Bradley Merrill Thompson Quoted in Article, “US Regulators Remove Two Acne Medical Apps”Mobilehealthnews.com September 9, 2011
Bradley Merrill Thompson, a Member of the firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "US Regulators Remove Two Acne Medical Apps."
Following is an excerpt:
In a watershed moment, the FTC this week fined two app developers who falsely advertised that their smart phone apps could treat acne. The apps, AcneApp and Acne Pwner, were sold in the iTunes App Store and Android Marketplace, respectively. The settlements ban the developers from stating certain health-related claims without scientific evidence. AcneApp's developer has to pay the FTC $14,294 and the developer of Acne Pwnder must pay $1,700. ...
"It's surprising that FTC took this action, because it would have been more natural for FDA," Bradley Merrill Thompson told MobiHealthNews in an email. "I have had no knowledge beyond what I've read in the FTC press release, so I don't know the company side of the story, but it would appear that the app would fall squarely into FDA regulation. Under the draft FDA guidance released in July, this would be an app that would transform a cell phone into a medical device, and thus fall within FDA's jurisdiction."
FDA's draft guidelines actually specifically point to "apps that use the light source from a mobile platform to cure and treat specific conditions, such as acne" as one type of app that would be considered a medical device and subject to regulation under the proposed guidelines.
Both of the apps claimed that colored lights emitted from smart phones would reduce acne if held up daily to the user's skin. According to the FTC, Acne Pwner was downloaded approximately 3,300 times from the Android store at a $0.99 price point, while AcneApp secured approximately 11,600 downloads from the iTunes store at $1.99.