FDA Further Appeals Loss over Graphic Tobacco Packages Regulation

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Agency seeks further review of lower court decision on graphic warnings rule.

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In an attempt to discourage smoking and reduce smoking rates in America, the Food and Drug Administration (FDA) promulgated regulations last year that called for graphic warnings to take up half of the space on cigarette packaging.  The images chosen were intensely graphic:  pictures of black lungs overtaken by disease, dead bodies on autopsy tables, and a man smoking out of a hole in his neck.  Studies have suggested that, in terms of smoking prevention, the more grisly the better.

But recently, a three-judge panel on the D.C. Circuit Court of Appeals held that these regulations are unconstitutional.  The FDA has petitioned for further review by the full appeals court, hoping that the opinion of the sole dissenting judge on the panel will prevail if all the appeals court’s judges review the case.

The legal controversy began when several cigarette companies sued the FDA in federal court claiming that the new required warning labels compelled speech in violation of the First Amendment.  A lower federal court ruled in favor of the companies last February.  After the FDA appealed, the three-judge appellate panel upheld the district court’s decision in August.

The FDA had argued on appeal that the images were simply visualizations of factual information.  Such factual information, the FDA asserted, does not qualify as compelled speech under the commercial speech doctrine; rather it is an attempt on the government’s part to prevent fraud and the deception of consumers.  For this reason, the FDA argued, the regulation should only have to withstand a minimal level of judicial scrutiny.

The cigarette companies, by contrast, argued that the graphic depictions were intended to “repulse” smokers and “denigrate smoking as an antisocial act.” As a result, the messages on the cigarettes were not purely factual, they argued.  The messages qualified as compelled speech and needed to be subjected to a high standard of judicial review.

The three-judge panel agreed and applied heightened scrutiny to the regulation. It determined that, while the government does have a substantial interest in reducing the number of Americans who smoke, the FDA did not provide “ample evidence” that the new graphics would advance that interest.

The FDA hopes the other appellate judges on the D.C. Circuit will agree with the sole dissenting judge on the three-judge panel, Judge Rogers.  Rogers argued that the panel majority used the wrong standard in evaluating the new warning labels and that the labels should be subject to a “rational-basis” test instead.

Under heightened scrutiny analysis – the standard applied by the two judges in the majority on the three-judge panel – the government must prove that its asserted interest is substantial, the restriction directly advances the interest, and the restriction is narrowly tailored.

By contrast, a rational basis standard is more lenient and only requires the government show that its regulation is a reasonable means to achieve a legitimate government interest.

Because he found the warning labels present factually accurate information and the FDA was intending to counteract a history of misleading commercial speech by tobacco companies, Judge Rogers argued that the regulations should survive.

The D.C. Circuit Court is not obligated to rehear the issue in front of the full court. If, as is expected, the D.C. appeals court denies the rehearing, the agency will still have the option to appeal to the Supreme Court of the United States.