FDA Seeks Delay Of Graphic Cigarette Warnings Due To Virus

By Kevin Stawicki
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Law360 (May 6, 2020, 5:27 PM EDT) -- The U.S. Food and Drug Administration and major tobacco companies asked a Texas federal judge on Wednesday to delay the agency's new requirement for graphic warning labels on cigarette packs, which Big Tobacco is suing to block, because of disruptions caused by the coronavirus pandemic. 

The FDA asked the court to push back the effective date of the agency's new cigarette warnings by 120 days, saying the extension would not affect the merits of the lawsuit filed by R.J. Reynolds and other tobacco companies alleging the "emotionally charged" required labels violate the First Amendment.

"Defendants remain fully committed to the rule, and would not agree to postpone its effective date but for the extraordinary disruptions caused by the COVID-19 pandemic," the FDA and the companies said in a joint motion.

While the FDA said "justice requires" extending the effective date from June 18, 2021, to Oct. 16, 2021, it declined to concede that the companies would be harmed if it didn't agree to the postponement.

Wednesday's request is likely due in part to FDA staffers having been enlisted by the U.S. Public Health Service to help fight the pandemic, limiting the agency's ability to focus on implementation of the rule. Additionally, the tobacco manufacturers said implementing the rule would "require them to commence substantial efforts as soon as possible" to meet its requirements, and that the pandemic has only made compliance more difficult.

If the judge doesn't grant the postponement request, the manufacturers will move to enjoin the rule immediately, as they maintain the rule will cause them harm even if it's postponed, according to the motion.

R.J. Reynolds, ITG Brands and Liggett Group said in their complaint filed in April 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.

"These requirements force plaintiffs not to convey purely factual and uncontroversial statements about the risks of smoking, but to become a mouthpiece for the government's anti-smoking advocacy," the companies said in the lawsuit. "This is precisely the type of compelled speech that the First Amendment prohibits."

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."

Also on Wednesday, tobacco company Philip Morris and Altria subsidiary Sherman Group Holdings LLC filed a similar complaint against the FDA over the labeling rule, saying the rule violates the First Amendment and that its requirements will take too much time to implement before the June 18, 2021, deadline.

A representative for the FDA said that the agency does not comment on litigation.

Counsel and representatives for the tobacco companies didn't immediately respond to requests for comment.

R.J. Reynolds is 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.

Phillip Morris Inc. and Sherman Group Holdings LLC are represented by Lisa S. Blatt, Stephen D. Andrews, Sarah M. Harris, Matthew J. Greer and Jack F. Pararas of Williams & Connolly LLP.

The FDA is represented in-house by Stacy C. Amin, Robert P. Charrow, Perham Gorji, Julie B. Lovas and Michael H. Baer. 

The cases are 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 and Phillip Morris USA Inc. et al. v U.S. Food and Drug Administration et al., case number 1:20-cv-01181, in the U.S. District Court for the District of Columbia.

--Additional reporting by Emily Field. Editing by Nicole Bleier.

For a reprint of this article, please contact reprints@law360.com.

Attached Documents

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Case Information

Case Title

R.J. Reynolds Tobacco Company et al v. United States Food And Drug Administration et al

Case Number



Texas Eastern

Nature of Suit

Other Statutes: Administrative Procedures Act/Review or Appeal of Agency Decision


J. Campbell Barker

Date Filed

April 03, 2020

Case Title


Case Number



District Of Columbia

Nature of Suit

Other Statutory Actions


Ketanji Brown Jackson

Date Filed

May 06, 2020

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