federal court issued a final ruling halting enforcement against NMN

The Natural Products Association (NPA) has expressed support for a federal court ruling that halted enforcement by the Food and Drug Administration (FDA) of niacinamide mononucleotide (NMN) supplements.

Abstract:

• A federal court ruled in favor of the FDA in a lawsuit against the FDA, halting the FDA's enforcement of NMN supplements.

• The court also asked the FDA to address the NPA citizen petition filed in 2023, which asked the FDA not to exclude NMN from the definition of dietary supplement.

In what the NPA called a "huge victory," a federal court moved to block the FDA from taking disciplinary action against suppliers selling NMN products.

The court's motion appears to remain in effect until the NPA's lawsuit against the FDA over its ruling on NMN is resolved.

The court ruled that the FDA must process citizen petitions filed by the National Action Plan in 2023.

"This is a huge win for NPA, our members and American consumers," Dr. Daniel Fabricant, NPA president and CEO, said in a press release. .

1. Legal dispute regarding the sale of NMN supplements

The legal dispute between the NPA and the FDA stems from November 2022, when the FDA stated that NMN is not a legitimate dietary ingredient.

This comes a few months after NMN was approved for sale through the New Dietary Composition Notification (NDIN) in May 2022.

In a November 2022 announcement, the FDA rescinded the NDIN notice because, after the notice was issued, the FDA found that NMN was under investigation as a new drug.

Under FDA regulatory guidelines, investigations into NMN as a drug exempt it from classification as a new dietary ingredient.

The NPA and the Alliance for Natural Health (ANH) filed the citizen petition on March 7, 2023, in response to the FDA's November 2022 announcement.

The petition asks the U.S. Food and Drug Administration not to exclude NMN from dietary supplements.

The petition also asks the FDA to exercise enforcement discretion to allow NMN suppliers to bypass FDA regulatory enforcement.

Then, in September 2023, the FDA issued a statement saying it was unable to meet the demands in the citizen petition due to "competing agency priorities."

The National Drug Administration filed a lawsuit against the U.S. Food and Drug Administration in August 2024 over its declaration that NMN is not a legal dietary ingredient.

2. Breakthrough of NPA and NMN suppliers

With the federal court ruling that the FDA has temporarily stopped punishing NMN suppliers, it is unclear how this will affect companies that continue to sell NMN even after the FDA has announced its opposition to the sale.

It is unclear whether any companies have been prosecuted for continuing to sell NMN after the FDA announcement in November 2022.

Another problem, says Dr Fabricant, is the process of issuing NDIN.

Since the US Food and Drug Administration initially provided NDIN for NMN and then withdrew it, the integrity of the issuance of NDIN is called into question.

"The court made it clear that the FDA greatly overstepped their authority and needs to return to an enforcement system that follows the letter of the law," Dr. Fabricant said. .

"Fundamentally, FDA's past decisions have weakened the integrity of the New Dietary Ingredient Notification (NDIN) process as NPA members look to bring 21st century consumer health products to market."

Tag: NMN

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