FTC Settles with Med Gen Concerning Claims on Sleep Apnea

WASHINGTON--This past January, the Federal Trade Commission (FTC) alerted Boca Raton, Fla.-based Med Gen Inc. that its product, Snorenz, had unsubstantiated efficacy claims. FTC alleged that both Med Gen and the company behind its infomercial, Niles, Ill.-based Tru-Vantage International (TVI) LLC, had made claims that Snorenz was an effective treatment for snoring as well as for sleep apnea. Paul Kravitz, chairman and chief executive officer of Med Gen, was also named in the complaint.

According to FTC, the complaints against Snorenz alleged that the product made unsubstantiated claims that it could reduce or eliminate snoring or the sound of snoring; that a single application could reduce or eliminate snoring or the sound of snoring for six to eight hours; that testimonials for the product implied that these results were typical or ordinary; and that the product could eliminate, reduce or mitigate the symptoms of sleep apnea.

In a release dated March 29, FTC stated that it had settled with both companies. FTC required that each company needed to have "competent and reliable scientific evidence to substantiate . that Snorenz . reduces or eliminates snoring or eliminates, reduces or mitigates the symptoms of sleep apnea." Also, the companies now need to include warnings that Snorenz has not been shown to be effective in treating sleep apnea.

"The FTC quoted me as saying that [Snorenz] does cure sleep apnea, which I never said in any way, shape or form," said Kravitz, adding that the FTC did not find Med Gen liable in any way, nor did it levy fines against the company. It did ask the Med Gen to list on the Snorenz packaging that it is not a cure for sleep apnea, and that people who believe they have sleep apnea should consult with a physician. "The other claims we made [regarding snoring] are perfectly okay [according to FTC]." The new packaging for Snorenz has been approved by FTC and is currently on supermarket shelves.

Snorenz, a dietary supplement consisting of olive and peppermint oils, as well as vitamins B6, C and E, was promoted primarily through 30-minute infomercials produced by TVI and later by Med Gen itself.

Kravitz did note that the infomercial's personality, Kevin Trudeau, is still under review by FTC for this as well as other "unsubstantiated" claims. "[The problem is that] he did not tell people emphatically that this product does not cure sleep apnea," Kravitz said. He added that by FTC approaching Med Gen with these concerns, it sent a message to all makers of snoring aids to include a disclaimer about sleep apnea. For more information, visit www.ftc.gov or www.medgen.com.