PA 301: UNIT 4 DISCUSSION INSTRUCTIONS
FDA Rulemaking Delegation
While agencies possess considerable discretion in the rulemaking process, if Congress has not delegated authority to an agency, any actions taken by an agency, including rulemaking, will be found invalid. This limitation is no more obvious than when considering the regulation of tobacco.
Prior to the passage of the Family Smoking Prevention and Tobacco Control Act in 2009, Congress had not delegated authority to the FDA to regulate tobacco products.
Beginning on page 179, read FDA v. Brown and Williamson Tobacco Corp., 529 U.S. 120 (2000), then answer the following questions:
1. In what rulemaking process did the FDA appear to have engaged?
2. Why did the Supreme Court hold that the actions taken by the FDA to regulate tobacco were invalid?
3. Do you agree with the Court’s ruling? Why, or why not?
