The Federal Trade Commission (FTC) announced this week that it had settled with two marketers of mobile medical apps (MMAs) — New Consumer Solutions LLC and Health Discovery Corp. — for claiming that their MMAs (Mole Detective and MelApp, respectively) could diagnose melanoma from photographs of the users’ moles. The Mole Detective and MelApp work by instructing users to photograph a mole with a smart phone camera and also input other descriptive information about the mole. After this information had been inputted, the apps calculate the mole’s melanoma risk as low, medium, or high. The FTC alleged that the marketers deceptively claimed the apps accurately analyzed melanoma risk and could assess such risk in early stages without adequate evidence to support such claims. The Mole Detective, which was sold in Apple and Google app stores, had been marketed since 2012 for a price of about $4.99. MelApp had been marketed since 2011 for about $1.99.
The FTC’s settlement with each company bars them from making further melanoma diagnosis claims unless the claim is truthful, not misleading, and is supported by competent and reliable scientific evidence in the form of human clinical testing of the device. It also prohibits the companies from making any other misleading or unsubstantiated health claims about a product or service. The FTC’s complaint against New Consumer Solutions was filed in the US District Court for the Northern District of Illinois on February 23, 2015, and the proposed settlement with the company has been submitted to the Court for final action. The FTC expects to publish a description of the settlement agreement shortly in the Federal Register. The agreement will then be subject to a 30-day public comment period that ends on March 25, 2015.
These federal government enforcement actions are several of the first such cases against marketers of MMAs since the US Food and Drug Administration (FDA) issued its final MMA guidance exempting MMAs from regulation as medical devices provided they bare no medical diagnostic or treatment claims. Indeed, the current settlements against New Consumer Solutions and Health Discovery could signal an uptick in FDA oversight being focused on MMA promotional claims. The FDA does not yet appear to have taken any enforcement action against New Consumer Solutions LLC or Health Discovery Corp. for their respective marketing of the Mole Detective and MelApp. However, the FDA is certainly following these FTC enforcement actions, and could take its own enforcement action as well.