| U.S. Federal Trade Commission |
FTC News Release, Oct 5, 2004
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.
Infomercial 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 formats 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.
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.
“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.
The text in this article was prepared by the U.S. Federal Trade Commission.