The Food and Drug Administration (FDA) has determined that text included in the preambles to three regulations adopted over the past 10 years and purporting to preempt state law “are not legally justified.”
The agency reviewed all of its regulations in response to President Barack Obama’s (D) May 20, 2009, memorandum outlining the administration’s preemption policy. The three affected regulations include: “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products” (the physician labeling rule); “Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile”; and “Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices.”
FDA also clarified the preemption language in other regulations, including one on food labeling. According to the agency, the preamble, which discusses the rule’s “pre-emptive effect, in that it would preclude states from issuing any … requirements … that are not identical to those required by the final rule,” failed to “acknowledge the applicability limitation set forth in section 6 (c)(2) of the Nutrition Labeling and Education Act.” According to FDA, that section, which provides that 403A of the Food, Drug, and Cosmetic Act “shall not be construed to apply to any requirement respecting a statement on the labeling of food that provides for a warning concerning the safety of the food or component of the food,” should have been included in the preamble’s preemption discussion. See Federal Register, October 5, 2011.