On October 25, 2024, the fate of NMN as a dietary supplement took another turn. According to the SupplySide Supplement Journal, the dispute between the Natural Products Association (NPA) and the Food and Drug Administration (FDA) may be temporarily suspended.
The incident began in August of this year when the NPA—the industry association for the largest retail and manufacturing of dietary supplements in the United States—filed a lawsuit against the FDA in the District of Columbia District Court, demanding that the FDA not exclude NMN from its list of dietary supplements. According to publicly available litigation documents, the NPA’s main arguments include: the FDA misinterpreted the Dietary Supplement Health and Education Act (DSHEA). The FDA’s basis for banning NMN is the drug exclusion clause, which applies to ingredients already approved as drugs. NMN has been sold as a supplement for many years and therefore is not subject to this clause. Furthermore, the standards for “substantial clinical studies” lack clear definition. Previously, the FDA had concluded that NMN could not be sold as an ingredient in dietary supplement products, triggering a chain reaction in the NMN-related industry.
On October 24, the NPA, FDA, and the U.S. Department of Justice jointly requested a suspension of legal proceedings in court, pending the FDA’s response to a citizen petition concerning NMN. Meanwhile, the FDA stated that, while considering the arguments in the citizen petition, it will not take enforcement action against dietary supplements containing NMN for the time being , as long as these products can be legally sold as long as NMN is not excluded from the list of dietary supplements. However, if the FDA discovers new safety concerns, it may reassess its enforcement priorities. This means the FDA will maintain a degree of flexibility but will adjust its strategy based on safety issues.
In March 2023, the NPA and other organizations submitted a citizen petition to the FDA, requesting that NMN be recognized as a legal dietary supplement and hoping that health authorities would issue relevant regulations to ensure the legal sale of NMN. The FDA will respond to this citizen petition by July 2025.
This is not the first lawsuit the NPA has filed against the FDA. In December 2021, the NPA sued the FDA over its decision that N-acetylcysteine, another ingredient, did not fall under the definition of a dietary supplement. Ultimately, the NPA voluntarily withdrew the case after the FDA issued its enforcement policy regarding N-acetylcysteine products. This summer, the FDA plans to issue a regulation recognizing N-acetylcysteine as a legal dietary supplement, despite the ingredient’s initial research and approval as a drug.
Amidst ongoing controversy, can NMN still be trusted?
The controversy surrounding NMN has lasted for three years.
• In late 2021 , Metro International Biotech (hereinafter referred to as Metro), a pharmaceutical company co-founded by Harvard University professor David Sinclair, submitted an Investigational New Drug (IND) application to the FDA to conduct clinical trials of NMN (drug code: MIB-626).
• In November 2022 , the FDA ruled that NMN is prohibited from being sold as a dietary supplement because it is an investigational drug in clinical trials, and revoked its previous approval of NMN as a new dietary ingredient (NDI).
• February 2023 : Amazon announced it would no longer allow the sale of supplements containing NMN. However, this removal was unrelated to the FDA ruling; the main reason was serious quality issues with NMN products on the Amazon platform, including false advertising and mislabeling of added amounts. Previously, a study by the National University of Singapore’s Centre for Healthy Longevity found that only two of the best-selling NMN supplements had ingredients that matched their labels, while the majority of the remaining products had NMN content far lower than advertised, with two products containing zero NMN.
About NMN
NMN ( β -nicotinamide mononucleotide) is a naturally occurring compound and a direct precursor to nicotinamide adenosine dinucleotide (NAD+). NAD+ plays a crucial role in cellular energy metabolism, DNA repair, and aging. In recent years, NMN has garnered significant attention due to its potential anti-aging effects; studies have shown it may help improve sleep, metabolism, cellular energy, and slow aging. However, recent FDA regulatory scrutiny and controversies surrounding NMN have complicated its market situation. Currently, there is no final decision on whether the FDA will formally exclude NMN from dietary supplements. The NPA lawsuit is crucial for NMN ingredient suppliers and finished product brands; the final ruling will determine the fate of NMN in dietary supplements and may impact innovation in the pharmaceutical and natural products industries.
NMN enzyme product
As one of the drafting units of the NMN group standard, Enzyme Products strictly controls product quality to provide users with high-quality NMN products, and has passed GRAS certification. In addition, another nutritional health ingredient that Enzyme Products has developed in the anti-aging field—ergothioneine—also obtained GRAS certification this August. These two star ingredients work together to support your health management, making anti-aging more scientifically supported and professionally guaranteed.
Certificate of the drafting unit of the NMN group standard
Regarding enzyme products
Enzyme Products is committed to becoming a global leader in green active ingredients , employing next-generation synthetic biology technologies to focus on the green production of active ingredients such as peptides, proteins, sugars, and nucleic acids. Leveraging over 20 years of research and industry experience accumulated by its founding team, the company has established a leading multidisciplinary technology platform in China. It has now achieved mass production of dozens of green active ingredients, including Smegglutinin, Telborpeptide, S -Pros-Xylane, NAD+, Blue Copper Peptide, HMOs, and various peptides. It has cumulatively provided high-quality green active ingredients to over a thousand well-known companies in the fields of biopharmaceuticals , functional skincare, nutritional health, and pet and animal health .
After seven years of rapid development, the company has achieved a leading position among global companies of its kind in terms of R&D investment, scale, and output. It has applied for more than 150 invention patents and has won more than ten national and local titles, including National Specialized and Innovative Small Giant, National High-tech Enterprise, Shenzhen Specialized and Innovative Small and Medium Enterprise, Shenzhen Potential Unicorn Enterprise, Guangdong Postdoctoral Innovation Practice Base, Shenzhen Top 30 Medical and Health Innovation Team, Zhuhai Innovation and Entrepreneurship Team, and Gansu Specialized and Innovative Small and Medium Enterprise. In 2022, it was selected as one of Shenzhen’s Top 100 High-Growth Enterprises (ranked first among unlisted biotech companies), and in 2023, it was selected as a Harvard Business Review High-Energy Innovation Team.
Source:
1.https://www.supplysidesj.com/supplement-regulations/fda-telegraphs-enforcement-strategy-against-nmn-supplements-amid-npa-lawsuit
2.https://www.supplysidesj.com/supplement-regulations/fda-faces-new-lawsuit-from-npa-over-anti-aging-ingredient-nmn
3.https://www.supplysidesj.com/supplement-regulations/fda-says-ingredient-studied-as-drug-nmn-is-excluded-from-supplements