Why Is NMN Banned By FDA? Latest Updates And FDA's Decision

No, NMN is not banned by FDA and can be legally sold as a dietary supplement in the U.S. without any hindrance.

Nicotinamide mononucleotide (NMN) exploded onto the supplement scene as an anti‑aging powerhouse, only to be yanked from U.S. shelves in 2022. That whiplash left many consumers scratching their heads and searching the web for one question: is NMN still banned by FDA?

This guide answers that query while unpacking the science, history and regulatory context behind the controversy. You’ll learn why NMN was originally banned, how lawsuits and citizen petitions forced the agency to revisit its stance, and what the 2025 decision means for your health.

We’ll also discuss safety, dosages, potential benefits and why you should only buy ultra pure NMN.

Is NMN Banned By The FDA?

No. As of September 2025, NMN is legal to sell as a dietary supplement in the United States. The Food and Drug Administration (FDA) reversed its 2022 determination that nicotinamide mononucleotide was excluded from the definition of a dietary supplement and cannot be marketed. The FDA decision in 2025 clarified NMN's regulatory status, and the FDA concluded that NMN can be lawfully sold as a supplement.

The agency now acknowledges that evidence exists showing NMN was marketed as a supplement in the U.S. by 2017. Based on that, its earlier interpretation of the “drug preclusion” clause was not the best reading of the law. The FDA's interpretation of this clause had previously restricted the nmn market and created uncertainty for both sellers and consumers.

While NMN is not an FDA‑approved drug, its sale as a supplement is 100% legal. The confusion caused for consumers and manufacturers by the FDA's decision led to panic buying and instability in the nmn market.

Introduction to NMN and Dietary Supplements

Nicotinamide Mononucleotide (NMN) has rapidly emerged as one of the most talked-about dietary supplements in the wellness world, thanks to its promising potential for supporting healthy ageing, energy production, and overall cellular health. As a direct precursor to Nicotinamide Adenine Dinucleotide (NAD+), NMN plays a vital role in key biological processes such as DNA repair, metabolic health, and maintaining optimal cellular function. These attributes have made NMN supplementation a popular choice among those seeking to support healthy ageing and boost energy metabolism naturally.

The growing interest in NMN supplements has also brought increased scrutiny from regulatory bodies like the Food and Drug Administration (FDA). Under the Federal Food, Drug, and Cosmetic Act, the FDA oversees the safety and labeling of dietary supplements, including requirements for manufacturers to submit a new dietary ingredient notification before bringing novel ingredients to market. A central point of contention has been the drug preclusion clause, which states that if a substance is under substantial clinical investigations as a new drug, it cannot be marketed as a dietary supplement unless it was lawfully marketed as such beforehand. This regulatory technicality led the FDA to initially exclude NMN from the definition of a dietary supplement, sparking debate and uncertainty across the supplement industry.

Organizations such as the Natural Products Association (NPA) have been at the forefront of advocating for consumer access to NMN products. The NPA and other industry groups argued that NMN was lawfully marketed as a dietary supplement prior to any substantial clinical investigations, challenging the FDA’s interpretation of the drug exclusion clause. Their efforts, along with those of other stakeholders, have highlighted the complexities of FDA regulations and the importance of clear guidelines for both manufacturers and consumers.

Despite the regulatory back-and-forth, NMN supplements have remained in high demand. The supplement industry has seen a surge in NMN products, available in various forms such as capsules, powders, and tablets. However, the FDA’s enforcement discretion policy—whereby the agency temporarily allowed NMN sales while reviewing its stance—created confusion for both consumers and NMN manufacturers. Some companies chose to pull NMN from their shelves, while others continued to sell NMN, leading to uncertainty about the legal status of these products.

The FDA’s decision in September 2025 to reinstate NMN as a lawful dietary supplement ingredient has brought much-needed clarity to the market. However, the situation remains dynamic, as the FDA’s interpretation of the drug preclusion clause and the definition of a dietary supplement continue to evolve. For NMN suppliers and manufacturers, staying compliant with changing FDA regulations is essential. For consumers, it’s more important than ever to purchase NMN from reputable sources that prioritize quality, safety, and transparency.

As the demand for NMN supplementation continues to grow, so does the need for reliable information about its potential benefits and the latest research surrounding NMN. Whether you are a healthcare provider, a supplement industry professional, or simply someone interested in supporting healthy ageing and metabolic health, staying informed about the regulatory landscape and scientific developments is key. In the next section, we’ll explore the science behind NMN, its potential to support energy production and cellular health, and what current research reveals about its role in healthy ageing.

Why Did The FDA Ban NMN In 2022?

FDA banned NMN in 2022 due to the drug preclusion, after the FDA determined NMN was not eligible for sale as a supplement. Let’s explore it in detail.

