FDA sends Amazon letter over sexual enhancement & weight loss products

In a July 26 letter​ to new Amazon CEO Andy Jassy from Donald Ashley, Director of the Office of Compliance at the Center for Drug Evaluation and Research (CDER) at the FDA, the Agency states that FDA purchased “dozens of products intended for sexual enhancement and weight loss”​ from www.amazon.com, “and, after subsequent laboratory analysis, determined that all tested products contain undeclared and potentially harmful drug ingredients. As discussed further below, your firm is responsible for introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs”.

Twenty-six sexual enhancement products were purchased between December 2019 and February 2020. All but one of these were marketed as dietary supplements. FDA stated that lab analysis revealed the presence of “one or more of the drug ingredients sildenafil, tadalafil and vardenafil”​. Amazon subsequently represented to FDA that the products had been restricted, but the agency was able to re-purchase one of the products in January 2021 leading the agency to express concern that Amazon’s filters are “inadequate”​.

In March of this year, the agency “purchased samples of two additional and different sexual enhancement products and one weight loss product through your website, www.amazon.com, all of which were introduced or delivered for introduction into interstate commerce by Amazon via your Fulfillment by Amazon service.”

FDA analysis confirmed the presence of tadalafil in the sexual enhancement products and the presence of sibutramine in the weight loss product.

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