The US Food and Drug Administration (FDA) appears to be fighting a losing battle with manufacturers of sexual aids marketed as "natural" products and sold over the counter. It's not a question of whether they work. The issue is that they contain sildenafil, the active ingredient in Viagra, which requires a prescription.
The US Food and Drug Administration (FDA) appears to be fighting a losing battle against manufacturers of sexual aids marketed as “natural” products and sold over the counter.
It's not a question of whether they work. The issue is that they contain sildenafil, the active ingredient in Viagra, which requires a prescription.
The latest warnings, issued today, are for sildenafil products sold as Mme Maxman, Vigour 300, Hard Wang, and FX3000. They are often sold online.
The FDA says that “hidden ingredients are increasingly becoming a problem in products promoted for sexual enhancement.” Sildenafil has the potential to cause harmful side effects.
The agency has put out dozens of such warnings since 2008, and was involved in the successful federal prosecution of one manufacturer.
In that case, Phu Tan Luong, also known as Peter Luong, formerly of Huntington Beach, CA, and his daughter sold a product called Vitalex as an “herbal sexual enhancement supplement.” But it contained an Acetildenafil-analog which the FDA and National Institutes of Health said poses a serious health risk. According to government prosecutors, the Luongs obtained the components from suppliers in China, assembled the product in California, and shipped it globally.
Following a successful prosecution, Luong is now in a federal prison.
Despite his example, and repeated FDA warning letters and other enforcement actions, the tainted drugs just keep on coming. The agency’s announcements that it was launching crackdowns date to at least 2008.
But the market is apparently irresistible to black market entrepreneurs. In 2014 there were FDA warnings aimed at 24 products—sold with names like Black Storm, Happy Passengers, and OMG.
“Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market,” the FDA warned in today’s notifications.