FDA Stops Sale and Distribution of Dietary Supplements Making Misleading Claims About Obesity and Impotence

The Food and Drug Administration (FDA) today announced that on September 22, 2003, U.S. District Court Judge Robert J. Vining, Jr. entered a Consent Decree of Permanent Injunction against Hi-Tech Pharmaceuticals, National Urological Group, National Institute for Clinical Weight Loss, American Weight Loss Clinic, United Metabolic Research Center, and Jared R. Wheat, President of these corporations, to prevent the sale and distribution of unapproved and misbranded products. FDA took this enforcement action because the defendants repeatedly sold dietary supplements making disease claims for the treatment of obesity and erectile dysfunction.

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 FDA has initiated this action as part of its responsibility for advancing and protecting the public health by enforcing the Federal Food, Drug and Cosmetic Act, and related laws and regulations. FDA’s mission includes ensuring the safety or safety and effectiveness of a broad spectrum of regulated products, including food, human and animal drugs, vaccines, blood products, medical devices, devices that emit radiation, and cosmetics.

The listed corporations conduct business out of one office located in Norcross, Ga.


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