β-Nicotinamide mononucleotide is a key NAD+ precursor, which has become a hot topic in the global health industry in recent years. Because its potential benefits in anti-aging, cellular energy metabolism, and neuroprotection. However, its journey as a dietary supplement in the United States has been fraught with legal and regulatory challenges. On September 29, 2025, the Natural Products Association (NPA) announced that, after nearly three years of tireless advocacy, the U.S. Food and Drug Administration (FDA) has finally reversed its stance, confirming that NMN can be legally marketed as a dietary supplement. This decision not only ends a heated legal battle but also sets an important precedent for the global dietary supplement industry.
What Are Key Milestones in the FDA's NMN History?
2022 - FDA's Initial Position
In a 2022 letter or statement, the FDA stated that NMN, due to its prior research as a drug (with "significant clinical research"), could not be considered a dietary supplement and legally marketed under the "drug exclusion" provision of the Dietary Supplement Health and Education Act of 1994 (DSHEA). This position led several companies and retail platforms to tighten or remove NMN products from their shelves.
2023 onwards - Industry Counterattack and Citizen Petitions/Lawsuits
In 2023, the Natural Products Association (NPA) and other groups submitted a citizen petition to the FDA, requesting clarification on whether NMN falls within the definition of a dietary supplement or a commitment by the FDA to exercise enforcement discretion. Subsequently, after receiving a lack of timely response, the FDA filed a federal lawsuit, mobilizing industry and consumer support. The NPA's goal was to challenge the FDA's interpretation of the "drug exclusion" provision and its efforts to prevent NMN from continuing to be sold in the supplement market.
Mid-2025 - FDA staffing and review schedule impacted progress
In 2025, internal FDA staff reductions and organizational restructuring delayed its response to the NMN citizen petition, further delaying the industry's decision-making timeline.
September 29, 2025 - NMN can be used in dietary supplements
Under pressure and litigation from the NPA, the FDA acknowledged in its response to the petition that evidence indicates NMN was marketed in the US as a dietary supplement as early as 2017. The FDA also provided more detailed explanations of its interpretation of the drug preclusion provisions of DSHEA, clarifying that the earliest legally marketed status would no longer be the sole or mandatory criterion for determining whether an ingredient is excluded under DSHEA (in other words, the interpretation of the term "lawfully marketed" was adjusted). The NPA therefore declared NMN legal in supplements.
Why didn't the FDA "approve" NMN?
"Approval" and "legal use as a dietary supplement"
The FDA has an "approval" process for drugs (new drugs, new biologics, etc.) (clinical trials and marketing authorization). Dietary supplements are not subject to this "approval" system. For dietary supplements, the FDA's role is primarily to regulate, inspect, and take enforcement action against illegal claims or unsafe products. The FDA does not "approve" every dietary supplement ingredient or product as it does for prescription drugs.
DSHEA's "Drug Exclusion"
DSHEA stipulates that if a substance has been authorized for investigational new drug development and has undergone "significant and publicly available clinical research," it cannot be used as a dietary supplement. The controversy lies in what constitutes "drug-authorized research" and how "marketing history" should be considered in this determination. In this response, the FDA has adjusted its interpretation of these terms (or clarified its logic).
Adjustments to the "Lawfully Marketed" Standard
In its response, the FDA acknowledged evidence that NMN was already marketed as a dietary supplement in the US in 2017. The agency also stated that in certain scenarios, it will not solely rely on whether it was legally marketed at the time as an exclusion criterion (in other words, it is reconsidering its past position). This means greater flexibility in regulatory judgments for similar situations (where an ingredient has both been investigated as a drug and previously appeared on the market), but it also sparks discussion about the consistency of the FDA's future enforcement.
What does this mean for the industry?
Despite a bright future, the NMN powder bulk industry still faces challenges.
Ongoing Regulatory Challenges
The FDA's decision does not completely resolve all legal disputes. The NMN Association itself acknowledged that it still disagrees with certain aspects of the FDA's legal interpretation of DSHEA. Future litigation regarding the definition of the "drug exclusion clause" may still lead to new lawsuits regarding other ingredients. Furthermore, the FDA will continue to strictly regulate NMN products and crack down on companies that make false or exaggerated efficacy claims.
Market Chaos and Industry Self-Regulation
As market enthusiasm returns, it may attract a mix of high-quality and low-quality vendors. Problems such as insufficient product content, substandard products, and false advertising may emerge. Therefore, industry self-regulation is crucial. Leading companies should take the lead in establishing industry standards, promoting transparent production, and supporting third-party testing to safeguard the reputation of the entire industry.
Continuous Accumulation of Scientific Evidence
Currently, most of NMN's health benefits in humans are still based on preliminary preclinical studies and early clinical trials. Going forward, more large-scale, long-term, randomized, double-blind, placebo-controlled human clinical trials are needed to confirm its efficacy and long-term safety, providing solid scientific support for the product.
Conclusion
The FDA's shift in policy on NMN in 2025 represents a landmark victory for the industry in successfully defending its rights through legal channels. It not only removes the biggest obstacle to NMN's development in the US market but also reshapes the interaction between the dietary supplement industry and regulators. This incident profoundly demonstrates that, within a clear regulatory framework, through reasoned, evidence-based, and measured advocacy, the industry can push regulatory policies towards more rational and scientific approaches. For the global anti-aging health industry, this is a strong acceleration signal, heralding a new era of development for NMN bulk powder and related fields, characterized by greater standardization, innovation, and globalization.
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References:
[1] U.S. Food and Drug Administration (FDA). (1994). Dietary Supplement Health and Education Act (DSHEA) of 1994. Public Law 103-417.
[2] U.S. Food and Drug Administration (FDA). (2025). Response to Citizen Petition from the Natural Products Association Regarding Beta-Nicotinamide Mononucleotide (NMN) [Hypothetical Docket Number].
[3] Natural Products Association (NPA). (2022). FDA Grants NPA Petition on NAC, Allows Supplements to Remain on Market [Historical Press Release]. Retrieved from NPA website.
[4] European Food Safety Authority (EFSA). (2024). *Administrative Guidance on the Preparation and Presentation of Applications for Authorisation of Novel Foods pursuant to Article 10 of Regulation (EU) 2015/2283*.
