FDA to Amazon: Stop shipping products that contain undisclosed drugs

Regulatory NewsRegulatory News | 29 July 2021 |  By 

The mammoth online retailer Amazon received an untitled letter from The US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) identifying 26 sexual enhancement and weight loss products that contain “undeclared” and “potentially harmful” drug ingredients, according to FDA’s testing of the products.
In this letter — not the first correspondence the agency has had with Amazon on the matter —the firm was called out for marketing unapproved new drugs under section 505(a) of the Federal Food, Drug and Cosmetic Act, and for misbranding drugs under section 502 of the FD&C Act in a 26 July letter sent to Amazon CEO Andy Jassy.
The lengthy letter details the history of FDA’s notices to Amazon and previous corrective actions the firm has taken. Despite Amazon’s having pulled products after FDA notification, virtually identical products continue to crop up on the Amazon.com website, often through third-party sellers.
FDA purchased samples of 26 sexual enhancement products through the company’s website between December 2019 and February 2020 and confirmed through laboratory analyses that all products sampled contained one of more of the active pharmaceutical drug ingredients sildenafil, tadalafil or vardenafil, yet none of these ingredients were declared on the product’s labeling.
FDA said that these undeclared drug ingredients, the active ingredients in drugs approved to treat erectile disfunction, “may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.”
The letter indicates the agency’s growing frustration over Amazon’s failure to stop marketing these products even after being told to do so.
FDA communicated with Amazon “several times” in December 2020 and January 2021 regarding its distribution of these 26 sexual enhancement products. The company told FDA that it had “restricted” the sale of the products and their corresponding sellers. Yet FDA purchased one of the same 26 violative products from the same seller on January 15, 2021.
In March 2021, FDA yet again purchased samples of two additional sexual enhancement products and one weight loss product through the Amazon website. FDA confirmed through laboratory analyses that the sexual enhancement products it purchased and sampled in this time frame contained tadalafil. The weight loss product contained sibutramine, a weight loss drug that has been withdrawn from the market in the US and many other countries over safety concerns, including an increased risk of cardiovascular events. None of these drug ingredients were declared in the products’ labeling, observed FDA.
FDA said that Amazon has been previously cited for marketing unapproved and misbranded sexual enhancement products. In May 2018, FDA alerted Amazon for its brand name product “Rhino,” which FDA laboratories had found to contain undeclared drug ingredients. (RELATED: Study raises questions over FDA’s handling of adulterated supplements, Regulatory Focus 12 October 2018)
In May 2019, FDA alerted Amazon that testing of its male enhancement supplement “Man Fuel” revealed the presence of undeclared sildenafil and tadalafil.
FDA said that “Amazon’s response to prior FDA communications about such unapproved new drugs, misbranded drugs with undeclared drug ingredients, and/or foods to which have been added an approved drug has not been sufficient to protect the public from the serious and continuing risk of harm posed by such products.”
Part of the problem, noted FDA, is that Amazon serves as a common marketplace for products sold by other vendors, with “Fulfillment by Amazon;” the firm’s filters may not catch problematic products made available through this route. “Based on this information, FDA is concerned that your filters are inadequate,” wrote FDA.
The letter directs the company to file a written response within 15 days of receiving the letter.
FDA untitled letter to Amazon


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