For more than 50 years, the federal government has required health warnings on cigarette packaging and advertising.  Originally, the law required the now-familiar boxed disclaimer, "Caution:  Cigarette Smoking May Be Hazardous To Your Health."  Since that time, the required warnings have evolved.  

In 2020, the U.S. Food & Drug Administration promulgated a rule requiring updated warnings.  The rule created 11 new health warnings, each of which included a graphic photo and a health warning.  At the end of last year, in a lawsuit that a group of cigarette manufacturers and retailers brought against the FDA, a federal court in Texas vacated the rule, holding that it violates the First Amendment. 

What standard applies? 

When considering whether a government restriction on speech violates the First Amendment, courts first look to the test set out by the U.S. Supreme Court in Central Hudsonessentially:  (1) does the regulated speech concern constitutionally protected speech (as opposed to misleading speech, for example); (2) does the government have a substantial interest to be achieved the restriction; (3) does the restriction directly advance the government's interest (as opposed to only providing remote support); and (4) is the restriction narrowly drawn, and not more extensive than is necessary? 

Because the FDA's rule is requiring speech -- as opposed to prohibiting it -- a slightly different standard may apply.  In Zauderer, the Supreme Court said that, where the restriction relates to commercial advertising -- and where the required disclosures are "purely factual" and "uncontroversial" -- the government only has to show (for the fourth factor) that the disclosure requirements are reasonably related to the state's interest and that they are not unjustified or unduly burdensome.  

Here, the court held that the lower standard wasn't applicable, because the government couldn't show that the required disclosures -- in particular, the images -- were "purely factual" and "uncontroversial." 

First, the court said that it didn't think the images were "purely factual."  The court explained, "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 images 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." 

Next, the court said that it also thought that the images were not "uncontroversial."  The court explained, "The imagery in the warnings here is provocative.  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' with in the meaning of Zauderer."

The court also questioned whether the FDA could show that each image and text pairing has one factually-correct, unambiguous meaning.  The court explained, "Because of their capacity for multiple reasonable interpretations, consumers may perceive expression whose truth has not been established by the record." 

The court determined, then, that, at a minimum, the restriction must satisfy Central Hudson's intermediate scrutiny standard. 

Is the restriction "narrowly drawn"? 

In looking at whether the FDA's rule satisfies the Central Hudson test, the court honed in on whether it was "narrowly drawn" and "not more extensive than necessary."  And the court held that it wasn't, writing, "the government has not shown that compelling these large, graphic warnings is necessary in light of other options."  

The court pointed to the fact that the government could run anti-smoking campaigns instead.  The court explained, "Increasing resources for such a public-information campaign not only is less burdensome of private speech but also offers the ability to target particular groups in different channels of communication with different messages."  

The court also questioned whether the FDA could have proposed warnings on the packaging that were less burdensome.  The could explained, "The FDA also cannot argue that less burdensome warnings on cigarette packages and advertisements would not achieve the government's interest, for the FDA did not test the efficacy of 'smaller or differently placed warnings.'"

Reynolds v. FDA, 2022 WL 17489170 (E.D. Tx. 2022).