Recalls & Warnings
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Posted October 6, 2004
False Claims Made by Marketer of Cortisol-related Weight-Loss Supplements According to FTC
“The Window Rock defendants’ weight-loss and disease-prevention claims fly in the face of reality,” said Lydia B. Parnes, Acting Director of the FTC’s Bureau of Consumer Protection. “No pill can replace a healthy program of diet and exercise.”
The FTC’s complaint alleges that the Window Rock defendants violated the FTC Act by making deceptive efficacy claims for CortiSlim and CortiStress. In addition, the complaint alleges that the defendants violated the FTC Act by using a deceptive format in at least two of their infomercials to suggest falsely that the infomercials were independent television programs, rather than paid commercial advertising. The complaint seeks permanent injunctive relief, including redress for consumers who purchased the products.
According to the FTC, the defendants began marketing CortiSlim in August 2003, through nationally disseminated infomercials featuring Cynaumon and Talbott that aired on anumber of television channels, including Access Television, Travel Channel, and Discovery Channel. The FTC alleges that the defendants promoted cortisol control as “the answer” for anyone who wants to lose weight, especially abdominal weight. According to the FTC’s complaint, the defendants’ broadcast ads, print ads, and Web sites claimed that persistently elevated levels of cortisol, the “stress hormone,” are the underlying cause of weight gain and weight retention and also claimed that CortiSlim effectively reduces and controls cortisol levels and thereby causes substantial weight loss. The FTC alleges that the defendants claimed that CortiSlim: (1) causes weight loss of 10 to 50 pounds for virtually all users; (2) causes users to lose as much as 4 to 10 pounds per week over multiple weeks; (3) causes users to lose weight specifically from the abdomen, stomach, and thighs; (4) causes rapid and substantial weight loss; (5) causes long-term or permanent weight loss; and (6) causes weight loss. The FTC also alleges that the defendants claimed that the effectiveness of CortiSlim and its ingredients is demonstrated by over 15 years of scientific research. According to the FTC’s complaint, these claims are false or unsubstantiated.
According to the FTC, the defendants began marketing CortiStress in September 2003, through a nationally disseminated infomercial, also featuring Cynaumon and Talbott, that aired on a number of television channels, including TVN Direct. The FTC alleges that the defendants promoted cortisol control as “perhaps the most important aspect” of reducing health and disease risks. According to the FTC’s complaint, the defendants’ infomercial claimed that persistently elevated levels of cortisol are the underlying cause of “every modern lifestyle disease that is associated with this fast-paced 21st century lifestyle” and also claimed that CortiStress controls cortisol and thus should be taken “for as long as you want to have good health.” The FTC alleges that the defendants claimed that CortiStress reduces the risk of, or prevents, conditions such as osteoporosis, obesity, diabetes, Alzheimers’ disease, cancer, and cardiovascular disease. According to the FTC’s complaint, these claims are false or unsubstantiated.
The FTC’s complaint also alleges that the defendants produced their infomercials for CortiSlim and CortiStress to look like episodes of a talk show called “Breakthroughs” that features Cynaumon as the “host.” According to the complaint, the “Breakthroughs” logo appears in the lower right-hand corner of the screen throughout one of the CortiSlim infomercials. Cynaumon introduces Talbott as a “guest” he wanted on that particular “program” to tell the “audience” about Talbott’s scientific breakthrough regarding cortisol and his related product, either CortiSlim or CortiStress. The infomercials do not indicate or otherwise reveal that Cynaumon and Talbott are part of a joint venture to create, manufacture, and market CortiSlim and CortiStress. When a toll-free telephone number appears on-screen, Cynaumon presents the number for “more information” and states that callers who mention the “Breakthroughs” program will receive a special discount. According to the complaint, when the toll-free number appears on-screen, no oral or written disclaimer is provided to indicate that “Breakthroughs” is, in fact, a paid advertisement for CortiSlim or CortiStress; rather, the paid advertisement disclaimers appear only at the very beginning and very end of the infomercials.
The complaint against the Window Rock defendants signals the Commission’s continuing concern about the use of deceptive format in infomercials, and this is the second recent case to include an allegation that the format of the infomercial misleads consumers. In July 2004, the Commission filed charges, including a deceptive format charge, against the marketers of a product called “Supreme Greens with MSM.” In that case, the Commission won a preliminary injunction that prohibits efficacy claims for the product and requires clear “paid advertising” disclosures in any future infomercial advertising. (See press release dated July 1, 2004; www.ftc.gov/os/caselist/0233138/0233138.htm.
Stipulated Interim Agreement and Order
The Commission and the Window Rock defendants have also submitted a stipulated interim agreement that, with the court’s approval, will become an order. Under the agreement, advertising for CortiSlim and CortiStress cannot make any of the claims alleged in the FTC’s complaint. In addition, the defendants agree to limit their future advertising to claims that are supported by competent and reliable scientific evidence and agree not to misrepresent that their products are supported by scientific studies. Finally, the defendants agree not to use any advertisement that misrepresents itself as something other than a paid advertisement, and they also agree to include appropriate “paid advertisement” disclaimers in their advertising.
FTC Warning Letters
In a related development, the FTC has begun sending warning letters to more than 25 Web site operators and others who are marketing products with claims that the products will affect cortisol and thereby cause weight loss, reduce the risk of or prevent disease, or produce other health benefits. In its warning letters, the FTC states that it is not aware of any competent and reliable scientific evidence to support those claims and warns that unsupported claims are unlawful under the FTC Act. Accordingly, the FTC’s warning letters instruct the Web site operators and other marketers to discontinue any false or deceptive claims immediately.
FDA Warning Letter
The U.S. Food and Drug Administration (FDA) also has taken regulatory action against the marketers of CortiSlim. On August 19, 2004, the FDA sent a warning letter to Stephen Cheng and Window Rock Enterprises, Inc., stating that the dietary supplement CortiSlim is misbranded and violates the provisions of the Federal Food, Drug, and Cosmetic Act (the Act). According to the FDA’s letter, CortiSlim’s label and accompanying information make unsubstantiated claims that CortiSlim “eliminates cravings,” “controls appetite,” “burn[s] calories more efficiently and naturally through thermogenesis,” and “diminishe[s] hunger and stress eating.” The FDA also asserts that claims that CortiSlim “supports healthy cortisol levels” or “supports weight maintenance efforts” would be unsubstantiated. FDA further expressed to the firm that if prompt action to correct these violations was not taken, enforcement action may be initiated without further notice. The Act provides for seizure of illegal products and for an injunction against the manufacturer and/or distributor of illegal products. For additional information and a copy of the warning letter, please visit the FDA’s Web site, www.fda.gov.
“We will take appropriate enforcement action against firms that promote dietary supplement products with unsubstantiated claims about the benefits of the product,” said Dr. Lester M. Crawford, Acting FDA Commissioner. “Consumers rely on the claimed benefits of the product, and we owe it to them that such claims be supported by competent and reliable scientific evidence.”