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

Five tobacco companies challenged the constitutionality of a Food and Drug Administration Final Rule requiring the display of a series of textual and graphical warnings that would occupy the front and back panels of the cigarette packaging.  The Court found a substantial likelihood that plaintiffs would succeed on the merits, ruling that the mandatory graphical images were unconstitutionally compelled speech in violation of the First Amendment.  In so ruling, the Court pointed to the government's reliance on the emotional impact of the images for "salience" and the failure of the FDA's benefit analysis to prove efficacy in reducing the national rate of tobacco usage through implementation of the graphical warning labels.  The Court also found that the government's assertions regarding the large number of children who experiment with tobacco and become regular smokers each day was insufficient to show a substantial harm caused by delaying enforcement of the Rule. As result, the Court granted the plaintiffs' request for a preliminary injunction.


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

  • United States
  • Nov 7, 2011
  • 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