FDA Graphic Warnings

This page contains summaries of three cases involving FDA’s implementation of graphic health warnings:
Discount Tobacco & Lottery v. U.S. (2012)
R.J. Reynolds v. F.D.A. (2012)
American Academy of Pediatrics, et al. v. F.D.A. (2016)

Discount Tobacco & Lottery v. United States, Nos. 10-5234 and 10-5235, 674 F.3d 509 (6th Cir. 2012)

The ink was barely dry on the Family Smoking Prevention and Tobacco Control Act (FSPTCA) of 2009 when several large tobacco manufacturers filed suit against the FDA in a federal district court in Western Kentucky. Plaintiffs challenged FSPTCA provisions requiring that tobacco companies place health warnings, including color graphic images, on the top 50 percent of cigarette packages and on 20 percent of all cigarette advertisements. (In this same lawsuit Plaintiffs challenged several provisions of the FSPTCA that restrict marketing to reduce product appeal; we discuss these other claims here.) Plaintiff companies claimed, in part, the required health warnings violated First Amendment speech protections. They argued the mandated size of the warnings impermissibly restricted opportunity for manufacturer messaging, and mandated graphic and textual warnings impermissibly compelled manufacturers to deliver the government’s message. After a district court upheld the statute’s health warning requirement, the case was elevated to and affirmed by the Sixth Circuit.

The Sixth Circuit concluded the Act’s mandate that tobacco packaging and advertising include color graphic and non-graphic warnings along with new textual warnings, would satisfy the First Amendment so long as the warning requirement was reasonably related to the a legitimate government interest and not unduly burdensome. Plaintiffs argued against this “reasonableness” standard on the basis that health warnings are subjective and highly controversial, rather than factual disclosures, and therefore must directly and materially advance a significant government interest and be no more extensive than necessary to serve that interest.

While adhering to its conclusion that the Act need only meet the “reasonableness” standard, the court simultaneously defended the health warnings under the more stringent standard. Namely, the court found: 1) the warning requirement addressed an important government interest (preventing smoking and consumer deception regarding the risk of suffering from tobacco related illness); and 2) the warning requirement directly advanced this government interest (ample scientific evidence supports large graphic warnings as a tool to reduce tobacco use); while 3) being no more extensive than necessary to serve that interest (the warning requirements are tightly focused on being seen by consumers and have particular impact on youth; and they are not unduly burdensome, but rather leave ample space available on packaging and advertisements for manufacturer messaging).

While the district and appellate court decisions were supportive of the concept of FSPTCA’s graphic warning mandate, the courts in this case did not address FDA’s specific warnings as applied, because the agency had not yet issued the warnings.


RJ. Reynolds v. United States Food and Drug Administration, 696 F.3d 1205 (D.C. Cir. 2012).

Once the FDA finally chose the specific warning labels, which were scheduled to go into effect in September of 2012, the tobacco industry lost no time in challenging them. Echoing arguments in the Discount Lottery case, described above, tobacco product manufacturers argued the graphic warnings impermissibly violated First Amendment speech protections. R.J. Reynolds v. FDA was filed in Washington, D.C., where the district court struck down the images, siding with the Plaintiff tobacco companies in its finding that the warnings violated First Amendment protections against compelled government speech. The case was appealed to the U.S. Court of Appeals for the District of Columbia, which held 2-1 that the district court erred in its review, but nevertheless ruled the required health warnings violated tobacco companies’ First Amendment speech protections. The government lost its petition for a panel rehearing en banc, and decided not to seek further review of the court’s ruling.

