Legal challenges to new tobacco warnings may have long-term public health consequences

Graphic health warnings on cigarette packs, if implemented in 2022, may provide a major boon to public health—however, continued legal opposition and industry litigation may compromise these benefits and set a dangerous precedent for challenges to future public health regulations, experts warned.

Since the passage of the Federal Cigarette Labeling and Advertising Act (FCLA) in 1965, the tobacco industry has been forced to include the following warning label on all cigarette packages and advertisements: “Caution: Cigarette smoking may be hazardous to your health.” But as time went on, there has been growing evidence that textual warnings are not enough to reduce smoking. As a result, starting in 2022, the FDA will require cigarette packs to carry graphic health warnings covering 50% of the front and back of the packaging… assuming the new labels are deemed constitutional by the courts, which is far from a sure thing.

This is not the first time the FDA tried to pass graphic warning labels for cigarettes. The agency’s first attempt, in 2021, was struck down by tobacco industry litigation, delaying implementation of the rule. And, according to model estimates from Rafael Meza, PhD, of the University of Michigan School of Public Health in Ann Arbor, and colleagues, that delay may have staved off a substantial public health benefit.

Meza and colleagues’ findings were published in JAMA Health Forum.

The study authors found that implementation of graphic health warnings from 2022 through 2100 would avert an estimated 539,000 smoking-attributable deaths and 7.9 million life-years gained. Meanwhile, if those same warnings had been implemented in 2021, the model estimated 33% more smoking-attributable deaths could have been averted, for an additional 42.7% life-years gained compared to implementation in 2022.

“We acknowledge that the counterfactual of having had no delays to the implementation of graphic health warnings in 2012 is unlikely to reflect real-world policy making,” they wrote. “Past policy delays cannot be undone, and protracted litigation in the present tobacco regulatory environment may be inevitable. Other factors beyond legal challenges, such as limited agency capacity (e.g., resources and personnel) and changing leadership, can delay the implementation of regulations. In some instances, such as a lawsuit filed against the FDA by public health organizations, a court decision may expedite policy implementation. However, by quantifying the potential losses associated with delayed implementation, the findings of this study suggest a need to act quickly while minimizing the chances of future procedural delays.”

For their decision analytical model, Meza and colleagues used simulation modeling of smoking prevalence and smoking-attributable mortality in the U.S. from 2012 to 2100 using the Cancer Intervention and Surveillance Modeling Network (CISNET) smoking population model.

The primary outcomes were annual adult smoking prevalence, smoking-attributable deaths averted, and life-years gained versus a baseline scenario that assumed no graphic health warnings were implemented. The authors modeled policy effects under varying assumptions of the association of the policy with smoking initiation and cessation, ranging from most conservative to most optimistic—they also evaluated a maximum smoking reduction scenario in which all smoking would stop by the end of 2022 for comparison.

“In the baseline scenario, an estimated 13.2 million smoking-attributable deaths would have occurred from 2012 to 2100,” Meza and colleagues wrote. “Under a maximum smoking-reduction scenario, 5.5 million of these deaths would be averted. Implementation of graphic health warnings from 2022 to 2100 would be associated with 539 000 (range, 275 000-794 000) smoking-attributable deaths averted and 7.9 million (range, 4.0-11.6 million) life-years gained, representing less than 10% of the 5.5 million estimated smoking-attributable deaths averted and 81.8 million life-years gained in the maximum smoking-reduction scenario. Implementation from 2012 to 2100 would be associated with 33.2% (range, 32.9%-33.5%) more deaths averted (718 000; range, 365 000 to 1.1 million) and 42.7% (range, 42.3%-43.1%) more life-years gained (11.2 million; range, 5.7-16.6 million) compared with implementation in 2022.”

While their results suggested an improvement in smoking-related mortality as a result of graphic warning labels, they acknowledged “the need for progressive policy action that goes beyond graphic health warnings… Even larger health gains would likely be achieved by reducing the level of nicotine in combustible cigarettes to minimally addictive levels.”

Commercial Speech vs The Public’s Right to Truth—Who Wins?

Regardless of how many lives could be saved by graphic warning labels for cigarettes, the policy can’t be enacted until it gets through the courts, which is far from a sure thing.

But according to Gregory Curfman, MD, deputy editor for JAMA, the tobacco industry’s First Amendment right to commercial speech does not trump the public’s right to receive honest, accurate information about critical health risks linked to smoking—and, he added, a ruling in favor of the tobacco industry could have disastrous public health consequences. His Special Communication was also published in JAMA Health Forum.