What's The Drug Preclusion Clause?

The 1994 Dietary Supplement Health and Education Act (DSHEA) defined dietary supplements and included a “drug preclusion” clause (21 USC § 321(ff)(3)(B)). This clause states that if an article (ingredient):

• Has been authorized for investigation as a new drug, which involves submitting a drug application, specifically an investigational new drug application (IND)

• And substantial clinical investigations have begun

• And been made public

The ingredient cannot subsequently be marketed as a dietary supplement unless it was previously sold as a supplement before the drug investigation. Additionally, the ingredient must not have been previously approved as a supplement to be excluded.

FDA's 2022 NMN Ban

In October 2022, Inner Mongolia Kingdomway Pharmaceutical Limited submitted a new dietary ingredient (NDI) notification to market NMN. The FDA responded that NMN had been authorized for investigation as a drug and that substantial clinical investigations were underway. Metro International Biotech and Metro International Biotech LLC were key players in the drug investigation process, actively involved in seeking regulatory approval for NMN.

The agency concluded that NMN had not been marketed as a dietary supplement before being authorized as a new drug and thus was excluded from the definition of a dietary supplement. A pharmaceutical company was pursuing NMN as a drug candidate, which contributed to the FDA's regulatory stance.

The October 11 response letter stated that “NMN is excluded from the dietary supplement definition … and may not be marketed as or in a dietary supplement”. The supplemental response letter dated November 4, 2022 reinforced the agency’s position. It explained that NMN was not marketed as a dietary supplement before the investigational new drug (IND) went into effect and reiterated that NMN could not be sold as supplements.

The letter dismissed evidence of NMN sales in Japan, noting that the U.S. food supply is distinct and that Japanese sales do not satisfy the requirement. Consequently, major retailers like Amazon and payment processors such as PayPal and Shopify removed NMN products from their platforms, triggering a market collapse.

Challenging The FDA NMN Ban: A Timeline

Citizen Petition By NPA And Others For FDA To Lift NMN Ban

Industry groups quickly contested the FDA’s interpretation. Three organizations filed petitions in March 2023:

• The Natural Products Association (NPA)

• Alliance for Natural Health USA (ANH)

• Council for Responsible Nutrition (CRN)

These petitions were submitted within the broader regulatory framework overseen by the U.S. Department of Health and Human Services, which supervises the FDA’s actions regarding dietary supplements.

The organizations argued that the FDA misread the drug preclusion clause and overlooked evidence that NMN had been marketed in the U.S. The petitions asked the agency to reverse its ban or at least exercise enforcement discretion so consumers could access NMN.

Lawsuit In 2024

When the FDA failed to respond promptly, the NPA filed a lawsuit in the U.S. District Court for the District of Columbia in August 2024. An FDA law blog explained that the lawsuit argued the agency improperly interpreted the exclusionary clause by using the date an IND becomes effective (a non‑public date) rather than the date substantial clinical investigations are publicly disclosed.

The role of human services is significant in shaping public health policy and supplement regulation, as federal agencies and health advocates work to influence these decisions.

The NPA contended that this interpretation makes it impossible for supplement companies to know whether an ingredient is precluded. The complaint also asserted that the FDA did not consider whether the clinical investigations were truly substantial.

Partial Stay And Enforcement Discretion

During the lawsuit, the FDA and the Department of Justice agreed to a temporary stay. During the stay, the agency said it would exercise enforcement discretion for NMN supplements. This meant that NMN could be sold while the agency revisited its decision. Meanwhile, the case highlighted broader concerns about the drug preclusion clause and its chilling effect on supplement innovation.

September 2025: FDA Revises Its Ruling And NMN becomes Lawful

On September 30, 2025, the FDA reinstates NMN as a lawful dietary supplement ingredient, issuing a response to the NPA and ANH citizen petitions. The FDA now concluded that NMN is not excluded from the definition of a dietary supplement because, although NMN was authorized as a drug and clinical investigations had begun, NMN was marketed as a dietary supplement in the U.S. before those investigations were authorized. The agency noted evidence of NMN supplements on the U.S. market as early as 2017.

Crucially, the FDA admitted that its prior requirement that an ingredient must have been lawfully marketed before drug authorization was “not the best reading” of DSHEA. The agency said it would no longer assess whether the early marketing was legal. And that it only needs to confirm that the ingredient was marketed in the U.S. at all. This shift means NMN meets the race‑to‑market exception, and it can be sold as a dietary supplement.

Industry reactions

The NPA celebrated the decision, with its president Daniel Fabricant stating that the ruling “confirms NMN is lawful in supplements” and urging e‑commerce platforms to restore NMN products. The ANH also hailed the decision as a victory for consumer choice and transparency, noting that the petition ensured Americans would continue to have access to NMN.

