The warning came in response to FDA testing of products purchased online that found active pharmaceutical ingredients not listed on their labels, including some with ingredients found in prescription drugs.
The agency found that nearly 50 men’s weight loss or enhancement products contained hidden ingredients and could pose a significant health risk. Apparently, the 26 products the FDA purchased from Amazon and 20 of the 25 products purchased from eBay contained undeclared active pharmaceutical ingredients. Various undeclared active ingredients included sildenafil, tadalafil, vardenafil, sibutramine, desmethylsibutramine, phenolphthalein and / or fluoxetine.
“Protecting the health and safety of Americans is the top priority for the FDA, and we will remain vigilant and communicate about the products and companies that put American consumers at risk.”said Donald Ashley, JD, director of the FDA’s Center for Drug Evaluation and Research Office of Compliance.
“Although the FDA has engaged in discussions with online marketplaces like Amazon and eBay regarding these issues in the past, we believe it 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 products regulated by the FDA. “
The American Herbal Products Association (AHPA) released a statement applauding the FDA “Continued efforts to educate the public about illegal pharmaceuticals masquerading as supplements”. AHPA President Michael McGuffin said: “These strong actions clearly demonstrate the agency’s effective use of existing authority to ensure a safe market for supplement consumers. We particularly appreciate the agency’s exhortation to online retailers to stop selling or facilitate the sale of these products.
In response to a request for comment from NutraIngredients-USA, an Amazon spokesperson said: “Selling partners are responsible for complying with all applicable Amazon laws, regulations and policies when listing items in our store. We have proactive measures in place to prevent the list of banned products and we are constantly monitoring our store. Those who violate our policies are subject to action, including the potential deletion of their account. We are reviewing the information from the FDA and taking action. “
eBay did not respond to a request for comment from NutraIngredients-USA prior to publication.
FDA Contaminated Products Database
The FDA noted in a statement that products containing undeclared drug ingredients violate federal law. Typically, these products are new, unapproved drugs and / or adulterated dietary supplements. In addition, they are mislabeled because their labels do not accurately reflect their ingredients.
The agency went on to say that its database of contaminated products can help consumers identify nearly 1,000 potentially hazardous products, but even if a product is not included in the list, consumers should be careful about to the use of certain products, especially those promoted for sexual enhancement, weight loss, bodybuilding, sleeping pills or pain relief.