Med Gen Inc., Boca Raton, FL, the company that produces Snorenz, a snore-treatment spray, and Tru-Vantage International LLC, Niles, IL, the DRTV producer responsible for the Snorenz campaign, have agreed to settle Federal Trade Commission charges that the companies did not have adequate substantiation to back up their claims about the efficacy of the product.
The FTC alleged that the companies' claims that Snorenz is an effective treatment for snoring and sleep apnea, a potentially life-threatening breathing disorder during sleep, are unsubstantiated. Under the consent agreements, the companies will be required to have scientific evidence to substantiate representations that Snorenz or any other food, drug or dietary supplement reduces or eliminates snoring or the symptoms of sleep apnea. Both companies also must include a warning about sleep apnea in ads for snoring remedies that have not been shown to be effective in treating the disorder.
The warning must state that the product is not intended to treat sleep apnea. It also must detail the symptoms of the disorder and its consequences and must note that people with sleep apnea should consult a doctor.