Key takeaways

• The FDA removed NMN from the supplement list because it was already under pharmaceutical investigation as a drug via IND filings, making it ineligible as a dietary supplement under U.S. law.
• NMN is not illegal to possess or use personally, but it cannot be legally marketed or sold as a dietary supplement in the U.S.
• Nicotinamide Riboside (NR) remains a safe, FDA-compliant NAD⁺ precursor available to consumers and supported by multiple clinical trials.

Overview

Nicotinamide Mononucleotide (NMN), once a go-to supplement for boosting NAD⁺ levels and promoting longevity, now sits in regulatory limbo. 

Following the FDA’s 2022 decision to revoke NMN’s dietary supplement status after pharmaceutical firms filed Investigational New Drug (IND) applications, the supplement landscape has undergone a significant shift.

For millions of consumers, the ruling has created uncertainty around NMN’s legality, safety, and availability. This article breaks down the implications of the FDA decision, clarifies current regulations, and examines the future of NMN and its alternatives. 

Whether you’re currently taking NMN or exploring NAD⁺ precursors for the first time, understanding these developments is essential for making informed, science-backed health decisions in 2025 and beyond.

What happened: The FDA decision timeline for NMN 

The FDA’s evolving stance on NMN as a dietary supplement has been a focal point for both the supplement industry and consumers interested in longevity. In 2022, the agency announced that NMN, a key precursor to nicotinamide adenine dinucleotide (NAD+), could no longer be marketed as a dietary supplement in the United States. 

This decision was rooted in the fact that NMN was already under investigation as a new drug, which, under current FDA regulations, requires it to undergo the entire FDA approval process before being sold as a supplement. 

Key timeline events 

• Before 2022, NMN was extensively marketed as a dietary supplement and quickly gained popularity due to its perceived benefits in boosting NAD+ levels. 
• October 2022: The FDA removed NMN from the list of ingredients eligible as dietary supplements, citing its filing under Investigational New Drug (IND) applications by companies intending to develop it as a pharmaceutical drug. 
• Present Status: While possession and personal use of NMN are not illegal, its marketing and sale as a supplement are prohibited within the United States, creating a gray market with unregulated suppliers. 

The Natural Products Association (NPA), a leading advocate for the supplement industry, quickly responded by filing a citizen petition with the FDA. The petition urged the agency to reconsider and determine that NMN should not be excluded from the dietary supplement definition, arguing that NMN had been available as a supplement before any new drug investigations began. 

Recent developments (2025): 

• August 28, 2024: The Natural Products Association (NPA) filed a lawsuit against the FDA, demanding that NMN remain a dietary supplement 
• October 24, 2024: A Federal judge paused court proceedings, giving the FDA more time to review the NPA’s petition 
• Current Status: The FDA has paused enforcement of the NMN ban while reviewing the petition 
• July 31, 2025: FDA’s deadline to announce whether NMN can officially return to the supplement market

Why did the FDA remove NMN from supplement status?

The crux of NMN’s FDA status lies in the Drug Development and Safety Act of 1994, a provision within the Dietary Supplement Health and Education Act (DSHEA) of 1994. According to DSHEA, if a substance is first filed as an Investigational New Drug (IND), it cannot be subsequently marketed as a dietary supplement. 

Some companies are developing proprietary forms of NMN specifically for drug development. For example, Metro International Biotech LLC is involved in synthesizing a proprietary form of NMN, known as MIB-626, which is being investigated as a pharmaceutical drug rather than a dietary supplement. 

The FDA’s official rationale 

The FDA outlined several reasons for its decision: 

1. Protection of Drug Development Investments: Allowing NMN to remain a supplement while being developed as a drug poses conflicts of interest and jeopardizes pharmaceutical investments. 
2. Safety Considerations: Although NMN has generally demonstrated a favorable safety profile in clinical studies and has been well-tolerated in human participants, potential side effects are still being evaluated. The FDA prefers a structured drug development pathway to comprehensively address long-term safety. 
3. Regulatory Consistency: Clear distinctions between drugs and supplements provide a more predictable framework for oversight and enforcement.

Is NMN illegal? Clearing up the confusion 

The FDA’s decision regarding NMN has led to widespread confusion about its legal status in the United States. While the agency has stated that NMN is excluded from the definition of a dietary supplement, this does not mean that NMN itself is illegal. Instead, the ruling means that NMN cannot be marketed or sold as a dietary supplement unless manufacturers undergo FDA registration and comply with all relevant FDA regulations. 

What’s legal and what’s not 

Legal: 

• Purchasing, possessing, and using NMN for personal purposes 
• Importing for personal use within what is considered a gray regulatory area 

Prohibited: 

• Marketing, selling, or packaging NMN as a dietary supplement within the U.S. 

Enforcement realities 

The FDA’s enforcement efforts predominantly target manufacturers and supplement companies rather than individual consumers. The agency exercises enforcement discretion, meaning it prioritizes enforcement actions against products that make false or misleading claims or pose significant risks to public health. 

Online retailers and companies attempting to sell NMN face restrictions, and reputable platforms like Amazon have ceased offering NMN products. However, international markets and less-regulated suppliers continue to sell NMN, albeit with significant safety risks. 

