Days after the FDA issued new draft guidance that may be softer on devices making certain kinds of medical claims, the FTC has reminded companies that it also has regulatory power over health claims and might be stepping up to the plate.
The FTC announced an administrative complaint against Focus Education, a company that makes a brain training game for children called Jungle Rangers. The complaint charges that the company advertised permanent brain improvements in "focus, memory, attention, behavior, and/or school performance", including for children with ADHD, and backed up the claims with what the FTC said were nonexistent scientific studies.
“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,” Jessica Rich, Director of the FTC's Bureau of Consumer Protection, said in a 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.”
For now, the FTC has issued an order prohibiting Focus Education from making the claims addressed in the complaint, making any further unsubstantiated claims, or misrepresenting the results of any study or test. Each violation of the order could result in a $16,000 penalty, which could add up very quickly if the company doesn't comply. MobiHealthNews has reached out to Focus Education for comment and will update if they respond.
Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in regulatory law relating to medical devices, sees a likely connection between this injunction and the FDA's recent draft guidance.
"In some ways, it’s kind of interesting that FTC brought this action instead of FDA," he wrote in an email to MobiHealthNews. "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. Further, many of the claims the company appeared to be making were pretty general in nature, so perhaps FDA, in line with last week’s wellness guidance, felt that FDA should not be the regulatory agency here."
The acne case Thompson is referring to dealt with claims that were a little more cut-and-dry bogus: Two apps, AcneApp and Acne Pwner, claimed to treat acne with blue and red light emitted from the user's smartphone. That case seemed like it might be the beginning of an FTC crackdown, but there weren't any additional, similar high-profile announcements.
Brad added that, in this case, the new FDA guidance specifically addresses this kind of software, or at least a very similar category.
"In the guidance FDA published just last Friday, the agency says that it will not regulate apps designed to help with 'mental acuity.'" Thompson wrote. "The FDA guidance goes on to say that it will not regulate, for example, 'Claims to improve mental acuity, instruction following, concentration, problem solving, multitasking, resource management, decision-making, logic, pattern recognition or eye-hand coordination.' The claims the company was making were admittedly a bit different and in some cases more clinical sounding, but did involve mental acuity. The infomercials promoting the game even included a child psychiatrist, stating that Jungle Rangers had improved children’s school performance and behavior."
Like the acne case in 2011, the FTC here has gone after a single company in what is a rather large, emerging field of brain-training game companies. These companies' programs were called out for the shakiness of their own scientific evidence in October by a coalition of nearly 70 neuroscientists writing on behalf of the Max Planck Institute for Human Development.
"It is customary for advertising to highlight the benefits and overstate potential advantages of their products," they wrote. "In the brain-game market, advertisements also reassure consumers that claims and promises are based on solid scientific evidence, as the games are 'designed by neuroscientists' at top universities and research centers. Some companies present lists of credentialed scientific consultants and keep registries of scientific studies pertinent to cognitive training. Often, however, the cited research is only tangentially related to the scientific claims of the company, and to the games they sell. In addition, even published peer-reviewed studies merit critical evaluation. A prudent approach calls for integrating findings over a body of research rather than relying on single studies that often include only a small number of participants."
It's too early to say if this is a solitary FTC action or the beginning of a campaign. All we know is that the FTC believes this particular game wasn't backing up its scientific and medical claims.
"At FTC, because there’s no pre-clearance requirement, it generally all comes down to data," Thompson wrote. "FTC examines the data the company has to support its claims. Here, apparently FTC felt the claims far exceeded what the data showed."