The Food and Drug Administration reversed its position on nicotinamide mononucleotide (NMN) supplement sales, acknowledging the ingredient was on the market prior to being studied as an investigational new drug. The decision, reported by Nutrition Business Journal, opens the door for continued NMN supplement sales while generating divergent reactions from supplement industry trade associations.

The FDA's announcement on September 29 came in response to a lawsuit from the Natural Products Association (NPA) and citizen petitions from the Council for Responsible Nutrition (CRN). The agency had previously declared NMN sales unlawful under language in the Dietary Supplement Health and Education Act (DSHEA), which bars supplement companies from selling ingredients that have been investigated as drugs.

NMN is one of several "precursors" that drive cells to produce nicotinamide adenine dinucleotide (NAD), a coenzyme vital to cellular metabolism. Brands claim that NAD precursors can support healthy aging.

Industry Trade Associations Respond

The Natural Products Association characterized the FDA's decision as a "victory" and highlighted its role in prompting the agency's determination. The organization also took credit for the FDA allowing sales of N-acetyl-L-cysteine (NAC) after that ingredient was barred from supplement sales in 2022.

In contrast, the Council for Responsible Nutrition acknowledged the positive outcome for brands selling NMN while criticizing the FDA's failure to provide clarity on how the agency intends to handle drug preclusion cases. In a press release, CRN pointed to the agency's unwillingness to offer guidance and rulemaking on the matter, specifically noting the lack of a definition for "substantial clinical investigations" that pharmaceutical companies could use to claim an ingredient was an Investigational New Drug.

CRN maintains that the decision in the NMN case "broadened" the definition, allowing early phase studies to grant drug companies a monopoly on ingredients. CRN President and CEO Steve Mister stated: "FDA missed a pivotal opportunity to bring clarity and balance to the line between pharmaceuticals and dietary supplements. At every juncture where FDA had the opportunity to choose between two interpretations of the statute, it chose one that favors pharmaceutical development over supplements. Consumer access to affordable and accessible health care products will be stymied as a result."

Patent Disputes and Future Legal Questions

Niagen Biosciences CEO Rob Fried indicated the matter is far from resolved. Fried's company manufactures branded nicotinamide riboside (NR), which he describes as superior to NMN as an NAD precursor. In a text response to Nutrition Business Journal, Fried questioned the FDA's position, stating: "We think it was a bizarre decision that basically incentivizes illegal selling of ingredients to avoid drug preclusion. Don't expect it will hold for long as drug companies prepare their reaction."

Fried also raised patent questions around NMN, predicting that removing drug preclusion from consideration could trigger additional legal action. Niagen Biosciences holds a patent on its NR ingredient, but Fried indicated a different company may hold patent positions on NMN.

"All NMN products that we have seen infringe on existing patents," Fried stated. "The patent holders have refrained from taking action due to the drug preclusion. We will see."

Market Implications and Product Development

Jordan Glenn, who leads the science team at SuppCo—a platform that helps consumers learn which supplements they should take and which brands they can trust—predicts an "NAD arms race," with new brands rushing into the market with NMN products and positioning their offerings as more effective than Niagen's NR.

Glenn suggested that increased competition could lead to more research around NMN's potential in healthy aging and other conditions. With restrictions lifted, brands will have motivation to conduct that research.

However, Glenn also expressed concerns that the decision could "open the door to some less than savory products as well." Less responsible brands could rush into the perceived white space with products that don't meet label claims or incorporate NMN into formulations that don't pass scientific muster. Glenn characterized NMN as having been "champing at the bit," and stated the FDA's decision "takes the guardrails off."

Drug Preclusion Policy Background

The Dietary Supplement Health and Education Act includes provisions that prohibit supplement companies from selling ingredients that have been investigated as drugs, a policy known as drug preclusion. This provision aims to prevent supplement manufacturers from circumventing the more rigorous testing and approval processes required for pharmaceutical products.

The policy has created challenges for ingredient suppliers and supplement manufacturers, particularly when pharmaceutical companies conduct early-stage research on substances that were previously available as dietary ingredients. The lack of clarity around what constitutes "substantial clinical investigations" has generated uncertainty in product development decisions.

The NMN case represents one of several high-profile disputes over drug preclusion in recent years. NAC, which the FDA temporarily barred from supplement sales in 2022 before reversing that position, highlighted similar tensions between pharmaceutical development and supplement market access.

Compliance Considerations for Supplement Manufacturers

The FDA's evolving positions on ingredients like NMN and NAC underscore the regulatory complexity facing dietary supplement manufacturers. Companies developing products with novel ingredients or ingredients under pharmaceutical investigation must maintain comprehensive documentation systems tracking ingredient market history, clinical research timelines, and regulatory determinations.

Supplement manufacturers should implement quality management systems that document ingredient sourcing, manufacturing processes, testing protocols, and label claim substantiation. These systems become particularly important when operating in areas where regulatory guidance remains unclear or subject to change.

For ingredients with contested regulatory status, maintaining detailed records of market presence prior to drug investigations provides critical evidence in potential enforcement actions or legal challenges. Companies should also monitor pharmaceutical research pipelines to identify ingredients that may face future drug preclusion questions.

Quality Management in Uncertain Regulatory Environment

The NMN decision demonstrates how quickly regulatory frameworks can shift for dietary supplement ingredients. Manufacturers must balance market opportunities against evolving compliance requirements and potential legal challenges from both regulators and competitors holding patent positions.

Companies that proactively implement comprehensive quality management systems, rigorous testing protocols, and conservative marketing practices position themselves more favorably regardless of how ingredient-specific regulations develop. This includes maintaining detailed supply chain documentation, third-party testing verification, and clear substantiation for product claims.

Patent considerations add another layer of complexity to ingredient selection and product development decisions. Manufacturers should conduct patent landscape analysis before launching products containing ingredients that may be subject to intellectual property claims, particularly when regulatory barriers that previously discouraged enforcement are removed.

Navigate Complex Supplement Ingredient Regulation

Operating in the dietary supplement industry requires sophisticated quality management infrastructure to track regulatory changes, document ingredient compliance, and maintain rigorous manufacturing standards. Qredible's Q-Trust system provides supplement companies with comprehensive quality management tools, secure documentation systems, and transparent supply chain oversight. Contact our team today to learn how our platform can help your business maintain compliance in evolving regulatory environments.

Source: This article is based on reporting by Rick Polito for Nutrition Business Journal, published September 29, 2025.