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US
Weight-Loss Pill Marketers Fined for False Claims
The FTC has filed complaints in four separate cases alleging that
weight-loss and weight-control claims were not supported by competent
and reliable scientific evidence. Marketers of the four products –Xenadrine
EFX, CortiSlim, TrimSpa, and One-A-Day WeightSmart – have settled
with the FTC, surrendered cash and other assets worth at least $25
million, and agreed to limit their future advertising claims.
“You won’t find weight loss in a bottle of pills that
claims it has the latest scientific breakthrough or miracle ingredient,”
said FTC Chairman Deborah Platt Majoras. “Paying for fad science
is a good way to lose cash, not pounds.”
Xenadrine EFX
Two marketers of Xenadrine EFX will pay at least $8 million and as
much as $12.8 million to settle FTC allegations that Xenadrine EFX’s
weight-loss claims were false and unsubstantiated. The funds will
be used for consumer redress. In a bankruptcy case not involving the
Commission, the defendants have also agreed to pay at least an additional
$22.75 million to settle claims brought by creditors and consumers,
including personal injury claims for an earlier ephedra-based product.
Xenadrine EFX, which contains, among other ingredients, green tea
extract (EGCG), caffeine, and bitter orange (Citrus aurantium), was
advertised heavily in print and on television, including in such publications
as People, TV Guide, Cosmopolitan, and Men’s Fitness. Xenadrine
EFX advertising also appeared in Spanish-language publications.
The FTC’s complaint alleged that the defendants made false or
unsubstantiated claims for Xenadrine EFX, including that it was clinically
proven to cause rapid and substantial weight loss and clinically proven
to be more effective than leading ephedrine-based diet products. According
to the complaint, Robert Chinery commissioned several studies of Xenadrine
EFX, none of which showed substantial weight loss. The complaint alleged
that in one of these studies, subjects taking Xenadrine EFX lost an
average of only 1.5 pounds over the 10-week study, while a control
group taking a placebo lost an average of 2.5 pounds over the same
period.
The complaint also alleged that Xenadrine EFX advertisements falsely
represented that persons appearing in the ads achieved the reported
weight loss solely by using Xenadrine EFX. According to the FTC complaint,
consumer endorsers lost weight by engaging in rigorous diet and/or
exercise programs. In addition, the endorsers were paid from $1,000
to $20,000 in connection with their testimonials; according to the
complaint, Xenadrine EFX advertisements failed to disclose those payments.
The stipulated federal court order with Robert Chinery, Jr. and RTC
Research & Development, LLC (“RTC”) prohibits certain
claims regarding Xenadrine EFX and prohibits all claims regarding
the health benefits, performance, efficacy, safety, or side effects
of any weight-loss product, dietary supplement, food, drug, or device,
unless the representation is true, not misleading, and substantiated
by competent and reliable scientific evidence. The settlement also
prohibits misrepresentations about any test or study. In addition,
the order prohibits misrepresentations of the actual experience of
any user or endorser and requires clear and prominent disclosure of
any relationship that would materially affect the weight or credibility
given to a user testimonial or endorsement. Finally, Robert Chinery
and RTC cannot use their settlement with the Commission as a basis
for seeking a cash refund of Xenadrine EFX-related income taxes that
they previously reported as paid.
CortiSlim and CortiStress
The seven marketers of CortiSlim and CortiStress will surrender, in
total, assets worth at least $12 million to settle FTC charges that
they made false and unsubstantiated claims that their products can
cause weight loss and reduce the risk of, or prevent, serious health
conditions. In the final three settlement agreements announced today,
the FTC will recover $8.4 million in cash, along with proceeds from
the sale of a residence acquired with CortiSlim profits. The settlements
also require the two individual defendants to liquidate tax shelters
and transfer to the Commission any funds that remain after paying
taxes and penalties. In two earlier settlement agreements, the defendants
turned over $1.5 million in cash, a boat, a truck, a real estate interest,
and proceeds from a tax shelter. The funds recovered from the seven
defendants will be used for consumer redress.
The advertising campaign for CortiSlim ran nationwide, including ads
on broadcast and cable television, radio, print media, and the Internet.
The FTC’s complaint alleged that advertising claims about CortiSlim’s
ability to cause rapid, substantial, and permanent weight loss in
all users were false or unsubstantiated, as were claims about CortiStress’s
ability to reduce the risk of osteoporosis, obesity, diabetes, Alzheimer’s
disease, cancer, and cardiovascular disease. The FTC also alleged
that CortiSlim and CortiStress infomercials were deceptively formatted
to appear as talk shows rather than advertisements.
The final settlements announced today are with Stephen F. Cheng and
his company, Window Rock Enterprises, Inc., and with Gregory S. Cynaumon
and his company, Infinity Advertising, Inc. All of the settlements
bar misrepresentations of any tests or studies and prohibit claims
about the performance, effects on weight, or other health benefits
of any dietary supplement, food, drug, cosmetic, or device unless
the claims are true, not misleading, and substantiated by competent
and reliable scientific evidence. The stipulated orders prohibit the
use of deceptively formatted television and radio advertisements.
