As devices plug more people into the “Internet of Things,” there is a growing overlap between the world of smartphones, tablets and software, and the world of dietary supplements, cosmetics and nutraceuticals. Regulatory agencies are also becoming more involved in the mobile and online space. The Food and Drug Administration’s (FDA’s) recently released draft guidance document for general wellness products, which adds to the agency’s previously finalized guidance on mobile medical apps, and the Federal Trade Commission’s (FTC’s) recent enforcement actions could direct the development of health and beauty mobile apps.
FDA has issued a guidance document governing mobile apps that it will regulate as medical devices. Most apps for dietary supplements, cosmetics and nutraceuticals, however, are likely to fall into the “general wellness” category. According to the draft guidance, FDA does not intend to regulate low-risk general wellness devices. The agency defines “lowrisk” products as those that are non-invasive, do not involve a technology or intervention that poses a risk to user safety if it is uncontrolled (e.g. lasers), and do not raise novel questions of usability or biocompatibility. “General wellness” products fall into two categories: (1) They can be intended for use to sustain or encourage a general state of health without referencing specific diseases or conditions; and (2) They can be intended for use as a way to promote, track or encourage choices that may help people live well or reduce the risk of certain chronic diseases or conditions. The draft guidance document for general wellness products is currently available for public comment until April 20, 2015.
In the mobile app field, FTC has focused on two primary areas: data privacy and deceptive marketing claims. FTC has sent warning letters to app makers for collecting data in violation of the Children’s Online Privacy Protection Act and for failing to disclose types of private data that apps collect.
In the past, app makers who claimed that their apps could detect skin cancer were charged with deceptive marketing practices and forced to give up their profits to settle FTC’s claims, as were app makers who claimed that their product could treat acne.
As an example of a mobile app in this space, the National Institutes of Health (NIH) has created a My Dietary Supplements app to help consumers keep track of vitamins, minerals, herbs, and any other dietary supplements they take. It contains information from product labels, including directions, health claims and warnings. Because the NIH app is low-risk and intended to help consumers track their general wellness, it would not be regulated by FDA, but the FTC may be interested in how the NIH stores consumers’ information and the privacy disclosures that are made when consumers download the app.
Companies have new opportunities to reach clients, market their products and grow their businesses through mobile apps, but this evolving landscape comes with possible legal and regulatory risks. Being aware of regulatory concerns will ensure that mobile apps in the health and beauty space help grow businesses without triggering legal or regulatory minefields.