Key Progress for NMN NDI Notifications: Three Companies Receive FDA’s Written Responses
On December 2, 2025, the U.S. Food and Drug Administration (FDA) issued long-awaited written responses to several companies submitting New Dietary Ingredient (NDI) notifications for β-Nicotinamide Mononucleotide (NMN). These responses were officially posted on December 9, 2025, on the respective NDI pages at www.regulations.gov, marking the end of nearly five years of regulatory uncertainty.
As of December 11, 2025, BYSEE’s review of public records confirms that three companies have received FDA’s written evaluations for their NMN NDI submissions:
- Willy Chemicals & Willy Nutra NDI 1189 and NDI 1234
- SyncoZymes (Shanghai) Co., Ltd. NDI 1240 and NDI 1247
- Inner Mongolia Kingdomway Pharmaceutical Limited NDI 1259
These NDI responses align with the FDA’s formal decision issued on September 29, 2025, in response to the Natural Products Association (NPA) Citizen Petition. In that decision, FDA confirmed that NMN is not excluded from the dietary supplement definition under 21 U.S.C. § 321(ff)(3)(B).
FDA stated:
“We have reconsidered our interpretation of one aspect of 21 U.S.C. § 321(ff)(3)(B), and have determined that NMN is not excluded from the dietary supplement definition.”
The NMN NDI process has experienced multiple unexpected delays across nearly five years, including acceptance followed by withdrawal of previous notices, staffing shortages, temporary office closures, and review backlogs. With the issuance of written responses to three companies in December 2025, the NMN NDI review has now returned to a standard regulatory process.
References
https://www.regulations.gov/document/FDA-2022-S-0023-0066
https://www.regulations.gov/document/FDA-2022-S-0023-0067
https://www.regulations.gov/document/FDA-2022-S-0023-0068
https://www.regulations.gov/document/FDA-2022-S-0023-0069
https://downloads.regulations.gov/FDA-2023-P-0872-2754/attachment_1.pdf