External Dynamics Contextualizing the FDA's Role in E-Cigarette Regulation.

Abstract

The authors of the target article articulate the complicated, often conflicting demands of U.S. Food and Drug Administration (FDA) roles as justification for the FDA’s delay in releasing guidelines and health-related safety information regarding e-cigarette consumption. However, despite emphasizing that “The FDA’s actions should not be taken in a historical or social vacuum” (Svirsky, Howard, and Berman 2022, 8) the authors fail to contextualize current e-cigarette regulatory decisions in the rich, recent history of Big Tobacco regulation. A critical examination of these intertwined sociopolitical and industrial forces which act upon the FDA and shape the regulatory landscape is necessary to understand the authors’ proposed roles. When the authors say, “The point here is not to paint the e-cigarette industry as similarly vicious or manipulative” relative to Big Tobacco (Svirsky, Howard, and Berman 2022, 8), they not only fail to view the two as connected, but explicitly communicate the opposite. Their description is ambiguous and misleading, implying that the e-cigarette industry exists as a separate entity from Big Tobacco. In the current industry landscape, every Big Tobacco company owns at least one e-cigarette brand (Gelder 2022). Juul and Vuse, the two most popular e-cigarette brands in the US by market share, are owned by Big Tobacco: Altria Group purchased a 35% stake in Juul in 2018, and Vuse is owned by Reynolds American Tobacco (Gelder 2022). Given these enmeshed corporate alliances, a more nuanced examination of the FDA’s roles requires specification of the e-cigarette/Big Tobacco industrial complex, its relationship to the FDA, and the remarkable ways in which this entity has shaped its own regulation. The impact of the authors’ neglect of this context is particularly glaring in their description of the FDA as a unidirectional Market Agent. The FDA historically has had the regulatory ability to shift the free-market environment, and evaluating its decision-making in that context is important. However, we must acknowledge that this role is fundamentally bidirectional, so-far-as the government’s ability to effectively regulate is contingent upon market cooperation. This is especially true in the case of e-cigarette regulation and the Altria Group as Altria, the previously introduced stakeholder in Juul, was crucially involved in the legislation behind the 2009 Tobacco Control Act through its subsidiary Phillip Morris (Barker 2009). Their active involvement in regulatory decision-making, as well as their global rebrand to the Altria Group from Phillip Morris, were means by which to distance the company from the successful public health campaigns against combustible tobacco use in the late 20th century (Barker 2009). In 2009, Altria only acquiesced to and ultimately supported federal intervention when it was able to create a favorable regulatory environment that boosted credibility (Barker 2009, 200). Through the years leading up to the act’s passage, Phillip Morris was “working closely with Congress for years on the specifics” to form “crucial industry-lobbied compromises” in regulatory frameworks (Barker 2009, 200). This regulation only occurred after it “in addition to boosting Philip Morris’s corporate image and deflated stock price, would supplant patchwork state and local regulations, defuse costly lawsuits, divert resources away from more effective tobacco-control efforts, prevent new companies from entering the cigarette market, and potentially stave off future, more damaging measures” (Barker 2009, 206). It also incentivized the future passage of reduced risk cigarettes, but importantly relied heavily on tobacco companies’ research to