The FDA, Congress, and Mobile Health Apps: Lessons from DSHEA and the Regulation of Dietary Supplements

Natalie R. Bilbrough

Within the past few years, the mobile health applications (“apps”) industry has exploded, with the number of available apps surpassing 100,000. One study shows that by 2018, more than half of the 3.4 billion smartphone and tablet users will have downloaded a mobile health app. The sheer scope of mHealth, and particularly mobile health apps, presents exciting possibilities for public health, but also formidable obstacles for the federal agencies charged with protecting consumers. Given that many mobile health apps are not developed with professional medical input, the risks of malfunction or erroneous health advice are great. For these reasons and others, physicians and other health care providers have generally been reluctant to incorporate mobile health apps and other types of mHealth into their practices.

Recognizing the need for some measure of oversight, the Food and Drug Administration (“FDA”) released a guidance document in September 2013 proposing a risk-based approach in which the FDA would actively regulate only a smaller subset of mobile health apps. According to the guidance document, the FDA will regulate only “mobile medical apps” (“MMAs”), which are mobile apps that meet “the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act” (“FDCA”). However, some stakeholders, scholars, and members of Congress consider FDA interference in this area to be unwarranted or ill-fitting. In 2013 and 2014, several members of Congress proposed bills to amend the FDCA, the source of the FDA's authority to regulate medical devices, by excluding certain types of software used in MMAs from the FDA's jurisdiction.