FTC Charges Marketers with Making Deceptive Efficacy and Safety Claims about Ephedra and Yohimbine Dietary Supplements

October 10, 2005

FTC News Release
November 30, 2004

The Federal Trade Commission has charged three related dietary supplement companies located in Norcross, Georgia, their corporate officers, and a physician with deceiving consumers through deceptive advertising for their weight-loss and erectile dysfunction products. The case is part of the agency’s on-going effort to combat deceptive claims for dietary supplements that purport to enable obese or overweight consumers to lose substantial amounts of weight safely.

The FTC filed charges against National Urological Group, Inc.; National Institute for Clinical Weight Loss, Inc.; Hi-Tech Pharmaceuticals, Inc.; Jared Wheat; Thomasz Holda; Stephen Smith; Michael Howell; and Dr. Terrill Mark Wright. The Commission’s complaint alleges that the defendants made deceptive claims about the effectiveness and safety of “Thermalean” and “Lipodrene,” purported weight-loss products with ephedra, and “Spontane-ES,” a purported erectile dysfunction product with yohimbine.

According to the FTC’s complaint, the defendants’ direct mail and Internet advertisements contained false and unsubstantiated efficacy and safety claims for the weight-loss products Thermalean and Lipodrene. The central theme of the Thermalean advertising campaign was that the product was an effective treatment for obesity, and that it combined the weight-loss benefits of three different prescription drugs. Consumers paid $80 for a two-month supply of Thermalean. The defendants promoted Lipodrene as a dietary supplement that had undergone substantial clinical testing proving that it enabled consumers to lose large amounts of weight safely. Consumers paid about $30 for a one-month supply of Lipodrene. The active ingredient in Thermalean and Lipodrene was ephedra.

The FTC has alleged that, contrary to the defendants’ claims, dietary supplements with ephedra do not cause substantial, long-term weight loss, and create safety risks because they increase blood pressure and stress the circulatory system. In April 2004, the US Food and Drug Administration (FDA) banned sales of dietary supplements with ephedra because they pose an unreasonable risk of illness or injury. The defendants have not advertised or sold Thermalean or Lipodrene containing ephedra since the FDA prohibited the sale of dietary supplements containing ephedra.

The FTC’s complaint also alleges that the defendants represented that Spontane-ES, a dietary supplement with yohimbine, was effective in treating erectile dysfunction in 90 percent of users and Spontane-ES was safe. Consumers paid about $100 for a 60-count bottle of Spontane-ES. The Commission challenged the defendants’ specific 90 percent efficacy claims as unsubstantiated. The FTC also alleged that their safety claim for Spontane-ES was unsubstantiated, because yohimbine creates safety risks by significantly raising blood pressure and interacting adversely with certain medications, such as beta-blockers that are used to treat heart disease.

The defendants, according to the FTC, made further deceptive claims to reinforce the efficacy and safety claims they were making for their products. The FTC also alleged that ads for Thermalean contained several deceptive claims made by Dr. Wright, who is named in the complaint. In addition, the defendants allegedly made the false claim in ads that Warner Laboratories and the National Institute for Clinical Weight Loss were legitimate research or medical facilities engaged in the scientific or medical research and testing of their products.

The FTC complaint seeks injunctive and other equitable relief including, but not limited to, consumer redress, restitution, and disgorgement of ill-gotten gains.

The Commission vote authorizing the staff to file the complaint was 5-0. The complaint was filed in the US District Court for the Northern District of Georgia on November 10, 2004.

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This page was posted on October 10, 2005.