12.18.20
The U.S. Food and Drug Administration recently issued a consumer warning about dozens of male enhancement and weight loss products marketed as dietary supplements which were available to purchase via a number of online retailers.
According to the agency, there has been a trend of incidences in which hidden ingredients have been discovered in products within those two categories, including potentially dangerous drug ingredients, which may pose a significant health risk.
This month, the agency tested nearly 50 products which were found to contain active pharmaceutical ingredients that weren’t listed on their labels, including ingredients found in prescription drugs. The products discovered this year could cause potentially serious side effects, and may interact with medications or dietary supplements a consumer is taking.
The agency reported that each of the products tested this month were purchased online, including marketplaces such as Amazon and eBay which made up about 80% of the tested products, as well as in retail stores. Consumers are warned against purchasing or using 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,” Donald D. Ashley, J.D., director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, said. “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 undeclared ingredients included sildenafil, tadalafil, vardenafil, sibutramine, desmethylsibutramine, phenolphthalein, and fluoxetine, which are active ingredients in FDA-approved prescription drugs, which FDA reminds consumers are restricted to use under the supervision of a licensed health care professional. Many of the products the agency purchased online had names that were similar to tainted products that were subject to previous FDA consumer warnings.
Several of the tainted Amazon products were designated as an “Amazon Choice” or “#1 Bestseller,” the agency said, even though they were misbranded and considered by the agency to be unapproved new drugs/ adulterated dietary supplements.
FDA’s tainted products database contains nearly 1,000 products which were discovered to have potentially harmful hidden ingredients, however, the agency reminded consumers that it doesn’t have the ability to test every single supplement for hidden ingredients. The agency listed sexual enhancement, weight loss, bodybuilding, sleep aids, and pain relief as marketed applications which should be looked at with the most caution.
“Consumers should also be on alert for products that offer immediate or quick results and that sound too good to be true,” the agency added in the warning. “Consumers using or considering using any over-the-counter product marketed for sexual enhancement, weight loss, body building, 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 also encouraged consumers and health care professionals to report adverse events to the agency’s MedWatch Adverse Event Reporting program.
According to the agency, there has been a trend of incidences in which hidden ingredients have been discovered in products within those two categories, including potentially dangerous drug ingredients, which may pose a significant health risk.
This month, the agency tested nearly 50 products which were found to contain active pharmaceutical ingredients that weren’t listed on their labels, including ingredients found in prescription drugs. The products discovered this year could cause potentially serious side effects, and may interact with medications or dietary supplements a consumer is taking.
The agency reported that each of the products tested this month were purchased online, including marketplaces such as Amazon and eBay which made up about 80% of the tested products, as well as in retail stores. Consumers are warned against purchasing or using 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,” Donald D. Ashley, J.D., director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, said. “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 undeclared ingredients included sildenafil, tadalafil, vardenafil, sibutramine, desmethylsibutramine, phenolphthalein, and fluoxetine, which are active ingredients in FDA-approved prescription drugs, which FDA reminds consumers are restricted to use under the supervision of a licensed health care professional. Many of the products the agency purchased online had names that were similar to tainted products that were subject to previous FDA consumer warnings.
Several of the tainted Amazon products were designated as an “Amazon Choice” or “#1 Bestseller,” the agency said, even though they were misbranded and considered by the agency to be unapproved new drugs/ adulterated dietary supplements.
FDA’s tainted products database contains nearly 1,000 products which were discovered to have potentially harmful hidden ingredients, however, the agency reminded consumers that it doesn’t have the ability to test every single supplement for hidden ingredients. The agency listed sexual enhancement, weight loss, bodybuilding, sleep aids, and pain relief as marketed applications which should be looked at with the most caution.
“Consumers should also be on alert for products that offer immediate or quick results and that sound too good to be true,” the agency added in the warning. “Consumers using or considering using any over-the-counter product marketed for sexual enhancement, weight loss, body building, 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 also encouraged consumers and health care professionals to report adverse events to the agency’s MedWatch Adverse Event Reporting program.
