The Federal Trade Commission announced this week that Lumos Labs had agreed to settle false and deceptive advertising claims related to the company’s promotion of its “Lumosity” cognitive training programs (commonly referred to as “brain training”). Under the FTC’s Settlement Order, Lumos Labs will pay $2 million in consumer redress and notify its on-line subscribers of the FTC settlement, as well as provide them with directions on how to cancel their Lumosity auto-renewal subscriptions. The Settlement Order also requires the company and individual defendants, co-founder and former CEO Kunal Sarkar and co-founder and former Chief Scientific Officer Michael Scanlon, to have competent and reliable scientific evidence (in the form of human clinical data) before making future claims about any mental health related benefits associated with use of the product. The FTC Complaint and Settlement Order can be found here.

As noted in the FTC’s Complaint, which was filed this week in US District Court, Northern District of California, Lumosity was promoted for with claims of delaying onset of age-related cognitive decline, dementia, and Alzheimer’s, as well as for improving performance on everyday tasks such as “school, work, and athletic performance.” However, on the basis of its investigation, the FTC determined that the company did not have adequate scientific evidence to support such cognitive health and real-world product performance claims. In addition,  the Complaint also charged the company with failing to disclose that some consumer testimonials featured on its website had been solicited through contests that promised significant prizes, including a free iPad, trip to San Francisco, and other inducements.

The Lumosity programs consist of over 40 subscription-based games that can either be played on-line or via mobile app. Each game is purportedly designed to target and train specific areas of the brain. Lumosity has been marketed in the US since 2007, and has been widely promoted though TV and radio advertisements. The company also marketed Lumosity through emails, blog posts, social media, on their website, Lumosity.com, and used Google AdWords to drive traffic to their website, purchasing hundreds of keywords related to memory, cognition, dementia, and Alzheimer’s disease.

This enforcement action is indicative of the FTC’s and also the Food and Drug Administration’s increasing scrutiny concerning online programs and mobile apps that are promoted for medical-related uses and health benefits. Indeed, FDA introduced final guidance to industry in 2014 on how it planned to regulate health-related mobile medical apps (MMAs) in terms of which types of apps would be regulated as medical devices and which types would be subject to Agency enforcement discretion, and instead regulated as consumer products. Since then, FDA has continued to monitor the app marketplace to ensure consumer-related apps are not promoted for unapproved medical purposes. Thus, marketers of brain training programs, games, and apps should continue to ensure they have both adequate substantiation to support product performance claims and also remain mindful that FDA has established guidelines for what types of apps are medical devices and what types are consumer products.