The company that manufacturers and sells a throat spray that purportedly reduces or eliminates snoring and the company that produced infomercials promoting the product have agreed to settle Federal Trade Commission charges that they did not have adequate substantiation to back up the claims they made about the efficacy of the product. The FTC alleged that Tru-Vantage International, LLC, based in Niles, Illinois, and Med Gen, Inc., of Boca Raton, Florida, and its principal, Paul Kravitz, claimed that Snorenz is an effective treatment for snoring as well as sleep apnea - a potentially life-threatening breathing disorder that affects at least 12 million adults who snore. Sleep apnea is characterized by repeated cessation of breathing during sleep and, if left untreated, poses risk of hypertension, stroke and heart disease.
Under the terms of separate consent agreements, the respondents would be required to have competent and reliable scientific evidence to substantiate representations that Snorenz or any other food, drug, or dietary supplement reduces or eliminates snoring or eliminates, reduces, or mitigates the symptoms of sleep apnea. In addition, the proposed settlements would require the respondents to include warnings about sleep apnea in their advertisements for snoring remedies that have not been shown to be effective in treating sleep apnea.
Snorenz is a dietary supplement consisting of oils and vitamins that is sprayed on the back of the throat of persons who snore. Snorenz sold for $20 for a 2-ounce spray bottle and $30 for a 4-ounce refill. According to the FTC, the respondents promoted Snorenz primarily through 30-minute infomercials produced first by Tru-Vantage International and later by Med Gen itself. The claims for the product also appeared on its labels and on Med Gen's website.
The complaints allege that both companies lacked a reasonable basis for the efficacy claims they made about Snorenz. Specifically, the complaints allege that the respondents made the following unsubstantiated claims:
The complaints further allege that the respondents falsely represented that clinical research proves the efficacy of Snorenz. In addition, the FTC's complaints allege that the respondents failed to disclose material facts about sleep apnea. The ads failed to adequately disclose that Snorenz is not intended to treat sleep apnea; sleep apnea is a potential life-threatening condition; and persons who have symptoms of sleep apnea should consult a physician. The complaints further allege that the respondents failed to disclose that a purported expert endorser featured in some of the infomercials for the product had an investment in Med Gen, giving him a financial interest in promoting sales of the product.
Under the terms of the proposed consent agreements, announced today for public comment, both sets of respondents must possess competent and reliable scientific evidence to substantiate claims that Snorenz or any food, drug or dietary supplement reduces or eliminates snoring; reduces or eliminates snoring for a specified period of time through a single application; or eliminates, reduces or mitigates the symptoms of sleep apnea. The Med Gen consent agreement also would require the respondents to substantiate any representation about the benefits, performance, efficacy or safety of Snorenz or any other food, drug, or dietary supplement, while a similar provision in the Tru-Vantage consent agreement applies to Snorenz or any other product, service or program.
In addition, both agreements would require the respondents to include a warning about sleep apnea in their ads for snoring remedies that have not been shown to be effective in treating sleep apnea. The warning must tell consumers that:
Further, the consent agreements would prohibit the respondents from claiming or implying that an endorsement is typical of the experience of consumers who use the product, unless the claim is substantiated. In addition, the consent agreements would require the respondents to disclose affirmatively any material connection between any endorser and any marketer.
The consent agreements would allow the respondents to use certain claims for drugs or dietary supplements that are approved by the Food and Drug Administration.
The Commission vote to accept the two proposed consent agreements and place them on the public record was 5-0. A summary of the proposed consent agreements will be published in the Federal Register shortly. The agreements will be subject to public comment for 30 days, until April 30, 2001, after which the Commission will decide whether to make them final. Comments should be addressed to the FTC, Office of the Secretary, 600 Pennsylvania Avenue, NW, 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 complaints, the proposed consent agreements and analyses to aid public comments 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, NW, 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. The FTC enters Internet, telemarketing and other fraud-related complaints into Consumer Sentinel, a secure, online database available to hundreds of civil and criminal law enforcement agencies worldwide.
Office of Public Affairs
Lemuel Dowdy or Walter Gross
Bureau of Consumer Protection
202-326-2981 or 202-326-3319
(Tru-Vantage - FTC File No. 002-3210; Med Gen - FTC File No. 002-3211)