15/16 February 2022
The U.S. Food and Drug Administration (FDA) has purchased different products intended for sexual enhancement and weight loss offered for sale on amazon's website. All of these products were introduced or delivered for introduction into interstate commerce by Amazon via the "Fulfillment by Amazon service". In subsequent laboratory analysis, it was determined that all tested products contain undeclared and potentially harmful drug ingredients. In a letter dated July 26, 2021, sent to Amazon CEO Andy Jassy, the FDA requires Amazon to take measures to prevent such violations in the future.
In detail, it is about a whole series of violations: Between December 2019 and February 2020, and in March 2021, FDA purchased samples of 26 sexual enhancement products and one weight loss product through amazon's website. According to the FDA, laboratory analyses confirmed that all products sampled contained drug ingredients which were not declared on the products’ labeling.
In the letter, the FDA lists in detail the violations of various laws and regulations. The products were marketed as dietary supplements, but do not meet the legal definition of “dietary supplement". Instead, the FDA classifies the products as Unapproved New Drugs. A list of the tainted products is attached to the letter in the appendix.
The FDA seems to be very concerned. The products "contain the drug ingredients sildenafil, tadalafil, vardenafil and/or sibutramine. The presence of undeclared PDE-5 inhibitors and/or sibutramine contained in these products may pose serious health risks because consumers with underlying medical issues may take these products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking." The FDA goes on to say that there have been similar violations in the past. "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 sold on www.amazon.com."
While Amazon has taken some action when alerted by the FDA, it was found out found that other such products continue to be offered for sale on www.amazon.com with Fulfillment by Amazon. The FDA is concerned that the filters used to detect specific products Amazon attempts to restrict are inadequate. Therefore, the FDA concludes that "despite actions Amazon has taken to date, the continued availability on www.amazon.com of these unapproved new drugs, misbranded drugs, and/or foods to which an approved drug product been added poses a continuing risk of harm to the American public."
The FDA points out that Amazon is "responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations." Furthermore, the firm is must comply "with all requirements of federal law, including FDA regulations."
The FDA expects a written response to the letter within fifteen working days explaining the specific steps Amazon has taken.
Please read the complete letter (CMS # 608717), available for download as a PDF file on the FDA's website, for further details.