The FDA’s Graphic Warning Rule is struck down as unconstitutional under the First Amendment.


The Tobacco Control Act requires the FDA to establish a rule requiring tobacco manufacturers to place warning labels that cover 50 percent of the surface of the front and rear of cigarette packages, as well as warning labels covering 20 percent of the area of cigarette advertisements. The Act also requires the FDA to issue regulations requiring color graphics “depicting the negative health consequences of smoking.” The FDA released the final rule governing the new graphic warnings in June 2011 and scheduled the regulation to take effect in September, 2012.

District Court Proceedings

On August 16, 2011, five tobacco manufacturers (R.J. Reynolds, Lorillard, Commonwealth Brands, Liggett Group, and Santa Fe Natural) filed suit against the FDA in the U.S. District Court for the District of Columbia, challenging the FDA’s graphic warning rule. The companies argued that the rule, “rather than providing uncontroversial factual information to allow consumers to make an educated decision about whether to use tobacco products,…cross[ed] the line into governmental anti-smoking advocacy.” Specifically, the companies took issue with the fact that the warnings included “emotionally charged graphics that employ cartoons, actors, and/or technological manipulations,” that “exaggerate the potential effects of smoking.” Because the warnings amounted to government-compelled speech, the companies argued, the warnings violated the companies’ First Amendment rights. The companies also argued that FDA had failed to provide adequate justification for the rule in violation of the Administrative Procedure Act. As an immediate remedy, the plaintiffs requested that the warning requirements be put on hold until 15 months after FDA issued legally valid regulations.

The district court granted the tobacco companies’ request to bar the rule from taking effect pending resolution of the case. Additionally, on February 29, 2012, the district court held that the graphic warning rule violated the tobacco companies’ First Amendment rights. The FDA appealed this decision to the U.S. Court of Appeals for the D.C. Circuit.

Proceedings in the U.S. Court of Appeals for the D.C. Circuit

On August 24, 2012, a divided Court of Appeals affirmed the district court judgment striking down the FDA’s graphic warning rule. In a 2-1 ruling, the Court of Appeals agreed with the district court that the requirements violated the tobacco companies’ free speech rights guaranteed by the First Amendment.

In determining that the graphic warning rule violated the First Amendment, the district court had applied a stringent standard, called “strict scrutiny,” for analyzing the constitutionality of the rule. Under “strict scrutiny,” the government can only take action if it has a “compelling interest,” and the regulation or law at issue must be "narrowly tailored” to further that interest. On appeal, the FDA argued that the district court had erred in using this standard. The Court of Appeals agreed with the FDA that the district court was incorrect in analyzing the graphic warning rule under the strict scrutiny standard, and instead the majority applied the more permissive Central Hudson standard. Under this standard, a law or regulation restricting speech does not violate the First Amendment if the government can show that the law or regulation directly advances a substantial government interest, and the law is no more restrictive than is necessary to achieve the government’s goal.

In applying the Central Hudson standard, the majority found that the government’s primary goal in adopting the graphic warning rule was to “discourage nonsmokers from initiating cigarette use and to encourage current smokers to consider quitting.” Although the majority conceded that the government’s goal may be “a substantial interest,” the court held that the rule was ultimately unconstitutional because the FDA failed to show that the graphic warning rule would directly advance this interest. The majority concluded that the FDA did not provide “a shred of evidence” that the graphic warnings would actually lower smoking rates. That is, the court found that the FDA did not show “substantial evidence” that the graphic warnings would “directly” reduce smoking rates by a “material degree.” It also found that there was “no evidence showing that [graphic] warnings have directly caused a material decrease in smoking rates in any of the countries that now require [large graphic warnings].”Additionally, the court noted that while “[s]ome Canadian and Australian studies indicated that large graphic warnings might induce individual smokers to reduce consumption, or to help persons who have already quit smoking remain abstinent,” the studies “did not purport to show that the implementation of large graphic warnings has actually led to a reduction in smoking rates.”

It is important to note that the Court of Appeals’ decision was not unanimous. The dissenting judge would have upheld the rule under a different standard, the Zauderer test, which applies to compelled commercial speech, rather than using the Central Hudson standard, which applies to restrictions on commercial speech. The dissenting judge also disagreed with the majority’s articulation of the government interest in the rule, finding that the real primary purpose of the graphic warning rule was to effectively communicate the negative health consequences of smoking to consumers.

Litigation Status

On October 9, 2012, the FDA filed a petition for a rehearing en banc (a rehearing before all of the judges of the U.S. Court of Appeals for the D.C. Circuit, instead of a three-judge panel), which was denied on December 5, 2012.

On March 15, 2013, Attorney General Eric Holder sent a letter to Speaker of the House John Boehner, advising that the U.S. government would not seek Supreme Court review of the Court of Appeals’ decision, effectively ending this litigation. The FDA instead announced its plans to develop and propose a new graphic warning rule.16 The FDA did not issue a proposed rule, however, until it was sued by public health groups and required to do so via court order. See the description of the American Academy of Pediatrics v. U.S. Food & Drug Administration case for more information about the litigation. The new version of the graphic warning rule was issued on March 18, 2020, and is now subject to two new industry-led legal challenges.

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