Tobacco manufacturers have gained at least another 90 days before potentially having to place graphic warning labels on their traditional cigarette packs.
A U.S. District Court judge in Texas on Wednesday gave R.J. Reynolds Tobacco Co., Philip Morris USA, ITG Brands LLC and Liggett Group LLC until Jan. 14, 2022, to comply.
That represents a delay from the Oct. 16, 2021, launch date set May 28 by the Food and Drug Administration. That deadline already was a postponement from the FDA's original June 18, 2021, launch date.
The graphic warnings are designed to cover the top 50% of the front and rear panels of packages, as well as at least 20% of the top of advertisements.
The new set of 11 images contains images of diseased lungs, a man experiencing erectile dysfunction, a man with surgical stitches from heart or lung surgery and a child with an oxygen mask.
But there is no smoke coming out of a tracheal hole, no cadaver and no photo of a man who appears deathly ill, as the FDA proposed using in previous warning submissions.
The FDA said the new images “depict some of the lesser-known, but serious health risks of cigarette smoking,” such as risk of blindness, lower blood flow to extremities and Type 2 diabetes.
The FDA said in a statement Friday that it "does not comment on possible, pending or ongoing litigation."
The manufacturers asked for the additional 90 days, arguing the FDA deadline was too onerous given the financial and logistical impact of the COVID-19 pandemic since mid-March.
"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 in a legal filing.
The manufacturers claim they would experience “irreparable harm because none of them will be compensable by money damages should the rule and/or graphic warnings requirement in the Tobacco Control Act be invalidated.”
In May, the FDA had "strongly encouraged" the manufacturers to submit cigarette plans as soon as possible with a Dec. 16 deadline in order to comply with the Oct. 16, 2021, implementation date.
“Early submission will facilitate timely FDA review of plans prior to the effective date of the required warnings, encourage dialogue with entities regarding any implementation concerns, and provide time to consider proposals by entities in a timely manner,” the FDA said.
On April 3, the four manufacturers filed a joint motion requesting a preliminary injunction on implementing the labels and a ruling to prohibit enforcement. The manufacturers repeated their claims that the labels violate the First Amendment of the U.S. Constitution.
On May 8, the FDA and the manufacturers filed a joint motion to extend the deadline by 120 days.
There is a recent precedent in a federal court issuing a request deadline delay.
On April 23, the manufacturers received a 120-day extension — from May 12 until Sept. 9 — for filing premarket applications with the FDA for electronic cigarettes and other next-generation products.
The FDA said in the May 8 motion that it “remains 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.”
“Defendants do not concede that plaintiffs will suffer irreparable harm absent this postponement, or are entitled to any form of preliminary relief.”
The 11 finalized cigarette health warnings "represent the most significant change to cigarette labels in more than 35 years,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.
The new warnings must be randomly and equally displayed and distributed on cigarette packages and rotated quarterly in cigarette advertisements.
A coalition of anti-tobacco and public-health groups sued the FDA in October 2016, saying it “unlawfully withheld” or “unreasonably delayed” issuing its final rule.