When the FDA initially moved to issue graphic warning labels, the labels were challenged before they could be deployed in a lawsuit filed by tobacco companies—RJ Reynolds Tobacco Company v FDA. The lawsuit, Curfman explained, argued that the requirement “constituted compelled speech that violated their First Amendment free speech rights.”

The U.S. Constitution protects speakers not only from government restrictions on speech, but also from government actions to compel them to speak. However, this symmetry does not pertain to “commercial speech, defined as speech intended solely to promote a commercial transaction,” Curfman wrote. “In this circumstance, the right of commercial speakers to speak is protected, while their right not to be compelled to speak receives lesser protection.” And, while commercial speech has historically been protected in regard to off-label promotion of drugs, the case of Zauderer v Office of Disciplinary Counsel, in which an attorney’s business advertising was inconsistent with state laws, established that commercial speech could be compelled when “reasonably related to the State’s interest in preventing deception of customers.”

Given this precedent, the 2012 outcome of RJ Reynolds Tobacco Company v FDA is “difficult to understand,” Curfman wrote—”[In] the court’s opinion, the absence of evidence that graphic warning labels reduce smoking, and despite a compelling dissent from the third judge on the panel, Judge Judith Rogers, on the basis of its First Amendment analysis, the court vacated the graphic warning requirements and remanded to the agency.”

Fast-forward to today, and the lawsuit is still ongoing (Reynolds [2020]), along with a second, similar lawsuit, Philip Morris USA Inc and Sherman Group Holdings, LLC v FDA.

“The principal question now at issue in RJ Reynolds (2020) is whether the tobacco companies are protected from being compelled to speak (via the requirement to include a display of graphic warnings) on the basis of First Amendment protection of commercial speech,” Curfman wrote. And, according to him, the tobacco companies don’t really have a leg to stand on.

The essence of the FDA’s argument is that “the core constitutional value of protecting speech does not lie in protecting the commercial speaker’s promotional speech, but rather in ensuring that consumers receive information that may be of value to them in decision-making,” he explained, and manufacturers may be held legally accountable when their product labels fail to warn consumers of potential harms from the product. Given that there is a lack of efficacy of textual warnings on cigarette labels, withholding graphic warnings may qualify as a form of failure to warn consumers.

Another factor that sank the FDA’s initial push for graphic warnings was the court’s stance that the images in question, as they existed in 2011, were “created primarily to arouse emotion and not provide factual information.” But this time around, the proposed graphic warnings are factually based and accurately depict human anatomy and disease pathology, laying out lesser-known risks of cigarette smoking, such as “bladder cancer, diabetes, and age-related macular degeneration.”

“The outcome of RJ Reynolds (2020) will have consequential implications not only for public health, but also for commercial speech law,” Curfman concluded. “The inclusion, for the first time in the U.S., of graphic warning labels on cigarette packages and advertising materials will be a novel requirement to inform consumers about the potential health hazards of smoking. The new labels, if deemed constitutional by the courts, can be expected to provide ’purely factual and uncontroversial’ information for consumers.

“However, should the new graphic labels be rejected by the courts on First Amendment grounds, such a ruling would set the stage for further First Amendment challenges of other public health regulations based on compulsion of commercial speech,” he continued. “The potential use of the First Amendment to prevent or reverse other government regulations involving mandatory disclosure of information to consumers, such as health warnings for sugar-sweetened beverages, only heightens this concern. Such a result would have lasting negative consequences for public health and commercial speech law.”

  1. Implementing graphic warning labels on cigarette packs in 2022 would be associated with public health benefits, and those benefits would have been even greater if the policy had been implemented in 2012.

  2. Legal analysis suggests that the First Amendment does not prohibit the requirement of the new tobacco warning labels, and that rejecting the labels on First Amendment grounds sets the stage for further challenges to public health regulations.

John McKenna, Associate Editor, BreakingMED™

Meza reported receiving grants from the NCI, NIH during the conduct of the study. Coauthor Tam reported receiving grants from the NCI and NIH during the conduct of the study and being a tobacco regulatory science fellow at the US Food and Drug Administration’s Center for Tobacco Products through the National Academy of Medicine. Coauthor Hammond has testified on behalf of public health authorities in response to industry legal challenges, including challenges to health warning regulations. Coauthor Holford reported receiving grants from the NCI, NIH during the conduct of the study.

Curfman is a deputy editor for JAMA.

Cat ID: 489

Topic ID: 89,489,730,143,192,150,151,489,925