakeholders argued that NMN had been sold in supplements lawfully (or at least without objection) before the drug IND, and they sought clarity and relief from the FDA’s sudden rule.

• Mid-Late 2023: The FDA did not promptly act on the petition. In fact, by late August 2023, the agency acknowledged it was unable to reach a decision within the 180-day window for citizen petitions, citing “competing agency priorities.” (SupplySide SJ). This delay left NMN’s status in limbo. Meanwhile, the FDA’s 2022 stance had a chilling effect on the market: major retailers reacted, and at least one import of bulk NMN was detained at the US border as an “unapproved new drug” in mid-2023.

• August 2024: With the FDA still dragging its feet, the NPA escalated the fight by filing a lawsuit against the FDA and the Department of Health & Human Services. The complaint (filed Aug. 28, 2024 in US District Court, D.C.) sought a declaratory judgment that β-NMN is a lawful dietary supplement and that FDA’s retroactive disqualification of NMN was unlawful (SupplySide SJ lawsuit coverage). This lawsuit highlighted that not only supplement companies but also the pharmaceutical IND sponsor (Metro Biotech) had vested interests in NMN’s status. The case essentially challenged the FDA’s interpretation of the drug-preclusion clause and its timeline – a dispute over whether NMN was “lawfully marketed” as a supplement first.

• October–November 2024: A breakthrough came via the courts. In late October 2024, a federal judge approved a joint motion to stay the NPA lawsuit, effectively pausing the litigation because FDA agreed to take specific actions (NutraIngredients article). In this agreement, the FDA stated it “does not intend to prioritize enforcement” against NMN supplements that would be legal if not for the drug-exclusion issue, as long as the case is on hold. The court also set a deadline: FDA is required to respond to the NMN citizen petition with a final decision. Initially, the deadline was July 31, 2025, but due to FDA staffing shortages, the agency later obtained an extension to September 30, 2025 (CIRS Group report). During this period, the sale of NMN supplements in the US remains legal by default (since FDA enforcement is on hold) until the FDA issues its final ruling or unless new safety concerns arise.

(Upcoming: The FDA’s pending decision in late 2025 will clarify whether NMN can be sold as a supplement or remains excluded. Industry advocates are hopeful for a positive outcome, especially given growing political support for longevity research, but as of now the official status is unresolved.)

 Is NMN Banned or Restricted as a Supplement in the US?

Despite some alarming headlines, NMN is not “banned” in the United States – at least not in the traditional sense of a safety ban. The FDA’s position since late 2022 is that NMN does not meet the legal definition of a dietary supplement (due to the prior drug trials), which means the agency technically considers any NMN supplement adulterated (unlawful) under the Food, Drug & Cosmetic Act (PMC, SupplySide SJ). However, this was a regulatory technicality – not the result of any safety findings. In fact, FDA’s move was “not related to safety”, and no safety-related recall or prohibition was ever issued (ForYouth). To date, NMN has a strong track record of safety/purity in studies and has been Generally Recognized As Safe in practice by manufacturers.

Enforcement status: As of now (late 2025), the FDA is not actively enforcing that restrictive stance. Due to the ongoing legal challenge, the FDA agreed in court that it “will not prioritize enforcement actions” against NMN-containing products labeled as supplements, as long as those products are otherwise compliant with supplement regulations (NutraIngredients). This effectively puts NMN in a gray area – it’s formally disallowed by FDA’s 2022 interpretation but temporarily tolerated pending a final decision on the petition. In plain terms, you can still legally buy and sell NMN supplements in the US right now without FDA interference (DecodeAge).

It’s important to note that this situation is unusual. The FDA’s stance hinges on the “drug preclusion” clause (Section 201(ff)(3)(B)(ii) of the law) (SupplySide SJ). Industry groups like NPA argue FDA applied this rule improperly (saying NMN was indeed marketed as a supplement first, or that the “race” between drug and supplement was mishandled) (legal analysis). The final outcome is awaiting the FDA’s response to the industry petition by September 2025.

If FDA grants the petition (or if new legislation/regulation intervenes), NMN would explicitly be allowed as a supplement. If FDA denies it, the issue could head back to court. For now, NMN supplements are not banned for consumers – they remain available and in a sort of legal limbo. The FDA has even signaled possible willingness to exercise “enforcement discretion” (similar to what happened with NAC supplements) if needed to avoid depriving consumers of NMN (SupplySide SJ).

Bottom line: NMN’s legal status in the US is unresolved, but current law does not stop retailers from selling it and the FDA is not pulling products from shelves at this time (NutraIngredients). The restriction is on paper only, pending a clearer ruling. Consumers and companies should stay tuned for the FDA’s final decision in 2025. Still, they can take some comfort that the dispute is about regulatory definitions rather than any inherent danger of NMN.

NMN Availability on Major Retailers and Online Platforms

The FDA’s actions had immediate ripple effects in the marketplace. Starting in late 2022 and early 2023, many large retailers and e-commerce platforms voluntarily halted sales of NMN supplements due to the regulatory uncertainty:

• Amazon: In February 2023, Amazon notified sellers that products containing NMN would be delisted by March 13, 2023, because the FDA determined NMN is “no longer considered a dietary supplement” but rather a drug requiring FDA approval (SupplySide SJ). Amazon’s policy allowed NMN listings only if sellers could meet drug-level requirements (such as providing a National Drug Code on the label) – effectively banning NMN supplements on the platform. This mirrors Amazon’s previous removal of NAC supplements during an FDA dispute (later reinstated after the FDA exercised enforcement discretion).

