FTC singles out brain training business over marketing pitch claims

For companies in the evolving subsector of consumer health devoted to helping people concentrate or relax their minds there’s a new issue likely to get their undivided attention. The Federal Trade Commission has singled out Focus Education for making what it calls unsubstantiated claims for its computer game, including that it “permanently improves” children’s focus, […]

For companies in the evolving subsector of consumer health devoted to helping people concentrate or relax their minds there’s a new issue likely to get their undivided attention. The Federal Trade Commission has singled out Focus Education for making what it calls unsubstantiated claims for its computer game, including that it “permanently improves” children’s focus, behavior and children with ADHD, according to a statement from the FTC.

In a settlement with the company, the regulator highlighted claims over its iFocus Systems platform that spurred it to act. The platform includes brain training game Jungle Rangers.

Advertisements by Focus Education for the software included children, parents, teachers and a child psychiatrist who said the product helped children pay attention to their teachers, get better grades, and improved their behavior, according to the FTC complaint. The company also “allegedly falsely” claimed that these benefits were scientifically proven.

As part of the proposed consent order to settle the regulator’s charges, the principals are prohibited from making claims about iFocus Systems, unless they’re “non-misleading” and are supported by “competent and reliable scientific evidence.”

Each violation of the order could result in a $16,000 penalty, the statement said.

iFocus Systems has been a strong seller for the company. The FTC notes that the product, priced at $214.75 plus tax, generated sales of $4.5 million from 2012 to mid-2013.

One of the most interesting points in the FTC statement is this one:

“The proposed order 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.”

Several companies in the digital health space have made claims connecting their apps with improving concentration, although they usually caution that it’s not designed to diagnose conditions like ADHD or PTSD.

As MobiHealthNews points out, the move indicates a few things. It signals the FTC’s willingness to take the lead in regulating these companies. Jessica Rich, the FTC’s Director of the Bureau of Consumer Protection, said in the statement that the case shows that it wants to ensure advertisements for cognitive products, especially those marketed for children, are true and supported by evidence.

“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.”

It is also comes on the heels of proposed guidance from the FDA on how companies promote their general wellness products.

Bradley Merrill Thompson, a partner at Epstein Becker Green, told MobiHealthNews that the FTC’s move was interesting because the FDA’s guidance suggested that it was OK with companies making claims to improve mental acuity.

“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 agreement will be subject to public comment for 30 days, starting January 20 and lasting through February 20. At that point, the commission is expected to decide whether to make the proposed consent order final.