| U.S. Federal Trade Commission |
FTC News Release, Jun 12, 2003
FTC Alleges Maryland Companies Lack Support for Claims That Heartbar Is Effective Against Cardiovascular Diseases
Unither Pharma, Inc. and United Therapeutics
Corporation have agreed to settle Federal Trade Commission
charges that they made deceptive claims in advertising for
their HeartBar product. The respondents represented that
HeartBar - a chewy food bar and powder containing the amino
acid L-Arginine - reduces the risk of developing heart
disease, reverses damage to the heart, reduces or eliminates
heart disease patients’ need for surgery and medications, and
substantially decreases leg pain in people with cardiovascular
disease. The FTC alleges that these claims were deceptive, in
violation of Section 5 of the FTC Act, because they are not
supported by scientific evidence. The proposed settlement
announced today prohibits the respondents from repeating these
type of claims for HeartBar and other L-Arginine products
unless they have adequate scientific support. It also bars
them from making any unsubstantiated claims about the health
benefits, performance, or efficacy of any food, medical food,
or dietary supplement used in or marketed for the treatment,
cure, or prevention of cardiovascular disease.
According to the FTC, the respondents, based
in Silver Spring, Maryland, sell and market an
L-Arginine-based dietary supplement (and purported medical
food) under the HeartBar brand name. According to the
complaint, the respondents made a number of unsubstantiated
claims, such as the HeartBar decreases leg pain, prevents
age-related vascular problems, reduces the risk of
cardiovascular disease, and reduces or eliminates the need for
surgery and medications among patients with cardiovascular
disease. The complaint also alleges that the respondents
falsely claimed that scientific studies prove that HeartBar
decreases angina pain by 70 percent and leg pain by 66
percent, and reverses the effects of high cholesterol,
smoking, diabetes, and estrogen deficiency on the heart. The
respondents’ products are HeartBar, HeartBar Plus, and
HeartBar Sport. Since at least 1999, the respondents have
advertised on “cookepharma.com” and
“unither.com” Web sites, and in print media, such as
Reader’s Digest, Modern Maturity, The
San Francisco Chronicle, The Chicago Sun-Times,
and others.
The proposed consent agreement to settle the
charges prohibits the respondents from making the challenged
unsubstantiated claims for HeartBar or any other product
containing L-Arginine used in or marketed for the treatment,
cure, or prevention of cardiovascular disease. It also
prohibits unsubstantiated health benefits, performance, and
efficacy claims for any food, medical food, or dietary
supplement used in the marketing of a treatment, cure, or
prevention of cardiovascular disease, as well as
misrepresentations concerning tests, studies or research. The
proposed consent order further requires that the respondents
contact all of their distributors and sellers and request that
they immediately stop using any false or deceptive
advertisements for HeartBar, and that they notify the
Commission of any distributors who continue to make claims
that the order prohibits.
The proposed settlement
allows the respondents to use certain claims for foods that
the Food and Drug Administration approved for labels through
its regulations under the Nutrition Labeling and Education Act
of 1990, and certain claims for drugs that the FDA
approved.
Finally, the consent order contains standard
record-keeping requirements to allow the FTC to monitor the
respondents’ compliance with the order.
The Commission
vote to accept the proposed consent agreement was 5-0. An
announcement regarding the proposed consent agreement will be
published in the Federal Register shortly. It will be subject
to public comment for 30 days, until July 14, 2003, after
which the Commission will decide whether to make it final.
Comments should be addressed to the FTC, Office of the
Secretary, 600 Pennsylvania Avenue, N.W., Washington, D.C.,
20580.
NOTE: A consent agreement
is for settlement purposes only and does not constitute an
admission of a law violation. When the Commission issues a
consent order 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.
The text in this article was prepared by the U.S. Federal Trade Commission.