This Article Makes You Smarter! (Or, Regulating Health and Wellness Claims)

Abstract

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.

Regulatory overlap: A systematic quantitative literature review

“…Where overlap was reviewed positively, papers most often recognized more than one benefit. Of the 34 papers that identified benefits of regulatory overlap, 21 listed two or more of the different Tier 3 codes (see, e.g., Gersen, 2013; Naso et al, 2020; Weaver, 2014) with 10 papers including over three or more codes (see, e.g., Aagaard, 2011; Buzbee, 2017; Duranske, 2017) and one paper was coded with seven different identified benefits (Babcock, 2012). Interestingly, many of these papers also argued that regulatory overlap could be a problem.…”

“…The US papers commonly identified the need for “departmental” solutions, and more specifically to allow for controlled overlap (11/31 papers) (see, e.g., Lee, 2016; Macey, 2017; Marisam, 2011). US papers also identified the government solution of clear government standards (Tier 4) to resolve overlap (11/31 papers) (see, e.g., Chen, 2017; Duranske, 2017; Michaels, 2016). Also, within the US coded papers, reform through “prioritize clarity” (10/31 papers) (see, e.g., Thurmond, 2012; Weaver, 2014; Welsh, 2013) and “prioritize consultation” (10/31 papers) were frequently proposed (see, e.g., Michaels, 2016; Orozco, 2020; Robbins, 2015).…”

“…Indeed, even where regulatory overlap was not seen as a problem, 19 poor management of overlap is always identified as an issue and risk (see, e.g., Li, 2015;Robbins, 2015). Consistently, the literature and the data suggest that governments and departments must increase communication, ensure they are speaking to relevant parties, communicate clearly, and at times agree to informal solutions (see, e.g., Carter et al, 2017;Duranske, 2017;Macey, 2017). 20 Hence, the literature suggests that where governments face problems of regulatory overlap, they must develop a clear approach to ensure operational efficiency, both internally and externally.…”

“…The combination of the data elements above allowed us to differentiate or compare circumstances of regulatory overlap as reported in the literature. For instance, the situation of regulatory overlap that occurs between two departments in the United States regulating a food or medical product (see, e.g., Duranske, 2017; Johnson, 2019; Macey, 2017) is fundamentally different from “regulatory overlap” in Indonesia where there is a conflict between the customary and traditional laws relating to forestry uses, and a governmental approach that permits deforestation (see, e.g., Boer, 2018; Kunz et al, 2017; Setiawan et al, 2016). Both scenarios identify where laws and policies overlap and create confusion and uncertainty.…”

“…12 In reference to the type of reform, the recurring proposed solutions were for "act reform" (23 papers) (see, e.g., Murray, 2012;Shih, 2020;Windholz, 2013a) 13 followed by the proposal to reduce regulations (13 papers) (see, e.g., Anker et al, 2015;Unruh, 2012;Vaale-Hallberg, 2014). The solution of reduced regulations was linked to papers that were calling for either a single act or standard (4 papers) (see, e.g., Benson, 2012;Junita, 2015;Middleton, 2015) or conversely those that suggested multiple acts (two papers) (see, e.g., Kim, 2011;Windholz, 2013b) or multiple departments (five papers) (see, e.g., Duranske, 2017;Godwin et al, 2017;Godwin et al, 2016). When identifying a method of reform, academics most frequently argued that it was necessary to "prioritize clarity when reforming the overlapping law" (33 papers) (see, e.g., Dombora, 2019;Kalabamu, 2019;Vaale-Hallberg, 2014) 14 to "prioritize consultation when reforming" (18 papers) (see, e.g., Breen, 2013;Michaels, 2016;Robbins, 2015) and to "prioritize informality" and "not overly regulate" (17 papers) (see, e.g., Chen, 2017;Crabb, 2019;Dombora, 2019).…”