The appellate court concluded that FDA’s rule requiring graphic and larger textual health warnings avoided First Amendment violation if it directly advanced a substantial government interest asserted by the government, and was no more extensive than necessary to serve that interest. The court proceeded to grant the agency a substantial interest in reducing smoking rates, but held that the FDA has not provided a “shred of evidence” showing that the graphic warnings will “directly advance” this interest. Rather, in determining that measureable increases in consumer attention to smoking dangers and intentions to quit resulting from the health warnings would translate to fewer people smoking, the agency relied on “mere speculation,” according to the court. The court reasoned that FDA must show evidence that the graphic warnings would actually reduce smoking rates (not merely educate consumers). It dismissed existing studies from outside the U.S. demonstrating the effectiveness of graphic health warnings in making smokers quit on the basis that the graphic warnings were implemented at the same time as other tobacco controls. That is, the court concluded, the FDA failed to show that the graphic warning rule would directly advance their interest in reducing smoking rates. The proposed warnings therefore violated First Amendment protections against compelled government speech.

In 2013, the FDA dropped continued appeals, instead intending to undertake further rulemaking and propose a new set of graphic warnings, which brings us to the 2016 challenge by public health advocates seeking to compel agency action on this issue, summarized below.


American Academy of Pediatrics, Massachusetts Chapter of American Academy of Pediatrics, Inc., American Cancer Society, Inc., American Cancer Society Cancer Action Network, Inc., American Heart Association, Inc., American Lung Association, Campaign for Tobacco-Free Kids, Truth Initiative Foundation d/b/a Truth Initiative, Dr. Ted Kremer, Dr. Jonathan Winickoff and Dr. Lynda Young v. U.S. Food & Drug Administration, 1:16-cv-11985 (D. Mass. September 5, 2018)

On October 4, 2016, a group of eight public health advocacy organizations and several physicians filed suit against the U.S. Food & Drug Administration (FDA) to compel the agency to carry out its obligation under the Family Smoking Prevention and Tobacco Control Act (FSPTCA) to require cigarette packages and advertisements to bear graphic health warnings.

In 2011, the FDA promulgated a final rule designating nine graphic warning labels depicting the negative health consequences of cigarette smoking. That rule and the designated graphic warnings were successfully challenged by the industry as impermissible government compelled speech violating the First Amendment. In ordering the graphic warnings legally problematic, the court largely rested on its finding that the FDA lacked evidence to establish the effectiveness of the graphic warnings in deterring tobacco use. Rather than further appeal the case, the FDA opted to undertake further research in support of a new graphic warnings rule.

The complaint alleged that while more than four years passed since the rule was vacated, the FDA failed to even begin rulemaking proceedings for new graphic warnings as required by FSPTCA. During that time, the plaintiffs say more than 3 million Americans, most of them minors, began to smoke on a regular basis and half of them will die prematurely as a result. Plaintiffs also assert that 2 million people have died of tobacco-related diseases during the time the FDA has been in violation of FSPTCA.

The complaint alleged that promulgating these rules is nondiscretionary—in other words, the FDA cannot decide to forego implementing a rule requiring graphic health warnings on packages of tobacco product. The plaintiffs further assert that there is extensive scientific evidence supporting the positive impact of graphic health warnings on public health (indeed, Plaintiffs say such evidence existed to support the agency’s original rules in 2011). Thus, Plaintiffs sought a declaration that FDA “unlawfully withheld” or “unreasonably delayed” promulgating the final rule and requested the court compel the FDA to begin expedited rulemaking procedures to implement the graphic warnings requirement of FSPTCA.

The court agreed, and on September 5, 2018, ruling on cross motions for summary judgment ruled the FDA “unlawfully withheld” and “unreasonably delayed” agency action and compelled agency action as requested by Plaintiff advocacy groups. The court found the FDA has been illegally avoiding its “mandatory duty” and ordered the agency to provide an expedited schedule to comply with FSPTCA’s mandate to implement a rule requiring graphic health warnings on packages of tobacco products. Calling this an “extraordinary delay,” the court noted that records show gaps of time in which little or no work on revising the graphic warnings occurred at the agency. FDA responded with an expedited schedule, stating in court documents that the agency anticipates adopting new labels in May of 2021. Before implementing a final rule requiring the warnings, FDA must first complete “outstanding studies, the publication of the proposed graphic warnings rule for public comment, [and] review of public comments,” as described by the District Court.  FDA may appeal the trial court’s ruling, and tobacco companies and others will inevitably challenge and thus delay implementation of the final warnings issued by the agency.