In a case that may have far-reaching consequences for mobile app developers, the Federal Trade Commission has told a Texas company it must stop making unsubstantiated claims that their computer game permanently improves children’s focus, memory, attention, behavior, and school performance, including for children with attention deficit hyperactivity disorder.

According to the FTC’s administrative complaint, Focus Education in advertisements claimed that its Jungle Rangers computer game had “scientifically proven memory and attention brain training exercises, designed to improve focus, concentration and memory” and touted the software as giving children “the ability to focus, complete school work, homework, and to stay on task.” In addition, Focus Education’s website implied that these benefits would be permanent.

However, the FTC has charged that Focus Education and its officers violated the FTC Act by making false or unsubstantiated claims. A proposed consent order settling the FTC’s charges prohibits Focus Education and its principals from making the claims alleged in the complaint and further prohibits the company and its principals from making unsubstantiated claims about the benefits, performance, or efficacy of products or services that supposedly alter the brain’s structure or function, improve cognitive abilities, behavior, or academic performance, or treat or reduce the symptoms of cognitive disorders, including ADHD.

“This case is the most recent example of the FTC’s efforts to ensure that advertisements for cognitive products, especially those marketed for children, are true and supported by evidence,” said Jessica Rich, Director of the Bureau of Consumer Protection, in a written statement.  “Many parents are interested in products that can improve their children’s focus, behavior, and grades, but companies must back up their brain training claims with reliable science.”

In response to the FTC action, Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green who counsels medical device companies on regulatory issues, reminds developers that it is not just the FDA that regulates medical claims based on software. 

“Claims that a product can be used to help treat diseases and conditions such as ADHD would suggest the product meets the definition of a medical device. But similar to the enforcement action a couple years ago brought by the FTC against software developers that treated acne, FDA let FTC handle this one,” Thompson tells Health Data Management. “This serves as an important reminder that developers are still subject to FTC regulation.”

In Tuesday’s Federal Register, FDA published draft guidance on general wellness products including exercise equipment, audio recordings, mobile apps, video games, and other products. The agency guidance proposes that it would not enforce regulatory compliance for “low-risk general wellness devices” that are “designed to maintain or encourage a general state of health” and that “may associate a healthy lifestyle with reducing the risk or impact of certain diseases or conditions.”

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