Defending Graphic Warnings on Cigarette Packs and Ads

April 17, 2024

ACS CAN and other tobacco control partners celebrated a huge public health victory when the US Court of Appeals for the Fifth Circuit upheld the Food and Drug Administration (FDA)’s final rule requiring graphic warnings on cigarette packages and advertisements in late March. ACS CAN has been supporting the FDA for years in challenges brought by the tobacco industry by filing amicus curiae briefs in federal lawsuits challenging the rule. Our briefs provide critical scientific data to the courts about the need for graphic warnings, the reliability of studies conducted by FDA to support them, and international use of similar warnings.  The most recent brief was filed at the U.S. Court of Appeals for the Fifth Circuit in May of 2023.  Unfortunately, in December of 2022, a US District Court in Texas had struck down the rule as violating the First Amendment rights of the tobacco manufacturers.

ACS CAN filed amicus briefs at US District Courts in two different legal challenges to the rule, Philip Morris USA v US FDA in the US District Court in DC, and RJ Reynolds v. FDA in the US District Court in Texas, the case mentioned in which the rule was struck down.  After winning its challenge in Texas, tobacco manufacturers dismissed the lawsuit in DC.

The final rule requires 11 new textual and graphic warnings on cigarette packs and ads.  The warnings must cover 50 percent of the front and rear panels of the pack, as well as 20 percent of advertisements, and would be rotated quarterly.  The new warnings were scheduled to appear in June 2021, but were delayed due to the COVID-19 pandemic until October of 2021, and have already been challenged in court.  


The 2009 Tobacco Control Act (TCA) required graphic warnings covering the top half of the front and back of cigarette packs and 20 percent of cigarette advertising.  The law gave FDA until June 22, 2011 to issue a final rule requiring the warnings. While the FDA met the deadline, the specific graphic warnings the agency required were struck down in August 2012 by a three-judge panel of the U.S. Court of Appeals for the D.C. Circuit.  The panel ruled 2-1 that the proposed warnings violated the First Amendment. The panel’s ruling only applied to the specific images proposed by the FDA and did not address the law’s underlying requirement.

In a separate case in March 2012, the U.S. Court of Appeals for the Sixth Circuit upheld the law’s requirement for graphic warnings, finding that the provision did not violate the First Amendment. That court found the graphic warnings “are reasonably related to the government’s interest in preventing consumer deception and are therefore constitutional.” The U.S. Supreme Court declined to hear a tobacco industry appeal of this ruling.

Taken together, these two federal court decisions mean the FDA was still legally obligated to require graphic health warnings, and the agency is free to use different images than the ones struck down by the D.C. Circuit in 2012. The FDA stated in March 2013 that it planned to issue a new rule requiring graphic warnings but failed to do so.

In October 2016, ACS CAN, along with our partners, filed a lawsuit to force the FDA to comply with the graphic warning provisions of the TCA. In a 2018 ruling, Judge Indira Talwani of the U.S. District Court for the District of Massachusetts ruled in our favor, finding that the FDA “unlawfully withheld” and “unreasonably delayed” agency action to require the graphic warnings. In a final order issued in March of 2019, Judge Talwani ordered the FDA to issue a proposed rule by August 15, 2019, and a final rule by March 15, 2020.

FDA Final Rule - New Warnings

The Final Rule issued in 2020 requires 11 different images and textual warnings be displayed.   In addition, the cigarette manufacturers are required to establish marketing plans to meet the requirements for random display and distribution of the required warnings for both packages and advertisements. FDA must approve those plans in advance.
The FDA specifically focused on “lesser known” health risks of smoking for the proposed warnings as “new” information would better promote greater public understanding of the risks associated with cigarette smoking. In other words, there would be less of an impact for health risks the public is already aware of. 

The effective date of the rule is June 18, 2021, but that date has been delayed until October 16, 2021 due to the COVID-19 pandemic. 

Legal Challenges

The FDA’s 2011 rule requiring graphic warnings on cigarette packages was struck down as a violation of the First Amendment. The legal test governing mandatory disclosures such as warning labels is that the compelled speech must be "purely factual and uncontroversial" and "justified principally by the value to consumers of the information such speech provides... in order to dissipate the possibility of consumer confusion or deception."

In the new rule, FDA indicated its purpose is to help the public better understand the negative health consequences of smoking.  The agency also included extensive scientific information about why graphic images communicate more effectively than text-only, as well as the disparate burden of smoking on people with lower income and education levels.

In the Final Rule, FDA provided extensive legal justifications for the images and text.  It also provided that any warnings that are found unconstitutional should be severed from the rest of the rule, meaning if some are struck down, the remaining warnings could stand.  

RJ Reynolds, Liggett, ITG Brands, Santa Fe Tobacco and several convenience stores in Texas have already brought a lawsuit in federal court in the Eastern District of Texas.  The case of RJ Reynolds v. FDA seeks to invalidate not only the new rule, but the TCA’s statutory mandate to the FDA on graphic warnings altogether.  Here is ACS CAN’s amicus curiae brief helping to defend the Final Rule in the Texas case.  The US District Court struck down the FDA rule based on the images promulgated by the agency, but left the statutory provision of the TCA requiring graphic warnings intact.  The case is on appeal to the Fifth Circuit, to which ACS CAN and partners filed another amicus brief.

Another lawsuit making similar arguments was filed in federal court in Washington, DC in the case of Philip Morris USA v. US FDA. Read our brief here. That case was dismissed after tobacco manufacturers prevailed in the Texas case described above.