| U.S. Federal Trade Commission |
FTC News Release, Nov 30, 2004
FTC Charges Marketers with Making Deceptive Efficacy and Safety Claims about Ephedra and Yohimbine Dietary Supplements
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 U.S. 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 U.S. District Court for the
Northern District of Georgia on November 10, 2004.
The text in this article was prepared by the U.S. Federal Trade Commission.