In addition, the defendants cannot use their settlement with the Commission
as a basis for seeking a cash refund of income taxes that they reported
as paid.
TrimSpa
The marketers of TrimSpa will pay $1.5 million to settle FTC allegations
that their weight-loss claims were unsubstantiated. According to the
FTC’s complaint, the marketers had inadequate scientific evidence
to support their advertising claims that TrimSpa causes rapid and
substantial weight loss and that one of its ingredients, Hoodia gordonii,
enables users to lose substantial amounts of weight by suppressing
appetite.
Many ads for “TrimSpa Completely Ephedra Free Formula X32”
featured testimonials. Celebrity Anna Nicole Smith claimed to have
lost 69 pounds in eight months by using TrimSpa.
Other advertising claims included “Your high speed dream body
diet pill” and “It makes losing 30, 50, even 70 pounds
(or however many pounds you need to lose) painless.”
TrimSpa ads appeared on television, in magazines, on radio, and in
local newspapers. TrimSpa was also promoted on a Web site, at some
NASCAR events, and other live events.
The FTC consent agreement requires TrimSpa’s marketers –
Goen Technologies Corp., Nutramerica Corp., TrimSpa, Inc., and Alexander
Szynalski, also known as Alexander Goen – to pay $1.5 million.
The agreement also prohibits the marketers from making any claims
about the health benefits, performance, efficacy, safety, or side
effects of TrimSpa, Hoodia gordonii, or any dietary supplement, food,
drug, or health-related service or program, unless the claims are
true, not misleading, and substantiated by competent and reliable
scientific evidence.
One-A-Day WeightSmart
The Bayer Corporation will pay a $3.2 million civil penalty to settle
FTC allegations that advertisements for One-A-Day WeightSmart multivitamins
violated an earlier Commission order requiring all health claims for
One-A-Day brand vitamins to be supported by competent and reliable
scientific evidence.
Bayer ran a national advertising campaign for One-A-Day WeightSmart,
which contains EGCG (epigallocatechin gallate), a green tea extract.
Bayer also advertised on television, radio, and the Internet, and
in newspapers and magazines, such as RedBook, Family Circle, and TV
Guide.
Advertising claims included statements such as:
“Just in! Most women over 30 can gain 10 pounds a decade, due
in part to slowing metabolism.… So eat right, exercise, and
take One-A-Day WeightSmart. The complete multi-vitamin with EGCG to
enhance metabolism.”
“One-A-Day WeightSmart. The first and only complete multivitamin
with an ingredient to enhance your metabolism. EGCG, a natural green
tea extract, to help you while you manage your weight.”
The complaint alleges that Bayer Corporation marketed One-A-Day WeightSmart
with unsubstantiated claims that it increases metabolism;
enhances metabolism through its EGCG content; helps prevent some of
the weight gain associated with a decline in metabolism in users over
age 30; and helps users control their weight by enhancing their metabolism.
The FTC alleges that these unsubstantiated claims violate a 1991 Commission
order against Bayer’s predecessor, Miles Inc., that require
all claims about the benefits of One-A-Day brand products to be substantiated
by competent and reliable scientific evidence.
In addition to the $3.2 million civil penalty, Bayer is prohibited
from violating the FTC order and from making unsubstantiated representations
regarding the benefits, performance, efficacy, safety, or side effects
of any dietary supplement, multivitamin, or weight-control product.
The FTC acknowledges the National Advertising Division of the Council
of Better Business Bureaus for its referrals of some of these cases.
The Commission vote to accept the Bayer settlement was 5-0. At the
Commission’s request, the Department of Justice filed the complaint
and proposed consent decree on January 3, 2007, in the U.S. District
Court for the District of New Jersey.
The Commission vote to accept the TrimSpa consent agreement, subject
to public comment, was 4-0, with Commissioner Rosch recused. The FTC
will publish an announcement regarding the agreement in the Federal
Register. The agreement will be subject to public comment for 30 days,
beginning today and ending February 5, 2007. Comments should be addressed
to the FTC, Office of the Secretary, Room H-135, 600 Pennsylvania
Avenue, N.W., Washington, DC 20580. The FTC requests that any comment
filed in paper form be sent by courier or overnight service, if possible,
because U.S. postal mail in the Washington area and at the Commission
is subject to delay due to heightened security precautions.
The Commission votes to authorize staff to file the CortiSlim stipulated
final orders were both 5-0. The stipulated final orders for permanent
injunction were filed in the U.S. District Court for the Central District
of California on October 3, 2006 for Stephen Cheng and Window Rock
Enterprises, Inc. and on January 3, 2007 for Gregory Cynaumon and
Infinity Advertising, Inc.
The Commission vote to authorize staff to file the Xenadrine EFX stipulated
final order was 5-0. The stipulated final order for permanent injunction
was filed in the U.S. District Court for the District of New Jersey
on December 26, 2006.
The proposed consent decree and the stipulated final orders are for
settlement purposes only and do not constitute admissions by the settling
defendants of law violations. They are subject to court approval and
have the force of law when signed by the judge. Likewise, the administrative
consent agreement is for settlement purposes only and does not constitute
an admission of a law violation. When the Commission issues a consent
agreement 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.
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