Graphic Cigarette Warning Labels, the First Amendment, and Public Right to Accurate Public Health Information: Graphic Cigarette Warning Labels Back Under Legal Scrutiny

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.

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)

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.

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

Given this background, the outcome of the 2012 lawsuit challenging the FDA’s graphic cigarette warning labels, RJ Reynolds Tobacco Company v FDA,¹⁷ is difficult to understand. In the US District Court for the District of Columbia, Judge Richard Leon rejected the application of the Zauderer standard of review because he did not agree that the FDA’s graphic images were “purely factual.”¹⁷ Instead, he argued that the images were intended to evoke emotion, and that the inclusion of the hotline number “1-800-I-QUIT” in the label was meant to extoll consumers to quit smoking, which in his opinion was also not “purely factual.” Consequently, the judge applied the strict scrutiny standard of review in his First Amendment analysis of compelled commercial speech, and intermediate scrutiny based on Central Hudson, which may have been a plausibly acceptable alternative to Zauderer review, was not mentioned at all. With the application of the strict scrutiny standard, the judge concluded that the graphic images were not narrowly tailored to the government’s interest of persuading people not to smoke and therefore ruled the FDA’s graphic warning labels to be unconstitutional.

On appeal to the US Court of Appeals for the DC Circuit, 2 of the 3 judges on the panel agreed with the District Court Judge Leon that the graphic warning labels did not qualify for Zauderer review.¹⁸ Their rationale was that graphic cigarette labels were not intended to prevent deception of the public and therefore were not appropriate for Zauderer review. However, as discussed previously, Post⁸ has commented that the Zauderer standard of review is not applicable only to compelled commercial speech (mandated disclosure) that is intended to prevent public deception but may be more broadly applicable.

Even in Justice White’s opinion in Zauderer, he made it clear that disclosures may be appropriate beyond addressing consumer deception and may also include “consumer confusion”: “warning[s] or disclaimer[s] might be appropriately required…in order to dissipate the possibility of consumer confusion or deception.”¹⁶

In RJ Reynolds Tobacco Co v FDA (2012),¹⁸ the 2 DC Circuit judges agreed with the district court judge that the warning labels were not purely factual, but they disagreed that strict scrutiny was the appropriate standard of review and instead applied intermediate scrutiny according to Central Hudson. In their assessment based on the Central Hudson test, the judges concluded that the FDA had failed to satisfy the third prong of the test: “FDA has not provided a shred of evidence—much less the ‘substantial evidence’ required by the APA [Administrative Procedure Act]—showing that the graphic warnings will ‘directly advance’ its interest in reducing the number of Americans who smoke.”¹⁸ Thus, 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.

Since that time, in response to the opinion of the DC Circuit, the FDA has undertaken further extensive studies to create, in collaboration with a professional medical illustrator, 13 new graphic warning labels.¹⁹ Like the original 2011 FDA rule requiring graphic labels, the new FDA rule requiring labels was also quickly challenged in a lawsuit brought by the tobacco industry in the US District Court for the Eastern District of Texas (RJ Reynolds Tobacco Company v FDA, No. 6:20-cv-00176 2020).²⁰ As the lawsuit proceeds, the implementation of the new graphic warnings has been twice delayed by the court until July 13, 2022.

At the same time, a second similar lawsuit was brought against the FDA by tobacco companies owned by the Altria Group (Philip Morris USA Inc and Sherman Group Holdings, LLC v FDA²¹). This case is proceeding concurrently with RJ Reynolds (2020) in the US District Court for the District of Columbia.

More than a decade after passage of the TCA, which first mandated graphic warning labels in the US, no graphic labels have yet been displayed on any cigarette packages or advertisements, and a national controversy continues to foment around the application of graphic warning labels. At the core of the matter is still the First Amendment, which has stymied the placement of graphic warning labels, despite the need for public education on the well-documented serious adverse health effects of cigarette smoking. The focus of the controversy remains centered on commercial speech—the extent to which this form of speech is protected by the First Amendment and the extent to which it may be regulated by the government.

While political speech (speech used in public discourse), which promotes our participatory democracy, is highly protected by the First Amendment, commercial speech, which serves only to promote commercial transactions, has received less constitutional protection.⁸ As in the RJ Reynolds (2012) lawsuit, compelled speech is again at issue in RJ Reynolds (2020). In the new lawsuit, the tobacco companies claim, as they did in 2012, that the requirement that they display graphic warning labels on their products and advertising materials is a form of compelled speech that does not survive First Amendment analysis. They further claim that the graphic warnings do not accurately reflect their products and simply induce emotional reactions but do not convey valid information.

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 warnings¹⁹) on the basis of First Amendment protection of commercial speech.²² The companies argue that the compulsion for them to display graphic warnings must be subjected to strict scrutiny, yet it is clear from prior case law, discussed previously and reviewed here, that strict scrutiny is not the appropriate standard of review in this situation.

