Importance The 2009 Family Smoking Prevention and Tobacco Control Act required the US Food and Drug Administration (FDA) to issue a rule requiring graphic warning labels depicting the health consequences of smoking for prominent placement on cigarette packages and advertising. The tobacco industry filed a lawsuit against the FDA claiming that the required graphic labels constituted compelled speech in violation of First Amendment speech rights, and courts ruled for the tobacco industry. Subsequently, the FDA thoroughly redesigned the graphic labels and issued a revised rule, but the tobacco industry immediately filed a similar lawsuit against the FDA again on First Amendment grounds.
Observations This article examines the delicate balance between First Amendment speech rights vs the right of the public to receive truthful, accurate, and understandable public health information. The article argues that the newly designed warning labels should easily pass First Amendment analysis. The need for new warning labels on tobacco products and advertising is a critical public health intervention to promote greater public understanding of the negative consequences of cigarette smoking, especially among the young.
Conclusions and Relevance The legal analysis in this article marshals arguments that the First Amendment does not prohibit the requirement of the new tobacco warning labels. Commercial speech receives First Amendment protection primarily for the benefit of the public (listeners) and not the tobacco industry (compelled speakers). The balance favors the right of the public to receive accurate information about critical health risks.
With the passage of the Federal Cigarette Labeling and Advertising Act (FCLA, 15 USC 1333) in 1965, the US government mandated for the first time that all cigarette packages and advertising materials must include the following warning label: “Caution: Cigarette smoking may be hazardous to your health.” This requirement set off a protracted conflict between the tobacco industry and the federal government, which has continued until this day, centered on the issue of compelled commercial speech.
For 2 decades following the passage of the FCLA, the US and other countries around the world applied various iterations of health warnings on cigarette packages, but all of them were based on presentation of textual warnings on packaging and advertising materials.1 With the growing realization that textual warnings have limited effectiveness in conveying information or reducing smoking, including ineffectiveness among adolescents,2 interest grew in the creation of graphic warning labels depicting with illustrations the adverse health consequences of smoking. The first country to adopt graphic warning labels was Iceland, which began to apply them in 1985.3 As government interest in the public health value of graphic warning labels grew internationally, by 2012, 49 countries had adopted them—except the US, despite that they may decrease positive perceptions of cigarettes, increase quitting cognitions, and modify smoking behavior.4,5
Since 2009, the US Food and Drug Administration (FDA) has had the authority to regulate tobacco products. In that year, the Family Smoking Prevention and Tobacco Control Act (TCA),6 which granted the FDA’s regulatory authority over tobacco, was signed into law by President Barack Obama. Among the provisions in the TCA is an amendment to section 4 of the FCLA, which includes a regulation requiring that color graphic depictions of the health consequences of smoking be displayed on all cigarette packages and advertising materials.
First Amendment Protection of Commercial Speech
In 2011, the FDA issued graphic warning labels, which pictured serious health complications of cigarette smoking. The graphic labels illustrated adverse health consequences of cigarette use to more fully inform the public about the range of health complications. Before they were deployed, however, the labels were challenged in a lawsuit filed by tobacco companies (RJ Reynolds Tobacco Company v FDA).7 The companies’ claim was that the graphic labeling requirement constituted compelled speech that violated their First Amendment free speech rights.
The US Constitution protects speakers not only from government restrictions on their right to speak, but also from government actions to compel them to speak. As First Amendment scholar Robert Post has noted, in the realm of political speech (ie, public discourse as part of participatory democracy), there is “a constitutional symmetry between restrictions on public discourse and compulsions to participate in public discourse.”8(p877) Both the freedom to speak and the right not to be compelled to speak receive equal constitutional protection. This symmetry does not, however, pertain to commercial speech, defined as speech intended solely to promote a commercial transaction.9 In this circumstance, the right of commercial speakers to speak is protected, while their right not to be compelled to speak receives lesser protection.
