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FDA's dietary supplement office did not advise Amazon, other retailers on NMN decisionFDA's dietary supplement office did not advise Amazon, other retailers on NMN decision

Josh Long

April 24, 2023

3 Min Read
FDA's dietary supplement office did not advise Amazon, other retailers on NMN decision

Amazon’s recent decision to ban the sale of NMN supplements highlighted that the ecommerce powerhouse is paying attention to FDA determinations about nuanced regulatory issues.

But Amazon’s move was not the result of FDA’s dietary supplement office reaching out directly to the company in an advisory capacity, an FDA official confirmed.

FDA has concluded NMN, or beta-nicotinamide mononucleotide, is a substance authorized for investigation as a new drug and precluded in dietary supplements.

After FDA’s determination was made public in the fall of 2022, Amazon prohibited the sale of NMN supplements, effective in March. Amazon also stopped selling NAC-containing supplements in 2021 after FDA said in warning letters that the ingredient was approved as a drug in 1963, barring its use in supplements. The company later resumed sales after FDA issued an enforcement discretion policy on NAC (N-acetyl cysteine) in a final guidance.

FDA remarks on third-party communications

Cara Welch, Ph.D., who oversees FDA’s Office of Dietary Supplement Programs (ODSP), said her office is not directly communicating decisions about the regulatory status of an ingredient like NMN with Amazon or other retailers. 

“As a matter of policy, we don’t discuss the compliance status of specific products with third parties, and that includes retailers,” she said in an April 18 interview at the SupplySide East trade show in Secaucus, New Jersey. “If it moves to a warning letter or some other type of public-facing communication, they may find out about it through that means.”

Related:FDA official concedes, ‘We didn’t connect those dots’ in reviews of NMN

On the other hand, Welch suggested she is not displeased that Amazon has acted to stop selling certain ingredients in the wake of FDA determinations.

“And to be blunt, it doesn’t bother me that they are aware of these things,” the FDA official said. “I think it’s important for the industry to be a strong industry and sometimes that includes saying, ‘No, this product shouldn’t be sold, or this ingredient shouldn’t be sold,’ and manufacturers can make that decision on whether or not they want to market a product containing that ingredient. Retailers can make a decision on whether they want to sell a product containing that ingredient.”

Welch disclosed she is not aware of any enforcement action taken against NMN marketed in supplements. Asked whether FDA plans to enforce against the ingredient, she responded, “I can’t speak to future enforcement priorities.”

Dan Fabricant, Ph.D., a former FDA official who leads the Natural Products Association (NPA), pointed out retailers like Amazon are making decisions to remove products from the market based on tentative conclusions from FDA. NPA and the Alliance for Natural Health USA have filed a citizen petition requesting FDA reverse its position on NMN.

Related:Amazon bans NMN in dietary supplements

“Why are these decisions from ecommerce platforms and third-party retailers on ingredients like NMN being made on what the agency itself says is not final agency action?” he asked in an interview. 

Amazon did not immediately respond to a request for comment for this story.

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long has been a journalist since 1997, holds a J.D. from the University of Wyoming College of Law, and was admitted to practice law in Colorado in 2008. Josh is the legal and regulatory editor with Informa's Health and Nutrition Network, specializing on matters related to Natural Products Insider. Ping him with story ideas at [email protected].

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