- For Immediate Release:
On July 26, 2021, the FDA issued an untitled letter to notify Amazon about its distribution of sexual enhancement and weight loss products in violation of the Federal Food, Drug, and Cosmetic Act. The FDA continues to find potentially dangerous products available for purchase and urges stores, websites, and online marketplaces, including Amazon, to stop selling these potentially dangerous products. The FDA will continue to alert the public when products and companies place consumers’ health at risk.
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.
“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.”
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.
The FDA’s tainted products database can help consumers identify nearly 1,000 of these potentially dangerous products. However, the agency is unable to test and identify all products that have potentially harmful hidden ingredients. Even if a product is not included in the list, consumers should be cautious about using certain products, especially those promoted for sexual enhancement, weight loss, bodybuilding, sleep aids or pain relief. Consumers should also be on alert for products that offer immediate or quick results and that sound too good to be true. The FDA is committed to protecting consumers by identifying and removing these potentially dangerous products from the market.
Consumers using or considering using any over-the-counter product marketed for sexual enhancement, weight loss or bodybuilding, or any product marketed as a dietary supplement for pain relief, should talk to a health care professional first, as some ingredients may interact with medications or dietary supplements. Additionally, consumers should search for product information from sources other than sellers and ask a doctor for help distinguishing between reliable and questionable information.
The FDA encourages consumers and health care professionals to report any adverse events to the agency’s MedWatch Adverse Event Reporting program so the agency can take action to protect the public from any unsafe products. The FDA is also committed to protecting consumers from the risks of buying medicines online and helping them be more aware of how to buy online safely.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Jeremy Kahn