Hey Alexa, quit it with the bootleg Viagra, says the FDA

Amrita Khalid

Amrita Khalid is one of the authors of audio industry newsletter Hot Pod. Khalid has covered tech, surveillance policy, consumer gadgets, and online communities for more than a decade.

The FDA has issued a stern warning to Amazon regarding the presence of “bootleg Viagra” products on its website which have been deceptively marketed as men's energy or health supplements. In a detailed letter sent to Amazon on December 20th, the agency not only threatened legal repercussions but also enumerated seven specific items being sold on the platform that contained ingredients found in well-known prescription drugs Viagra and Cialis. With eye-catching names and vibrant, cartoonish packaging, distinguishing these counterfeit items from genuine prescription medications might seem quite challenging.

Following an extensive investigation, the FDA discovered that numerous supplements or powders available for purchase on Amazon harbored either sildenafil or tadalafil—the active components found in Cialis and Viagra—yet they failed to disclose this critical information. Among the products flagged were MANNERS Energy Boost, Round 2, WeFun, Genergy, Big Guys Male Energy Supplement, Men’s Maximum Energy Supplement, and X Max Triple Shot Energy Honey. This raises significant safety concerns for consumers who might be unwittingly purchasing these risky products.

In a response to The Verge, Amazon spokesperson Samantha Boyd stated via email that the products were taken off the site prior to receiving the December letter. The FDA had previously identified the products individually across the year for review. “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.” This statement highlights Amazon's commitment to consumer safety while also acknowledging the gravity of the situation.

In the correspondence from the FDA, the agency urged Amazon to provide a thorough explanation of the measures it would implement to prevent the emergence of similarly mislabeled drugs on its marketplace in the future. They emphasized the importance of investigation by stating, “You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.” As of now, Amazon has not disclosed its planned course of action in response to this directive.

Viagra and Cialis belong to a category of medications known as PDE-5 inhibitors, which can also have the effect of lowering blood pressure. This poses significant risks, particularly to individuals with pre-existing heart conditions, as these interactions can lead to severe or even fatal outcomes. It's important to note that many of these counterfeit products likely emerged in search results when customers looked for terms like “Viagra” or “erectile dysfunction” on Amazon. However, some of these items were mislabeled and presented as simple health supplements that included various ingredients, such as royal jelly, ginseng, or even honey.

Historically, Amazon has grappled with the issue of third-party vendors selling counterfeit medicinal products and medical supplies. Yet, this latest occurrence with bootleg Viagra represents a contrasting dilemma: products containing actual prescription ingredients that are falsely marketed as harmless over-the-counter health supplements. A search query for “viagra” continues to yield a lengthy list of results for men’s health and energy supplements, many of which employ terminology reminiscent of the identified items. Some even explicitly promote themselves as solutions for improving male sexual performance or enhancing libido levels.