The FTC has finally stepped in for the first time and started cracking down on questionable health care and medical apps — shutting down two medical apps that claimed to treat acne by light therapy (The apps were available in both the Apple App Store and Android Marketplace). This is absolutely huge and monumental news in the mobile medical ecosystem, and the FTC’s first time action is hugely welcome to medical professionals — especially those of us at iMedicalApps.
We were the only publication to highlight the integrity of these Acne “treatment” apps over a year ago. One of our senior editors, Satish Misra, MD, looked at the medical literature the app makers were using to base their claims and he even analyzed the physics behind the light therapy emitted from the iPhone — showing these apps were completely erroneous. In his report titled “Acne treatment apps could be taking advantage of patients,” Misra wrote the following:
“While these developers do not claim to be medical professionals, they do claim to treat a medical condition and should be held to the same Hippocratic standards that we hold all others in the medical field.
As such, I hope that one of two things would happen here. My preference would be that someone, preferably the developers, prove me wrong — give me some reason to believe that a reasonable argument could be made that these apps are effective. I promise I’d happily recant everything I’ve said.
Otherwise, I hope someone — the developers themselves or Apple — pull these apps out of the app store, thereby preventing vulnerable patients on wasting their money on what is likely just a glorified mood light.”
This is an absolutely huge moment for the mHealth world, and health care professionals should be applauding the move from the FTC. We just wish the FTC had heeded our warnings over a year ago, when we systematically broke down the false information these apps were peddling to potential patients.
We’ll have significantly more on this in the coming days. Until then, the FTC has given links allowing the public to comment on their rulings (included in the press release we have attached below).
My favorite line from their press release: “Smartphones make our lives easier in countless ways, but unfortunately when it comes to curing acne, there’s no app for that,” said FTC Chairman, Jon Leibowitz.
The following is a full press release from the FTC:
Marketers who advertised that their smartphone applications could treat acne have agreed to stop making baseless claims in order to settle FTC charges. The mobile applications, commonly referred to as “apps,” were sold in Apple’s iTunes Store and Google’s Android Marketplace. The settlements in two separate cases would bar the marketers from making certain health-related claims without scientific evidence.
“Smartphones make our lives easier in countless ways, but unfortunately when it comes to curing acne, there’s no app for that,” said FTC Chairman, Jon Leibowitz.
The cases involving mobile apps “AcneApp” and “Acne Pwner” are the first the FTC has brought targeting health claims in the mobile application marketplace.
The FTC alleged that the mobile apps were advertised to work in the same way: both claimed to be able to treat acne with colored lights emitted from smartphones or mobile devices. Consumers were advised to hold the display screen next to the area of skin to be treated for few minutes daily while the app was activated.
According to the FTC complaint, there were approximately 3,300 downloads of AcnePwner, which was offered for 99 cents in the Android Marketplace. Ads for Acne Pwner stated, “Kill ACNE with this simple, yet powerful tool!” The marketers of AcneApp claimed, “This app was developed by a dermatologist. A study published by the British Journal of Dermatology showed blue and red light treatments eliminated p-acne bacteria (a major cause of acne) and reduces skin blemishes by 76%.” There were approximately 11,600 downloads of AcneApp from the iTunes store, where it was sold for $1.99.
The FTC charged the acne treatment claims made for both apps were unsubstantiated. It also charged 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.
The settlements would bar the marketers from making acne-treatment claims about their mobile apps and other medical devices, as well as the safety, performance, benefits, or efficacy claims about any device, without competent and reliable scientific evidence. The two marketers of AcneApp would also be barred from misrepresenting research, tests, or studies.
Finally, the settlement orders would require 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.
The Commission vote to approve the administrative complaints and proposed consent agreements was 5-0. The FTC will publish a description of the consent agreement package in the Federal Register shortly. The agreement will be subject to public comment for 30 days, beginning today and continuing through October 10, 2011, after which the Commission will decide whether to make the proposed consent order final.
Interested parties can submit written comments electronically or in paper form by following the instructions in the “Invitation To Comment” part of the “supplementary Information” section. Comments in electronic form should be submitted using the following web links:https://ftcpublic.commentworks.com/ftc/acneappconsent and https://ftcpublic.commentworks.com/ftc/acnepwnerconsent and following the instruction on the web-based form. Comments in paper form should be mailed or delivered to: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex D) 600 Pennsylvania Avenue, N.W., Washington, DC 20580. The FTC is requesting that any comment filed in paper form near the end of the public comment period be sent by courier or overnight service, if possible, because U.S. postal mail in the Washington area and at the Commission is subject to delay due to heightened security precautions.
NOTE: The Commission issues an administrative complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The complaint is not a finding or ruling that the respondent has actually violated the law. A consent agreement is for settlement purposes only and does not constitute an admission by the respondent that the law has been violated. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of up to $16,000.
The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s website provides free information on a variety of consumer topics. Like the FTC on Facebook and follow us on Twitter.