More than a year and a half ago, in March 2020, the U.S. Food and Drug Administration (FDA) issued its final rule on a graphic-warning requirement for cigarettes. The rule—initially slated to take effect June 18, 2021—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. The rule’s effective date, however, has been extended multiple times by court order and is currently set for October 11, 2022. So when might tobacco manufacturers need to start producing new cigarette packs and ads?
Our guess? Not right away. We’d wager the effective date will be extended yet again in mid-November.
Tobacco manufacturers have challenged 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 the effective date of the rule citing not only current challenges associated with the COVID-19 pandemic, but millions of dollars in compliance costs for package and ad replacements that would be unnecessary if they prevail. Thus far, the Texas court has been receptive of these arguments, granting R.J. Reynolds Tobacco Co.’s requests to postpone the rule’s effective date in May 2020, December 2020, March 2021, and May 2021. In August 2021, the court even acted on its own accord and postponed the date again to October 11, 2022—the current effective date.
In light of the Texas court’s action, the D.C. court appears to have taken more of a “wait and see” approach. On October 27, the D.C. court denied Philip Morris USA, Inc.’s similar request to postpone the effective date of the rule until 15 months after final judgment, citing a lack of urgency under the current timeline. The court, however, did not rule out considering such a request in the future.
Barring resolution of one of the cases on the merits, we anticipate the Texas court will again extend the effective date later this month. Although there is no pending motion requesting an extension, the Texas court showed with its last order that it is willing to extend the rule’s effective date of its own accord. Moreover, the possible harm to plaintiffs absent an extension—which the court has found persuasive at each juncture—remains the same. For the last three extensions, 80 to 90 days elapsed between court orders and each time the court extended the deadline 408 to 419 days beyond the order’s date. Should the court replicate its last action, it would issue an order on November 15, 2021 (89 days after its last order) and postpone the effective date again to January 7, 2023 (419 days past the order date).
That said, resolution of one of the cases on the merits before then could change the landscape. If tobacco manufacturers prevail, the rule would be invalidated. If not, the most recent effective date would likely govern.
In both courts, motions for summary judgment that could resolve the case are ripe for a decision. So far, the D.C. court has opted to let the Texas court go first—holding the parties’ cross-motions for summary judgment in abeyance pending resolution of the Texas matter. Meanwhile, in Texas, U.S. District Judge J. Campbell Barker held a hearing on the motions for summary judgment in December 2020. According to Thomson Reuters Westlaw Litigation Analytics, Judge Barker tends to rule on a motion for summary judgment within around 120 days, but given the complexity of the motions, it is unsurprising that a decision in this case has required significantly more time.
Bottom line: Stay tuned to the Texas suit for a possible extension of the effective date or a decision on the merits sometime soon.