But research has shown that these warnings have become virtually invisible to both smokers and nonsmokers, the FDA noted.
A previous effort to toughen warning labels by the FDA was defeated in court in 2012. A panel of judges ruled that the agency couldn’t force tobacco companies to slap grisly images of dead bodies, diseased lungs and cancerous mouth sores on cigarette packs.
The FDA began working on the research to inform this latest proposed rule in the middle part of 2013, after the agency decided to not take that first legal fight to the U.S. Supreme Court, Zeller said.
The agency is currently under court order to issue a final rule on warning labels by March 2020, Zeller said during a media briefing Thursday.
“We took the time to get this right, so that we have when this is final the strongest combination of color graphics and text warnings to advance the fundamental governmental interest, which is to improve the public’s understanding of the negative health consequences of smoking,” Zeller said.
More than 34 million adults and 1.4 million adolescents currently smoke cigarettes, the FDA said. Tobacco use kills about 480,000 Americans every year, more people than alcohol, HIV, car accidents, illegal drugs, murders and suicides combined, the agency said.
The new warning labels will include images and messages regarding lung disease, head and neck cancer, bladder cancer, stunted fetal growth, erectile dysfunction, type 2 diabetes, cataracts and age-related macular degeneration.
“While most people assume the public knows all they need to understand about the harms of cigarette smoking, there’s a surprising number of lesser known risks that both youth and adult smokers and nonsmokers may simply not be aware of,” Acting FDA Commissioner Dr. Ned Sharpless said.
Sharpless pointed out bladder cancer as one example — that health impact that would be highlighted with the image of bloody urine.
“While many people are aware smoking causes lung cancer, research has shown that the public is generally not aware of the very strong link between bladder cancer and smoking,” Sharpless said. “In fact, current smokers have nearly four times the risk of bladder cancer compared to people who have never smoked.”
The proposed rule will be open for public comments for 60 days through Oct. 15. After it goes into effect, tobacco companies will have 15 months to slap them onto their packaging and advertisements.