The dietary supplement Rock-It Man was touted as a potent, all-natural solution for the symptoms of erectile dysfunction, one that promised results in just 25 minutes.
But when it was tested in a federal lab earlier this year, Rock-It Man turned out to contain a chemical compound that structurally resembles sildenafil, the active ingredient in the prescription drug Viagra.
In what the Food and Drug Administration calls an escalating public health threat, "natural" supplements are being spiked with undeclared pharmaceutical drugs, often in higher-than-recommended doses. Supplements promising sexual prowess and fulfillment are the most commonly recalled category of tainted products.
So far this year, the FDA has issued public warnings for at least 24 suggestively named sexual supplements because they contained hidden active ingredients that could be harmful. Nearly all were advertised as natural and promised results in less than an hour. The agency also said 10 companies have voluntarily recalled products after they tested positive for unapproved drugs.
In some cases, the supplements were laced with the very prescription drugs they claimed to replace, such as sildenafil. Others contained chemical variants of existing drugs, including those found in Rock-It Man, a product apparently no longer on the market. These compounds, called analogues, lack human safety data and often can slip through testing undetected.
Last year, FDA testing found that a product called Mojo Nights contained five drugs, including two known pharmaceuticals and three variants. Last week, the agency announced it had found a product adulterated with two analogues and an unapproved antidepressant.
The mainstream success of Viagra's little blue pill has fueled demand for cheaper herbal alternatives sold at convenience stores, pharmacies and online. Some men buy them to avoid the hassle or embarrassment of visiting a doctor. Others are seeking a safe and natural alternative to prescription drugs, whose potential side effects include headaches, blurred vision, flushing and nasal congestion.
"People are turning away from talking to practitioners and taking matters into their own hands," said the FDA's Daniel Fabricant, director of the agency's Division of Dietary Supplement Programs.
But pharmaceutical additives — which are never listed on the supplement label — can cause serious side effects, such as low blood pressure. If a consumer has an adverse reaction, it can be difficult for a doctor to help because it is unclear what the supplement may have contained.
The added drugs also can adversely interact with the nitrates found in some prescription medications, such as nitroglycerin. Drugs containing nitrates are often prescribed to men with heart disease, among whom erectile dysfunction is more common.
Pharmaceutical companies complain that their patented and rigorously tested medications are being counterfeited and illegally offered for sale in unsafe ways. The natural products industry, meanwhile, worries that adulterated products give supplements a bad name.
Increasing the risk for unwitting consumers, the FDA has limited regulatory powers over supplements.
In March, the agency warned men not to buy or use Stiff Days after testing found sildenafil in the supplement. The distributor, however, is still selling the product, which is available online at $19.95 for six pills.
"When we purchase these products for resale from overseas, they are advertised as 100 percent herbal, so some may be tainted depending on the source, but I really believe that would be the exception and not the rule," a spokesman for Georgia-based Vertex Technologies wrote in an email.
Other companies have temporarily halted sales. Mojo Nights' website states that "due to severe counterfeit problems ... we have suspended all sales until further notice." A recorded phone message cites a "possible production error" and adds that "we cannot guarantee the authenticity of the product in the marketplace."
One manufacturer's view
Some supplement manufacturers say their herbal products aren't designed to treat a problem but rather to enhance health and wellness, the same way a multivitamin might.
"Picture two marathoner runners, one with just water and the other with electrolyte replenishment that enhances their performance," said Chris Kanik, CEO of a Southern California-based company that sells the "all natural male enhancement" product Affirm XL. "We give men an above-satisfactory sexual experience by supporting their stamina, drive and energy."
The supplement is a blend of vitamins, minerals and herbs, including extracts of ginseng and maca, "horny goat weed," L-arginine, saw palmetto and Tribulus terrestris, according to the label.
But in April, FDA testing showed a batch manufactured in Korea in 2010 was tainted with sulfoaildenfil, a tweaked version of sildenafil.