By Carmelina G. Allis –
As reported in FTC Watch Issue No. 823 (Feb. 13, 2013), the Federal Trade Commission has plans to increase enforcement actions against mobile apps – including mobile medical apps.
During a Consumer Protection Conference sponsored by the American Bar Association earlier this month, FTC Commissioner Julie Brill and the former head of the agency’s Bureau of Consumer Protection, David Vladeck, discussed the agency’s renewed focus on advertising and consumer protection, and the need for more aggressive enforcement action against health claims, social media apps, and medical apps.
Commissioner Brill specifically referenced FTC’s action during the fall 2011 ordering a company to stop making claims that its mobile medical app could cure acne. As we previously blogged, that was FTC’s first case targeting health claims related to a mobile medical app sold in Apple’s iTunes Store and Google’s Android Marketplace under the names “AcneApp” and “Acne Pwner.” The mobile apps claimed that the colored lights emitted from the mobile devices could treat acne.
The marketers of the acne apps were fined and the FTC barred them from making any further claims on the mobile apps without competent and reliable scientific evidence. As Commissioner Brill explained during the Conference, the laws that apply to traditional kinds of companies also apply to “cutting-edge social media apps,” because there “’isn’t any mobile ‘exceptionalism’ going on.’”
Despite FTC’s action against the maker of the acne apps, we are not aware of FDA initiating an enforcement action against that company. As we previously blogged, 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 regulatory landscape for these products, although somewhat defined, is still being carved out, and enforcement actions against mobile medical app developers do not appear to be at the top of FDA’s agenda.
The FTC, however, apparently has a different agenda on mobile apps. So if you market a mobile medical app, bear in mind the FTC initiative.