Venable partner Randy Shaheen was quoted in a January 22, 2015 Law360 article on the Federal Trade Commission's (FTC) recent rebuke of a company claiming its video games could help improve mental health. The move is significant because it came just days after the Food and Drug Administration (FDA) announced it would not regulate low-risk software with certain wellness claims.
Shaheen said, "Software developers need to understand that just because they can make such claims without causing their products to be treated as medical devices, doesn’t mean they can make such claims without reliable evidence to back them up." He added that the FDA "in no way suggested that if a product falls into any of the exception categories they don’t have to have support for any of their claims."
Speaking hypothetically, Shaheen described an activity tracking product claiming to help someone lose weight. According to Shaheen, such a claim would fall under FDA exception but the product's developer "would still need to substantiate those claims from an FTC perspective."