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FTC Requires Scientific Evidence for [04/15/2003]

April 15, 2003

An Arizona-based company, Snore Formula, Inc., its officers, and a distributor have agreed to settle Federal Trade Commission charges that they failed to have scientific substantiation for the claims made for "Dr. Harris' Original Snore Formula" (Snore Formula) tablets. Snore Formula is an herbal supplement purported to cure snoring. The Commission's complaint charges that the respondents made unsubstantiated claims about the tablets' efficacy in preventing sleep apnea in adult and child users and significantly reducing snoring. The Commission accepted the consent agreement subject to public comment. It requires that the respondents possess competent and reliable scientific evidence to substantiate representations that Snore Formula or any other food, drug, device, service, or dietary supplement prevents, treats, eliminates, or reduces snoring and sleep apnea in both adult or child users.

The FTC charges Ronald General and Dennis H. Harris, M.D., and their company, Snore Formula, Inc., with violating the FTC Act by failing to possess evidence substantiating their claims for Snore Formula. The FTC also charged Snore Formula distributor Gerald L. "Jerry" Harris, owner of the SnoreFormula.com Web site. According to the FTC's complaint, the respondents failed to have a reasonable basis for claims they made about their product's efficacy in: preventing sleep apnea in adult and child users who would otherwise develop sleep apnea; treating the "early stages" of sleep apnea; and eliminating, preventing, or significantly reducing snoring. The complaint alleges that the respondents failed to disclose the importance of seeing a physician for people who have symptoms of sleep apnea because the condition may be fatal. The complaint further alleges that the respondents falsely claimed that scientific testing demonstrates that the tablets eliminate, prevent, or significantly reduce snoring in 86 percent of users.

In addition, the FTC alleges that Dennis H. Harris, M.D., acting as an expert endorser for the product, misrepresented that he had sufficiently exercised his purported expertise to determine the accuracy of his claims for the product.

The consent agreement to settle the charges requires the respondents to have scientific evidence for any future claims about the effect of any food, drug, device, service, or dietary supplement on the structure or function of the human body, or about any other health benefit, or the safety, of any such product or service. The consent agreement also requires the respondents to disclose clearly and prominently that the product is not intended to treat sleep apnea and to provide a warning statement for consumers with symptoms of sleep apnea to see a physician or a specialist in sleep medicine. These disclosures must be made whenever the respondents represent that a product not shown to treat sleep apnea can eliminate, prevent, or reduce snoring.

The consent agreement prohibits Snore Formula, Inc. and its officers from providing the "means and instrumentalities" to others to make claims without scientific support about the benefits, performance, efficacy, of safety of any food, drug, device, service, or dietary supplement.

In addition, the consent agreement requires that Dennis H. Harris, M.D., sufficiently examine or test products that he endorses as an expert. Further, the proposed settlement requires the company and its officers to disseminate a copy of the order to its past and future distributors, and requires them to monitor their distributors and terminate any distributor who continues to make prohibited claims. Finally, the consent order contains standard recordkeeping requirements to allow the agency to monitor the respondents' compliance with the order.

The FTC 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 May 15, 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.

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