In 2013, a man stopped by a store in Kansas City and purchased a male enhancement product called Stiff Nights. After taking the product a couple days later, the man suffered a severe drop in blood pressure that resulted in unconsciousness followed by fatal cardiac arrest. The man didn’t know that the product he was buying, even though it said it was 100 percent natural and 100 percent safe, was made with sildenafil citrate, the same active ingredient that’s in Viagra. The deceased man’s family filed a lawsuit against the manufacturer and the retailer of Stiff Nights after the FDA warned the supplement was not safe for sale as an over-the counter medication.
This case highlights a serious problem. Consumers count on the FDA to ensure medical devices and products are safe. But supplements, like male enhancement products, performance and weight loss supplements, and bodybuilding and dietary supplements are not considered medical products and are not analyzed by the FDA for safety and efficacy.
The FDA is Constantly Behind the 8-Ball
Basically, in 1994 the Dietary Supplement Health and Education Act (DSHAE) defined these ‘natural’ supplements as food, effectively tying the FDAs hands and forcing them to rely on complaints and adverse event reports before taking action. Because of how they are regulated, the FDA only gets involved after these products are on the market and side effects, complaints, and injuries are reported.
But be aware, the government agency has tested nearly 300 male enhancement products and posted Public Notices for all of them after finding the ‘natural’ supplements contained ingredients that weren’t listed on the label, were contaminated with unknown ingredients, or contained controlled ingredients. To make matters worse, the FDA has acknowledged that the number of products tested is only a small percentage of the products on the market.
Industry Operates in the Shadows but That Doesn’t Mean They’re Not Liable
Many of the companies that make and distribute male enhancement and other ‘natural’ supplements are fly-by-night operations that are here one day and gone the next. When they are warned about one of their products they simply change the name or the composition and put them back on the shelves. Under the DHSEA, manufacturers and distributors are responsible for ensuring their products are not adulterated or misbranded, and if they fail, the FDA can take action.
While manufacturers and distributors can all be held liable for dangerous products, retailers are held to a high duty of care. They must ensure the products they sell to consumers are safe and once the FDA has posted public notices about a product, retailers must remove the products from their shelves.