The defendant (FDA) points to Zauderer v Office of Disciplinary Counsel¹⁶ as the relevant precedent for determining the appropriate standard of review. In that case, the court concluded that when commercial disclosures are mandated and the mandated disclosures are “purely factual and noncontroversial,” the appropriate standard of review is whether the “disclosure requirements are reasonably related to the State’s interest.” Among the established standards of review, the terminology used in the opinion most logically resembles rational basis review. Whether or not the “rational basis review” terminology is applied, Public Citizen as an amicus to the FDA observed: “The FDA’s disclosure regulation undisputedly governs only commercial speech, and regulation of commercial speech is subject either to intermediate scrutiny under Central Hudson or even less demanding scrutiny under Zauderer.”^23(p13)

Thus, a critical matter to be determined in RJ Reynolds (2020) is the appropriate standard of review of the regulation of compelled commercial speech requiring tobacco companies to display graphic warning labels.¹⁹ The FDA argues that compelled commercial speech in this case easily passes First Amendment analysis, which, on the basis of relevant Zauderer precedent, should be conducted according to whether the application of warning labels is “reasonably related to the State’s interest” and not according to a heightened level of scrutiny. As a caveat, in National Institute of Family and Life Advocates v Becerra,²⁴ the court did not apply the Zauderer review standard to a California law compelling disclosures by crisis pregnancy centers. It is plausible that graphic warning labels would also survive intermediate scrutiny according to Central Hudson if application of that test were required by the court. However, it is noteworthy that in Sorrell v IMS Health Inc²⁵ overruling a Vermont law restricting commercial speech, the court applied a “heightened” level of scrutiny, not intermediate scrutiny (though strict scrutiny was not applied). If the Central Hudson test were to be applied in RJ Reynolds (2020), resolution may come down to whether the FDA can successfully address the third prong of the test, ie, whether the “regulation directly advances the governmental interest asserted.”¹¹ The FDA failed to convince the DC Circuit judges on the third prong of the test in the RJ Reynolds (2012) litigation, and it is possible that the question will come up again in the RJ Reynolds (2020) litigation. In the new rule, the FDA has made it clear that the government interest is “to promote greater public understanding of the negative consequences of smoking.”²⁶ It is not relevant to this rule whether it will be effective in reducing cigarette smoking.

It is worthy of note that while some scholars have questioned the constitutionality of rational basis review,²⁷ others have observed that not only is rational basis review constitutional, but it is also desirable.²⁸ In RJ Reynolds (2020), the tobacco companies do not argue that Zauderer review (equivalent to rational basis review) is unconstitutional, only that it does not apply in this case.

The FDA’s position is that an important part of the rationale for providing First Amendment protection for commercial speech is to ensure that listeners (consumers) receive information about products they are considering for purchase.²⁰ The importance to consumers of receiving factual information about the potential health harms of cigarette smoking, which is clearly provided by the new warning labels, is difficult to dispute. In this instance, 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. The mandated disclosure of information provided in the new warning labels, as an example of compelled commercial speech, is representative of the central rationale for constitutional protection of commercial speech. It is also worthy of note that manufacturers, including pharmaceutical manufacturers, may be held legally accountable when their product labels fail to warn consumers of potential harms from their products.²⁹ Given the known lack of efficacy of textual warnings on cigarette packages in communicating information to consumers, withholding graphic warning labels may qualify as a form of failure to warn.

Another notable issue in RJ Reynolds (2020) is whether the graphic warning labels are considered by the court to represent fact or opinion. While mandated disclosures based on facts may pass First Amendment analysis, disclosures that solely represent opinion may not. In commenting on the 2011 versions of the FDA’s graphic warning labels, Post wrote: “The required FDA graphic warnings are constitutionally ambiguous, however, because graphic images can sometimes convey opinion instead of information.”⁸

In 2012, the DC Circuit ruled against the FDA’s graphic warning labels in part because the court believed the images were created primarily to arouse emotion and not to provide factual information. It may be surmised that the court regarded the images as conveying opinion, but not fact, and it may be concluded that this distinction proved critical in the court’s ruling to strike down the labels. However, in developing the updated 2020 versions of the graphic warning labels, FDA explicitly created new graphic images that are factually based and accurately depict human anatomy and disease pathology. The images are based on expert professional knowledge. To extend the information value of the graphic images, the FDA selected for graphic presentation some of the lesser-known health consequences of cigarette smoking, such as bladder cancer, diabetes, and age-related macular degeneration, which would be unknown to many smokers and provide additional information of public health value. The new versions of the images are objectively based and were not created to evoke an emotional response. It is noteworthy in this context that the court in Zauderer observed: “The use of illustrations or pictures in advertisements serves important communicative functions…. Accordingly, commercial illustrations are entitled to the First Amendment protections afforded verbal commercial speech.”¹⁶

Thus, the new graphic warning labels, by providing accurate information vetted by expert professionals that is of value to the public, contribute to democratic competence and warrant constitutional protection on this basis.⁸ The FDA has underscored that the new graphic warning labels are intended “to promote greater public understanding of the negative consequences of smoking.”²⁶ Lindblom and colleagues³⁰ have suggested that the use of inserts and onserts might be an alternative strategy to communicate such information to the public.

The outcome of RJ Reynolds (2020) will have consequential implications not only for public health, but also for commercial speech law. The inclusion, for the first time in the US, 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.¹⁵

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. 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,³¹ only heightens this concern. Such a result would have lasting negative consequences for public health and commercial speech law.

Accepted for Publication: August 4, 2021.

Published: September 24, 2021. doi:10.1001/jamahealthforum.2021.2886

Correction: This article was corrected on February 3, 2023, to change “upholding” to “overruling” in the text discussion of Sorrell v IMS Health Inc.

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Curfman G. JAMA Health Forum.

Corresponding Author: Gregory Curfman, MD, Journal of the American Medical Association (JAMA), Editorial Office, 330 N Wabash Ave, 41st Floor, Chicago, IL 60611 (gregory.curfman@jamanetwork.org).

Author Contributions: Dr Curfman had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Curfman.

Acquisition, analysis, or interpretation of data: Curfman.

Drafting of the manuscript: Curfman.

Critical revision of the manuscript for important intellectual content: Curfman.

Administrative, technical, or material support: Curfman.

Conflict of Interest Disclosures: None reported.