FDA Appeals Decision to Block Graphic Cigarette Warnings

The U.S. District Court for the Eastern District of Texas nullified the warnings in late 2021.

SILVER SPRING, Md. — The Food and Drug Administration (FDA) wants its graphic cigarette health warning regulations back in play.

Earlier this month, the agency filed a notice of appeal with the U.S. Court of Appeals for the Fifth Circuit to appeal the decision by the U.S. District Court for the Eastern District of Texas to invalidate the FDA's graphic warnings, according to the National Association of Tobacco Outlets.

On Dec. 7, 2022, 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, as Convenience Store News previously reported.

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

In that 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.

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 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. 

The rule came against several legal challenges and implementation was postponed multiple times after several tobacco companies asked for the date to be moved back.

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