• Walmart: By late 2023, Walmart also quietly stopped selling NMN in its stores and on its website, according to SupplySide SJ. Walmart did not publicly announce the policy, but it appears to have followed Amazon’s lead in response to the FDA stance.

• iHerb: iHerb, a major online supplement retailer, continued carrying NMN a bit longer but ultimately joined in. In February 2024, iHerb confirmed it had ceased US sales of NMN supplements, citing the FDA’s 2022 determination. An internal notice had gone out to iHerb customers that NMN products would be discontinued as of February 26, 2024. iHerb stated: “Given the FDA’s restrictions on NMN dietary supplements, these products are no longer available to our U.S.-based customers.”

• Other Platforms: PayPal and Shopify (payment processors and e-commerce infrastructure providers) also took actions in 2023 to disallow transactions involving NMN products, treating NMN as an unapproved drug after the FDA’s announcement. Additionally, compliance monitoring services flagged NMN as a “pseudo-pharmaceutical” based on FDA statements, creating challenges for supplement brands that sell directly to consumers.

Despite those hurdles, NMN has not disappeared from the consumer market:

• Many specialty supplement brands continue to sell NMN directly through their own websites or smaller retail channels. In fact, even after Amazon’s ban, several NMN brands still offer the product in the US and have loyal customers. Companies have shifted to selling direct or via alternative marketplaces.

• Smaller retailers and health stores that are not closely monitored by FDA or significant e-commerce policies may still stock NMN capsules. The enforcement pause means there is little risk to these sellers for the time being.

In summary, major mainstream retailers (Amazon, Walmart, iHerb) have pulled NMN supplements from their US catalogs in an abundance of caution (SupplySide SJ). But consumers can still readily find NMN from supplement companies online and in some brick-and-mortar vitamin shops. As one industry insider noted when iHerb left the market: “iHerb taking NMN off its platform is a big deal... It was the last major online retailer to carry NMN. First Amazon, then Walmart, and now iHerb... Brands are really getting backed into a corner to supply safe nutritional supplements to their customers. We’re now at a pivotal moment for NMN.” This underscores that while availability through big-box channels is curtailed, consumer demand remains – and suppliers are finding ways to meet it while the legal status gets sorted out.

Global Markets: Where is NMN Most Accepted?

Interestingly, NMN’s fate varies widely around the world. Some geographic markets are more favorable to NMN sales, thanks to either supportive regulations or high consumer interest (or both):

Japan:

Japan is one of the most NMN-friendly markets. NMN is legal to purchase, sell, and use, and is treated as a regular dietary supplement (often marketed as a functional food for anti-aging) (Simply Nootropics). Japan was also an early adopter – the first NMN supplements launched around 2015–2016, and demand quickly grew. Today, Japan has a thriving anti-aging supplement industry and is a leading market for NMN globally.

India:

In India, NMN supplements are permitted and not explicitly banned by regulators. The Food Safety and Standards Authority of India (FSSAI) has not prohibited NMN (Decode Age). Indian companies such as Decode Age actively market clinically validated NMN products for healthy aging. While the NMN trend in India is still growing, the regulatory openness makes it a favorable market.

European Union & UK:

In the EU, NMN is treated as a “Novel Food”, requiring pre-approval. As of 2025, NMN is not yet authorized for sale, though five Novel Food applications are under review with EFSA (CIRS Group). Two large Chinese NMN producers (EffePharm and SyncoZymes) already have applications in risk assessment. If approved, NMN could be sold across Europe, marking a regulatory breakthrough. For now, European consumers can only obtain NMN via personal imports. The UK follows a similar approach post-Brexit.

China

Mainland China’s stance is restrictive despite high demand. As of 2024, NMN is not approved for supplements, food, or drugs – it’s only permitted in cosmetics (NutraIngredients). However, millions of consumers purchase NMN via cross-border e-commerce for personal use. Chinese firms are also leaders in NMN research and are driving EU applications. For now, NMN in China is a paradox: a banned domestic supplement, yet hugely popular via imports.

Other Markets

Canada may regulate NMN as a Natural Health Product. Health Canada in 2023 proposed steps to expedite approval (Quality Smart Solutions). Australia classifies NMN as a prescription medicine, so it’s not sold freely as a supplement. Many other countries have no specific rules, so NMN circulates via international websites.

In terms of consumer trends, demand for NMN is global and growing wherever accessible. The anti-aging and biohacking communities have driven interest from North America to Asia. The global NMN market was about $250 million USD in 2020 and is projected to exceed $380 million by 2027 (PMC). Much growth is expected in Japan and Asia, though the US could expand rapidly if FDA hurdles are cleared.

In the US, discussions around an FDA ban NMN created regulatory uncertainty, but industry groups achieved a substantial legal victory when a federal court paused enforcement. While clinical studies continue to show safety benefits, the FDA concluded that NMN required further review under the new dietary ingredient process. At the same time, the agency also signaled interest in whether a proprietary form had been submitted by pharmaceutical companies. Ultimately, the FDA decided not to issue a final ruling yet, leaving NMN in a gray regulatory area.

Summary

In short, in the US, NMN’s legal status is in flux, caught between drug and supplement law. It is not banned for safety and remains available through some channels. Internationally, NMN is thriving in Japan and India, while the EU and China move cautiously. Consumers remain highly interested in NMN’s longevity potential. All claims should be verified against official agency statements, as this is a fast-evolving space. With high-profile support for longevity research, many are hopeful regulators will eventually allow NMN supplements under proper oversight.