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FDA found these products contain active pharmaceutical ingredients (APIs) not listed on their labels, including some with ingredients found in prescription drugs.
The U.S. Food and Drug Administration (FDA) is warning consumers against 50 male enhancement or weight-loss products sold on Amazon and eBay. FDA found these products contain active pharmaceutical ingredients (APIs) not listed on their labels, including some with ingredients found in prescription drugs. These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking.
“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, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, in a press release. “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.”
All 26 of the products FDA purchased on Amazon and 20 of 25 products purchased on eBay contained undeclared APIs, including sildenafil, tadalafil, vardenafil, sibutramine, desmethylsibutramine, phenolphthalein and/or fluoxetine. These are restricted to use under the supervision of a licensed health care professional and violate federal law when used in supplements. What’s alarming, too, is several of the products on Amazon were designated “Amazon Choice” or “#1 Best Seller.”
Consumes can identify almost 1,000 of these dangerous products on FDA’s tainted products database, but it’s not possible for the agency to test and identify all products that have potentially harmful hidden ingredients. Regardless of whether a product is on the list, FDA is urging consumers to beware of products that make claims regarding sexual enhancement, weight loss, bodybuilding, sleep, or pain relief.
FDA also encourages consumers and health care professionals to report any adverse events to the agency’s MedWatch Adverse Event Reporting program. This way, the agency can take action to protect the public from any unsafe products.