On September 29, 2025, the website of the National Natural Products Association (NPA) announced that the US Food and Drug Administration (FDA) has officially lifted the sales ban on NMN (β-nicotinamide mononucleotide), confirming its lawful sale as a dietary supplement. The release of this information marks the end of years of NMN regulatory controversy.

FDA had previously attempted to block NMN from the supplement market, claiming it was first investigated as a new drug. NPA refused to accept that interpretation, filing a citizen petition with FDA, launching a federal lawsuit against the agency in the nation's capital, and mobilizing industry and consumer support to challenge the FDA. In response to the petition and lawsuit, FDA acknowledged evidence that NMN was marketed as a dietary supplement in the United States since 2017 and consequently is not excluded from the definition of a dietary supplement.

Review of key time nodes of the event

1 In 2016

NMN has been approved as a new dietary ingredient (NDI) for the first time in the United States, allowing it to be sold as a dietary supplement.

2 In November 2022

The FDA's attitude changed, citing the "drug preclusion" and announcing that NMN can no longer be sold as a dietary supplement.

3 In August 2024

Industry organizations such as the NPA have filed legal lawsuits and citizen petitions against this.

4 In October 2024

The court suspends the lawsuit and demands that the FDA respond to the petition within 90 days. The FDA announced that it will not prioritize enforcement until July 31, 2025, allowing NMN to continue selling.

5 In July 31, 2025

The originally scheduled date for the ruling. However, due to the large-scale layoffs within the FDA resulting in a shortage of manpower, the ruling has been postponed until September 30.

6 In September 29, 2025

The FDA has officially changed its stance and ruled to confirm that the use of NMN in dietary supplements is legal.

The root cause of this regulatory controversy lies in the FDA's application of the "drug preclusion" in the Federal Food, Drug, and Cosmetic Act. This clause stipulates that if a certain ingredient has not been extensively used in dietary supplements before being approved for research as a new drug, it cannot be sold as a dietary supplement.

Industry organizations such as the NPA believe that the FDA's application constitutes "illegal retrospective enforcement", as NMN was approved as a dietary supplement in 2016, prior to its research authorization as a new drug. At the same time, there is a lack of clear standards for "substantive clinical research".

After a series of efforts such as citizen petitions and federal lawsuits by NPA, the FDA finally recognized NMN as a legal dietary supplement.

This is not the first time that FDA has changed course in response to NPA actions. In 2022, after NPA filed a citizen petition and lawsuit over FDA's attempt to exclude NAC (N-acetyl-L-cysteine) from supplements, the agency ultimately issued a final guideline - or policy of enforcement discretion – that allowed NAC products back on the market.

Source: JIANKANG XIAOYUN HUI

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