R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration, F.3d (D.C. Cir. 2012)

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Status: Closed

Legal Issue

Whether the district court was correct in granting a preliminary injunction against enforcement of graphic warnings on cigarette packages, required by the Family Smoking Prevention and Tobacco Control Act, which illustrate well-documented consequences of smoking in an easy-to-understand and memorable way, thus raising public awareness of the risks of smoking and promoting public health by reducing tobacco use.


On August 16, 2011, five tobacco companies (R.J. Reynolds, Lorillard, Commonwealth Brands, Liggett, and Santa Fe) filed a Complaint with the U.S. District Court for the District of Columbia, challenging the Food and Drug Administration (FDA)’s final rule announcing graphic warning requirements on cigarette packages and advertising, scheduled to go into effect in September 2012. The companies opposed the FDA’s new warning label requirements on First Amendment grounds. 

On Nov. 7, 2011, U.S. District Judge Richard Leon sided with the tobacco company plaintiffs and granted their motion for a preliminary injunction – an order from the court putting the requirements on hold until there is a final judgment on the merits of the claims. The tobacco companies successfully argued that they were likely to prevail on their claim that the graphic warnings compelled them to “engage in anti-smoking advocacy” on behalf of the government, breaching their right to free speech. The Department of Justice appealed Judge Leon's ruling to the U.S. Court of Appeals for the District of Columbia Circuit. 

On December 19, 2011, the Tobacco Control Legal Consortium joined eleven other major non-profit public health organizations, consumer advocacy groups, and physicians’ associations in submitting an amicus curiae brief to the D.C. Circuit in support of the graphic warning labels required by the Family Smoking Prevention and Tobacco Control Act (Act) and issued by the Food and Drug Administration. Our brief argues that, in granting the injunction, the district court (1) ignored all the evidence on which Congress relied when it passed the Act; (2) gave no weight to Congress’s interest in ensuring that consumers are effectively informed about the health consequences and addictive impact of cigarettes; and (3) made no effort to examine the truthfulness of any of the specific images depicted on the warnings.


On February 29, 2012, Judge Leon, applying a standard of strict scrutiny, declared that the graphic warnings constituted unconstitutional compelled speech in violation of the First Amendment and granted summary judgment in favor of the tobacco companies. 

The U.S. Court of Appeals for the DC Circuit issued its decision on August 24, 2012. The court of appeals reversed the district court’s application of strict scrutiny, determining that an intermediate level of scrutiny was appropriate. Nonetheless, the circuit court determined that the graphic warnings were unconstitutional under the intermediate standard because the government failed to provide evidence that the graphic warnings directly advanced its substantial interest in decreasing smoking rates.

The DC Circuit’s decision is in tension with the 6th Circuit’s March 2012 decision in Discount Tobacco City & Lottery, Inc. v. U.S., which held that the new warning requirements under the Family Smoking Prevention and Tobacco Control Act, including graphic warnings, were constitutional; this conflict between the Circuits may lead to review by the Supreme Court. 

Case Documents & Information

Case Documents