Preemption Review

The Food and Drug Administration (FDA) is announcing that it has determined, after conducting a review of its existing regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the Agency to preempt State law, that three FDA regulatory preambles contain or refer to statements about preemption that are not legally justified. FDA conducted this review in response to the President's May 20, 2009, "Memorandum for the Heads of Executive Departments and Agencies," which outlined the Administration's policy on preemption, in keeping with the principles in Executive Order 13132 on Federalism. The President's memorandum included a directive that such a review be conducted. FDA is also taking this opportunity to clarify certain preamble statements related to preemption resulting from express preemption provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act) concerning nonprescription drugs and food labeling.