Amazon is banning the sale of beta-nicotinamide mononucleotide (NMN) products, according to a letter from Amazon’s Restricted Products Team furnished by the Natural Products Association.
Amazon is banning the sale of beta-nicotinamide mononucleotide (NMN) products, according to a letter from Amazon’s Restricted Products Team furnished by the Natural Products Association (NPA; Washington, D.C.). The letter told sellers that NMN products would be banned after March 13, 2023. In November of 2022, the U.S. Food and Drug Administration (FDA) determined that NMN was not a dietary ingredient, citing the drug preclusion clause of the Food, Drug and Cosmetic Act. As such, according to Amazon, if someone wants to sell NMN on Amazon, they must produce proof that it is approved by FDA for over-the-counter sales. NPA had requested on December 1, 2022 that FDA initiate a public comment period on NMN to provide stakeholders the opportunity to submit relevant safety data but the agency rejected the request.
“This latest example of the FDA misinterpretation of the law is wreaking havoc on the marketplace and causing confusion and significant economic harm,” said Daniel Fabricant, PhD, president and CEO of the NPA, in a press release. “This the first time in history that FDA reversed itself on an acknowledgement letter for a new dietary ingredient without a shred of evidence that safety was at risk. It is setting a new precedent in that an announcement of Generally Recognized as Safe no longer constitutes evidence of the marketing of NMN as a food before the ingredient was authorized for investigation as a new drug.”
The current saga with NMN resembles that of N-Acetyl Cysteine (NAC). While FDA ultimately elected to exercise enforcement discretion on NAC while the agency considers rulemaking on the ingredient, FDA’s position on NMN represents another major disruption for industry. NPA had filed a lawsuit against FDA because of the NAC ban, which it later withdrew after the agency published its final guidance.
“If the FDA can change decisions overnight by repealing an acknowledgement letter without foundation, what’s to stop them again?” said Fabricant. “If the agency can exclude NAC from the definition of a dietary supplement despite the science, what’s to stop them from doing it to a different ingredient? If the agency can lobby for unneeded new authorities like a mandatory product listing while ignoring a regulatory path for CBD which is available on every street corner in America, who will stop them? This is inexcusable and downright shameful, and NPA will use every available resource to ensure the agency is again accountable to consumers and the industry.”