What Is “Appropriate for the Protection of the Public Health” Under the U.S. Tobacco Control Act?

Eric N. Lindblom*

Abstract

In 2009, the U.S. Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) gave the U.S. Food and Drug Administration (FDA) extensive new powers to issue rules and take other regulatory actions to reduce tobacco use and its massive harms, so long as FDA determined that doing so was “appropriate for the protection of the public health” (AFPPH). What exactly that phrase means and how much it constrains or facilitates effective FDA tobacco control efforts has not been determined, and FDA has yet to implement a rule that would sharply reduce U.S. tobacco use harms. Through a careful analysis of the Tobacco Control Act, applicable case law, and other relevant sources, this Article reveals what FDA must, may, and must not do when issuing tobacco control rules or orders; identifies the remaining gray areas and how they might be clarified; and suggests new FDA approaches to insulate its regulatory actions against future legal challenges and better protect the public health.

Some assume that FDA must evaluate costs, illicit trade impacts, and other non-health effects when determining whether a regulatory action is “appropriate” or must put a higher priority on protecting youth than helping adult smokers. However, this Article’s analysis finds that the Tobacco Control Act’s unique public health standard focuses exclusively on ensuring that any FDA tobacco control rules or orders will benefit the health of the U.S. population as a whole. FDA may consider non-health impacts or subpopulation health impacts when deciding what regulatory actions to take. But such impacts are irrelevant to FDA appropriate-for-the-protection-of-the-public-health determinations (or related court review), except to the extent they contribute to the regulatory action’s net public health impact.

Gaps in the statute leave certain aspects of this public health standard unsettled. It does not tell us what “appropriate” means, how large and likely a net gain to the public health must be to qualify as AFPPH, or how to estimate such inevitably uncertain future health impacts. Nor does it say whether an FDA regulatory action that creates a risk of a negative public health impact could be “appropriate,” or, if so, what ratios of likelihood and size between the potential net public health benefits and the potential net harms would be AFPPH. The Act leaves resolving these issues almost entirely to FDA’s discretion, subject only to the Administrative Procedure Act’s “not arbitrary or capricious” standard. But, as detailed herein, FDA must find certain tobacco control orders AFPPH even if they create a risk of producing a negative public health impact. At the same time, FDA still has a legal duty to minimize any risk that an otherwise AFPPH regulatory action might produce a net public health harm, and FDA must also take steps to refine its final AFPPH tobacco control rules and orders to reduce certain non-health harms and negative individual or subpopulation health impacts, at least when that can be done without reducing the expected net public health gains.

When developing tobacco control rules and orders and trying to predict their public health impacts, FDA unavoidably works in areas of considerable uncertainty. As shown here, however, FDA has enormous discretion in terms of evaluating research and other evidence, making projections of future impacts, and, should it choose to do so, moving forward with aggressive tobacco control actions even when real-world experience and directly relevant research are scarce or nonexistent.

This Article’s comprehensive analysis of the Tobacco Control Act’s public health and evidentiary standards provides important new insights for FDA, tobacco industry members, and other parties interested in commenting on FDA’s proposed rules and orders (or challenging or defending them in court).

* Eric N. Lindblom is a Senior Scholar at Georgetown Law’s O’Neill Institute for National & Global Health Law. He was Director of the Office of Policy at FDA’s Center for Tobacco Products from 2011 to 2014, and previously served as General Counsel and Director for Policy Research at the Campaign for Tobacco-Free Kids. The development of this Article was supported by a Greenwall Foundation “Making a Difference in Real-World Bioethics Dilemmas” grant.

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