FTC Beats FDA to the Punch Regulating Medical Mobile Applications

In July 2011, the FDA created a stir when it announced it was in the beginning stages of regulating mobile applications for smart phones that were used an accessory to a medical device or transform a mobile platform into a regulated medical device. Currently the FDA  is seeking input and comments from the industry and public on the related guidance by October 19, 2011. In the interim, it seems the Federal Trade Commission (FTC) has beaten the FDA to the punch by charging two marketers of applications designed to treat acne with making unsubstantiated medical claims.

The mobile applications, sold in Apple’s iTunes Store and Google’s Android Marketplace, claimed to treat acne by emitting colored lights (red and blue) from the smart phone and were sold under the names “AcneApp” and “Acne Pwner.”

In 2009, when the New York Times wrote about the AcneApp, a dermatologist interviewed expressed scepticism over its efficacy and safety. The FTC has now charged that the acne treatment claims made for both apps were unsubstantiated and that the marketers of AcneApp falsely claimed that the study in the British Journal of Dermatology proves that blue and red light therapy, such as the type provided by AcneApp, is an effective acne treatment.

According to the FTC, there were approximately 3,300 downloads of AcnePwner, which was offered for 99 cents in the Android Marketplace.  There were approximately 11,600 downloads of AcneApp from the iTunes store, where it was sold for $1.99, and ads for the application stated that it was developed by a dermatologist and was backed by a study in the British Journal of Dermatology.  The settlements between the FTC and marketeres prohibit the marketers from making acne-treatment claims about their mobile apps and other medical devices, as well statements regarding the safety, performance, benefits, or efficacy claims about any device, without competent and reliable scientific evidence. The two marketers of AcneApp are also barred from misrepresenting research, tests, or studies. The settlement also requires Koby Brown and Gregory W. Pearson, doing business as DermApps, to pay $14,294, and Andrew N. Finkle, doing business as Acne Pwner, to pay $1,700 to the FTC.

It will be interesting to watch the interplay between the FDA and the FTC, and worth paying attention to see if the FTC steps up to the plate to enforce these applications before the FDA is fully prepared to do so.