Establishing ethical interpretations of not yet fully interpreted public health and evidentiary standards in the Federal Tobacco Control Act

The U.S. Tobacco Control Act generally empowers FDA to act within its authorities to reduce tobacco use harms whenever FDA determines, without being “arbitrary or capricious,” that the action is “appropriate for the protection of the public health.” But these statutory standards have not yet been fully defined or clarified. This project will use bioethical principles and analyses to develop those legally viable interpretations that would operate most effectively and ethically to promote the public health - and then show how the clarified standards apply to FDA’s pre-market review of new tobacco products and possible future rulemaking. This ethical analysis will facilitate more rapid and constructive FDA action to reduce tobacco’s toll by providing a clearer, more complete framework to guide stakeholders, FDA staff, government officials who clear proposed FDA actions, and researchers, and by helping ensure that future court rulings on the Tobacco Act’s standards consider their ethical dimensions.