Claims that Herbal Ecstacy, a supplement product that has been widely promoted as a natural herbal "high," is absolutely safe and will cause no side effects are false, the Federal Trade Commission said in accepting a settlement with a California company and its owner. The FTC charged that the company's marketing of Ecstacy, which included ads in media with large youth audiences, made explicit and unqualified false claims about safety, and did not disclose the health and safety risks of using the product. The company, Global World Media Corp. and Sean Shayan, the company's owner, have agreed that all future safety claims for any food, drug, or dietary supplement must be truthful, and that their advertising and labeling of Ecstacy will warn consumers about the potentially serious safety risks of taking the product. They have also agreed to refrain from promoting Ecstacy or any similar product for its mind-altering effects in media with a predominant youth audience.

"This case involves deceptive advertising that raises serious safety concerns," said Jodie Bernstein, Director of the FTC's Bureau of Consumer Protection. "Despite evidence of those health risks and at least one death of a college student in Florida, which was directly attributed to taking a large dose of a product similar to Ecstacy, the company continued to promote this product as a safe and natural high and have encouraged the young people who buy Ecstacy to take exceedingly high doses." Bernstein added, "This kind of conduct and abuse of consumers' interest in botanical products also does a disservice to members of the dietary supplements industry who are acting responsibly to promote the legitimate benefits of their products."

According to the FTC, Herbal Ecstacy's principal ingredient is the herb ephedra, also known as Ma-Huang, a botanical source of ephedrine alkaloids which can have dangerous effects on the nervous system and heart. The U.S. Food and Drug Administration has compiled hundreds of reports of injury associated with supplements containing ephedrine alkaloids, a number of these complaints have involved Ecstacy. FDA has published a proposed rule that would impose strict limits on serving size and would require warnings in labeling for all ephedra supplements. Various states also have barred or restricted the marketing of products like Ecstacy.

Ecstacy advertising advised consumers to take as many as five Ecstacy tablets at a time, nearly eight times the amount of ephedra allowed in the FDA proposed rulemaking, the FTC said. Consumers who called the company's toll-free number were told to take even higher doses if they didn't achieve the advertised mind-altering effects. Advertising included television and radio spots, Internet advertising, and magazine ads, as well as brochures, catalogues, and point-of-sale displays. Advertising appeared on certain local cable systems on Nickelodeon and MTV which have substantial youth audiences, the FTC said.

The FTC's complaint charges that Global World and Shayan advertised that "herbal ecstacy is 100% natural & absolutely safe." In truth, use of Ecstacy in the doses recommended or in other forseeable amounts is not absolutely safe and may cause side effects, the FTC alleged. Therefore, the representations made by the company are false or misleading and unsubstantiated, the complaint states. The FTC also charged that the company included in its ads an endorsement pertaining to the safety and lack of side effects of Ectascy made by Dr. Steven Jonson of Tel Aviv, Israel who, in fact, is a fictitious person.

The proposed consent agreement to settle these allegations, announced today for public comment, would prohibit Global World and Shayan from claiming that Ecstacy or any other food, drug, or dietary supplement is safe or will cause no side effects unless the claim is true and substantiated by scientific evidence. They also would be prohibited from making any representation that any product containing ephedrine alkaloids can be consumed in an amount that exceeds any level to be established by the FDA.

In addition, Global World and Shayan would be required to make the following warning in all future advertising and labeling of any ephedrine-alkaloid-containing product: WARNING: This product contains ephedrine which can have dangerous effects on the central nervous system and heart and could result in serious injury. Risk of injury increases with dose. Should the FDA require a different warning on labeling in the future, it would be substituted for the above language.

The agreement would prohibit misrepresentations of testimonials or endorsements of any product. It also would require Global World and Shayan to refrain from marketing Ecstacy or any other ephedrine product as an alternative to an illegal drug or for its euphoric, psychotropic or sexual effects (including through the name "Ecstacy") in material directed to consumers under the age of 21.

Finally, the agreement includes, among other requirements, provisions requiring Global World and Shayan to notify their employees and distributors about the order requirements and terminate those who fail to comply.

The Commission vote to accept the proposed consent agreement for public comment was 5-0.

An analysis of the proposed consent agreement will be published in the Federal Register shortly. The agreement will be subject to public comment for 60 days, after which the Commission will decide whether to make it final. Comments should be addressed to the FTC, Office of the Secretary, 6th Street and Pennsylvania Avenue, N.W., Washington, D.C. 20580.

NOTE: A consent agreement is for settlement purposes only and does not constitute an admission of a law violation. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of $11,000.