On Monday, U.S. District Judge Richard Leon issued a preliminary injunction blocking implementation of FDA’s new graphic warnings requirements, which would have required, beginning September 22, 2012, all cigarette packages to display one of nine new textual warnings showing the dangers of smoking, graphic images on the top fifty percent of both the front and rear panels. The new warnings requirement also would require display of a smoking cessation assistance telephone number. The court’s injunction stays implementation of the requirements until 15 months after a final ruling from the court resolving the lawsuit. Opponents were vocal in their dislike for this opinion, citing studies that allegedly show positive effects of graphic warnings used in other jurisdictions. There were calls for the Justice Department to appeal the ruling.

This action was taken by the Court because it found that the plaintiff tobacco manufacturers had demonstrated a substantial likelihood that they would prevail on the merits of their position at trial. The manufacturers claim that the new requirements unconstitutionally compel speech, and that their companies will suffer irreparable harm in the absence of injunctive relief.

The reasoning for the decision includes that the graphic image requirements are not purely factual and uncontroversial, making them subject to a stricter analysis applicable to government regulations which compel commercial speech. The Court noted that some of the pictures appeared digitally enhanced to “evoke emotion” and thus the Judge concluded that these were not “purely factual.”

To withstand this stricter analysis, the graphic warnings must be narrowly tailored to achieve a compelling government interest. Noting that FDA’s purpose in promulgating the warning requirements is unclear, the Court said that, regardless of the purpose, the requirements are not narrowly tailored to achieve any government purpose, as demonstrated by the expansive size and display requirements for the new warnings and the existence of alternative means of disseminating the same type of information.

The Court also found that, without the injunction, the plaintiffs would suffer irreparable injury, in a couple of ways, namely (i) in an inability to recover from FDA costs incurred in preparing to comply with the new requirements and (ii) because of the harm flowing from a First Amendment violation.

Although FDA argued that injunctive relief would harm the public, the Court disagreed, finding that Congress’s lack of urgency in passing the graphic warning statute and FDA’s use of the full two-year period to promulgate the final requirements undercut the public harm argument.

Contributor: Nancyellen Keane

For questions and/or comments, please contact Bryan Haynes, at 804.697.1420 or by email.