The Federal Trade Commission (FTC) has filed a law suit to stop two companies from making health claims about two dietary supplements called CortiSlim and CortiStress. CortiSlim is promoted as producing a quick 10-50 pound weight loss. CortiStress claims to prevent a whole range of medical conditions including osteoporosis, obesity, diabetes, Alzheimer's disease, cancer and cardiovascular disease. According to the FTC, "...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.' "
The FTC is hoping to negotiate a settlement that not only results in a permanent injunction against advertising claims but also monetary reimbursement for consumers who have purchased the CortiSlim and CortiStress.
Comment: Cortisol is the major natural glucocorticoid. (A glucocorticoid is a hormone that predominantly affects the metabolism of carbohydrates and, to a lesser extent, fats and proteins in the body. The term glucocorticoid also applies to equivalent hormones synthesized in the laboratory.) Cortisol is the primary stress hormone.
CortiSlim and CortiStress are not the only dietary supplements out there. There are a number of products (Corti-something-or-other) which claim to interfere with cortisol production and control cortisol levels in the body. The FTC has also 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.
Conflict of Interest: We typed "cortisol" into the MedicineNet search engine and noticed that there are "sponsored results" (ads) for some of these Corti-something-or-other products. So this may be a good time to state (or restate) the basic fundamental principle that the health information (the "content") on MedicineNet is independent of the advertising.
Other products investigated and charged by the FTC:
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FTC Targets Products Claiming to Affect the Stress Hormone Cortisol
Agency Alleges That Marketers of CortiSlim and CortiStress Made False or Unsubstantiated Claims
The Federal Trade Commission has charged marketers of two dietary supplements with claiming, falsely and without substantiation, that their products can cause weight loss and reduce the risk of, or prevent, serious health conditions. According to the FTC's complaint, Los Angeles-area marketers Window Rock Enterprises, Inc. and Infinity Advertising, Inc., their principals, Stephen Cheng and Gregory Cynaumon, and business partner and product formulator Shawn Talbott have sold "CortiSlim" and "CortiStress" through a number of widely aired infomercials and short TV commercials, as well as radio and print advertisements and Internet Web sites. "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.
CortiSlim
According to the FTC, the
defendants began marketing CortiSlim in August 2003, through nationally
disseminated infomercials featuring Cynaumon and Talbott that aired on a number
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.
CortiStress
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.

QUESTION
What causes tooth decay? See AnswerInfomercial Format
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.
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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."
The Commission vote to authorize staff to file the complaint was 5-0. The complaint and the stipulated interim agreement and order were filed in the U.S. District Court for the Central District of California on September 30, 2004.
NOTE: The Commission files a complaint when it has "reason to believe" that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The complaint is not a finding or ruling that the defendant has actually violated the law. The case will be decided by the court.

SLIDESHOW
Heart Disease: Causes of a Heart Attack See SlideshowCopies of the complaint, the stipulated interim agreement and order, and a sample warning letter are available from the FTC's Web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. The FTC works for the consumer to prevent fraudulent, deceptive, and unfair business practices in the marketplace and to provide information to help consumers spot, stop, and avoid them. To file a complaint in English or Spanish (bilingual counselors are available to take complaints), or to get free information on any of 150 consumer topics, call toll-free, 1-877-FTC-HELP (1-877-382-4357), or use the complaint form at http://www.ftc.gov. The FTC enters Internet, telemarketing, identity theft, and other fraud-related complaints into Consumer Sentinel, a secure, online database available to hundreds of civil and criminal law enforcement agencies in the U.S. and abroad.
Source: Federal Trade Commission press release, October 5, 2004
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