Last month, the U.S. District Court for the District of Massachusetts found that FDA “unlawfully withheld” and “unreasonably delayed” the promulgation of a rule mandating color graphic warnings for cigarettes, as set forth in the 2009 Tobacco Control Act. The Court ordered FDA to provide an accelerated timeline for the completion of its rulemaking. On October 5, 2018, FDA provided the Court an accelerated schedule that would result in the submission of the final rule for publication in the Federal Register by May 2021 (i.e., six months sooner than FDA’s initial estimated timeline of November 2021). The plaintiffs, largely comprised of public health organizations such as the American Academy of Pediatrics, American Cancer Society, American Heart Association, and the American Lung Association, among others, were asked to submit a response.
In their response, the plaintiffs contend that FDA’s proposed schedule “shows that the agency continues to act with no sense of urgency even while it trumpets, as it should, the massive adverse public health consequences associated with smoking and the importance of the graphic warnings Congress mandated in 2009.” Accordingly, the plaintiffs urge the court to reject FDA’s proposed schedule and issue an order for the following schedule instead:
- “Experimental Study of Cigarette Warnings” to be completed by February 28, 2019
- NPRM to be submitted for publication in the Federal Register by June 30, 2019
- Review of public comments to be completed by October 31, 2019
- Final Rule to be submitted for publication in the Federal Register by January 31, 2020
The plaintiffs urge the Court, as soon as possible, to establish firm deadlines for FDA’s completion of each of the remaining steps of its rulemaking. In addition, the plaintiffs urge the court to require FDA to notify the plaintiffs no later 45 days before each of these milestones if FDA has any reason to believe that it will be unable to comply with a court-ordered deadline.