FDA Warning on Male Enhancement and Weight Loss Products Sold Online

FDA Warning on Male Enhancement and Weight Loss Products Sold Online
Ashton Forst, PharmD, Hennepin Healthcare

The Director of the Office of Compliance with the Food and Drug Administration (FDA), Donald D. Ashley, stated “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.” This statement was made after a December 2020 warning released by the FDA for consumers to not use about 50 weight loss and male enhancement supplements due to the products containing potentially harmful, hidden ingredients. Of these products, 26 were purchased on Amazon and 25 were purchased on eBay. Laboratory testing of these products indicated that all 26 products from Amazon and 20 of the 25 products from eBay contained active pharmaceutical ingredients that were not listed on the product labels. Some of the active pharmaceutical ingredients detected included sildenafil, tadalafil, vardenafil, sibutramine, desmethylsibutramine, phenolphthalein, and fluoxetine. Nearly all of these active ingredients are FDA-approved only for use under the supervision of a healthcare professional as a prescription medication due to potentially significant health risks associated with use.

Although this specific warning is recent, this is not the first time the FDA has released warnings regarding weight loss and male enhancement products. Over the past decade, the FDA has released several warnings on similar products sold through online marketplaces such as Amazon and eBay. The FDA’s tainted products database includes nearly 1,000 products identified as potentially harmful and can be used as a resource for consumers when purchasing products online. Despite the FDA’s effort to capture all products that are misbranded, they do not have the bandwidth to test every product sold online or in retail stores. Consumers are encouraged to use caution when purchasing products or supplements online, especially those marketed for sexual dysfunction, weight loss, bodybuilding, sleep aids, or pain relief. Buyers are encouraged to consult with a healthcare professional before purchasing products online to ensure safety of the product as some ingredients may interact with prescription medications or may be unsafe in certain medical conditions. If a consumer is unable to contact a healthcare professional, it is advised that they research product information from sources other than the seller to help differentiate between reliable and questionable information.

Due to the increased prevalence of hidden ingredients in products sold through online marketplaces, the FDA encourages reporting of adverse events to the MedWatch Adverse Event Reporting program by both healthcare professionals and consumers; this allows the agency to take action on potentially harmful products on the market.

FDA tainted products database:
https://www.fda.gov/drugs/buying-using-medicine-safely/medication-health...

FDA MedWatch Adverse Event Reporting:
https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-e...

 

References:

  1. “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.” FDA. https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-.... 2020, Dec 17. Accessed January 29th, 2021.