Developers of mobile applications MelApp and Mole Detective, which claimed to detect the symptoms of melanoma, settled actions brought by the Federal Trade Commission in connection with their deceptive health claims.
The apps, priced at $1.99 (MelApp) and $4.99 (Mole Detective), instructed consumers to take a photograph of a mole with their smartphone cameras and upload the image to the app along with other information about the mole.
MelApp and Mole Detective promised to calculate the melanoma risk as low, medium, or high and claimed they could correctly analyze the risk of melanoma based on the photographs and a mathematical algorithm using “ABCDE” (Asymmetry, Border, Color, Diameter, and Evolution) criteria, even in its early stages. But the claims were deceptive in violation of Section 5 of the FTC Act, the agency said, as the marketers lacked evidence that the apps could actually detect melanoma at any stage.
Pursuant to the stipulated final judgment filed in Illinois federal court, the marketers of Mole Detective, Kristi Kimball and New Consumer Solutions LLC, are prohibited from claiming that a device—such as an app—can detect or diagnose melanoma unless the claim is truthful, not misleading, and supported by competent and reliable scientific evidence in the form of human clinical testing.
Defendants are further barred from making misleading or unsubstantiated health claims about products or services and must pay disgorgement of $3,930. Litigation is continuing against two additional defendants that assumed marketing responsibility for Mole Detective in August 2012.
In the MelApp case, Health Discovery Corporation is barred from making claims about a device’s ability to detect melanoma and other misleading claims, and must pay disgorgement of $17,693.
The actions also provided Commissioner Maureen Ohlhausen with the opportunity to reiterate her position regarding substantiation. “These matters are another example of the Commission using an unduly expansive interpretation of advertising claims to justify imposing an inappropriately high substantiation requirement on a relatively safe product,” she wrote in her dissent.
Ohlhausen agreed that the companies should provide adequate substantiation, but felt that the complaints and orders went too far, “demanding a high level of substantiation for a wide range of potential advertising claims.”
“This approach concerns me. Health-related apps have enormous potential to improve access to health information for underserved populations and to enable individuals to monitor more effectively their own well-being, thereby improving health outcomes,” Ohlhausen wrote. “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. If the Commission continues to adopt such conclusions without any evidence of consumers’ actual interpretations, and thus requires a very high level of substantiation for health-related apps, we are likely to chill innovation in such apps, limit the potential benefits of this innovation, and ultimately make consumers worse off.”
To read the complaint and stipulated final judgment in FTC v. Lasarow, the Mole Detective case, click here.
To read the administrative complaint and proposed consent order in In the Matter of Health Discovery Corporation, the MelApp case, click here.
To read Commissioner Ohlhausen’s dissenting statement, click here.
To read a statement from Chairwoman Ramirez and Commissioners Brill and McSweeny, click here.
Why it matters: The Director of the FTC’s Bureau of Consumer Protection, Jessica Rich, said the actions provide a twofold lesson for advertisers. “Truth in advertising laws apply in the mobile marketplace,” she said in a statement, adding that app developers and marketers “must have scientific evidence to support any health or disease claims that they make for their apps.”