FDA Graphic Warnings

RJ. Reynolds v. United States Food and Drug Administration, 696 F.3d 1205 (2012).

In August 2012 The U.S. Court of Appeals for the D.C. Circuit issued a ruling finding the FDA’s new graphic health warning requirement for cigarettes and advertising unlawful.  The FDA rule, which was scheduled to go into effect in September 2012, would require larger health warnings that cover the top 50 percent of the front and back panels of cigarette packages and the top 20 percent of printed cigarette advertisements.  The rule was mandated by Congress as part of the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA).  More information on the proposed warnings is available here.

Several tobacco companies challenged the FDA rule in federal court, claiming that it violated their First Amendment rights by restricting their speech and requiring them to distribute a message with which they did not agree. In February, U.S. District Court Judge Richard Leon ruled that the FDA rule requiring graphic warning labels on cigarette packs violated the First Amendment.  On August 24th, the D.C. Circuit Court agreed, for different reasons, in a 2-1 decision filed by Circuit Judge Janice Rogers Brown. The U.S. government has decided against pursuing an appeal and the FDA is going to review and create new warning labels.

In a separate case, the Sixth Circuit Court of Appeals issued a 2-1 decision in March upholding the FSPTCA’s requirement for the graphic warnings.  The Sixth Circuit panel concluded that there is “abundant evidence that larger warnings with graphics promote a greater understanding of tobacco related health risks and materially affect consumers’ decisions regarding tobacco use.”  The D.C. Circuit Court, however, insisted that the FDA must show evidence that the warnings would reduce smoking rates (not merely educate consumers), and it found that the FDA had not done so.  The court was not persuaded by the evidence from other countries, insisting that such evidence could not show that the warnings themselves directly accomplished the reduction in tobacco use found in those countries (because other tobacco-control measures were implemented around the same time).

In our view, the decision is flawed in many respects.  First, the Court misapplied the Central Hudson test, which is typically used to analyze restrictions on commercial speech; this case pertains to the doctrine of compelled speech, which applies when the government requires private parties to carry a message on behalf of the government.  (For more information about the First Amendment and tobacco control issues, click here.)  Second, the court ignored the government’s interest in effectively communicating information about the health consequences of tobacco use. Finally, the court dismissed out of hand the significant evidence offered by the government that demonstrates that its graphic warnings would directly advance its substantial interest in communicating this information and reducing tobacco use.

The full text of the decision is available here.

Commentary from the Campaign from Tobacco-Free Kids is available here.


American Academy of Pediatrics, Massachusetts Chapter of American Academy of Pediatrics, Inc., American Cancer Society, Inc., American Cancer Society Cancer Action Network, Inc., American Heart Association, Inc., American Lung Association, Campaign for Tobacco-Free Kids, Truth Initiative Foundation d/b/a Truth Initiative, Dr. Ted Kremer, Dr. Jonathan Winickoff and Dr. Lynda Young v. U.S. Food & Drug Administration, 1:16-cv-11985 (D. Mass. October 4, 2016)

On October 4, 2016, a group of eight public health advocacy organizations and several physicians filed suit against the U.S. Food & Drug Administration (FDA) to compel the agency to carry out its obligation under the Family Smoking Prevention and Tobacco Control Act to require cigarette packages and advertisements to bear graphic health warnings.

In 2011, the FDA promulgated a final rule designating nine graphic warning labels depicting the negative health consequences of cigarette smoking. That rule and the designated graphic warnings were successfully challenged by the industry. The court’s decision largely rested on what the district court judge claimed was a lack of evidence presented by the FDA to establish the effectiveness of the graphic warnings in deterring tobacco use. Rather than further appeal the case, the FDA opted to undertake further research in support of a new graphic warnings rule.

The complaint alleges that while more than four years have passed since the rule was vacated, the FDA has failed to even begin rulemaking proceedings for new graphic warnings as required by the Tobacco Control Act. During that time, the plaintiffs say more than 3 million Americans, most of them minors, have begun to smoke on a regular basis and half of them will die prematurely as a result. Plaintiffs also assert that 2 million people have died of tobacco-related diseases during the time the FDA has been in violation of the Tobacco Control Act.

The complaint alleges that promulgating these rules is nondiscretionary—in other words, the FDA cannot decide to forego the requirement, but rather, is legally required to comply. The plaintiffs further assert that there is extensive scientific evidence supporting the positive impact of graphic health warnings on public health (indeed, plaintiffs say such evidence existed to support the agency’s original rules in 2011). Thus, the plaintiffs request the court compel the FDA to begin expedited rulemaking procedures to implement the graphic warnings requirement of the Tobacco Control Act.

This summary will be updated as the case progresses.