The FTC has challenged makers of melanoma detecting mobile apps that claim to detect melanoma, even in its earliest stages. Two of the companies, MelApp and Mole Detective, have reached settlements with the FTC, but two other melanoma detecting mobile app makers are still being pursued by the FTC after they did not agree to settle. The FTC’s complaints alleges that the melanoma detecting mobile apps had users take pictures of their moles with their mobile device, and then input other information about the mole. The app then claims to classify the mole’s melanoma risk from low to high based upon the photo and other information. The FTC disagreed with that claim, saying the makers of the melanoma detecting mobile apps made those claims without adequate scientific evidence.
The MelApp Settlement and the Mole Detective Settlement both prohibit the melanoma detecting mobile app makers from making claims that their products can detect melanoma unless those claims are not misleading and supported by competent and reliable scientific evidence shown by clinical testing. “Truth in advertising laws apply in the mobile marketplace,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “App developers and marketers must have scientific evidence to support any health or disease claims that they make for their apps.”
The FTC voted to approve the settlements on a 4-1 vote. Commissioner Maureen Ohlhausen dissented, asserting that the ruling has the potential to chill the development of future healthcare apps that can be useful to consumers. Ohlhausen said the scientific testing threshold is too high, especially in healthcare apps that only claim that they can enhance or improve a self-assessment, and do not claim dermatologist-level accuracy. She said the deceptive advertising claim against the apps was too “amorphous.”
Three of the commissioners that voted to approve the settlements, responded, saying the ruling simply requires scientific testing to demonstrate accuracy “at a level appropriate to the claim being made.” “Thus, if scientific testing demonstrates that the app is accurate 60 percent of the time, the advertisers would be able to make a 60 percent accuracy claim,” they said. “It would be incumbent upon these marketers to make sure that their advertising conveyed that level of accuracy and did not suggest a stronger level of science to reasonable consumers.”
The commentary amongst the FTC’s own commissioners regarding the level of scientific evidence necessary to sustain the app makers claims is important. This is especially true in light of the recent ruling in the POM Wonderful case, where the court rejected the FTC’s categorical position that all disease-related claims had to be supported by at least two randomized clinical trials (RCTs). The court held that while two RCTs would be better and more reliable than one, the FTC had failed to justify the imposition of a two RCT requirement for all disease-related claims. The FTC appears to be internally struggling with some of the same issue the court addressed in the POM case. For now, it appears that the FTC is intent on requiring a high level of scientific evidence to support any disease related claims.