Smartphone app image
Photo courtesy of Flickr by highwaysengland


The FTC continued its campaign against deceptive health and disease claims with enforcement actions against the marketers of “MelApp” and “Mole Detective,” smartphone apps that claimed to detect melanoma. These enforcement actions follow earlier FTC actions against smartphone apps that claimed to cure acne.

The Commission voted 4-1 to settle deceptive advertising claims against the Mel App defendant and two of the Mole Detective defendants and to litigate against the remaining two Mole Detective defendants.  Commissioner Ohlhausen disagreed with the majority’s interpretation of the melanoma detection claims and thus with the amount of substantiation required.  The settlement agreements require defendants to substantiate future melanoma-related claims with “competent and reliable scientific evidence [that] shall consist of human clinical testing” that meets rigorous scientific standards.  Consistent with her analysis in POM Wonderful, Commissioner Ohlhausen’s dissent made clear that she  would not require such “onerous” substantiation because “substantiation requirements must flow from the claims made by the advertiser” and “[w]ithout extrinsic evidence, I do not have reason to believe that a reasonable consumer would take away the implied claim that using these apps would increase their chances of detecting skin cancer in the early stages as compared to an examination by a dermatologist.”

In her dissent, Commissioner Ohlhausen also expressed concern that requiring such rigorous substantiation could have an adverse impact on consumer health:

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. 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. 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.