The Food and Drug Administration on Thursday proposed long-delayed graphic health warnings for cigarette packages, taking a step toward fulfilling a requirement of a decade-old smoking prevention law.
The new warning label proposal will now be subject to a public comment period, and is under a court-ordered deadline to be finalized by March 15, 2020.
The warnings would update the textual statements already on cigarette packages, and for the first time include photorealistic images that depict smoking-related health problems. After soliciting comments, the FDA will choose from 13 combinations of text and images outlined in the rule.
For example, one proposal would warn that smoking causes head and neck cancer, with an image depicting a woman with a tumor on her neck. Other images to go along with other specific warnings show things like diseased or dead lungs, a cup of bloody urine and a low-birthweight infant.
Acting FDA Commissioner Ned Sharpless said in a statement on Thursday: “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, such as bladder cancer, diabetes and conditions that can cause blindness.”
The new proposal is a second attempt to put stronger warning labels in place after a tobacco industry lawsuit prompted a 2012 appeals court ruling that the FDA’s first attempt was a violation of the First Amendment.
Managing legal issues
The FDA proposal acknowledged previous legal issues and said that in the ensuing years it developed warnings with different images and messages that are now backed up by research about their effectiveness.
The proposed rule stated that the FDA was confident the new warnings could stand up to the legal challenges that took down the earlier rule.
This time anti-smoking groups are also confident the new proposal will stand up to any First Amendment challenges by the tobacco industry. Mary Rouvelas, senior counsel for the American Cancer Society Cancer Action Network, said that compared to 2011, there is now better science that can back up the FDA’s proposal.
“There absolutely can be graphic warnings that meet constitutional muster,” she said. “We have better data now than we did when the original challenge came about, that shows the efficacy of the graphic warnings.”
She said science shows that the graphic warnings do a better job of conveying cigarettes’ health effects, and consumers armed with that information are more likely to quit smoking or never try in the first place.
While the new rule only applies to traditional combustible cigarettes, and not the e-cigarettes and flavored cigars that are growing more popular with younger populations, advocates believe that the graphic warnings will play an important role in discouraging people from adopting the more dangerous products.
“They’ll start out with a vaping product but then they are twice as likely to move into a combustible, so the problems are still related,” Rouvelas said.
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