On February 29, 2012, the United States District Court for the District of Columbia held in R.J. Reynolds v. FDA that the Food & Drug Administration’s (FDA) final rule requiring the display of certain graphic images such as “diseased lungs” and a “cadaver bearing chest staples on an autopsy table” violated the First Amendment by impermissibly compelling commercial speech. The decision extends a previously granted preliminary injunction enjoining enforcement of the rule.

The challenged rule implemented the Family Smoking and Tobacco Control Act (“the Act”), which President Obama signed into law on June 22, 2009, and its direction to FDA to “issue regulations that require color graphics depicting the negative health consequences of smoking.” The Act required that textual warnings and graphic images occupy the top 50% of the front and back panels of all cigarette packages. The Rule would have required one of 9 graphic color images to be displayed along with the 9 textual warnings created by Congress.

The Court first noted that such images could not be fairly characterized as “warnings” because they are “more about shocking and repelling than warning.” Reiterating the principle that the First Amendment protects “both the right to speak freely and the right to refrain from speaking at all,” the Court noted that compelled speech is “presumptively unconstitutional.” While the government may require disclosure of purely factual and uncontroversial information so long as the requirement is not “unjustified or unduly burdensome,” compelled disclosure of more subjective information is subject to strict scrutiny. The Court explained that the images chosen in the Rule were not chosen to protect the consumer from confusion or deception, but rather to “evoke a strong emotional response calculated to provoke the viewer to quit or never start smoking.” Such images could not be considered “factual and uncontroversial” and thus the regulation was subject to strict scrutiny.

Applying strict scrutiny, the Court held that the government had failed to meet its burden to demonstrate that the Rule is “narrowly tailored to achieve a compelling government interest.” While FDA contended that the Rule sought to convey “to consumers generally, and adolescents in particular, the devastating consequences of smoking and nicotine addiction,” the Court stated that the actual purpose was “not to inform or educate, but rather to advocate a change in behavior—specifically to encourage smoking cessation and to discourage potential new smokers from starting.” This actual purpose could not pass strict scrutiny because “[a]lthough an interest in informing or educating the public about the dangers of smoking might be compelling, an interest in simply advocating that the public not purchase a legal product is not.”

Even assuming FDA had a compelling government interest, the Rule could not pass strict scrutiny because “the sheer size and display requirements for the graphic images are anything but narrowly tailored.” Along the same lines, the Court cited plaintiffs’ explanation of a number of less restrictive alternatives as further evidence that the Rule was not narrowly tailored. For instance, the Government could disseminate its anti-smoking message itself, change the display requirements, increase cigarette taxes or improve efforts to prevent the unlawful sale of cigarettes to minors.

The decision seems likely to be headed to the D.C. Circuit on appeal as the Department of Health and Human Services suggested in a statement that it was “confident that efforts to stop these important warnings from going forward will ultimately fail.” The decision also has important implications for other FDA labeling regulations, including a possible front-of-package labeling scheme suggested by a recent Institute of Medicine study for all food products. See Kelley Drye Client Advisory, IOM Issues Phase II Report Recommending Energy Star-Type Ratings for a Food Front-of-Package Nutrition Rating (Oct. 24, 2011).