49 Pages Posted: 28 May 2017 Last revised: 20 Sep 2017
Date Written: August 9, 2016
Information has power – to inspire, to transform, and to harm. Recent technological advancements have enabled the creation of products that offer consumers direct access to a level of personal health information unprecedented in history. But how are we to balance the promise of health and wellness information with its risks?
Two agencies are tasked with protecting consumers from false claims of health products: the FDA and the FTC. This Article investigates if they are up to the task. In part a study of agency policymaking choices, and in part a prescription for more thoughtful and focused regulation, this Article compares both intra-agency and inter-agency regulation of informational health and wellness products. Certain procedural and substantive characteristics of FDA regulation are unsuited to informational health and wellness products, rendering comprehensive regulation by the FDA unrealistic. This gap creates an opportunity for the FTC to use its distinct and well-tailored enforcement tools to police harmful product claims that escape the FDA’s purview. I posit that by tailoring the FDA’s responsibility and sustaining the FTC’s engagement with health claims, the agencies can dovetail into a cohesive and comprehensive regulatory regime.
Keywords: mobile health, apps, DTC, genetic test, FDA, FTC
Suggested Citation: Suggested Citation
Duranske, Sarah, This Article Makes You Smarter (Or, Regulating Health and Wellness Claims) (August 9, 2016). American Journal of Law & Medicine, 43 (2017): 7-55. Available at SSRN: https://ssrn.com/abstract=2975618