FDA's graphic tobacco warnings unconstitutional, dct rules

R.J. Reynolds Tobacco Co. v. U.S. Food & Drug Admin., No. 6:20-cv-00176 (E.D. Tex. Dec. 7, 2022)

The judge who issued a nationwide injunction against the CDC eviction moratorium here strikes down the graphic cigarette warnings promulgated by the FDA as unconstitutional compelled speech because images have no inherent meaning and thus can’t be truthful, ignoring the relevance of the text next to them and the longstanding rules for interpreting commercial speech that consider context. The opinion suggests that perhaps the only constitutional mandatory images are actually just fonts: warnings written in imitation of childish handwriting.

The FDA’s previous attempt at congressionally mandated image warnings was also struck down. Among other things, the DC Circuit held that the first set of graphic warnings wasn’t “purely” factual under Zauderer because they were primarily intended to evoke an emotional response or because they offered advocacy rather than factual information about health effects.This is the second attempt. Congress gave HHS authority to issue rules adjusting the type size, format, color graphics, and text of any label requirements “if the Secretary finds that such a change would promote greater public understanding of the risks associated with the use of tobacco products.”

The new eleven warnings omit two ones allowed in the law (“Cigarettes are addictive” and “Quitting smoking now greatly reduces serious risks to your health”) and includes new warnings, not required by the law, about three health outcomes (amputation, blindness, and erectile dysfunction), based in part on a 2014 Surgeon General’s report that identified additional health conditions whose causal link to smoking was reported as established at the highest level of evidence.

The new rule claims an interest not only in reducing smoking, but “in promoting greater public understanding of the negative health consequences of smoking,” consistent with the language of the Tobacco Control Act. The rule pointed to “considerable evidence that the Surgeon General’s warnings go largely unnoticed and unconsidered by both smokers and nonsmokers . . . [and] have been described as ʻinvisible’  ”

In this court’s view, Zauderer

provides a standard of review more lenient than Central Hudson’s. Specifically, Zauderer rejects a “strict ʻleast restrictive means’ analysis” under which disclosure rules “must be struck down if there are other means by which the State’s purposes may be served.” Zauderer requires only a “less exacting” tailoring inquiry that asks whether disclosure requirements are “reasonably related” to the state’s interest.

But a disclosure still must not be “unjustified or unduly burdensome,” as well as being factual and uncontroversial.

The court didn’t need to decide whether Zauderer scrutiny is only allowed when the state is trying to prevent consumer deception, because these images weren’t inherently “accurate” and purely factual. This was so because the images could have many meanings.

“For expression to be ‘purely factual,’ it must be information with an objective truth or existence.” While words “can usually be classified by courts as either purely factual or as value-laden opinion” (a bold statement in itself, demonstrating how reification occurs in law by use of contrast), “imagery can be more prone to ambiguous interpretation.” (Citing a discussion of nonrepresentational art: Hurley v. Irish-American Gay, Lesbian and Bisexual Group of Boston, 515 U.S. 557 (1995) (noting the painting of Jackson Pollock as an example of expression without a “narrow, succinctly articulable message”).)

For example, the “verbal aspect” of the head and neck cancer warning made a a “falsifiable” claim.

But it is unclear how a court would go about determining whether its graphic aspect is “accurate” and “factual” in nature. The image may convey one thing to one person and a different thing to another. One person might view the image as showing a typical representation of the sort of neck cancer caused by smoking before a person could seek medical treatment. Another person might view the image as showing a stylized, exaggerated representation of neck cancer, perhaps in an effort to provoke repulsion. Others might interpret the depicted person’s gaze, in conjunction with the text, as expressing regret at her choice to smoke or the message that smoking is a mistake. All of those interpretations would be at least reasonable.

First, it is not really unclear how to determine the accuracy of representational images—courts do it in advertising cases regularly. The court is adding extra interpretations to the fundamental meaning created by the text plus image: this image represents a person with neck cancer. The additional speculations are all immaterial variants of the same thing (and could, for what it’s worth, be said of verbal warnings too—some people may interpret them as neutral informational claims while others may interpret them as directions not to smoke because of the negative consequences. The evidence for multiple interpretations of the implications of verbal warnings is quite strong, but that doesn’t make the verbal warnings unconstitutional because the implications of the factual claim are different from the accuracy of the factual claim, which difference is inherent in the idea of providing people more information for them to use if they want to do so).

The court found the imagery “provocative.” (Yeah, neck cancer sucks.) “As to each warning, it is not beyond reasonable probability that consumers would take from it a value-laden message that smoking is a mistake. For that reason alone, the graphics make all of the warnings here not ‘purely factual’ and ‘uncontroversial’ within the meaning of Zauderer.” This is nonsense. Warnings are often messages that disregarding them would be a mistake, because they warn of unpleasant things. Consider lead paint disclosures: Any fair reading of lead paint disclosures discourages living—especially with children—in a place with lead paint. That’s because it’s bad for children to be exposed to lead, which is important for people to know!

