What Tobacco Control Rules Would an Ethically Responsible FDA Implement (If the White House Let It)? − Would a Nicotine-Reduction Rule Pass Muster?

The U.S. Food and Drug Administration (FDA) has not yet used its extraordinary tobacco control powers to implemented any substantive tobacco control rules that would sharply reduce the more than 400,000 deaths and other enormous harms and costs caused by smoking and other tobacco use each year. FDA’s failure is not entirely its fault. Since 2009, when FDA first received its tobacco control authorities, the agency has never received the support it needs from the White House and the Office of Management and Budget to move any major rules through the federal clearance process successfully. Instead, White House apathy or opposition, alternative priorities, or political concerns have impeded FDA’s efforts to put effective new tobacco control rules into effect.

Applying the most directly relevant ethical approaches – utilitarianism, bioethics, and public health ethics – this paper shows that the White House has an irrefutable ethical duty to ensure that FDA quickly uses its extraordinary statutory powers to issue strong, new rules to reduce the unnecessary harms and costs from tobacco use as quickly as possible – so long as those rules are ethically valid and appropriate. The paper then explains how the many complications that arise when trying to develop ethically appropriate policies or regulations because of conflicting ethical goals or perspectives and the subjectivity of values are reduced or eliminated by the Tobacco Control Act’s overriding goal of protecting the public health, the enormous ethical harms caused by tobacco use, and the ready availability of a range of effective measures to reduce them. It then shows how FDA could use the paper’s ethical framework and guidance to identify, structure, and implement new ethically appropriate rules that would quickly minimize tobacco use health harms and secure other ethical benefits – if FDA finally received the White House support it requires.

The tobacco industry often argues that respect for smokers’ rights or individual choice should constrain any efforts to prevent or reduce tobacco use by FDA or other government actors. But the ethical analysis presented here shows that, even if personal autonomy concerns are given as much weight as they could possibly deserve, a range of unprecedented new FDA tobacco control rules, including a rule to minimize nicotine in cigarettes, are not only legally viable and ethically appropriate but also ethically required. Through its analysis, this paper not only provides direct legal and ethical guidance for the White House and FDA but also provides an ethical framework for selecting and evaluating tobacco control proposals or actions at all levels of government in the United States and in other countries, as well.