The Federal Trade Commission recently approved a final consent order with Carrot Neurotechnology, Inc. and its co-owners, requiring them to stop making allegedly deceptive claims that their “Ultimeyes” video game app can improve users’ vision. The app allegedly featured claims such as “Turn Back The Clock On Your Vision,” and promised improvements in vision for daily activities such as sports, reading, and driving, and that using the app would reduce the need for glasses and contact lenses.

The final order settling the complaint requires Carrot and its owners to have competent and reliable scientific evidence before making the vision claims challenged in the FTC complaint for Ultimeyes and similar products. Competent and reliable scientific evidence is defined in the order as “human clinical testing of the Covered Product or Service that is sufficient in quality and quantity, based on standards generally accepted in the relevant field, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. Such testing shall be (1) randomized, double-blind, and adequately controlled; and (2) conducted by researchers qualified by training and experience to conduct such testing.”

Following the September 2015 release of the draft order, the Commission received 77 comments, including many from experts and researchers in the perceptual learning field that questioned the substantiation standard, particularly the requirement that studies be double-blind. For example, commenters noted that it is impossible to blind a perceptual learning tool, such as a video game, the same way that one would blind a pill or a cream. Others pointed out that published, peer-reviewed literature supported the claims and argued that the draft order would chill innovation.

The Commission responded to commenters with a letter explaining that the blinding requirement is flexible because “what constitutes appropriate blinding and controls … may differ depending on the nature of the intervention and other circumstances.” In a video game context, the Commission suggested that study participants could be blinded as to whether the game includes an intervention or as to the study hypothesis.

In addition, the Commission responded to the supporting studies by noting that peer review is not always a guarantor of high quality. During an investigation, the Commission may obtain information not available to peer reviewers that may identify design flaws, misreporting, or data analysis errors.

There are two key takeaways here: First, emerging technologies featuring health improvement claims are not exempt from the Commission’s health claim substantiation standards. Several commenters criticized the FTC for applying standards not required in the perceptual learning field. In the end, however, even Commissioner Ohlhausen, who has voiced concern about regulatory overreach and chilling innovation in other instances, supported the order. Second, the FTC staff is increasingly digging in to the details of studies and not relying on peer review as sufficient for advertising purposes. It is as important as ever for companies to conduct robust review of their substantiation prior to disseminating health claims.

The Carrot and the Stick: FTC’s Letter Evidences Flexible Yet Firm Approach to Claim Substantiation