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FDA Cigarette Graphic Warning Rule Delayed … Again


In a prior update, we discussed the ongoing legal challenges to the U.S. Food and Drug Administration’s (FDA) March 2020 rule on a graphic-warning requirement for cigarettes. Initially slated to take effect June 18, 2021, the rule would require 11 new textual, health warning statements accompanied by color, “photorealistic” images displayed on the top 50% of the front and rear panels of cigarette packs and top 20% of cigarette ads. Tobacco manufacturers have challenged the FDA’s graphic-warning rule in federal courts in Texas and the District of Columbia. See R.J. Reynolds Tobacco Co. v. U.S. Food & Drug Admin., No. 6:20cv176 (E.D. Tex. Apr. 3, 2020); Philip Morris USA, Inc. v. U.S. Food & Drug Admin., No. 1:20cv1181 (D.D.C. May 6, 2020). And, in each case, the manufacturers have asked the court to postpone, or the court has postponed on its own, the effective date of the rule for various reasons. In keeping with this trend, Judge Barker of the Eastern District of Texas recently issued an order, granting the plaintiffs’ request for postponement and therefore delaying any obligation to comply with the Tobacco Control Act’s warning requirements and the deadline tied to the effective date of the FDA rule for an additional 90 days, until October 6, 2023.

In its latest request for postponement, the plaintiffs made the same or similar arguments for postponement as in previous requests, which include:

  • The rule would cause the plaintiffs irreparable harm, including substantial compliance costs.
  • The plaintiffs would need to redesign packaging, modify the printing process, purchase and engrave printing cylinders, print compliant packages, and redesign, modify, and replace point-of-sale advertisements at hundreds of thousands of retailers.
  • The actions required to comply would cost millions of dollars and thousands of employee hours, which the plaintiffs would not be able to recover or obtain reimbursement from the government if they prevail.

The FDA strongly encourages companies to submit cigarette plans as soon as possible, but no later than December 7, 2022. Practically, however, the rule has now been postponed eight times, with the possibility of further delay. While companies should be prepared to submit plans to the FDA and comply with the rule when required to do so, it is also prudent to focus on enforceable requirements, such as the FDA’s current warning statements and filing cigarette rotational health warning plans with the Federal Trade Commission.



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