A Federal Judge strikes down FDA’s graphic image requirement on packs of cigarettes until the lawsuit is resolved.
On Monday, Nov. 7, U.S. District Judge Richard Leon ruled cigarette manufacturers will likely succeed in a lawsuit challenging the graphic label requirement, and stopped the requirement until the lawsuit is resolved—which could take years.
Judge Leon found the nine graphic images approved by the Food and Drug Administration (FDA) in June go beyond conveying the facts about the health risks of smoking, and could even extend into advocacy. Judge Leon also noted the size of the labels suggests they are unconstitutional. The labels required by the FDA are supposed to cover the entire top half of cigarette packs—both front and back—and include a number for a stop-smoking hotline. The labels were to take up 20% of cigarette advertising and the images were to be rotated. According to Judge Leon, the labels would amount to a “mini-billboard” for the agency’s “obvious anti-smoking agenda.”
The Justice Department argued that the images and written warnings were designed intended to communicate the dangers of smoking.
Congress asked the FDA to require the labels, following in the footsteps of regulations passed in Canada that require graphic images on cigarette packs.
The five major tobacco manufacturers that brought the lawsuit against the FDA include R.J. Reynolds Tobacco Co., Lorillard Tobacco Co., Commonwealth Brands Inc., Liggett Group LLC and Santa Fe Natural Tobacco Co. Inc.
Cigarette manufacturers noted that cigarette packs have featured Surgeon General warnings for more than 45 years, but manufacturers have never sought a legal challenge against them until these images were approved.
What Does It Mean For Retailers?
“Judge Leon’s decision not only issued an injunction against the FDA’s cigarette text and graphic image warnings, but also imposed a stay on the implementation of the health warning regulations until 15 months after a final ruling from Judge Leon on the merits of the claims in the lawsuit. A lawsuit seeking an injunction has two parts. First, a motion for a preliminary injunction which is the ruling that Judge Leon issued yesterday. Second, a hearing needs to be held at some point in the future on the actual merits of the manufacturers’ claims and Judge Leon will then issue another decision on whether the preliminary injunction becomes a permanent injunction. This second decision by Judge Leon could then be appealed by either the manufacturers or the FDA to the U.S. Circuit Court of Appeals. Also, the FDA has the right to appeal Judge Leon’s decision granting the preliminary injunction to the U.S. Circuit Court of Appeals,” the National Association of Tobacco Outlets (NATO) noted.
NATO added retailers, for now, are not required to comply with the regulation requiring the new text and graphic warning labels to be printed on cigarette advertisements that they produce in-house.