The Tobacco Control Act’s graphic warning and other requirements are upheld.


The Tobacco Control Act was passed in 2009, giving the FDA comprehensive regulatory authority over tobacco products. There are many different requirements contained in the law, which are described in more detail here. Some of those requirements include graphic warning labels on cigarette packages and advertisements, limitations on industry sponsorships, limitations on labels, and requirements that products receive marketing approval from the FDA before being sold, among others.

District Court Proceedings

On August 31, 2009, five tobacco manufacturers and one retailer filed suit in federal court in the U.S. District Court for the Western District of Kentucky to challenge the constitutionality of several parts of the Tobacco Control Act, including: 1) the graphic warning label requirement; 2) the Modified Risk Tobacco Product (“MRTP”) provision; 3) the prohibitions on event sponsorship, sampling, distribution of branded, non-tobacco merchandise, and so-called “continuity” programs—distribution of free items in consideration of a tobacco purchase; 4) the prohibition on color/imagery in tobacco product advertising; and 5) the restriction on claims that a tobacco product is safe or safer as a result of FDA regulation. The companies argued that these provisions of the Tobacco Control Act violated their First Amendment rights by “cut[ting] off nearly every currently available avenue of tobacco advertising and marketing,” and “confiscating [the companies’] packaging, advertising, and intellectual property for an anti-tobacco message drafted by the Government.” The industry plaintiffs also filed a request for a preliminary injunction against the enforcement of the Modified Risk Tobacco Products (“MRTP”) provision of the Tobacco Control Act, which was denied by the court on November 5, 2009.

On January 5, 2010, the District Court upheld the challenged provisions of the Act relating to graphic warning labels, MRTPs, prohibitions on certain sponsorship, merchandise, sampling, and continuity programs. However, the court found that the Tobacco Control Act’s prohibition of color and imagery in advertising was overly broad—under the applicable legal test known as Central Hudson, the government’s restriction must be only as broad as is necessary to directly advance a substantial government interest. The court also found that the prohibition of statements implying that a tobacco product is safe or safer as a result of FDA regulation unconstitutional due to the fact that the restriction applied to more than just commercial speech, and therefore needed to meet a standard of “strict scrutiny,” and failed to do so. Both the tobacco companies and the government appealed this decision.

Proceedings in the U.S. Court of Appeals for the Sixth Circuit

On March 19, 2012, a three-judge panel of the U.S. Court of Appeals for the Sixth Circuit upheld most of the challenged restrictions as constitutional, largely affirming the District Court’s prior decision.

The Court Upholds the Graphic Warning Label Requirement: The Court of Appeals held in a 2-1 decision that the graphic warning label requirement did not violate the First Amendment. In making this determination, the majority of the court applied a legal standard known as the Zauderer standard, based on the majority’s characterization of the required graphic warnings as compelled disclosures of factual information, rather than restrictions on commercial speech. (For more on the Zauderer standard, visit this page). In its decision, the court recognized that there are “myriad graphic images” that, like textual warnings, would provide “undisputed factual information about the health risks of using tobacco products.”

Under the Zauderer standard, disclosure requirements do not violate the First Amendment if they are reasonably related to the government’s interest—particularly if the interest is aimed at preventing consumer deception. The Court of Appeals determined that the government established a rational relationship between the goal of preventing consumer deception and the warning label requirement based on: 1) the tobacco industry’s extensive, documented history of deceiving the public about the health risks and addictiveness of smoking; 2) empirical evidence that existing warning requirements ineffectively convey the risks of tobacco use, particularly to youth as well as adults with low levels of education; and 3) scientific evidence that larger warnings incorporating imagery promote a greater understanding of tobacco-associated health risks. Thus, the Court of Appeals held that the Tobacco Control Act’s graphic warning requirement was permissible under the First Amendment.

The Court Upholds Other Challenged Provisions, with the Exception of the Prohibition on Continuity Programs and Color/Imagery in Advertising: The Court of Appeals analyzed the remaining provisions challenged under the First Amendment using a different standard, the Central Hudson standard employed by the district court in its analysis. Under this standard, a restriction does not violate the First Amendment if it advances a substantial governmental interest and is no more restrictive than is necessary to achieve that interest. Applying this standard, the court recognized that the government has substantial interests in reducing juvenile use of tobacco products and in ensuring that the health and safety claims made by tobacco companies are not misleading to consumers. The court found that the Tobacco Control Act provisions prohibiting specific promotional activities, requiring FDA review of product health claims, and ensuring that tobacco companies do not claim that FDA regulation makes their products safer, directly serve one or both of these interests. The court also recognized that the limits imposed by the Tobacco Control Act were generally no more restrictive than necessary to achieve the government’s goals, especially given the close tie between promotional activities such as sampling, branded merchandise, and event sponsorship and juvenile use of tobacco products, and the difficulties the government had encountered combating juvenile tobacco use and industry misinformation through alternative means.

The restriction on any imagery and color being used in tobacco advertising, however, failed under the Central Hudson analysis. While the court recognized that such a restriction served the government’s substantial interest in “alleviating the effects of tobacco advertising on juvenile consumers,” the court also determined that the restriction was “vastly overbroad” because it would also apply to all color and graphics—even those non-misleading, informative advertisements targeted at adults. The restriction on continuity programs was also held to violate the First Amendment because the court found no evidence to support the government’s argument that prohibiting these programs would advance the government’s interest in reducing juvenile tobacco use, given that the “overwhelming beneficiaries, both numerically and comparatively, of these continuity programs are adult consumers.”

Finally, the Court of Appeals reversed the portion of the district court’s ruling pertaining to the Tobacco Control Act’s restriction on claims that a tobacco product is safe or less harmful due to FDA regulation or compliance with FDA standards. Specifically, the court disagreed with the district court that the relevant provision should be analyzed under a “strict scrutiny” standard. Instead, the court found that the restriction regulated commercial speech--and perhaps more accurately, deceptive and untrue speech--and therefore needed to meet the standard outlined in either Central Hudson or Zauderer. The court determined that the restriction was constitutional under either test.

Litigation Status

The tobacco companies petitioned for a rehearing and a rehearing en banc (a rehearing with the full panel of Sixth Circuit judges, rather than the three-judge panel that issued the appellate court decision), both of which were denied on May 31, 2012. On October 26, 2012 the tobacco companies filed a Petition for Writ of Certiorari with the U.S. Supreme Court, requesting review of the Sixth Circuit’s decision. On April 22, 2013, the Supreme Court denied the tobacco industry’s appeal to review the case, rendering the Court of Appeals’ decision final. Because the Supreme Court declined to hear the case, the FDA retained the authority to promulgate a graphic warning rule. As for the fate of the rule itself—seeR.J. Reynolds Tobacco Co. v. U.S. Food & Drug Administration, which discusses the case challenging the FDA’s rule that established the content of the first round of graphic warnings, and American Academy of Pediatrics v. U.S. Food & Drug Administration, which discusses the public health groups’ suit to compel FDA action in promulgating a new rule.

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