Highlights

  • A federal court has issued a ruling in favor of the NPA in its lawsuit against the FDA, halting the FDA’s enforcement against NMN supplements.
  • The court also requires the FDA to address the NPA’s citizen’s petition, filed in 2023, which asked the FDA not to exclude NMN from the definition of a dietary supplement.

In what the NPA calls a “monumental victory,” a federal court motioned to stop the FDA from issuing disciplinary measures against vendors who sell NMN products. It also appears that this motion from the court will remain in effect until a lawsuit, which the NPA filed against the FDA regarding its ruling on NMN, is settled. Moreover, the court stipulated that the FDA must address a citizen’s petition that the NPA filed in 2023.

“This is a monumental victory for NPA, our members, and American consumers,” said Dr. Daniel Fabricant, PhD, president and CEO of the NPA, in a press release.

A Legal Dispute Between the NPA and FDA Regarding the Sale of NMN Supplements

The legal dispute between the NPA and the FDA stems from the FDA’s declaration in November 2022 that NMN is not a legal dietary ingredient, which occurred just months after greenlighting the sale of NMN with a new dietary ingredient notification (NDIN) in May 2022. In this way, with its November 2022 declaration, the FDA rescinded its NDIN, because after issuing it, the FDA uncovered that NMN was being investigated as a new drug. Thus, the investigation of NMN as a drug exempted its classification as a new dietary ingredient, according to the FDA’s regulatory guidelines.

In response to the FDA’s November 2022 declaration, the NPA and the Alliance for Natural Health (ANH) filed a citizen’s petition on March 7, 2023. The petition requested that the FDA not exclude NMN as being defined as a dietary supplement. The petition also asked the FDA to exercise enforcement discretion—allowing NMN vendors to bypass the FDA’s typical regulatory enforcement.

The FDA then issued a statement in September 2023 that it had been unable to address the requests made in the citizen’s petition due to “competing agency priorities.” The NPA responded in August 2024 with a lawsuit against the FDA regarding its declaration that NMN is not a legal dietary ingredient.

A Break in the Clouds for the NPA and NMN Vendors

With the federal court’s ruling that the FDA halt punishing NMN vendors for the time being, it remains unclear how this will affect companies that have continued selling NMN even with the FDA’s declaration against NMN sales. What’s more, it is also unclear whether any companies have been prosecuted for continuing NMN sales following the November 2022 FDA declaration.

Also, with online retailers like Amazon and Shopify stopping their sales of NMN products, vendors selling NMN have experienced substantial financial setbacks. Whether a pause in enforcement against those selling NMN will have any rebounding effect on these financial setbacks for the NMN market remains unclear.

According to Dr. Fabricant, another issue at hand is the process through which NDINs are issued. With the FDA initially providing an NDIN for NMN and then subsequently rescinding it, this calls into question the integrity of the NDIN issuance.


“The court said plainly that FDA vastly exceeded their authority and needs to go back to the enforcement regime that follows the letter of the law,” said Dr. Fabricant. “Fundamentally, FDA’s past decisions have weakened the integrity of the New Dietary Ingredient Notification (NDIN) process for members of the NPA who want to bring twenty-first-century consumer health products to the market.”