And here again the court pretends that there are messages that don’t imply “you should care about this message”: “For example, a map showing on which continent food was farmed, next to a disclosure naming that continent, would seem purely factual. And perhaps a stylized icon could be mere shorthand for factual information, such as a symbol denoting the presence of a given chemical in a product.” The first one is particularly laughable given the longstanding recognition of the selling power of geographical origin. And even the second one ignores that the point of disclosing the chemical is to allow some set of people to say “oh, I don’t want that!”

The court’s new standard—never mentioned in a previous case and impossible to satisfy for any claim because people vary in how they interpret claims, and there’s always some joker out there—is that the FDA must make a record-based showing that “each image-and-text pairing conveys only one, unambiguous meaning that is factually correct.” As to the heart disease warning, the court commented, “[c]onsumers may reasonably interpret the image in this warning as indicating that open-heart surgery, whose scars are shown, is the most common treatment for heart disease. But the court has no evidence of that assertion’s truth,” and in fact non-open heart treatment is more common. It was not enough for open-heart surgery to be “common” or “typical.” “Alternatively, the image could be reasonably understood as conveying that open-heart surgery is the best treatment for heart disease, even if not the most common. But that message would seem opinion-based, as opposed to a purely factual disclosure about an advertiser’s product,” and there was no record evidence that open-heart surgery was best. [That’s because the court made this meaning up! The text clarifies that this is about what smoking does, not how one should treat the consequences of smoking.]

It is important to recognize here that when, in Lanham Act cases, courts say that a message is “unambiguous” they do not mean that no person could conceivably interpret it differently or reach varying normative recommendations from the factual claim at issue. They find statements unambiguous without evidence of consumer perception—indeed, the point of finding a claim to be unambiguous under current Lanham Act doctrine is to avoid the need for any consumer perception evidence at all, because common sense is enough to say that an unambiguous message will be received by a substantial number of reasonable consumers, not every single one. So the court here is transforming the meaning of “unambiguous” to mean “impossible to misinterpret,” which is neither consistent with precedent nor a satisfiable standard.

The court applied the same logic to the cataracts warning: “the warning does not indicate whether it shows cataracts or blindness, both of which are mentioned. That alone creates a reasonable possibility of misinterpretation by some consumers.” [Why is that a material difference?] “[S]ome consumers may reasonably interpret the image as depicting [blindness as] the most common result of cataracts. But the court has no evidence of that depiction being accurate.”

For all the warnings, “[b]ecause of their capacity for multiple reasonable interpretations, consumers may perceive expression whose truth has not been established by the record.” Thus, Zauderer did not apply. [I know this is repetitive, but there was zero evidence in the Zauderer record that consumers would all interpret “costs and fees” in the same way. The whole point of the regulation at issue in Zauderer was that consumers didn’t generally know much about litigation costs.]

If Zauderer didn’t apply, Central Hudson or strict scrutiny did, and the warnings flunked even Central Hudson. The court didn’t decide whether “promoting understanding of the risks of smoking” was a substantial government interest, though seemingly expressed skepticism about that (because that wouldn’t require the government to show that behavioral change was likely, making the interest too “conceptual” to be substantial).

Instead, the disclosures were not “narrowly drawn.” “Rather than taking over half of a package’s face, the government may take advantage of other strategies such as increasing funding for anti-smoking advertisements in various forms of media, increasing funding for speakers and school instruction, and increasing anti-smoking resources in the government’s own communications.” This followed from NIFLA, as well as from the FDA’s own praise of its public-information campaigns, which allow “the ability to target particular groups in different channels of communication with different messages.” Even if current education wasn’t enough, NIFLA held that, “regardless, a tepid response does not prove that an advertising campaign is not a sufficient alternative” as a First Amendment matter. “NIFLA reasoned that the constitutional line is principled, not pragmatic: ‘The First Amendment does not permit the State to sacrifice speech for efficiency.’”

What does a tailoring requirement mean, then, if the fact that the alternatives don’t work as well does not show adequate tailoring? [I can recall this discussion in a very different context, US v. Playboy, and the answer seems to involve measuring the increment of improved furtherance of government interest against the increment of interference with a speaker’s own speech, but since those are incommensurable the measurement is always done implicitly and covertly, which is not very helpful to the rule of law.]

Also, the FDA didn’t consider smaller or differently placed warnings, because the statute specified size and placement. “But the First Amendment limits congressional action as much as agency action. So the lack of any such consideration in the record counts against the government.”