However, the Council for Responsible Nutrition cautioned that the response failed to resolve core problems with the exclusionary clause. CRN argued that the FDA still relies on non‑public IND dates and that the definition of “substantial clinical investigations” remains vague. In other words, while NMN is legal for now, the regulatory framework remains unstable for future ingredients.

Does This Mean NMN Is FDA‑Approved?

No. When the FDA says NMN is “lawful” in supplements, it simply means it is not excluded under the drug preclusion clause.

Unlike drugs, dietary supplements do not require pre‑market approval. Manufacturers must ensure their products are safe and properly labeled, but the FDA does not evaluate them for efficacy.

NMN is still not approved to diagnose, treat or cure disease, and companies cannot make drug‑like claims. NMN is also being explored by pharmaceutical companies as a potential therapeutic agent due to its ability to influence NAD+ levels, which could lead to its classification as a drug. If a company pursues NMN as a prescription drug (e.g., MIB‑626 under investigation for COVID‑19 and Alzheimer’s), that drug product will require rigorous approval and is separate from NMN sold as a supplement.

Is NMN Safe? Reviewing The Science

NMN is generally safe and well-tolerated. Clinical trials have investigated NMN at doses ranging up to 2,000 mg per day. The majority of participants experienced no serious adverse events. NAD+ is a coenzyme essential for metabolism and cellular repair, and NMN acts as its precursor, supporting these vital biological processes. Supplementing with NMN may help maintain overall cellular function by promoting energy production, DNA repair, and cellular health.

If you are interested in learning about the safety and dosage of NMN, please read our thoroughly curated research review.

However, researchers note that the sample sizes for these clinical trials are usually small. Additionally, the treatment periods are short. Therefore, we still need more clinical trials to establish long-term safety and efficacy of NMN.

Final Thoughts: Is NMN Still Banned By The FDA?

The question “is NMN still banned by the FDA?” can finally be answered with a confident no. After two years of uncertainty, the FDA acknowledged that NMN had been marketed as a supplement before pharmaceutical companies pursued it as a drug and that its previous requirement for lawful prior marketing was misplaced.

The 2025 letter makes NMN lawful in supplements, allowing companies to resume sales.

However, the journey underscores the fragile balance between pharmaceutical innovation and supplement access. The broader “race‑to‑market” framework remains contentious, with trade associations warning that the FDA still leans toward drug developers.

Consumers can take NMN legally but should stay informed about evolving regulations and emerging science. When purchasing NMN, consider selecting reputable brands, understanding the legal status in your region, and prioritizing quality, such as the HealthspanX Ultra Pure NMN™ capsules 500mg.

Start small, take moderate doses, and seek guidance from a healthcare professional. Here’s to adding many more years of health to your life!

Frequently asked questions (FAQ)

Is NMN Banned By The FDA?

No. The FDA's 2025 letter clarified that NMN is not excluded from the definition of a dietary supplement because it was marketed as a supplement before being investigated as a drug. As a result, NMN supplements are legal to sell in the U.S.

Is NMN FDA‑Approved?

No. Dietary supplements do not require FDA pre‑market approval. The FDA's decision simply means NMN is lawful to sell as a supplement; it is not approved as a drug and cannot be marketed with drug claims.

Why Did The FDA Try To Ban NMN?

The agency used the drug preclusion clause to argue that NMN could not be sold as a supplement because it had been authorized for investigation as a drug and the FDA believed it wasn't marketed as a supplement beforehand. Evidence later showed NMN was available in the U.S. by 2017, leading to the reversal.

Can NMN Cause Cancer Or Other Serious Side Effects?

Current human studies have not reported serious adverse events. However, some animal research suggests high doses of NAD+ precursors could potentially stimulate senescent cells and tumor growth. More research is needed to determine long‑term safety.

What Dose Of NMN Should I Take?

Studies suggest 250–500 mg/day is effective for boosting NAD+ and is well tolerated. Higher doses have been used safely for short periods, but there's no evidence of additional benefit. Always consult a healthcare professional.

Is NMN Better Than Nicotinamide Riboside (NR)?

Both raise NAD+ levels. NR has more clinical data but NMN converts to NAD+ more directly. The choice depends on individual preference, price, and how you respond.

Do I Need A Prescription To Buy NMN?

No. NMN can be purchased over the counter as a dietary supplement. However, any future drug versions (e.g., MIB‑626) would require a prescription.

Why Choose HealthspanX NMN?

HealthspanX's NMN 500 provides high‑purity β‑NMN capsules. The product is manufactured in GMP‑certified facilities and independently tested for quality. It's an excellent option if you want to support energy metabolism and healthy aging. Explore HealthspanX Ultra Pure NMN™ capsules 500mg here.