The warning came in response to FDA testing of products purchased online that revealed the presence of active pharmaceutical ingredients not listed on their labels, including some with ingredients found in prescription drugs.
The Agency found that almost 50 male enhancement or weight loss products contained hidden ingredients and may pose a significant health risk. Allegedly, all 26 of the products the FDA purchased on Amazon and 20 of 25 products purchased on eBay contained undeclared active pharmaceutical ingredients. The various undeclared active ingredients included sildenafil, tadalafil, vardenafil, sibutramine, desmethylsibutramine, phenolphthalein and/or fluoxetine.
“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 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.”
The American Herbal Products Association (AHPA) issued a statement applauding the FDA’s “ongoing efforts to inform the public of unlawful drug products that masquerade as supplements". AHPA president Michael McGuffin said: “These strong actions clearly demonstrate the agency’s effective use of existing authority to ensure a safe marketplace for supplement consumers. We especially appreciate the agency’s urging of online retailers to stop selling or facilitating the sale of these products.”
In response to a request for comment from NutraIngredients-USA, an Amazon spokesperson said: “Selling Partners are required to follow all applicable laws, regulations, and Amazon policies when listings items for sale in our store. We have proactive measures in place to prevent prohibited products from being listed and we continuously monitor our store. Those who violate our policies are subject to action including potential removal of their account. We are reviewing the information from the FDA and are taking action accordingly.”
eBay did not respond to a request to comment from NutraIngredients-USA prior to publication.
FDA’s tainted products database
The FDA noted in a release that 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 Agency went on to state that its tainted products database can help consumers identify nearly 1,000 potentially dangerous products, but 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.