The Feds Challenge Mobile Medical AppsSeptember 12, 2011
By Carmelina G. Allis –
If you thought you’ve had enough trying to figure out whether FDA regulates your mobile app, watch out for the FTC. The FTC has brought its first case targeting health claims related to mobile medical apps.
The mobile apps, sold in Apple’s iTunes Store and Google’s Android Marketplace under the names “AcneApp” and “Acne Pwner,” claimed that they could treat acne with colored lights emitted from the mobile devices. According to the FTC, the marketers alleged that the blue and red lights emitted by the apps kill acne-causing bacteria. The apps advised consumers to hold the display screen next to the area of skin to be treated while the app was activated.
The FTC alleged that the acne treatment claims made for both apps were unsubstantiated. The marketers of the apps have agreed to stop making claims about the products in order to settle charges with the FTC, which would bar them from making certain health-related claims without supporting scientific evidence.
The market for mobile medical apps appears to have grown exponentially recently, and one can only wonder whether FTC’s interest in this area will also intensify. If you worry about FDA, enforcement actions may not be at the top of its agenda quite yet; the FDA regulatory landscape for these products, although somewhat defined, is still being carved out. We previously blogged that FDA has proposed to exert regulatory authority over select mobile medical apps that meet the “device” definition in the Federal Food, Drug, and Cosmetic Act, and that are either used as an accessory to a regulated medical device, or transform a mobile platform into a regulated medical device. The FDA is now seeking public input on that proposal, and it is holding a public workshop on mobile medical apps on September 12-13, 2011.