How the government regulates fitness apps

By Brian Dolan

Brian Dolan, Editor, MobiHealthNewsThe Wall Street Journal published a report  last summer that questioned whether "toning" sneakers like Skechers Shape-Ups or Reebok's EasyTones really help users get in better shape. The article included two links to case studies on the respective sneaker makers' sites that touted the various fitness benefits provided by the sneakers. The sneakermakers actually asked the WSJ to update the article with those links to better tell their side of the story.

Neither of those two links work anymore.

That's probably because the Federal Trade Commission complained that Reebok had made unsupported claims in advertisements for the shoes.

"In its ongoing effort to stem overhyped advertising claims, the Federal Trade Commission announced that Reebok International Ltd. has agreed to resolve charges that the company deceptively advertised 'toning shoes,' which it claimed would provide extra tone and strength to leg and buttock muscles," a press release posted on the FTC site last month stated. "Reebok will pay $25 million as part of the settlement agreement. The funds will be made available for consumer refunds either directly from the FTC or through a court-approved class action lawsuit."

The FTC alleged that Reebok made false claims, including that "walking in EasyTone footwear had been proven to lead to 28 percent more strength and tone in the buttock muscles, 11 percent more strength and tone in the hamstring muscles, and 11 percent more strength and tone in the calf muscles than regular walking shoes."

While not mentioned by the FTC, Skechers also took down the case study for its toning sneakers, so I assume they got the hint.

About three weeks before the Reebok announcement, the FTC forced two "acne cure" smartphone app developers out of the Apple AppStore and Android Market for making certain health-related claims without scientific evidence.

Skechers actually has a companion iPhone app called Skechers Fitness Tracker that promises to make "tracking your workouts in Skechers Shape-Ups effortless" and uses the "iPhone's built-in GPS technology to track your walking, running, cycling and hiking activities." As far as we can tell, the app's description never made claims similar to the ones that the FTC complained about and, as a result, appears to have survived the fallout unchanged.

Still, it's clear that the US Food & Drug Administration (FDA) is not the only regulator that need be considered:

"While the current conversation around mobile health regulation has focused on whether a mobile medical app meets the FDA's definition of a medical device, these recent moves by the FTC make clear that health and fitness app and device developers also need to be careful about the kinds of claims they make," Robert Jarrin, Senior Director, Government Affairs for Qualcomm and Co-Chair Continua’s US Policy Group told me in a recent interview.

I think these recent moves by the FTC show that the regulator is paying attention to fitness and health claims, however, as our recent Consumer Health Apps for Apple's iPhone report found, there are some 9,000 such apps available for the iPhone alone. How will the FTC monitor them all? The acne apps and the toner sneakers may be the exceptions since they both received considerable attention from various media outlets.

A new app called GlassesOff is set to become available to iPhone users some time next year. The app developer, Ucansi, claims that the program "can help you achieve over 80 percent improvement in vision acuity." Wow. Given that CBS News is one of the first media outlets to report on the app pre-launch, they better be prepared to prove it works as advertised to the FTC, while proving it doesn't work like a medical device to the FDA.

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