FDA warns Amazon to stop selling bootleg Viagra

The FDA is warning Amazon to do something about “bootleg Viagra” found on its platform, misleadingly disguised as men’s energy or health supplements. In a letter to Amazon dated December 20th, the agency threatened legal action and listed seven different products available on the e-commerce platform with ingredients found in Viagra and Cialis. With outlandish names and brightly colored, cartoonish labels, it would be hard to confuse them with real-deal prescription drugs.

But a recent investigation by the FDA found several supplements or powders sold on the e-commerce platform contained either sildenafil or tadalafil (the active ingredients in Cialis and Viagra) and failed to disclose it: MANNERS Energy Boost, Round 2, WeFun, Genergy, Big Guys Male Energy Supplement, Men’s Maximum Energy Supplement, and X Max Triple Shot Energy Honey.

Amazon spokesperson Samantha Boyd writes in an email to The Verge that the products were removed from the site before the December letter. The agency had identified the products individually throughout the year. “Safety is a top priority at Amazon. We require all products offered in our store to comply with applicable laws and regulations. Following the FDA’s previous guidance, we removed the products in question earlier this year.”

In its letter, the FDA also told Amazon to explain how it will prevent similar mislabeled drugs from showing up on its platform in the future, saying, “You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.” The company has not commented on what it plans to do in response.

Both Viagra and Cialis are in a group of medications known as PDE-5 inhibitors, which also lower blood pressure. This can be dangerous or even fatal to people with heart problems. Many of these products likely surfaced when customers searched for “Viagra” or “erectile dysfunction” on Amazon, though some were also marketed as health supplements — containing ingredients like royal jelly, ginseng, and even honey.

While Amazon has long had a problem with third-party sellers selling counterfeit drugs and medical products, this most recent case with bootleg Viagra is the opposite problem: products with actual prescription ingredients that are mislabeled as harmless OTC health supplements. A search for “viagra” still delivers a long list of results for men’s health and energy supplements, some of which use similar language as the ones the FDA identified. Some are explicitly marketed as treatments to improve men’s sexual performance or boost their libido.