By Brian Dolan and Chris Gullo
In a watershed moment, the FTC this week fined two app developers who falsely advertised that their smartphone 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.
AcneApp may have been removed from Apple's AppStore as long ago as March 15, 2011 according to FTC documents. Acne Pwner may have left the Android Market last year.
"Smartphones make our lives easier in countless ways, but unfortunately when it comes to curing acne, there's no app for that," stated FTC Chairman Jon Leibowitz in a press release.
"It's surprising that FTC took this action, because it would have been more natural for FDA," Bradley Merrill Thompson, the co-founder of the mHealth Regulatory Coalition 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 smartphones 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 pricepoint, while AcneApp secured approximately 11,600 downloads from the iTunes store at $1.99.
Shortly after its release in September 2009, AcneApp received press from The New York Times (December 2009) as well as Fox News (January 2010). Dr. Gregory Pearson told the NY Times that “this would have to go through a lot more clinical study before I could quantify its efficacy.” In the Fox news segment, Dr. Pearson said he couldn't claim that the app offered any specific medical benefits: “I really can't because those studies have to be done. But the idea, I didn't just come up with it. It's really based on some science.”
That "science", according to the FTC, supposedly comes from a study in the British Journal of Dermatology that AcneApp falsely claimed proves that blue and red light therapy is an effective acne treatment. A dermatologist in the NY Times in the December 2009 article expressed skepticism as well: “In studies we’ve done, data has shown that both blue and red light have a low efficacy range in acne treatment,” Dr. Alexiades-Armenakas told them. “But it took dozens, and I mean dozens — 88 treatments — of the therapy, before we could see any results.”
According to MobiHealthNews' AppStore archive, AcneApp's description in the Apple Appstore as of February 2010 included a reference to plans for a clinical study of the app's efficacy: "Baylor College of Medicine is gearing up for the first ever clinical trial of a phone based application, AcneApp. The Baylor study is independent," the description read. "This is a really big deal," it continued.
Last February Kathleen Doheny of WebMDNews asked Baylor College of Medicine if any such study was planned or underway, but a spokesperson from the school told the publication that they couldn't find anyone employed there who had such plans. This past March when the app was removed from the AppStore its description made no mention of the supposedly planned Baylor study.
By our count there were five other apps that offered similar acne treatment to Acne Away back in February 2010. Four of those apps are no longer available for download: Anti-Aging ($2.99) by United Holdings Group, Acne Clear ($0.99) by United Holdings Group, ($0.99) Skin Cleanser by United Holdings Group, and ($4.99) Dr. Acne by Diomedics. Diomedics' Dr. Acne was the first app to use light treatment on acne since it launched in February 2009, about seven months before AcneApp.
Interestingly, LOL Software's Acne Away ($0.99) app, which launched in January 2010, is still available for download. Back in February 2010 Acne Away's description cited the same BJD study as AcneApp to back up its efficacy. The current description for Acne Away's iPad app claims that the larger screen of the device makes for a 113 percent more effective "in fighting acne in most people."
Including Acne Away there are currently five apps offering light treatments for acne in Apple's Appstore: M&R Selected's SkinApp (free), FunVid's Acne Light Waves ($1.99), Luke Campbell's Light Therapy ($1.99), and LightRx's ZITzapp ($0.99).
Read the full press release from the FTC below.
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 https://ftcpublic.commentworks.com/ftc/beiersdorfconsent 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.