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., No. 11-01482 (D.D.C. 2012).
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.
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)
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.
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.
Regulatory measures consisting of political actions designed to punish the tobacco industry or tobacco users. The industry may argue such arbitrary and capricious regulations will fail to achieve the stated objective. They may also argue that the measures are too extreme, prohibitively expensive, and violate the principle of proportionality.
Type of Tobacco Product
None
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
"Further, the graphic images are neither factual nor accurate. For example, the image of the body on an autopsy table suggests that smoking leads to autopsies; but the Government provides no support to show that autopsies are a common consequence of smoking. Indeed, it makes no attempt to do so. Instead, it contends that the image symbolizes that "smoking kills 443,000 Americans each year." Defs.' Opp'n at 42. The image, however, does not provide that factual information. Similarly, the image of a man exhaling cigarette smoke through a tracheotomy hole in his throat is not being used to show a usual consequence of smoking. Instead, it is used to symbolize "the addictive nature of smoking"-a fact that is not accurately conveyed by the image. Id. at 37. Put simply, the Government fails to convey any factual information supported by evidence about the actual health consequences of smoking through its use of these graphic images."
"First, after reviewing the evidence here it is clear 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. 12 To the contrary, the graphic images here were neither designed to protect the consumer from confusion or deception, nor to increase consumer awareness of smoking risks; rather, they were crafted to evoke a strong emotional response calculated to provoke the viewer to quit or never start smoking. Indeed, a report by the Institute of Medicine-an authority chiefly relied upon by the Government-very frankly acknowledges this very purpose. See Defs.' Opp'n at vi; Institution of Medicine, "Ending the Tobacco Problem: A Blueprint for the Nation" (Richard J. Bonnie ed. 2007) ("10M Report") at 290-91. According to the 10M Report, "[i]t is time to state unequivocally that the primary objective of tobacco regulation is not o promote informed choice but rather to discourage consumption of tobacco products, especially by children and youths, as a means of reducing tobacco-related death and disease." 10M Report at 291. Further, "[e]ven though tobacco products are legally available to adults, the paramount health aim is to reduce the number of people who use and become addicted to these products, through a focus on children and youths," and, therefore, the "warnings must be designed to promote this objective." "
Limitations regarding the use of quotes The quotes provided here reflect statements from a specific decision. Accordingly, the International Legal Consortium (ILC) cannot guarantee that an appellate court has not reversed a lower court decision which may influence the applicability or influence of a given quote. All quotes have been selected based on the subjective evaluations undertaken by the ILC meaning that quotes provided here may not accurately or comprehensively represent a given court’s opinion or conclusion, as such quotes may have originally appeared alongside other negative opinions or accompanying facts. Further, some quotes are derived from unofficial English translations, which may alter their original meaning. We emphasize the need to review the original decision and related decisions before authoritatively relying on quotes. Using quotes provided here should not be construed as legal advice and is not intended to be a substitute for legal counsel on any subject matter in any jurisdiction. Please see the full limitations at https://www.tobaccocontrollaws.org/about.
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").