| U.S. Federal Trade Commission |
FTC News Release, Jun 10, 2003
FTC and FDA Take New Actions in Fight Against Deceptive Marketing
FTC Charges Marketers of Coral Calcium Supreme Dietary Supplement and a Pain-Relief Product With Making False and Unsubstantiated Claims
The Federal Trade Commission has charged the
marketers of a dietary supplement called Coral Calcium Supreme
with making false and unsubstantiated claims about the
product's health benefits. This action is part of a series of
initiatives the FTC and the Food and Drug Administration (FDA)
are taking against the purveyors of products with
unsubstantiated health and medical claims. In a complaint
filed in federal district court, the FTC alleges that Kevin
Trudeau; Robert Barefoot; Shop America (USA), LLC; and Deonna
Enterprises, Inc., violated the FTC Act by claiming, falsely
and without substantiation, that Coral Calcium Supreme can
treat or cure cancer and other diseases, such as multiple
sclerosis and heart disease. The FTC charges that these and
other claims go far beyond existing scientific evidence
regarding the recognized health benefits of calcium.
The defendants promote the product primarily
through a nationally televised 30-minute infomercial featuring
Trudeau and Barefoot, and through statements made in brochures
accompanying the product. The informercial has aired on cable
channels such as Women's Entertainment, Comedy Central, the
Discovery Channel, and Bravo.
"The Commission has voiced strong concerns
about deceptive claims for dietary supplements," said Howard
Beales, Director of the FTC's Bureau of Consumer Protection.
"These cases demonstrate that the FTC will take aggressive
enforcement action, particularly when, as alleged in this
case, the products are marketed as cures for serious diseases
like cancer and heart disease. Marketers who step over the
line will find themselves between a rock and a hard place."
In a separate action, the FTC has charged
one of the defendants, Kevin Trudeau, with violating a
1998 federal district court order that prohibits him from
making unsubstantiated claims about the benefits, performance,
or efficacy of any products. The FTC alleges that Trudeau
violated that order by making false and unsubstantiated claims
about Coral Calcium Supreme, and by making unsubstantiated
claims that another product, Biotape, provides significant or
permanent relief from severe pain, including debilitating back
pain, and pain from arthritis, sciatica, and migraines. In
both of these actions, the FTC has asked the court for a
temporary restraining order that would prohibit the defendants
from making the challenged claims and would freeze their
assets.
In related law enforcement efforts, the FTC
and the FDA are sending strong warning letters to Web site
operators who are marketing coral calcium products claiming
that coral calcium is an effective treatment or cure for
cancer and/or other diseases. In dozens of warnings sent this
week, the FTC states it is aware of no competent and reliable
scientific evidence supporting such claims and that such
unsupported claims are unlawful under the FTC Act.
Accordingly, the FTC is instructing the Web site operators to
remove any false or deceptive claims from their sites
immediately. In a similar action, the FDA warned Web site
operators that disease claims and unsubstantiated
structure/function claims cause their products to be in
violation of the Federal Food, Drug, and Cosmetic Act.
"FDA and FTC are working together to
maximize our efforts to combat health fraud," said FDA
Commissioner Mark B. McCellan. "We are trying to be
particularly vigilant concerning fraudulent internet
promotion, because this is emerging as an increasingly
insidious way of trying to exploit the public."
FTC v. Kevin Trudeau, Robert
Barefoot, Shop America (USA), LLC, and Deonna Enterprises
The FTC's first action alleges that Kevin
Trudeau, Robert Barefoot, Shop America (USA), LLC, and Deonna
Enterprises, Inc., violated the FTC Act by claiming, falsely
and without substantiation, that Coral Calcium Supreme can
treat or cure cancer and other diseases such as multiple
sclerosis and heart disease. According to the FTC, Coral
Calcium Supreme is a dietary supplement purportedly comprised
of marine coral from Okinawa, Japan. A one-month supply of the
product (90 capsules) costs $19.95.
The FTC's complaint alleges that the
defendants claim, falsely and without substantiation, that
Coral Calcium Supreme will treat and/or cure all forms of
cancer and other diseases such as multiple sclerosis, lupus,
heart disease, and chronic high blood pressure. The complaint
also alleges that the defendants falsely claim that scientific
research published in reputable medical journals proves that
calcium supplements can reverse and/or cure all forms of
cancer. Finally, the complaint challenges the defendants'
claims that a daily serving of Coral Calcium Supreme provides
the same amount of bioavailable calcium as two gallons of
milk, and that the body absorbs significantly more of the
calcium in coral calcium - up to 100 times more, and at a
significantly faster rate - than the calcium contained in
commonly available calcium supplements. The FTC is seeking
preliminary and permanent injunctive relief, including
restitution to consumers who purchased Coral Calcium Supreme.
In addition, the FTC has asked the court for a temporary
restraining order that would prohibit the defendants from
making the challenged claims, and would freeze their
assets.
FTC v. Kevin Trudeau
The FTC's second action, against Trudeau
alone, alleges that Trudeau violated a 1998 FTC order
prohibiting him from making unsubstantiated claims about the
benefits, performance, or efficacy of any product. The FTC
alleges that Trudeau violated the order by making false and
unsubstantiated claims about Coral Calcium Supreme, and also
by making unsubstantiated claims about Biotape. According to
the FTC, Biotape is a purported pain-relief product which
Trudeau promotes through a separate infomercial, which has
aired on national cable channels such as PAX Television, the
Hallmark Channel, and E! Entertainment Television. Consumers
are instructed to place a strip of Biotape directly on the
parts of their bodies where they feel pain. One sheet of
Biotape, containing 10 strips, costs approximately $10. In
this action, the FTC is seeking a finding of contempt,
monetary relief, and other injunctive relief, as well as a
temporary restraining order that would prohibit Trudeau from
making the challenged claims, and would freeze his
assets.
Warning
Letters
In addition to the FTC's federal court
actions, the Commission is sending warning letters to dozens
of Web site operators who are making similar claims for coral
calcium products. In the warning letters, the FTC reminds the
Web site operators that any claim that coral calcium is an
effective treatment or cure for any disease must be supported
by competent and reliable scientific evidence to comply with
the law. The FTC states it is aware of no such evidence
supporting these claims, and that without the required
support, the claims are illegal under the FTC Act.
Accordingly, the FTC is instructing the Web site operators to
remove any false or deceptive claims from their sites
immediately.
In a similar action, the FDA issued warning
letters to numerous Web site operators who are promoting coral
calcium on the Internet. The letters cited the organizations
for representing the products as useful in the prevention or
treatment of serious diseases. In addition, a majority of the
letters also cited the firms for making unsubstantiated claims
regarding the effect of their products on the structure or
function of the body. The FDA letters warn the recipients that
FDA may initiate further enforcement action if the violations
are not corrected.
The FTC and FDA had conducted Internet
"surfs" and found numerous Web sites touting coral calcium
products as an effective treatment or cure for cancer and
other diseases such as lupus, multiple sclerosis, and heart
disease. The staffs of the two agencies will follow up by
revisiting the target sites to determine whether the Web site
operators have deleted or revised the unproven
claims.
The FTC vote to authorize filing of the
cases was 5-0. The cases were filed in the U.S. District Court
for the Northern District of Illinois, Eastern Division, on
June 9, 2003.
The text in this article was prepared by the U.S. Federal Trade Commission.