Ethically Interpreting the Tobacco Control Act to Help FDA and the Courts

The Tobacco Control Act of 2009 act generally empowers the U.S. Food and Drug Administration to issue new tobacco control rules or otherwise regulate tobacco products and their marketing, however, it stipulates that FDA’s action not be “arbitrary or capricious,” and that actions be “appropriate for the protection of the public health.” The aim of this project is to develop the most ethically appropriate, legally viable interpretations of this appropriateness and protection standard. By addressing how the public health and evidentiary standards in the Tobacco Control Act could best be interpreted and applied in different situations, the project will provide important new insights and analysis to support FDA’s tobacco control efforts. It will also directly inform the courts when they consider any tobacco industry claims that certain FDA regulatory actions do not comply with those statutory standards. Bruce Jennings is a member of the core project team. Project funded by the Greenwall Foundation through the O’Neill Institute for National and Global Health Law at the Georgetown University School of Law, 2017-2019.

For additional information:
O'Neill Institute for National & Global Health Law