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.

Copies of the complaint, the proposed consent agreement, and an analysis to aid public comment 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, 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.

(FTC File No. 022 3036)