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FDA Responds to Court Ruling on Graphic Warning Labels

In an apparent response to a recent court ruling that disapproved of FDA’s requirements for graphic warning labels on cigarette packages, FDA recently announced that it will be collecting data geared toward ascertaining the effectiveness of the warning labels, particularly on smoking cessation.

In an August 2012 decision, the D.C. Circuit Court of Appeals rejected FDA’s proposed warning labels. Among other reasons, the court disapproved the warnings because FDA offered no evidence that the chosen labels actually furthered FDA’s stated goal of encouraging people to quit smoking and discouraging people from starting.

Perhaps in response to the court’s ruling, FDA issued a December 5th notice in the Federal Register indicating that it will be collecting data from consumers regarding the warnings’ effectiveness. Specifically, FDA announced that its survey will collect information as to whether the warnings: (1) convey information about smoking’s health risks; (2) encourage smoking cessation; and (3) discourage smoking initiation. The stated goals of the survey are to: (1) measure consumer responses to the labels; (2) determine whether responses to the labels differ across various groups; and (3) evaluate the relative effectiveness of various graphic images. Presumably, the survey is intended to bolster FDA’s case in future litigation regarding the labels’ constitutionality.

In related news, the D.C. Circuit Court of Appeals last week rejected FDA’s request for en banc rehearing (rehearing by all of the judges on the D.C. Circuit) of the panel’s decision on the warning labels. This recent decision now makes the matter ripe for U.S. Supreme Court review of FDA’s labels. One federal court of appeals (the Sixth Circuit) has approved the Tobacco Control Act’s warning label requirement, while the D.C. Circuit has rejected the specific labels chosen by FDA. Differing opinions from federal courts of appeals increases the likelihood of Supreme Court review, although one could argue that the issues presented in the Sixth Circuit case (which considered the Tobacco Control Act’s warning label requirement, but without considering the specific warnings chosen by FDA) differ from those presented in the D.C. Circuit case (which involved an as applied challenge to the warnings actually chosen by FDA). Further commentary on this issue from the Troutman Sanders Tobacco practice can be found in a recent Law360 article.

For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 or by email.

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