By Dave Simpson

Law360 (December 2, 2020, 10:24 PM EST) -- A Texas federal court Wednesday further postponed the effective date of the U.S. Food and Drug Administration's new requirement for graphic warning labels on cigarette packs to 2022, siding with Big Tobacco, which argued that questions over the validity of the rule still remain unanswered.

Noting that a hearing for pending motions for summary judgment and motion for a preliminary injunction is scheduled for next week, U.S. District Judge J. Campbell Barker agreed to postpone the effective date by 90 days, to January 2022.

In the two-page order, he cited his previous decision for postponement of the rule in May, and "the further equitable reasons" given in the extension motion from cigarette manufacturers R.J. Reynolds Tobacco Co., Liggett Group LLC and ITG Brands LLC, along with cigarette retailers.

Last month, the companies told the judge he should delay the rule's already postponed effective date, currently Oct. 16, 2021, for another 90 days to Jan. 14, 2022. The companies argued they would suffer irreparable harm if they were forced to spend millions of dollars to comply with a rule that will soon be invalidated.

"These expenditures of resources for the purpose of meeting the rule's requirements constitute irreparable harm because plaintiffs cannot recover money damages should the rule and/or the graphic-warning requirement in the Tobacco Control Act be invalidated," the companies said.

The companies said they will have to "spend millions of dollars and thousands of employee hours to prepare to comply with the rule," including redesigning hundreds of packaging labels, purchasing printing cylinders to be engraved with the new designs and redesigning webpages.

The COVID-19 pandemic makes compliance efforts even more burdensome and complex, the companies argued.

Judge Barker has already pushed the rule's effective date back once in light of the current pandemic. In a May 8 order, the judge delayed the effective date 120 days from June 18, 2021, to Oct. 16, 2021.

In March, the FDA released a final rule requiring new graphic warnings for cigarettes that feature some of the lesser-known but still serious health risks of smoking, such as diabetes, on the top half of the front and back of cigarette packages and at least 20% of the area on the top of cigarette advertisements.

The warnings include statements that tobacco smoke can harm children and that smoking can cause bladder cancer and neck and head cancer. Others include: "Smoking reduces blood flow to the limbs, which can require amputation," "Smoking during pregnancy stunts fetal growth" and "Smoking causes cataracts, which can lead to blindness."


In April, the cigarette manufacturers and retailers sued the FDA, arguing that the graphic warning requirements cross the line into governmental anti-smoking advocacy because the government has never forced makers of a legal product to use their own advertising to spread an emotionally charged message urging adults not to use their products.

R.J. Reynolds and the retailers are represented by Autumn Hamit Patterson, Ryan J. Watson, Christian G. Vergonis and Alex Potapov of Jones Day.

ITG Brands is represented by Philip J. Perry, Richard P. Bress, Monica C. Groat and Nicholas L. Schlossman of Latham & Watkins LLP.

Liggett Group is represented by Meaghan VerGow and Scott Harman-Heath of O'Melveny & Myers LLP.

The FDA is represented by Michael H. Baer and Stephen M. Pezzi of the U.S. Department of Justice's Civil Division.

The case is R.J. Reynolds Tobacco Co. et al. v. U.S. Food and Drug Administration et al., case number 6:20-cv-00176, in the U.S. District Court for the Eastern District of Texas.

--Additional reporting by Kevin Stawicki and Katie Buehler. Editing by Jay Jackson Jr.

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