Dietary pills laced with drugs

The little blue pills sold by a Georgia company under the name Blue Steel claimed they were an all-natural dietary supplement. But the pills, marketed as an "extreme sexual stimulant," were spiked with a drug similar to Viagra–putting unsuspecting users at risk of life-threatening side effects, federal records show. And despite warnings by federal officials and the recall of the product, an Atlanta Journal-Constitution reporter was able to purchase Blue Steel over the Internet in recent weeks. It's unknown whether the pills still contain the Viagra-like drug. The product is one of the dietary supplements that the U.S. Food and Drug Administration has found contain hidden prescription drugs. Most are pills marketed for increasing male potency, but the FDA also has found prescription cholesterol-lowering statins and a prescription weight-loss drug in some other "all-natural" supplements. An estimated 150 million Americans use dietary supplements, ranging from multivitamins to herbal remedies to specialized mineral blends. They need to be careful about what they buy and who they buy it from, consumer watchdogs say. "One of the things that is frightening is that consumers may be under the misconception that these products wouldn't be on the market if the government hadn't approved them," said Richard Cleland, assistant director of the Federal Trade Commission's division of advertising practices, which polices fraudulent marketing claims. "That is a horrible misconception." Unlike prescription and over-the-counter drugs, dietary supplements can be put on the market without going through the FDA approval process that requires scientific proof they are both safe and effective. Regulations treat supplements more like food and assume they're safe unless proved harmful, leaving regulators to identify problem products after they're on the market. The firm selling Blue Steel did not respond to repeated interview requests. Officials at the Council for Responsible Nutrition, an industry group that represents major supplement companies, said the spiking of supplements with prescription drugs is rare. "These are very isolated incidents," said Andrew Shao, the council's vice president for scientific and regulatory affairs. "The mainstream products "the brands we all know well, that we trust–they are made to very high-quality standards, and the claims that they have on their products and their advertising are backed up by science," Shao said. Still, federal regulators have identified some that contain undisclosed prescription drugs. The scope of the problem is unknown because the FDA conducts only spot checks. "There are a lot of products being marketed out there that are nothing more than snake oil," Cleland said. "I'm not really talking about the basic multivitamin product, but the products that claim to make you thinner, give you more hair, make you more virile–and all you've got to do is take the pill." The government estimates that 30,000 to 40,000 supplement products are being sold by all sorts of companies, some large and reputable, others operating out of a garage or basement. The market, especially on the Internet, is vast and the resources of regulators are limited. "In terms of size, the challenge is massive," Cleland said. Since 2007 the FDA has announced recalls or issued warnings about 52 dietary supplement products. Some were contaminated with food allergens, bacteria, even human placenta. Others, the agency warned, contain undisclosed prescription drugs. The FDA has cited firms for selling cholesterol-lowering "red yeast rice" supplements that contain lovastatin, the FDA-approved prescription drug sold under the brand name Mevacor. The drug can interact with other medications and cause severe muscle problems and kidney impairment, the agency warned. At least 26 products claiming to be all-natural sexual enhancement pills have been the subject of FDA alerts since January 2007 because they contained chemicals similar to the active ingredients in the FDA-approved erectile dysfunction drugs Viagra and Levitra, enforcement records show. Two of the products were the subject of a March 25 FDA warning. The agency advised consumers not to use Blue Steel and Hero "sold by a Georgia firm, Active Nutraceuticals/the Marion Group in Carrollton. Tests by the FDA found the bright blue pills contained a variation of sildenafil, the active ingredient in Viagra, that wasn't listed on the products' labels. Prescription erectile dysfunction drugs can pose "serious health risks" to unsuspecting consumers because they can interact with other medications containing nitrates, such as nitroglycerin, and cause blood pressure to plummet. Erectile dysfunction is common in men with other medical conditions typically treated with nitrates, such as diabetes, high blood pressure, high cholesterol and heart disease. The AJC was able to purchase Blue Steel from health products Web sites in August and again in October. The bottle and a two-capsule blister pack purchased list the maker as Active Nutraceuticals and provide a residential address in South Milwaukee, Wis., a non-working telephone number and an undeveloped Web site that contains no information about the product or the company. The AJC received no response to e-mails sent to the registration holder for the Web site, nor to certified letters sent to the firm's addresses in Georgia and Wisconsin. "Consumers should beware of companies that do not have a working phone number or Web site," FDA spokeswoman Rita Chappelle said last week. Even with the change in address, Chappelle said, "Our overall message is that consumers shouldn't purchase the Blue Steel or Hero products."