Marketers behind so called melanoma detection apps MelApp and Mole Detective have agreed to a Federal Trade Commission settlement that bars them from making claims that these apps could detect melanoma symptoms, even in its early stages, according to a statement on the regulator’s website. It also levied a fine on the companies.
The actions by the FTC against the developers and marketers behind the apps, which have been on the market for at least the past three years, is the latest example of the FTC’s interest in making examples of some companies that make health claims for their products without adequate scientific evidence to back them up.
In a statement, FTC Bureau of Consumer Protection Director Jessica Rich reminded developers and marketers that they had to have scientific evidence to support health or disease claims that they make for their apps. “Truth in advertising laws apply in the mobile marketplace.”
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The underlying concern is that if consumers put their faith in mobile health app claims, there’s a chance they’ll delay making an appointment and increase their risk of a more serious outcome. Malanoma is considered to be the most serious type of skin cancer. But if it is caught in its early stages, it has a 98 percent survival rate. Although it only accounts for 2 percent of skin cancer cases in the U.S., it is blamed for the majority of deaths from skin cancer, according to stats from Cancer.net.
Kristi Kimball and her company, New Consumer Solutions LLC, developed and marketed Mole Detective in January 2012 before U.K.-based Avrom Lasarow and his company, L Health Ltd., took over marketing the app in August the same year. Lasarow is fighting the FTC’s action, according to the statement. The FTC filed a complaint against Lasarow in U.S. District Court for the Northern District of Illinois.
“The terms of the settlement for Kimball and her company prohibits them from claiming that a device, such as an app, can detect or diagnose melanoma, unless the representation is truthful, not misleading, and supported by competent and reliable scientific evidence in the form of human clinical testing of the device. It also prohibits them from making any other misleading or unsubstantiated health claims about a product or service…”
“Health Discovery Corporation began marketing MelApp online in 2011 for $1.99. The proposed settlement will bar the company from claiming that any device detects or diagnoses melanoma or its risk factors, or increases users’ chances of early detection, unless the representation is not misleading and supported by competent and reliable scientific evidence in the form of human clinical testing of the device. The settlement also prohibits the company from making any other misleading or unsubstantiated claims about a device’s health benefits or efficacy.”
The marketing company behind MelApp, which has been on the market since 2011, faces a $17,963 fine and Mole Detective’s was stung with a $3,930 fine.
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The agreement is subject to a 30 day public comment period from February 23 through March 25, 2015. Afterwards, the Commission will decide whether to issue the order on a final basis, according to the statement.
The digital health sector has wrestled with concerns that mobile health developers should offer studies backing up their health claims. But critics counter that more regulation will undermine the creative drive behind relatively young companies. Commissioner Maureen Ohlhausen disagreed with the FTC’s settlements, but was the only dissenting vote. In a statement, she argued that mobile health apps shouldn’t be held to the same standard as professional care.
“Health-related apps need not be as accurate as professional care to provide significant value for many consumers. The Commission should not subject such apps to overly stringent substantiation requirements, so long as developers adequately convey the limitations of their products. In particular, the Commission should be very wary of concluding that consumers interpret marketing for health-related apps as claiming that those apps substitute for professional medical care, unless we can point to express claims, clearly implied claims, or extrinsic evidence”