Following up the R.J. Reynolds-led challenge to FDA’s updated graphic warning label rule, which was filed in the federal court for the Eastern District of Texas, Philip Morris USA Inc. (“Philip Morris”) filed a second, similar challenge on May 6, 2020, in the U.S. District Court for the District of Columbia, Philip Morris USA Inc., et al., v. U.S. Food and Drug Administration, et al., (No. 1:20-cv-01181).
Philip Morris’ complaint makes many of the same challenges seen in the industry’s 2011 challenge to the previous iteration of the graphic warning rule and alleges that the graphic warning label rule violates the First Amendment for multiple reasons. First, the complaint alleges that the labeling requirements place an impermissible burden on manufacturers by forcing them to display anti-smoking messages over 50% of cigarette packaging and 20% of advertising, thus “drown[ing] out” their own messages about their product. Second, the complaint alleges that FDA failed to meet the strict standards required for compelled speech; it states that “FDA’s marginal interest in more effectively educating consumers about less-known health risks of smoking is insufficient to justify a regime that forces manufacturers to carry messages aimed at pushing away their own customers.” The complaint also alleges that the warnings are in fact misleading in that they misrepresent the relative risks of smoking-related health consequences. Lastly, the industry argues that the new labeling requirements violate the First Amendment by forcing manufacturers to seek pre-approval of their labeling and advertising plans.
Numerous Administrative Procedure Act violations have also been alleged, including that FDA undertook an effort designed to “thwart” meaningful notice-and-comment by withholding data and underlying reports and studies upon which the rule is based until issuing its final rule. In addition, the complaint includes allegations that FDA acted arbitrarily and capriciously by ignoring the findings of the qualitative studies it conducted and failing to adequately justify the rule. Finally, the complaint alleges that the FDA violated the Tobacco Control Act by requiring 11 total warnings while the Act itself specifies 9 warnings.
The complaint seeks both declaratory and injunctive relief to prevent implementation of the rule; however, it notes that the parties in the R.J. Reynolds-led challenge have requested that the original implementation date of June 18, 2021, be postponed 120 days—until October 16, 2021, due to the COVID-19 pandemic. That request has been now granted by the court in the Eastern District of Texas on May 8, 2020 in R.J. Reynolds Tobacco Co., et al. v. FDA, et al., (No. 20-176), in response to the parties’ joint motion.