R.J. Reynolds Tobacco Co. v. U.S. Food & Drug Administration

Five tobacco companies sued the U.S. Food and Drug Administration over a regulation requiring companies to label tobacco products with one of nine graphic warnings. The companies argued that the government-mandated warning infringed upon the companies’ First Amendment right to free speech. In order to assess the claim, the district court first determined that the graphic warnings did not fall into the narrow exception that allowed government-mandated disclosures when protecting consumers from confusion or deception. Without the exception, the court was required to view the graphic warnings using the most stringent standard of judicial review. The court found that the government’s purpose was not to inform or educate smokers but to encourage cessation and discourage potential new smokers. This purpose could have been accomplished using a variety of other methods that would not have infringed upon the companies’ First Amendment rights. Because the government had other options, the graphic warnings were not narrowly tailored enough to allow for the infringement. The court concluded that the images violated the First Amendment and found in favor of the tobacco companies.

The Campaign for Tobacco-Free Kids and our public health partners filed an amicus brief opposing the companies’ requested preliminary injunction, arguing that the warnings then in effect had failed to adequately inform consumers about the risks of tobacco use and that the government has a strong interest in more effectively informing consumers about these risks (see "Related Documents").


R.J. Reynolds Tobacco Co., et al. v. FDA, et al., U.S. District Court, District of Columbia, No. 11-01482.

  • United States
  • Feb 29, 2012
  • U.S. District Court for the District of Columbia



  • Commonweath Brands, Inc.
  • Liggett Group, LLC
  • Lorillard Tobacco Company
  • R.J. Reynolds Tobacco Company
  • Sante Fe Natural Tobacco Co., Inc.


  • Kathleen Sebelius, Sec'y of the. U.S. Dep't of Health and Human Services
  • Margaret Hamburg, Commissioner of the U.S. Food and Drug Admin.
  • U.S. Food and Drug Admin.

Legislation Cited

Related Documents

Type of Litigation

Tobacco Control Topics

Substantive Issues

Type of Tobacco Product