Industry response to the NMN ban 

The dietary supplement industry’s response to the FDA’s NMN decision has been both vocal and divided. At the forefront of the industry’s pushback is the Natural Products Association, which has filed a lawsuit against the FDA, arguing that the agency’s actions are not only unlawful but also detrimental to consumer choice and innovation. 

The debate extends beyond regulatory compliance, touching on the potential benefits and risks of NMN supplementation. Proponents highlight NMN’s anti-aging and cognitive support properties, citing animal studies and early human trials that suggest positive effects on energy metabolism, DNA repair, and overall cellular health.

Viable alternatives to NMN supplements 

For consumers seeking NAD+-boosting benefits, alternatives like Nicotinamide Riboside (NR) and Nicotinamide (NAM) are available as health supplements. NR is a derivative of vitamin B3 and has GRAS (Generally Recognized as Safe) status from the FDA, ensuring its safe use in dietary supplements. 

Comparison of alternatives 

Nicotinamide Riboside (NR): 

• FDA-approved NAD+ precursor with a well-documented safety profile 
• Widely available in supplement form with high regulatory standards 

Nicotinamide (NAM): 

• A traditional form of vitamin B3 found in conventional diets 
• Lesser efficacy for NAD+ boosting compared to NMN or NR 

Food sources: 

• Foods naturally containing NMN, such as edamame, broccoli, and avocado, provide modest NAD+-boosting potential, albeit at much lower concentrations than supplements. 

Choosing a safe option 

To ensure safety and effectiveness, prioritize supplements that have been tested by third-party laboratories and are ideally endorsed by healthcare providers. Avoid unregulated NMN products available through gray market sources, as their quality and authenticity cannot be guaranteed. 

Potential pathways for NMN to return 

The reintroduction of NMN supplements faces significant hurdles. Possible scenarios include: 

• Pharmaceutical Approval: NMN could be approved as a prescription drug once pharmaceutical development is completed; however, this process typically takes 10–15 years. 
• Legislative Action: Revisions to DSHEA could allow NMN to coexist as both a supplement and a drug, but no current legislative initiatives are in motion. 
• Industry Advocacy: Supplement industry players may petition the FDA, but such processes require considerable time, effort, and political traction. Recently, the NPA filed legal action challenging the FDA’s stance on NMN, and a monumental victory in these efforts could significantly impact the future availability of NMN.

What does this mean for consumers? 

The good news is that NMN supplements are currently available for purchase in the US while the FDA reviews the petition. 

• This enforcement pause means you can legally purchase NMN supplements through July 2025. 
• Consider stocking up on high-quality NMN from reputable sources before the July 31, 2025, deadline. 
• Transition to FDA-approved alternatives like NR or NAM as backup options 
• Consult with a trusted healthcare provider about your long-term supplementation strategy. 

Stay informed by monitoring updates from reliable sources, such as industry leaders and regulatory announcements. By building a diversified and sustainable longevity strategy that incorporates a balanced diet, regular exercise, and safe supplementation, you can continue to support optimal health.

Bottom line

Research on NMN highlights its promising role in enhancing NAD+ levels and mitigating age-related decline, with clinical data supporting its safety and efficacy. NMN supplementation has been studied for its effects on the aging process, as NAD+ levels naturally decline with age and may contribute to cellular aging and age-related diseases. 

Some studies have also explored the impact of NMN on cognitive function, though results are mixed, with specific assessments showing limited improvements. Additionally, research is ongoing into NMN’s potential to mitigate cognitive decline associated with Alzheimer’s disease by supporting NAD+ metabolism in the brain.

Frequently asked questions (FAQs) 

1. Is it illegal to buy or use NMN supplements? 

No, possessing or using NMN is not illegal. However, companies cannot legally market or sell NMN as a dietary supplement in the US due to FDA regulations. 

2. When will NMN be available as a supplement again? 

The FDA has until July 31, 2025, to respond to the Natural Products Association’s petition. Until then, NMN supplements remain available due to the enforcement pause. 

3. Are there safe alternatives to NMN supplements? 

Yes, nicotinamide riboside (NR) has FDA GRAS status and similar NAD+-boosting effects. Traditional nicotinamide (NAM) is also available, though less effective than NMN or NR. 

4. Can I legally buy NMN right now? 

Yes, the FDA has paused enforcement of the NMN ban while reviewing the petition, meaning NMN supplements are currently available for purchase in the US. 

5. What should I do if I have NMN supplements at home? 

Existing NMN supplements are not illegal to possess or use; however, consult with a healthcare provider about transitioning to legal alternatives, such as NR, for long-term use. 

6. Why did pharmaceutical companies target NMN specifically? 

NMN has shown promising therapeutic potential in early research, making it an attractive candidate for drug development. Filing IND applications before supplement status was established allowed companies to exclude it from the supplement market.

References 

1. Walling, D. Evaluation of the FDA’s Regulatory Role of Nicotinamide Mononucleotide and Nicotinamide Riboside as Molecules in Longevity Dietary Supplements. Eastern Michigan University Master’s Thesis. 2021. 
2. Yang, X., Lu, A., Guan, X., et al. An Updated Review on the Mechanisms, Pre-Clinical and Clinical Comparisons of Nicotinamide Mononucleotide (NMN) and Nicotinamide Riboside (NR). Food Frontiers. 2024. 
3. Brett J. Weiss. (2022, November 29). FDA Halts NMN Supplement Approval, Citing Pharmaceutical Potential.