NMN, or nicotinamide mononucleotide, is one of the forms of vitamin B3, or niacin, that has been shown to enhance the levels of the coenzyme nicotinamide adenine dinucleotide (NAD+) in the cells of the body. Boosting these levels has in turn demonstrated significant benefits in staving off cellular senescence.
FDA announced at the end of 2022 that NMN is not allowed as a dietary ingredient because of its prior investigation as a drug. The agency made this determination after having been made aware of recent drug studies on the ingredient. This reportedly came while doing due diligence on a recent New Dietary Ingredient Notification.
In an email from the Amazon Restricted Products team to sellers, shared with NutraIngredients-USA on Thursday, the e-tailer stated:“On November 4, 2022, the Food and Drug Administration (FDA) announced that NMN is no longer considered a dietary supplement. It is now considered a drug, or drug ingredient, that requires FDA approval. Products that contain NMN as an ingredient can no longer be sold or distributed as a dietary supplement by manufacturers or retailers in the United States. If you want to sell NMN on Amazon, you must show that you are approved by the FDA for over-the-counter sales.”
Amazon confirmed that sellers may continue to offer NMN-containing products until March 13, 2023.
The retailer added: “If you do not submit a removal order for impacted ASINs within 30 days of receiving a removal notice, we may dispose of this unsellable inventory in accordance with the Service Terms and policies applicable to your listings. You won’t be able to cancel a required removal order once Amazon creates it.”
The NAC comparison
This isn’t the first time that Amazon has removed specific dietary supplements from sale in response to FDA actions. Indeed, industry stakeholders point to the case of NAC from 2021-22.
N-acetyl cysteine (NAC) is a derivative of the amino acid L-cysteine and a precursor of the cellular antioxidant glutathione. It is naturally occurring in foods like onions and garlic.
Despite being used in supplements since the early 1990s, and therefore an “old dietary ingredient” according to the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA declared in July 2020 that NAC was not a legal dietary ingredient because of its prior approval as a drug. NAC was first approved as an inhaled mucolytic drug in 1963.
Amazon moved to remove NAC-containing supplements from its virtual shelves in May 2021 in response to FDA’s stance but resumed sales of NAC-containing dietary supplement products in August last year, a development that NutraIngredients-USA broke for the industry.
This reversal seemingly responded to FDA guidance that it would exercise enforcement discretion for NAC, basically turning a blind eye to the sale of NAC-containing dietary supplement products so long as products did not make non-compliant disease claims.
Commenting on the NMN news, the Natural Products Association (NPA) called on e-commerce retailers to continue selling products containing NMN.
“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, Ph.D., president and CEO of the NPA. “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 also setting new precedent in that the announcement of Generally Recognized as Safe (GRAS) doesn’t establish the marketing of NMN or place it in the food supply before someone could swoop in with an IND and keep it out of the market.
“FDA’s growing and repeated abuse of the law is sending shock waves across the dietary supplement industry. If the FDA can change decisions overnight by repealing an acknowledgement letter without foundation, what’s to stop them again?
“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.”
CRN: "We are disappointed, but not surprised"
Steve Mister, President and CEO of the Council for Responsible Nutrition (CRN), told us: “We are disappointed, but not surprised, that Amazon is once again getting ahead of its skis with this decision to remove NMN product from the platform. It behaved similarly with NAC and alienated many of its consumers before returning that ingredient to its platform. It makes the same mistake with NMN while allowing other, illegal products to be promoted, as evidenced by the recent warning letter for products making drug claims and containing unidentified ingredients harmful to consumers health. Both NAC and NMN have a history of safe use in supplements as FDA has acknowledged.
“Amazon’s decision will have negative effects—for consumers, for NMN marketers and for Amazon itself—by prematurely deciding not to offer these products. FDA’s initial reasoning that NMN is subject to drug preclusion, as espoused in its NDIN reversal, is flawed. Industry continues to develop its response, and Amazon’s overabundance of caution here is misplaced. But perhaps that is exactly what FDA hoped for—that a major retailer would overreact to the announcement, so it doesn’t have to actually enforce its decision and defend that determination in court.”
NutraIngredients-USA contacted Amazon for comment but had not received a response prior to publication.
This is a developing story, and we will bring more reaction as it comes in.
