TOBACCO CONTROL LAWS

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.

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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
View Case History

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

None

Type of Litigation

Challenge to Government Policies Relating to Tobacco Control/Public Health
Tobacco companies or front groups may challenge any legislative or regulatory measure that affects their business interests. Unlike public interest litigation, these cases seek to weaken health measures. These cases frequently involve the industry proceeding against the government. For example, a group of restaurant owners challenging a smoke free law as unconstitutional.

Tobacco Control Topics

Packaging and Labeling Measures
Measures to regulate the marketing on tobacco packages. This includes both bans on false, misleading, deceptive packaging, as well as required health warnings on packaging. (See FCTC Art. 11)
Advertising, Promotion and Sponsorship
Measures restricting any form of direct or indirect tobacco advertising, promotion and sponsorship. (See FCTC Art. 13)

Substantive Issues

Right to Commerce
A violation of the right to carry on trade, business, or profession of a person’s choice. This right may also be called the right to free enterprise or economic freedom. The industry may argue that a business should be able to conduct its business without government regulation, including whether or not to be smoke free.
Right to Freedom of Expression
A violation of the right to expression, free speech or similar right to express oneself without limitation or censorship. The industry may claim that a regulation infringes on their right to communicate with customers and the public. Similarly, they may claim that mandated warnings infringe on their freedom to communicate as they desire.
Sufficiency of Scientific Evidence
A discussion on whether current scientific evidence is sufficient to justify the regulatory measures.

Type of Tobacco Product

None

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