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

Five tobacco companies challenged regulations issued by the Food and Drug Administration that would have required graphic health warnings on cigarette packages and other advertisements.  The tobacco companies claimed that the health warnings violated their right to freedom of expression, because the warnings amounted to compelled speech.  The Appellate Court found the graphic warnings violated freedom of expression and rejected the regulations.  

The Justice Department subsequently decided against appeal to the Supreme Court.  The Food and Drug Administration will redesign the warnings to more closely align with the ruling of the Court of Appeals.

R.J. Reynolds Tobacco Co. v. Food & Drug Admin., 696 F.3d 1205 (D.C. Cir. 2012).

  • United States
  • Aug 24, 2012
  • U.S. Court of Appeals for the District of Columbia Circuit

Parties

Plaintiff

Defendant

Legislation Cited

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

Tobacco Products Regulations, 21 CFR §§ 1107.1 - 1150.17 (as amended)

Required Warnings for Cigarette Packages and Advertisements, 75 Fed. Reg. 69,524, 69,534 (Nov. 12, 2010)

Related Documents

Type of Litigation

Tobacco Control Topics

Substantive Issues

Type of Tobacco Product

None

"Given the evidence demonstrating the tenacity of nicotine addiction, the young age at which the vast majority of smokers begin smoking cigarettes, these smokers’ “incomplete understanding of the addictive nature of tobacco use that is related, in part, to their inaccurate assessment of smoking risks and their belief that they can quit at any time and therefore avoid addiction,” IOM Report at 89, and the significant negative health consequences of smoking, the government has an interest of paramount importance in effectively conveying information about the health risks of smoking to adolescent would-be smokers and other consumers. The tobacco companies’ decades of deception regarding these risks, especially the risk of addiction, buttress this interest. Contrary to their arguments, nothing in the Supreme Court’s commercial speech precedent would restrict the government to conveying these risks in ways that have already proved ineffective or would prohibit the government from employing the communication tools tobacco companies have wielded to great effect over the years."
"In the Proposed Rule, FDA lamented that their previous efforts to combat the tobacco companies’ advertising campaigns have been like bringing a butter knife to a gun fight. According to the FTC, tobacco companies spent approximately $12.49 billion on advertising and promotion in 2006 alone, employing marketing and advertising experts to incorporate current trends and target their messages toward certain demographics. Proposed Rule at 69,531. The graphic warnings represent FDA’s attempt to level the playing field, not only by limiting the Companies’ ability to advertise, but also by forcing the Companies to bear the cost of disseminating an anti-smoking message. But as the Supreme Court recently reminded us, “[t]hat the [government] finds expression too persuasive does not permit it to quiet the speech or to burden its messengers.” Sorrell v. IMS Health Inc., 131 S. Ct. 2653, 2671 (2011). The First Amendment requires the government not only to state a substantial interest justifying a regulation on commercial speech, but also to show that its regulation directly advances that goal. FDA failed to present any data—much less the substantial evidence required under the APA—showing that enacting their proposed graphic warnings will accomplish the agency’s stated objective of reducing smoking rates. The Rule thus cannot pass muster under Central Hudson."