First Amendment protection of commercial speech has evolved over the past 4 decades. Prior to Virginia State Board of Pharmacy v Virginia Citizens Consumer Council, Inc, decided in 1976, commercial speech received little or no constitutional protection. In that case,10 the US Supreme Court invalidated a Virginia statute stating that it was unprofessional conduct for a licensed pharmacist to advertise the prices of prescription drugs, on the basis of the First and Fourteenth Amendments. This was the first case in which the Supreme Court ruled that commercial speech was not excluded from First Amendment protection.
In 1980, in Central Hudson Gas & Electric Corporation v Public Service Commission, the US Supreme Court first established a new standard of review defining when commercial speech may be regulated.11 Justice Lewis Powell set out the 4-pronged Central Hudson test for commercial speech regulation:
At the outset, we must determine whether the expression is protected by the First Amendment. For commercial speech to come within that provision, it at least must concern lawful activity and not be misleading. Next, we ask whether the asserted governmental interest is substantial. If both inquiries yield positive answers, we must determine whether the regulation directly advances the governmental interest asserted, and whether it is not more extensive than necessary to serve that interest.11
On the basis of the text of the opinion in Central Hudson, the test is generally considered to establish an intermediate level of scrutiny for laws or regulations that may affect commercial speech.12 The principal rationale for allowing constitutional protection of commercial speech is that “the constitutional value of commercial speech lies in the circulation of information.”8(p877)
First Amendment Protection of Off-label Promotion
The Central Hudson test was also used in a recent legal case involving off-label promotion of a prescription drug.13 In Amarin Pharma Inc v FDA (119 F Supp 3d 196 [SDNY 2015]), the court ruled that Amarin’s off-label promotion of its omega-3 fatty acid formulation, Vascepa, received First Amendment protection as commercial speech, as long as the promotional materials were truthful and nonmisleading.14 In reaching this ruling, the court applied the Central Hudson test, concluding that the FDA’s claim of misbranding did not survive application of the test. The court also referred to US v Caronia, an earlier case in which the FDA brought criminal charges against a drug representative for off-label promotional activities.15 Here too, the court applied the Central Hudson test in concluding that off-label promotion received First Amendment protection as commercial speech. Taken together, these 2 legal cases greatly strengthened protection of commercial speech by the First Amendment.
Compelled Commercial Speech
For compelled commercial speech, such as mandated disclosures about marketed products, a different standard of review has been established. In Zauderer v Office of Disciplinary Counsel, a case that involved an attorney who was advertising his services, the Office of Disciplinary Council in Ohio brought a complaint against him for inconsistencies of his advertising with state law.16 The outcome of the complaint was that the Office of Disciplinary Council required disclosure of information that was not contained in the attorney’s original advertising materials. The Supreme Court rejected the use of the Central Hudson test as the standard of review for compelled commercial speech. Justice Byron White wrote for the Court:
Because the extension of First Amendment protection to commercial speech is justified principally by the value to consumers of the information such speech provides, see Virginia Pharmacy Board v Virginia Citizens Consumer Council, Inc, 425 US 748 (1976), appellant’s constitutionally protected interest in not providing any particular factual information in his advertising is minimal.16
Justice White added:
We do not suggest that disclosure requirements do not implicate the advertiser’s First Amendment rights at all. We recognize that unjustified or unduly burdensome disclosure requirements might offend the First Amendment by chilling protected commercial speech. But we hold that an advertiser’s rights are adequately protected as long as disclosure requirements are reasonably related to the State’s interest in preventing deception of consumers.16
Thus, in Zauderer, the standard of review for compelled disclosure was determined by the Court to be “reasonably related to the State’s interest in preventing deception of consumers.”16 This standard of review is, arguably, comparable to rational basis review, and the Central Hudson test was not invoked. Although some commentators have claimed that the Zauderer standard of review applies only to situations in which the State has an interest in preventing “deception of consumers,” Post8 has unambiguously refuted this claim. He noted that a mandated disclosure is constitutional as long as it is “purely factual and noncontroversial” and “reasonably related” to an appropriate State interest.8
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Estimated Prevalence of Smoking and Smoking-Attributable Mortality Associated With Graphic Health Warnings on Cigarette Packages in the US From 2022 to 2100
JAMA Health Forum. 2021;2(9):e212852. doi:10.1001/jamahealthforum.2021.2852
Key PointsQuestion What are the estimated population health outcomes associated with implementation of graphic health warnings on cigarette packages in 2022 and with delayed implementation of the warnings since 2012, as originally planned, in the US?
