D.D.C.: FDA’s rule re cigarette labels violates First Amendment

After finding that a recently-issued final rule by the U.S. Food and Drug Administration (“FDA”) likely violates the Free Speech Clause of the First Amendment, a district court issued a preliminary injunction against the enforcement of the final rule. R.J. Reynolds Tobacco Co. v. FDA, No. 11-1482 (D.D.C. Nov. 7, 2011). Richard J. Leon, a George W. Bush nominee, wrote the opinion.

In June 2011, the FDA issued a final rule – pursuant to a congressional directive – that requires tobacco companies to include textual and pictorial warnings on cigarette packages and printed advertisements. See FDA, Required Warnings for Cigarette Packages and Advertisements, 76 Fed. Reg. 36,628 (June 22, 2011) (“the Rule”). Under the Rule, the warnings are to include one of nine textual warnings – such as “Cigarettes cause cancer” – and one of nine pictorial warnings, which are to rotate according to an agency-approved plan.

The pictorial warnings depict some of the effects of smoking. For instance, one shows a pair of diseased lungs next to a pair of healthy lungs, and another shows a cadaver lying on a table. The Rule, which is set to go into effect in September 2012, requires the warnings to occupy the top 50% of the front and back of all cigarette packages and the top 20% of all printed advertisements.

In August 2011, five tobacco companies brought a lawsuit against the FDA, alleging that the Rule violates the First Amendment by compelling commercial speech in an impermissible manner. Specifically, the Plaintiffs challenged the substance of the pictorial warnings, and the prominent placement of the pictorial and textual warnings on cigarette packages and advertisements. In their lawsuit, the Plaintiffs also sought a preliminary injunction against enforcement of the Rule, which is the subject of the court’s recently-issued opinion. Notably, the Plaintiffs asked for the injunction to last until fifteen months after resolution of the Plaintiffs’ claims on the merits.

The court began its opinion by rejecting the Defendants’ contention that the Plaintiffs’ request for a preliminary injunction that extends for over a year after resolution on the merits is inappropriate. The court responded by stating that it has the inherent equitable power to issue the relief, and noted that, in fact, the court’s “powers extend even farther.”

Turning to the First Amendment claim, the court first discussed the possible standards of review. Under Zauderer, a disclosure requirement is constitutional if it is “reasonably related” to a governmental interest. See Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio, 471 U.S. 626, 651 (1985). However, for the Zauderer standard to apply the disclosure must be factual and uncontroversial. Id. If the speech is not factual and uncontroversial, strict scrutiny applies.

For several reasons, the court concluded that the Rule’s pictorial warnings are not factual and uncontroversial. First, the court stated that the fact that some of the images appear to be cartoons or to be digitally enhanced “contravene[s] the very definition of ‘purely factual.’” Second, the court stated that the fact that the images were designed to evoke emotion “further undercuts the Government’s argument that the pictures are purely factual and not controversial.” Finally, the court stated that because the images were designed to deter people from smoking, the images are not purely factual and uncontroversial.

The court went on to compare the Rule’s disclosures with a disclosure that the Seventh Circuit determined warranted strict scrutiny analysis. See Blagojevich, 469 F.3d 641,651 (7th Cir. 2006). In that case, a state law required video game retailers to prominently affix a sticker with the number “18” on any video game deemed “sexually explicit.” Id. at 652. The Seventh Circuit found that strict scrutiny was warranted because the conclusion of whether a video game was “sexually explicit” was opinion-based. Id. Regarding the FDA’s Rule, the court concluded that as with the stickers in Blagojevich, a less-exacting level of scrutiny is not warranted because the disclosures do not “deliver cold, hard facts.”

Applying strict scrutiny to the FDA’s Rule, the court concluded that the Plaintiffs were likely to succeed on the merits of their First Amendment claim. The court first rejected the Defendants’ stated interest – which was to educate consumers about the dangers of smoking – as a subterfuge for the Defendants’ real interest, which the court found was to advocate a change in consumer behavior.

Moreover, the court concluded that the means employed by the government are not narrowly tailored for two reasons. First, the court concluded the Rule’s requirement that the pictorial and textual warnings occupy a large portion of cigarette packs is “anything but narrowly tailored.” In the court’s view, the display requirements constitute “[a] ‘mini-billboard,’ indeed, for [the government’s] obvious anti-smoking agenda!” Second, the court concluded that the substance of the pictorial warnings is not narrowly tailored. The court noted with apparent approval two alternative images suggested by the tobacco companies: (1) a graph demonstrating the difficulty of quitting smoking, and (2) an image that depicts the dangers associated with secondhand smoke.

After concluding that the Plaintiffs were likely to succeed on the merits of their First Amendment claim, the court went on to find that the Plaintiffs offered sufficient evidence of irreparable harm absent injunctive relief, and that the governmental and public interest of desiring to limit the use of tobacco is outweighed by the substantial injury the Plaintiffs would endure absent an injunction. Consequently, the court granted the Plaintiffs’ request for a preliminary injunction.

Scott Herrig, University of California, Berkeley-School of Law 2012


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