Tobacco manufacturers have gained another two months — until October 2022 — before potentially having to place graphic warning labels on their traditional cigarette packs.
A U.S. District Court judge in Texas approved Aug. 18 the latest launch-date delay for R.J. Reynolds Tobacco Co., Philip Morris USA, ITG Brands LLC and Liggett Group LLC.
It is at least the fifth delay for the Food and Drug Administration-required graphic warning labels when counting previously set launch dates of June 18, 2021, Oct. 16, 2021, Jan. 14, 2022, April 14, 2022 and July 13, 2022.
“Pursuant to the court order, any obligation to comply with a deadline tied to the effective date is similarly postponed,” according to the FDA.
However, the FDA “strongly encourages entities to submit cigarette plans as soon as possible, but no later than Dec. 12.”
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 has said with previous court decisions that it “does not comment on possible, pending or ongoing litigation.”
The manufacturers have argued the FDA deadline was too onerous given the financial and logistical impact of the COVID-19 pandemic since mid-March 2020.
“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.”
On April 3, 2020, 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, 2020, the FDA and the manufacturers filed a joint motion to extend the deadline by 120 days.
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.