Findings In this decision analytical model using simulation modeling of smoking prevalence and smoking-attributable mortality in the US from 2012 to 2100, graphic health warnings, if implemented from 2022 to 2100, would be associated with 539 000 smoking-attributable deaths averted and 7.9 million life-years gained, and if implemented in 2012, with 718 000 deaths averted and 11.2 million life-years gained through 2100.
Meaning These findings suggest that graphic health warnings on cigarette packages may be associated with important public health benefits, and industry litigation and procedural delays to implementation may have been harmful for public health.
Importance Starting in 2022, the US Food and Drug Administration (FDA) plans to require all cigarette packages in the US to display graphic health warnings depicting health harms associated with smoking. The FDA originally planned to implement such warnings in 2012, but tobacco industry litigation delayed the effort.
Objective To assess the estimated population health outcomes associated with a policy requiring graphic health warnings on cigarette packages in the US and with a 10-year delay in implementation.
Design, Setting, and Participants This decision analytical model used simulation modeling of smoking prevalence and smoking-attributable mortality in the US from 2012 to 2100, using the Cancer Intervention and Surveillance Modeling Network smoking population model. The study was conducted from October 2020 to July 2021.
Main Outcomes and Measures The primary outcomes were annual adult smoking prevalence, smoking-attributable deaths averted, and life-years gained vs the baseline scenario. A baseline scenario assuming no graphic health warnings was compared with expected outcomes of implementing graphic health warnings in 2022 vs 2012. Policy effects were considered under varying assumptions of the association of the policy with smoking initiation and cessation, ranging from most conservative to most optimistic. A maximum smoking reduction scenario in which all smoking would stop by the end of 2022 was evaluated.
Results In the baseline scenario, an estimated 13.2 million smoking-attributable deaths would have occurred from 2012 to 2100. 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.
Conclusions and Relevance This decision analytical model estimated that FDA cigarette graphic health warnings, if implemented in 2022, would be associated with public health benefits. The model also estimated that more smoking-attributable deaths would have been averted if the policy had been implemented in 2012. Industry litigation and delays to implementing tobacco regulations may have been harmful for public health.
Cigarette health warnings in the US have remained unchanged for the past 35 years, but starting in 2022, pending legal challenges, the US Food and Drug Administration (FDA) will require cigarette manufacturers to display graphic health warnings covering 50% of the front and back of cigarette packages. These warnings will also be required in cigarette advertisements. Cigarette health warnings will feature 1 of 13 graphic images that depict some of the negative health consequences of smoking and brief warning statements (eg, “Smoking causes COPD, a lung disease that can be fatal”).1 The FDA originally planned to implement graphic health warnings in 2012, but tobacco industry litigation and resulting court decisions struck down the initial warnings, delaying implementation.1 Public health organizations and physicians filed a lawsuit against the FDA for these delays, and a court-ordered deadline forced the FDA to finalize new graphic health warnings nearly a decade later.2 The tobacco industry has also issued repeated legal challenges to the revised warning designs, and the implementation date is contingent on further court rulings.
Previous estimates of the potential population health benefits of graphic health warnings in the US were based on smoking prevalence trends through 2016.3 Since then, the prevalence of smoking—especially among youths and young adults—has decreased more than expected.4,5 Recent shifts in smoking trends may affect the outcomes associated with new regulations, including graphic health warnings. Past estimates also have not separately evaluated the outcomes for specific birth cohorts. This study used a simulation model to estimate smoking prevalence and mortality outcomes associated with graphic health warnings in the US under the planned policy for 2022 and compared these with estimated outcomes if the policy had been implemented in 2012.
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