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43 Am. J.L. & Med. 7 (2017)

handle is hein.journals/amlmed43 and id is 1 raw text is: American Journal ofLaw & Medicine, 43 (2017): 7-55 American Society of Law & Medical Ethics, C 2017 The Author(s) Boston University School of Law DOI: 10.1177/1559827617707977 THIS ARTICLE MAKES YOU SMARTER! (OR, REGULATING HEALTH AND WELLNESS CLAIMS) Sarah Duransket 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 ofFDA 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. INTRODUCTION Every day, consumers rely on health and wellness information provided directly to them by modem technology. A genetic test directs a user to a low-carb diet. An app analyzes a mole for cancer risk. An online symptom checker provides a list of possible diagnoses based on the user's symptoms. Outside the bounds of the doctor-patient relationship, consumers must judge whether this information is sufficiently accurate and useful to rely upon. Some decisions may be insignificant: eggs or cereal for breakfast? But other decisions could have major health implications: do I forgo a doctor's appointment for this low-risk mole? I Thomas C. Grey Fellow and Lecturer in Law, Stanford Law School. For their helpful comments and conversations, I am grateful to Hank Greely, Michelle Mello, Roland Nadler, Normal Spaulding, Natalie Salmanowitz, Rebecca Wolitz, Yanbai Andrea Yang, and the participants of the 2016 Grey Fellows forum.

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