In the United States, regulations surrounding the sale and distribution of NMN supplements reached a significant turning point in September 2025. This was because NMN, long considered a "drug," was officially recognized as a supplement ingredient by the U.S. Food and Drug Administration (FDA). This regulatory shift is a crucial change that Japanese companies considering OEM contract manufacturing and overseas sales of NMN supplements cannot afford to overlook. This article traces the journey from the origin of the regulatory issue to its resolution.Full timelineWe will organize and provide an overview of the impact on the OEM business.
Evolution of U.S. FDA Regulations: Timeline Organization
Here is a chronological summary of the main developments regarding NMN regulations in the United States from the end of 2022 to the end of 2025.
- Around 2017:NMN begins sales as a supplement in the US market (later becomes the basis for FDA approval)
- May 2022:SyncoZymes receives first NDI notification accepted for NMN, raising market expansion expectations within the industry.
- End of 2022:The FDA suddenly notified that NMN has been excluded from the definition of supplements. The reason is that MetroBiotech, Inc. had filed an IND (Investigational New Drug) application for NMN as a new drug candidate. NMN products have been successively removed from e-commerce sites such as Amazon, causing confusion in the industry.
- March 2023:Industry groups NPA (Natural Products Association) and ANH submitted a Citizen Petition to the FDA, demanding the reversal of the decision to exclude NMN.
- September 2023:The FDA responded that they "cannot make a judgment due to internal priorities." Industry dissatisfaction is growing.
- August 2024:NPA formally sues FDA in federal court
- November 2024The federal court grants a stay of proceedings. The FDA's enforcement discretion period begins, leading to a de facto tolerance of sales. Many brands resume sales.
- September 29, 2025:The FDA announced a historic policy change, officially recognizing that "NMN will not be excluded from the definition of supplements." The basis for this is a change in interpretation, stating "it was already on the market as a supplement as of 2017, predating the IND application."
- December 2025The FDA has formally notified major NMN ingredient manufacturers, including SyncoZymes and Inner Mongolia Kingdomway, in writing. This brings an end to approximately three years of regulatory uncertainty.
Why the shift from "exclusion" to "recognition": Overview
The reason the FDA classified NMN as a "drug" at the end of 2022 is included in the U.S. Dietary Supplement Health and Education Act (DSHEA).Drug preclusion clauseThis regulation stipulates that an ingredient cannot be sold as a supplement if it did not have a history of being marketed as a supplement "before" it was approved for clinical trials and subsequent approval as a new drug.
However, in the FDA's final decision in 2025,As of 2017, NMN was already being sold as a supplement.We confirm the fact that the drug preclusion clause does not apply because it predates MetroBiotech's IND application (2022). We will provide a detailed explanation of this legal judgment (interpretation of DSHEA provisions, race-to-market clause, and FDA's logic) at a later date, as it would be a bit lengthy to cover here.
Impact on OEM Business: 3 Key Points Japanese Companies Should Know
This regulatory shift is expected to bring direct business opportunities for OEM manufacturers producing and supplying NMN in Japan and for companies considering sales to the U.S.
Point 1: Export barriers to the US market have substantially decreased
Previously, regulatory gray areas posed a risk, but with the establishment of the FDA's official stance, we can now plan the manufacturing and supply of NMN supplements for the US market with greater confidence. For Japanese companies considering entering the US market, the world's largest supplement consumer, the significant reduction in regulatory risk is a major advantage.
Point 2: NDI notifications (NDIN) are still required
FDA approval permits NMN to enter the supplement market, but the prior notice (NDIN) requirement as a New Dietary Ingredient (NDI) still remains. When selling NMN products in the U.S., submission of an NDIN or the use of a notified ingredient is required.
Point 3: Quality transparency directly leads to competitive advantage.
Following the recent regulatory issues, quality and purity transparency have become even more important in the US NMN supplement market. Purity of 99%%or higher and the presentation of certificates of inspection by third-party organizations are becoming standard requirements from US buyers. NMN manufactured and inspected on Japanese GMP lines can be said to have a significant advantage in this regard.
Summary: US NMN Regulations Become a Tailwind for Japanese OEMs
With the FDA's policy shift in September 2025, the regulatory uncertainty that has persisted for approximately three years has finally been resolved. Export barriers to the U.S. market have effectively been lowered, and an environment is gradually being established where the quality advantage of Japanese-made NMN can be leveraged. Assuming compliance with NDIN and ensuring quality transparency, this is an opportune moment to seriously consider full-scale expansion into the U.S. market.
Consultation on OEM manufacturing of NMN supplements and expansion into the US marketThis inquiry formFrom.
Source: FDA letter (2025-09-29), NutraIngredients-USA, Venable LLP, NPA Official Announcement, DSHEA Section 201(ff)(3)(B)
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