FDA Declares Preemption Language in Regulation Preambles Not Legally Supportable
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 involve labeling rules for prescription drugs,
biological products and medical devices.
FDA also clarified the preemption language in other regulations, including
those on food labeling and specifically cited “74 FR 2443, January 15, 2009,”
which proposed amending the labeling for yogurt products.
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.