Recalls & Warnings
ConsumerLab.com is keeping you informed with current product recalls and warnings.
Posted October 10, 2003
Government Stops Sale of Supplements Claiming to Treat Obesity and Impotence
The government’s complaint, filed by the Department of Justice in the U.S. District Court for the Northern District of Georgia, alleges that Jared R. Wheat and his dietary supplement corporations violated the Federal Food, Drug and Cosmetic Act by distributing unapproved and misbranded drugs in interstate commerce.
Although FDA had repeatedly warned the individual and the corporations about their illegal actions, they continued to make false health and disease claims for the dietary supplement products. One of the provisions of the Consent Decree is that Mr. Wheat’s corporations will stop distributing all dietary supplements until the FDA has reviewed all revised product labeling, promotional literature, and detailed inspection reports from the defendants’ consulting firm.
"FDA will continue to take strong action to protect American consumers from dietary supplements that are not accurately labeled or that make false and misleading claims unsupported by scientific evidence," said FDA Commissioner Mark McClellan, M.D., Ph.D. "Today’s action demonstrates FDA’s continued commitment to help consumers make health and dietary choices based on accurate information –and to help them avoid bad outcomes from potentially dangerous products."
On June 20, 2003, FDA issued a “Public Health Alert” warning consumers not to purchase or consume certain dietary supplements sold by Hi-Tech Pharmaceuticals, Inc., and related corporation National Urological Group, because FDA test results found the supplements were adulterated with the prescription-strength drug ingredient, “taldalafil”. Taldalafil is the active drug ingredient in Cialis, an Eli Lilly prescription drug product approved in Europe. An interaction between certain prescription drugs containing nitrates (such as nitroglycerin) and taldalafil may cause a drastic lowering of blood pressure. There is a real danger these supplements may be taken by patients who take nitrates, since erectile dysfunction is often a common problem in people with diabetes, hypertension (high blood pressure), high cholesterol, heart disease and in people who smoke.
The listed corporations conduct business out of one office located in Norcross, Ga.