The FDA will recognize cosmetics apps as either medical devices or general wellness devices, explain Debra S. Dunne, Laurie A. Henry and Madeleine McDonough, partners at the firm of Shook Hardy & Bacon, in their article for lexology.com.
At the same time, the lawyers note that the FTC’s focus on truthfulness in marketing and data privacy has the potential to dictate the app strategy of beauty brands.
“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,” caution Dunne, Henry and McDonough.
Devices and apps that fall into the FDA’s General Wellness category and are low-risk will not be regulated by the agency, according to the latest draft guidance. Low-risk products “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,” explain the lawyers.
The agency has outlined two subcategories of General Wellness. The first is for products used to promote healthy living without alluding to a particular health condition and the second for products that track consumers and encourage healthful choices.
The FDA is accepting comment before finalizing its draft of General Wellness: Policy for Low Risk Devices. The agency will take into consideration any remarks received by or before April 20, 2015. According to the FDA site, no public comments have been filed to date. (Read the draft guidance and find instructions for submitting comment here.)
Over the limit
Beauty app marketing claims need to be well supported by scientific evidence to pass muster with the FTC. Skin care apps, like MelApp and Mole Detective, purported to help consumers detect skin cancer have fallen under scrutiny, according to an earlier article on Cosmetics Design. Similarly, companies marketing apps as acne cures and treatments gave up their profits and settled with the FTC, pointed out Dunne, Henry and McDonough.
Additionally, the commission 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.”
“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,” observe Dunne, Henry and McDonough.