By Laura Karas
The latest attempt of the U.S. Food and Drug Administration (FDA) to make a dent in the country’s intractable tobacco problem is a set of color graphic warnings that will appear on cigarette packages and advertisements beginning in June of 2021.
The legal battle surrounding the graphic warnings and other attempts to regulate commercial speech in the food and drug context illustrate the courts’ enduring failure to appreciate the full extent and substantiality of the government’s interest in promoting public health.
FDA Final Rule Mandates Color Graphic Warnings
In March 2020, FDA issued a final rule using its authority under the Family Smoking Prevention and Tobacco Control Act to require color graphic warnings on cigarette packages. Noting that “existing Surgeon General’s warnings [on tobacco products] . . . go unnoticed and are effectively ‘invisible,’” FDA designed thirteen graphic warnings depicting tobacco-induced ailments from chronic obstructive pulmonary disease (COPD) to cataracts and bladder cancer, among others.
Cigarette packages and advertisements will require a graphic warning, appearing alongside text warnings and covering the upper half of the front and back panels of each package. The proposed warnings, as well as a 3D model simulating the warning’s placement on a cigarette package, can be found on the FDA’s website. Per the final rule, tobacco makers must ensure a “random and equal display and distribution” of the various warnings and a “quarterly rotat[ion] . . . in advertisements.” Such a prominent display of “photorealistic image[s]” of the harmful health consequences of smoking, FDA explains, is designed to foster greater awareness among the lay public of the many injurious effects of smoking on health.
Research has demonstrated that smokers do not appreciate the various health risks of smoking, and that warnings – especially large graphic warnings – can be effective in conveying those risks. The March 2020 final rule had as a precursor a similar 2011 final rule requiring graphic warnings that – not surprisingly – faced legal challenges from the major tobacco companies.
Earlier Graphic Warning Efforts Faced First Amendment Challenges
In 2012, the U.S. Court of Appeals for the D.C. Circuit affirmed a lower court’s grant of summary judgment in favor of the tobacco companies, striking down graphic warnings as violative of tobacco companies’ First Amendment rights.
Applying the Central Hudson test for regulation of commercial speech, the court concluded that FDA failed to provide sufficient evidence that graphic warnings would “‘directly advance’ its interest in reducing the number of Americans who smoke.” Judge Brown, dissatisfied with the evidence the government presented and echoing courts’ general skepticism toward social science studies in the courtroom, concluded that the government had not shown conclusively that graphic warnings would “actually le[ad] to a reduction in smoking rates.” “Mere speculation” about whether the warnings would advance the government’s stated interest would not suffice, and an interest in “effective communication” of the health risks of smoking was “too vague to stand on its own.”
But what the court failed to realize is that lack of scientific evidence showing an effect does not prove a lack of effect. And, in light of the tremendous social and economic toll of smoking, provision of information about health risks is a legitimate government interest in itself.
Regulation of Commercial Speech in the Public Health Context
This case was not the first time that the courts have sided against government efforts to regulate commercial speech for the purpose of furthering public health: the courts came down in favor of commercial entities’ free speech rights in Amarin Pharma, Inc. v. FDA (settled in 2016) and United States v. Caronia (a Second Circuit decision from 2012), both in the context of off-label promotion of pharmaceutical drugs. These cases provide the legal precedent permitting drug companies to engage in truthful, non-misleading speech in promotion of off-label uses of FDA-approved drugs, without the risk that such speech alone could render them subject to a criminal misbranding charge under the Federal Food, Drug & Cosmetic Act (FDCA).
But how much leeway should the government have to compel speech in the form of warnings on food and drug products that have known harmful risks to the public’s health?
Recently, in American Beverage Ass’n v. City & County of San Francisco, the U.S. Court of Appeals for the Ninth Circuit reversed the lower court’s denial of a preliminary injunction to the American Beverage Association, finding that the government could not meet its burden of justifying a mandatory warning in advertisements for sugar-sweetened beverages. (The warning would have read: “WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay. This is a message from the City and County of San Francisco,” and would have occupied at least 20% of the area of the advertisement.) Again, with respect to sugar-sweetened beverages, research supports the effectiveness of warning labels on consumption choices.
The common denominator among these cases is the courts’ faulty weighing of the government’s interest in promoting public health via its regulation of commercial speech. The courts arguably curtail legitimate government interests in the public health arena, and undervalue the substantiality of those interests in the First Amendment analysis. In so doing, they consistently reach an outcome that is too permissive of corporate speech and too restrictive of reasonable public health-targeted constraints placed on it.
Smoking Prevalence: Some Recent Statistics
Roughly 15 of every 100 adult men and 13 of every 100 adult women smoke, with higher figures for certain racial and ethnic groups. Rates of smoking tend to increase as annual household income declines. (Compare a figure of 21 smokers per 100 adults earning less than $35,000 per year, to 7 smokers per 100 adults earning more than $100,000 per year.) The discrepancy based on education level is even more pronounced: thirty-five adults smoke for every 100 adults with a GED as their highest level of education, as compared to only 4 smokers for every 100 adults with a graduate degree.
The socioeconomic disparity in smoking rates underscores the importance of educating the public, and graphic warnings can reach across socioeconomic boundaries to raise awareness through a different medium than a textual warning. Only with accurate, complete, and understandable information about risks can a person make an informed decision about whether to engage in a risky activity. And, in the tobacco context, the government has a strong justification for regulating commercial speech to further that end.