Originally published September 28 2013
FDA now trying to regulate 'smartphone' apps by blocking all natural medicine technology from mobile devices
by Jonathan Benson, staff writer
(NaturalNews) The internet is no longer the only open-source communication medium that the U.S. Food and Drug Administration (FDA) is trying to censor. The Alliance for Natural Health - USA (ANH-USA) reports that the FDA is now going after "smartphones" by trying to force mobile "app" developers to gain pre-approval from the rogue federal agency before being allowed to publish certain health- and medicine-related apps for public use.
Based on the language in an agency draft guidance issued last summer for public review, the FDA appears poised to begin regulating medical mobile apps as if they were medical devices, which means they would be subject to the agency's extensive regulatory approval process before being made available in mobile app stores. And since medical devices are largely regulated in the same way that drugs are, medical mobile apps will essentially be treated as though they too are drugs.
This latest regulatory attack comes as health-related mobile phone apps are literally exploding across the smartphone landscape. There are now thousands of smartphone apps that help people track calorie intake, log exercise routines, obtain nutrition advice, and even self-regulate things like blood sugar levels. The medical app market, according to ANH-USA, is growing by a whopping 25 percent annually, more than any other app category.
What this means is that more people than ever are taking control of their own health, and using their smartphones as a convenient way to make better health decisions. But the FDA apparently does not approve of this, especially since it cannot extract user fees from this market segment under the current regulatory paradigm. So the agency is now trying to change the law in order to get its hands on this lucrative market.
FDA regulation of smartphone apps will stifle innovation, further erode freedom of health speech
The FDA's justification for attempting to inject itself into the mobile app business is that certain apps essentially turn a smartphone into a medical device, it says, which makes them subject to FDA jurisdiction. But the criteria used to determine whether or not a medical mobile app is also a medical device is somewhat ambiguous, particularly as it concerns users' ability to input specific health information for customized output.
Put another way, the FDA essentially wants to regulate any mobile app that provides specific, health-related information to users in a customized way. So while an app that keeps track of how many miles a user runs and calculates related calorie loss would be exempt, an app that allows a user to calculate which dietary supplements he could benefit from based on his specific health profile might be considered off limits apart from official FDA approval.
"Given the FDA's bias against alternative medicine, a pre-approval process for apps will very likely ensure that we won't see many that are focused on natural health," says ANH-USA. "An app, for example, that measures daily recommended intake for vitamins and minerals would adhere to the standards of conventional medicine rather than the nutrient standards recommended by integrative physicians."
Such regulations will also significantly stifle innovation, as it will be far too expensive for many mobile developers to gain FDA approval for their apps. Many of them will also likely be confused as to whether or not their apps even need FDA approval in the first place, as the proposed scope of enforcement is somewhat vague and open to interpretation.
The draft guidance specifically states, for instance, that exempted apps cannot be intended to cure, treat, seek treatment for mitigating, or diagnose any disease, disorder, "patient state," or any specific, identifiable health condition. Based on the FDA's extensive record of tyranny against supplement manufacturers using such legal terms, it seems obvious that the FDA will attempt to use such language to hamper all mobile apps that try to share truthful, unbiased health information with the public.
You can view the full FDA draft guidance here: http://www.fda.gov
Sources for this article include:
http://www.anh-usa.org/smartphone-apps-must-be-fda-approved/
http://www.npr.org
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