FDA purchased 26 products on Amazon and 25 products on eBay and tested them for various undeclared pharmaceutical ingredients, including sildenafil, tadalafil, vardenafil, sibutramine, desmethylsibutramine, phenolphthalein, and fluoxetine, many of which are active ingredients for use in FDA-approved prescription drugs.
One or more of the above ingredients were found in all 26 products purchased from Amazon and 20 out of 25—or 80%—of the products purchased from eBay. Several of the Amazon products are designated as “#1 Best Seller” or as an “Amazon Choice.” Many of the products, FDA’s press release noted, have names that are the same as or similar to tainted products that have been the subject of previous FDA consumer warnings. These products are illegal as unapproved new drugs and/or adulterated dietary supplements, and are misbranded.
Related: FDA Issues Warning Letter to Whole Foods Market for Misbranded Products Sports Nutrition Manufacturer Pleads Guilty to Distribution of Unapproved New Drugs Pesticide Tolerance Regs for Herbs and Spices Incorporate AHPA RecommendationsFDA noted that while the agency’stainted products databasecan help consumers identify nearly 1,000 of these dangerous products, FDA is unable to test and identify all products that have potentially harmful hidden ingredients. Consumers should be cautious regarding products promoted for sexual enhancement, weight loss, bodybuilding, sleep aids, or pain relief, and should be on alert for products that offer quick or immediate results.
“Protecting the health and safety of Americans is the FDA’s highest priority, and we will remain vigilant and communicate about products and companies that place U.S. consumers at risk,” said Donald D. Ashley, J.D., Director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “While the FDA has engaged in discussions with online marketplaces like Amazon and eBay regarding these issues in the past, we believe they can do more to protect consumers from these fraudulent and potentially dangerous products. We continue to urge stores, websites and online marketplaces, like Amazon and eBay, to take appropriate steps to protect the American public by not selling or facilitating the sale of illegal FDA-regulated products.”