On August 24, 2012, a federal appeals court ruled in R.J. Reynolds v. FDA that an FDA regulation requiring new, large graphic warning labels on cigarette packages violates the tobacco companies’ First Amendment rights.
The 2009 Family Smoking Prevention and Tobacco Control Act (the “Tobacco Control Act”) included a requirement that tobacco manufacturers place warning labels over 50% of the front and back of cigarette packages. Congress left it up to the FDA to determine the content of the labels.
In June 2011, the FDA released the warning label designs. Shortly after that, several large tobacco companies (including R.J. Reynolds, Lorillard, and Commonwealth Brands) sued the FDA, claiming that the labels violate the First Amendment. The labels were scheduled to be placed on cigarette packages in September 2012, but the companies asked the court to order that the implementation date of the labels be pushed back until 15 months after the case had been fully resolved, and the court agreed.
On February 12, 2012, the district court ruled that the regulation specifying the content of the new graphic warning labels violates the First Amendment because the mandated graphic warnings went beyond factual disclosures, which the government may legally require, and instead forced tobacco manufacturers to adopt the government’s anti-smoking message, which the judge said goes beyond the government’s legal authority. The FDA appealed the decision, and arguments were heard in April 2012.
The latest ruling
In August 2012, the Court of Appeals for the D.C. Circuit issued its ruling agreeing with the lower court that the nine warning labels designed by the FDA—which include images of a simulated cadaver, a cartoon drawing of a baby in a cloud of smoke, and a photo of a blackened lung, among others—go beyond simple factual warnings and are a form of advocacy imposed by the government. The court held that because the labels involve images that do more than convey dispassionate facts, the labels violate the First Amendment.
Impact of the ruling and next steps
This ruling contradicts a decision in another case by the Sixth Circuit Court of Appeals. In Discount Tobacco & Lottery v. United States, the Sixth Circuit held in March 2012 that the Tobacco Control Act’s cigarette package warning label requirement did not violate the First Amendment. (For more information about that case, see this FAQ.)
The FDA is undertaking research to support new regulations that will address the issues identified by the court. As a result, the agency has indefinitely postponed implementation of the graphic warning labels.
For more detailed information, contact our staff attorneys.