FDA Warns Consumers to Avoid Certain Products Sold Through Amazon, eBay and Other Retailers Due to Hidden Drug Ingredients – Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

FDA Warns Consumers to Avoid Certain Male Enhancement and Weight Loss Products Sold Through Amazon, eBay and Other Retailers Due to Hidden, Potentially Dangerous Drug Ingredients

The U.S. Food and Drug Administration is warning consumers not to use nearly 50 male enhancement or weight loss products that have been found to contain hidden ingredients and may pose a significant health risk. The FDA purchased these products on Amazon and eBay and agency testing found that the products contain active pharmaceutical ingredients 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.

Despite FDA consumer warnings about similar products over the past decade, the agency continues to find potentially dangerous products available for purchase on the internet, including from online marketplaces like Amazon and eBay, as well as in retail stores. The agency urges consumers to beware of purchasing or taking these products.

All 26 of the products the FDA purchased on Amazon and 20 of 25 products, or 80 percent, purchased on eBay contained undeclared active pharmaceutical ingredients. The FDA’s laboratory testing found the products contained various undeclared active ingredients, including sildenafil, tadalafil, vardenafil, sibutramine, desmethylsibutramine, phenolphthalein and/or fluoxetine. Many of these are active ingredients for use in FDA-approved prescription drugs, which are restricted to use under the supervision of a licensed health care professional.

Many of the products the agency purchased from Amazon and eBay have names that are the same as, or similar to, tainted products that have been the subject of previous FDA consumer warnings. Several of the Amazon products are designated as an “Amazon Choice” or “#1 Best Seller.” Products with undeclared drug ingredients violate federal law. In general, these products are unapproved new drugs and/or adulterated dietary supplements. In addition, they are misbranded because their labels do not accurately reflect their ingredients.

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