After sitting on the case for years, federal Judge J. Campbell Barker, an active member of the right-wing Federalist Society, finally issued his opinion vacating (rescinding) the FDA’s graphic warning labels on cigarette packs that Congress mandated in 2009 when it passed the Family Smoking Prevention and Tobacco Control Act. His decision rejecting the warning labels was not a surprise. But he really had to grasp at straws to give the tobacco companies what they wanted.
The FDA was very careful in writing the rule for the warning labels, learning from their earlier defeats in court. In addition to navigating around First Amendment issues, the FDA backed up everything they did with careful research showing that the warning messages were needed, were understood by the intended audiences of smokers and nonsmoking youth, and that the graphic images were consistent with and reinforced the text warnings.
In particular, the FDA went to great lengths to demonstrate that the warning text and accompanying images were “purely factual and uncontroversial” as required by the Supreme Court’s Zauderer First Amendment case.
Judge Campbell didn’t argue with the substance of the text warnings, but he came up with amazing arguments against the images.
Rather than trying to summarize his logic, here are a couple pages from his opinion:
Judge Campbell then makes similar arguments against that graphic accompanying the cataract warning, then, with a wave of the hand and no specific justification, rejected the rest of the images.
Leaving aside Judge Campbell’s rejection of the value of people thinking “smoking is a mistake,” the reality is that no image would be acceptable to him. No one image captures all the possibilities connected with any disease and it is also possible that multiple conditions can be manifest with the same outward appearances. That is why doctors have to do tests rather than just looking at their patients when diagnosing them.
In contrast to his art criticism, Judge Campbell ignores the question of whether the images somehow make the text warnings any less “factual and uncontroversial,” the legal standard. He also ignores the broader scientific literature and the studies the FDA conducted on the specific warnings and images in its rule that show that the images enhance the consumer’s understanding and recall of the (unconested) textual messages.
My colleagues at UCSF and elsewhere submitted a public comment, “FDA’s proposed required textual warning label statements and accompanying color images
will promote greater public understanding of the negative health consequences of smoking
and should be implemented with some improvements,” when the FDA was developing the warnings and images in 2019. Among other things, we said:
- The proposed color images are appropriate because they convey accurate, factual, and uncontroversial information that help promote greater public understanding of the negative health consequences of smoking
FDA’s proposed color images satisfy the D.C. Circuit Court’s requirements [which had rejected FDA’s original proposed graphic warning labels]. As FDA detailed in the preamble to the Proposed Rule and supported with significant scientific evidence, the proposed color images convey information that is both accurate and factual, are unambiguous, and are unlikely to be misinterpreted or misunderstood by consumers. FDA further demonstrated that these color images, when paired with the accompanying textual warnings, included new information that promotes greater public understanding of the negative health consequences of smoking.
The tobacco industry, as they did previously, might object to the use of the proposed images (or, for that matter, any images) because they “evoke an emotional response.” However, this objection should not be grounds for preventing the implementation of these warnings. It has been argued[9] and demonstrated empirically that any information about the actual negative health effects of smoking evokes emotion.[10] However, this does not make the information or images any less factual. A law review article on tobacco warnings and the First Amendment concluded, “Just because the images may be discomforting or even disturbing to look at does not make them factually inaccurate.”[11] Likewise, the 6th Circuit Court of Appeals found that, “Facts can disconcert, displease, provoke and emotional response, spark controversy, and even overwhelm reason, but that does not magically turn such facts into opinions.”[12] The selected text and images in the proposed warnings convey accurate, factual, and uncontroversial information.
Indeed, in the brief submitted by the cigarette companies in their appeal to the DC Circuit Court, the companies themselves stated that they “never disputed that graphics may sometimes convey purely factual and uncontroversial information,” and that graphic warnings can be effectively designed to provide information – “including as to risks of dependence or death.”[13]
The FDA has paid special attention to the importance of the concordance between the text and images on attention to and recall of the message, supported by recent health communication research (e.g., Lochbuehler et al., 2018[14]). The FDA has rigorously tested the images, ensuring that the resulting graphic warning labels meet the standards recommended by research.
Moreover, there is very good evidence that the implementation of graphic warning labels on cigarette packs will reduce smoking among youth and young adults.
A 2019 systematic review of 28 experimental studies that examined the impact of tobacco-pack graphic warnings on youth and youth adults concluded that such warnings are effective at increasing attention, eliciting stronger cognitive and affective reactions, and increasing intentions not to use tobacco products.[15]
This includes test studies among American adolescents that suggest that cigarette graphic warning labels will be successful in reducing youth smoking in the United States. Among middle school students, viewing graphic warning label cigarette packs stimulated greater negative affect (i.e., feeling afraid, disturbed, guilty, or scared) and greater risk beliefs about smoking.[16] In a study of adolescents experimenting with smoking, graphic warnings evoked fear, reduced cravings, and increased quitting contemplation.[17] In a brain imaging study, graphic warning labels reduced cravings among adolescent smokers to an even greater extent that measured among adults.[18]
Studies from countries where cigarette graphic warning labels are already present support graphic warning label effectiveness among youth. In national student surveys before and after the introduction of graphic warning labels in Australia, following warning label introduction, there was widespread awareness and recognition of the labels among adolescents, increased thinking about quitting among adolescents who had already smoked cigarettes, and decreased intentions to smoke cigarettes among youth who had talked about the warning labels.[19] Focus group study of youth in New Zealand, graphic warning labels were linked to greater perceptions of cigarette harms and less social appeal of smoking.[20]
Ironically, after rejecting the graphic images, Judge Campbell also rejected FDA’s argument that the images could be “severed” from the text warnings so that the text warnings could go ahead while litigation over the images proceeded the even though the Tobacco Control Act specifically allows for such severance. He argued that the text and images could only be treated as a unit despite the fact that he found that the images would confuse consumers.
There were other issues dealing with whether his court was the right venue and whether local retailers (the justification for the tobacco plaintiffs going to his court) that I will leave to the lawyers.
In any event, the DOJ (on FDA’s behalf) can finally file its appeal with the Fifth Circuit Court of Appeals. The Fifth Circuit is famously conservative (pro-business), but there is a chance that health will win there given how thin Judge Campbell’s reasoning is. But then, the industry will appeal to the Supreme Court, which could add another year.
And even if industry eventually looses, they will have won by delaying effective graphic warning labels for years.
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