Federal Judge Blocks FDA's Graphic Cigarette Warnings

SILVER SPRING, Md. — The Food and Drug Administration's (FDA) rule requiring tobacco companies to display graphic cigarette warnings on packaging and in advertisements is now on hold.

On Dec. 7, the U.S. District Court for the Eastern District of Texas blocked the agency's regulations citing free speech protections under the First Amendment to the U.S. Constitution.  By vacating the regulations, the graphic cigarette health warnings are nullified and devoid of any legal effect, according to the National Association of Tobacco Outlets (NATO).

"This is a significant legal decision for both cigarette manufacturers and retailers that sell cigarettes because the FDA graphic cigarette health warnings would have applied to not only cigarette manufacturers, but also to retailers, as would have criminal and civil penalties if the regulations were violated by either a manufacturer or a retailer," the association stated.

The decision by U.S. District Judge J. Campbell Barker came in a lawsuit filed by R.J. Reynolds Tobacco Co., ITG Brands LLC, Liggett Group LLC and several other companies. 

In the decision, the court determined that the set of graphic cigarette health warnings would have compelled manufacturers and retailers to speak by displaying cigarette packages on store shelves and advertising cigarettes when, if given the choice, manufacturers and retailers would choose not to do so, according to NATO.

The court also found that the graphic cigarette health warnings were not purely factual, but rather open to interpretation by consumers.  In addition, the warnings were not narrowly tailored, but rather more extensive than necessary, the association added.

The issue dates back to 2011 when the FDA issued its first rule requiring nine text and graphic picture health warnings on the top half of the main front and back panels of cigarette packages and 20 percent of the top of cigarette advertisements made or produced by manufacturers or retailers. 

That rule came two years after the Family Smoking Prevention and Tobacco Control Act granted the agency regulatory authority over tobacco.

The rule was immediately met with legal challenges from the tobacco industry, and after winding its way through the courts, the FDA issued its final rule on the warnings, which feature a combination of text and images depicting some of the health risks of cigarette smoking, in March 2020.  The warnings were required to appear on the top 50 percent of the front and back of cigarette packages and at least 20 percent of the top of ads. In addition, the warnings had to be randomly and equally displayed and distributed on cigarette packages and rotated quarterly in cigarette advertisements.

However, implementation has been postponed multiple times after several tobacco companies asked for the date to be moved back.

The latest postponement came a month ago when the U.S. District Court for the Eastern District of Texas pushed the implementation date from Oct. 6, 2023 to Nov. 6, 2023, as Convenience Store News reported.