Some readers might be surprised to know that a court in Texas has the authority to declare the Food and Drug Administration’s rules unconstitutional. Yet this is precisely what Judge Campbell Barker did last Wednesday in R.J. Reynolds v. FDA (2022), a case in which the Public Health Law Center filed an amicus brief. Not only are the FDA’s rules created hundreds of miles away from the Eastern District of Texas in which the case was heard, the agency’s rules and decisions to invalidate them also apply to the entire country.

Since 2009, the FDA has had an obligation under the Tobacco Control Act to replace the Surgeon General’s warnings that have been on cigarette packs since the 1960s with new warnings that include graphic images and text. The FDA attempted to follow through on this charge soon after the Tobacco Control Act’s passage, but tobacco companies sued, arguing that being compelled to place the government’s images and text on their cigarette packs violated their rights under the First Amendment.

Though tobacco companies were successful in their challenge, the FDA renewed its efforts after the decision and issued a revised rule on graphic and textual warnings on March 18, 2020. Rather than permitting the FDA to fulfill its duties under the Tobacco Control Act, however, tobacco companies filed suit again, arguing that the new images and text still violated their First Amendment rights.

Some readers might remain confused as to why tobacco companies brought a lawsuit in Texas about the FDA’s rulemaking in D.C. Indeed, the FDA argued that one of the plaintiffs, Neocom, should be dismissed and that venue was improper. Neocom is a tobacco retailer within the court’s district. Granted, the FDA’s rule impacted a product sold by tobacco retailers, including Neocom, but with over a hundred thousand tobacco retailers across the country, tobacco companies had their choice of judicial fora. To challenge the FDA’s rule, they needed only to decide which district they preferred and then partner with a local retailer.

Judge Barker, a Trump-appointee, was persuaded by tobacco companies that the FDA’s new rule violated their First Amendment rights. A central issue in the case was whether or not the FDA’s images and text were “purely factual and uncontroversial.” The FDA argued that they were, which would have triggered the “Zauderer standard” of judicial review. Under this standard, an agency’s rule must be only “reasonably related” to the interest it is trying to achieve. The judge took the FDA’s images and text to be susceptible to multiple interpretations and from this concluded that they were not purely factual and uncontroversial.

The judge therefore believed that the rule must meet the more exacting Central Hudson standard for compelled speech that is not purely factual and uncontroversial. Rather than inquiring into whether the FDA’s rule was reasonably related to the government’s interests, this meant that the judge required the rule to employ the “least restrictive means” necessary. From this vantage point, the judge determined that the FDA’s text and images were not the least restrictive means to increase public knowledge about the risks of smoking. He emphasized that anti-smoking efforts have already ensured that people are aware of the risks of smoking, making it difficult for the FDA to justify new compelled messages as increasing public understanding.

Nevertheless, the FDA could appeal to the Fifth Circuit. The judge only analyzed and rejected some of the FDA’s images, finding it unnecessary to address others on the grounds that they all were susceptible to multiple interpretations. But consider one of the images not discussed—an image of a child with an oxygen mask, accompanied by the text, “Tobacco smoke can harm your children.” This is a statement that can be assessed in terms of truth and falsity and is uncontroversial. Perhaps fewer people know what these harms could tangibly look like, and the image that joins the text supplies a possibility. Judge Barker would ask, Does this image depict a common effect of smoking on children? The most common one? His ultra-exacting standard takes the inability of a judge or consumer to formulate correct answers to such questions as establishing that the images and text themselves must consequently not be purely factual and uncontroversial. But the image illuminates a particular type of harm that tobacco smoke can cause children, and it depicts that type of harm regardless of whether it is a common effect or the most common one, and regardless of the opinions of a consumer or a judge on the matter.

The FDA could additionally challenge the more general assumption that “value-laden” statements cannot be purely factual. Statements can be both factual and prescriptive. A person might say, “I’m cold,” or “It’s zero degrees Fahrenheit in here,” implying a recommendation that the person next to the window ought to close it. Similarly, a warning that tobacco smoke can harm children does not become less factual simply because the FDA hopes that it incentivizes people to avoid certain behaviors.

The FDA might also choose not to appeal. For example, it might not do so if the agency anticipated that it would lose before the Fifth Circuit. But if the FDA cannot even use an image and text to convey that tobacco smoke can harm children, then how can it fulfill its mandate under the Tobacco Control Act? Surely Congress did not intend for the FDA to be so hogtied in implementing graphic warnings.

By Luke I. Haqq, Staff Attorney
December 13, 2022