Effective Date of FDA’s Tobacco Product Graphics Labelling Rule Pushed to 2022

The Eastern District of Texas, which is overseeing a dispute between R.J. Reynolds Tobacco Company and others against federal defendants the Food and Drug Administration (FDA), the Department of Health and Human Services, and their respective leaders, has agreed to further postpone the commencement of a rule requiring graphic warnings to be placed on cigarette product packaging. The Dec. 2 order comes in response to the plaintiffs’ Nov. 23 motion to extend postponement and now pushes the rule’s effective date off until Jan. 14, 2022. The present order dovetails off of the court’s initial postponement order issued in May following the parties’ joint request.

The rule change within the Tobacco Control Act issued by the FDA in March, mandating that manufacturers affix images of smoking injuries and side effects on cigarette packaging. These could include, for example, images depicting “a large tumor, bloody urine, or a pair of diseased feet with amputated toes,” according to an earlier filing submitted by the plaintiffs. In seeking to extend the rule’s effective date, the manufacturer plaintiffs explained that the rule would cause “irreparable harm, including substantial compliance cost.”

In its first postponement order, the court agreed with the parties’ conclusion, finding that the plaintiffs “would face imminent compliance costs, which appear likely to be heightened while disruptions from the COVID-19 pandemic exist, and those costs would not be reimbursed by the government if plaintiffs prevail on the merits.” In the instant order, the court harkens back to and affirms its previous determinations.

Procedurally, the court heard arguments on the defendants’ motion to dismiss for improper venue on Sept. 9. A ruling is soon anticipated, according to the plaintiffs’ Nov. 23 motion. Law Street Media covered the parties’ arguments in July. Since then, the parties have cross-moved for summary judgment and the plaintiffs for a preliminary injunction. The telephonic hearing on those issues is scheduled for Dec. 11.

R.J. Reynolds Tobacco Company, Santa Fe Natural Tobacco Company, Inc., Neocom, Inc., Rangila Enterprises Inc., Rangila LLC, Sahil Ismail, Inc., and Is Like You Inc., are represented by Jones Day. ITG Brands, LLC is represented by Latham & Watkins, LLP, and Liggett Group by O’Melveny & Myers and Kasowitz Benson Torres LLP.