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., No. 11-01482 (D.D.C. 2011).

  • United States
  • Nov 7, 2011
  • U.S. District Court for the District of Columbia

Parties

Plaintiff

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

Defendant

  • 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

Family Smoking Prevention and Tobacco Control Act, Public Law 111-31, June 22, 2009

Required Warnings for Cigarette Packages and Advertisements, 76 Fed. Reg. 36,628 (June 22, 2011)

Related Documents

Type of Litigation

Tobacco Control Topics

Substantive Issues

Type of Tobacco Product

None

"Unfortunately for the Government, the evidence here overwhelmingly suggests that the Rule's graphic-image requirements are not the type of purely factual and uncontroversial disclosures that are reviewable under this less stringent standard. Indeed, the fact alone that some of the graphic images here appear to be cartoons, and others appear to be digitally enhanced or manipulated, would seem to contravene the very definition of "purely factual." That the images were unquestionably designed to evoke emotion - or, at the very least, that their efficacy was measured by their "salience," which the FDA defines in large part as a viewer's emotional reaction, see Compl. ~ 58 (citing 76 Fed. Reg. at 36,638-36,639) - further undercuts the Government's argument that the images are purely factual and not controversial, see, e.g., Defs.' Opp'n at 22-29. Moreover, it is abundantly clear from viewing these images that the emotional response they were crafted to induce is calculated to provoke the viewer to quit, or never to start, smoking: an objective wholly apart from disseminating purely factual and uncontroversial information. 18 Thus, while the line between the constitutionally permissible dissemination of factual information and the impermissible expropriation of a company's advertising space for Government advocacy can be frustratingly blurry, 19 here - where these emotion-provoking images are coupled with text extolling consumers to call the phone number "I-800-QUIT" - the line seems quite clear."