FTC, not the FDA, Requires Peer Reviewed Data to Prove Claims
Written by Editor   
Wednesday, September 07, 2016 06:46 AM

The FTC has come down with a hammer on Lumosity — the online digital health company that promised consumers their games would help reduce neurocognitive deficits. The company has settled for $2 million, and is also being imposed a $50 million judgement by the FTC. The real story here is the wording the FTC used in their decision to put the digital health world on notice about creating apps that promise too much without having evidence and rigorous data to back it up their claims.

Notable in the FTC statement is:

In particular, I caution … companies about making representations that overstate the benefits of these products or misleadingly imply that improvements in the game setting transfer to real-world benefits. Section 5 of the FTC Act requires that advertisers have a reasonable basis to support their express and implied advertising claims before they are disseminated to ensure that such claims are truthful and non-deceptive. Advertisers must also have rigorous, scientific support to substantiate claims for products that purport to prevent or treat health or disease-related conditions.

Often times we think the FDA is the one that is pouring over literature reviews to make sure health related products work the way they should. Clearly the FTC is doing this now. Now it seems like the FTC should be more of a concern to digital health companies than even the FDA.  Basically, if you create an app or website that claims to improve health — you better have legitimate peer reviewed data to backup your claims.