As a follow-up to our earlier blog post on this topic, the FDA now has until October 5, 2018 to provide an expedited schedule for the issuance of a final graphic warnings rule in accordance with the Tobacco Control Act. As readers may recall, earlier this 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 mentioned previously, FDA’s proposed, expedited schedule needs to outline various milestones, including completion of outstanding studies, the publication of the proposed graphic warnings rule for public comment, and review of public comments. In its consent motion for extension of time to file proposed expedited schedule, FDA stated that it needs additional time to consult with other government entities, such as the Department of Health and Human Services and the Office of Management and Budget. According to FDA, these government entities will have “a vital role” in the reviews and clearances necessary for the FDA to perform supporting research, issue a notice of proposed rulemaking, and submit a final rule for publication in the Federal Register. FDA emphasized that having this additional time to seek input from other government agencies on the front-end will allow FDA to have more confidence “in the many internal estimates upon which its schedule depends.”

Once FDA files the proposed schedule, 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) will have 14 days to review the proposed schedule and submit a response. In the meantime, the plaintiffs have made it clear in the consent order that they will not consent to any further extensions of time for the filing of the schedule “in light of the need to expedite resolution of this matter.”

For now, we will sit tight as we wait to see the FDA’s proposed schedule. In the meantime, we encourage interested parties and stakeholders to review FDA’s recently published notice soliciting comments on an experimental study of cigarette warnings in support of the graphic label rule. According to FDA, the purpose of the study is to assess whether new cigarette warnings increase public understanding of the health consequences of cigarette smoking. FDA states that, in addition to assessing the extent to which the warnings are “informative, easy to understand, factual, attention grabbing, and recalled,” the study outcomes also seek to assess the extent to which:

  • Exposure to the graphic health warnings provide new information,
  • Increase self-reported learning,
  • Change beliefs about the health consequences of cigarette smoking,
  • Increase thinking about the risks of smoking

Given the potential impact of the study on the final rule, we encourage industry members and stakeholders to submit comments that can help inform FDA’s review of this issue.