The Food and Drug Administration proposed a rule Thursday morning to require cigarette packages to include realistic images showing the health consequences of smoking.
The rule would be the greatest change to cigarette labeling in 35 years.
The proposed rule was prompted by a court order from federal judge Indira Talwani, an appointee of President Barack Obama, who ruled in 2018 that the FDA “unlawfully withheld” and “unreasonably delayed” action on putting out rules about the graphics and told the agency to propose a rule by Thursday.
Including the graphic labels is a requirement as part of the Family Smoking Prevention and Tobacco Control Act of 2009, which authorized the FDA to regulate tobacco products. The FDA submitted a final rule on the graphics in 2011, but U.S. District Judge Richard Leon struck down the proposed rule, saying the labels should contain “only purely factual and uncontroversial information rather than gruesome images designed to disgust the consumer.”
After a back-and-forth in the courts, Talwani set the Thursday deadline and ordered that a final rule must be submitted by March 15, 2020.
The plaintiffs in the court-ordered Thursday deadline included the American Academy of Pediatrics, the American Cancer Society, and Campaign for Tobacco-Free Kids.
Many other countries require graphic labeling to illustrate the health effects of smoking. The World Health Organization has said that graphic warnings on packaging in 28 other countries were more effective than text-only warnings in educating smokers about the consequences of smoking. The WHO calls the images “fear appeals,” and reported that research dating back to the 1950s has shown their effectiveness.
The FDA rule mandates that tobacco companies display color graphics on the upper half of the front and back of packets, and on 20% of the space on print advertisements. The images are meant to turn off potential smokers and encourage current smokers to quit.
The graphic images will accompany warnings including: “tobacco smoke causes fatal lung disease in nonsmokers” and “smoking can cause heart disease and strokes by clogging arteries.”
