Court Urged to Permit U.S. Graphic Warnings

The U.S. Food and Drug Administration urged a federal appeals court to let a regulation requiring graphic health warnings on tobacco packaging and promotions take effect, a year after it was blocked by a lower court, reports Reuters.

On Dec. 5, FDA representative Lindsey Powell told the 5th U.S. Circuit Court of Appeals that the images on the proposed labels are necessary because text-only warnings failed to deter teenagers from starting to smoke. The labels would include 11 graphic images, such as diseased feet with amputated toes, to illustrate the risks of smoking.

The tobacco companies that challenged the regulation have argued that the graphic labels violate their right to free speech under the First Amendment of the U.S. Constitution by compelling them to make emotionally charged, controversial statements rather than mere facts like existing written labels stating that smoking can cause cancer.

The Family Smoking Prevention and Tobacco Control Act of 2009 instructs the FDA to create visual health warnings, but the D.C. Circuit in 2012 blocked the agency’s first attempt, saying that regulators had not convincingly demonstrated that the warnings would actually reduce smoking.

In March 2020, the FDA released the final rule requiring new graphic warnings for cigarettes that feature some of the lesser known but still serious health risks of smoking, such as diabetes, on the top half of the front and back of cigarette packages and at least 20 percent of the area on the top of cigarette advertisements.

R.J. Reynolds Tobacco Co., ITG Brands and Liggett Group filed a First Amendment challenge in April 2020. The rule was set to take effect in November 2023 after it was repeatedly pushed back by court.

In a lengthy opinion issued Dec. 7, 2022, U.S. District Judge J. Campbell Barker of the U.S. District Court for the Eastern District of Texas vacated the FDA’s rule after finding that the required label statements and graphic images are not narrowly tailored to the agency’s interest in promoting public awareness of the health risks of smoking.