E-cigarettes and the Multiple Responsibilities of the FDA
Abstract: Are e-cigarettes safer alternatives to combustible cigarettes? And if so, what are the U.S. Food and Drug Administration’s (FDA’s) responsibilities when it comes to disseminating this information? Prominent tobacco harm reduction advocates claim that [1] the evidence that e-cigarettes are safer is clear and incontrovertible, and [2] the FDA’s reluctance to actively disseminate that message is harmful for population health. In this paper we outline four different roles that the FDA plays that inform whether and how it should communicate evidence about e-cigarette risks and benefits to the public. The first two roles relate to the FDA’s responsibilities with respect to knowledge transmission and knowledge creation. The final two roles relate to the FDA’s ethical responsibilities related to its distinctive practical authority; the FDA acts as an advisor with significant practical implications for those whom it advises (and others), and it also possesses regulatory power through which it can directly change the material conditions of current smokers and non-smokers. We argue that in seeking to balance these four roles, the FDA must also remain cognizant that the evidence presented to establish the benefits of e-cigarettes for public health still comes with significant caveats and is far from definitive. As such, while the FDA should ensure that everything it says accurately reflects the best available science, it does not violate any right to information by remaining hesitant to endorse conclusive claims about the safety and efficacy of e-cigarettes while it continues to gather evidence bearing on those concerns.
For a copy email me: Thedanahoward "at" gmail.com