The FDA has submitted a proposed, expedited schedule for the issuance of a final graphic warnings rule for cigarettes. Last month, Judge Indira Talwani of the U.S. District Court for the District of Massachusetts ordered FDA to expedite the issuance of a final rule for cigarette graphic warnings after finding that FDA “unlawfully withheld” or “unreasonably delayed” the promulgation of graphic health warnings as mandated by the 2009 Tobacco Control Act. 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.
FDA describes its proposed, expedited schedule as “aggressive,” but expects that it will be achievable based on current information. The Agency emphasized that this accelerated timeline represents the “bare minimum amount of time” that FDA anticipates, based on current information, will be sufficient to accomplish the complex rulemaking in accordance with the law and FDA’s public health mission. In the proposed schedule, FDA provides the following milestones and timeline involved in the rulemaking process:
|Task||Expected Completion Date|
|Complete sole outstanding study: “Experimental Study of Cigarette Warnings”||May 2019|
|Submit Notice of Proposed Rulemaking to the Office of the Federal Register for publication||April 2020|
|Internal deadline for completing review of public comments on the proposed rule||December 2020|
|Submit final rule to the Office of the Federal Register for publication||May 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) now have 14 days to review the proposed schedule and submit a response. It will be interesting to see what the plaintiffs come back with, and whether the Court will adopt this proposed expedited rulemaking schedule – particularly given that it is only six months sooner than FDA’s initial estimated timeline of November 2021, which the Court described earlier as an “extraordinary delay.”