The Food and Drug Administration on Thursday unveiled new graphic health warnings for cigarette packs, the latest development in a decade-long battle between regulators and the tobacco industry.
The 13 proposed warning labels focus on lesser-known risks associated with smoking, such as erectile dysfunction, bladder cancer and cataracts. Messages include "tobacco smoke can harm your children" with an ill-looking child holding a nebulizer treatment to his face; "smoking reduces blood flow to the limbs, which can require amputation" that shows a pair of feet with amputated toes; and "smoking causes COPD, a lung disease that can be fatal" featuring a doctor holding a pair of diseased, darkened lungs.
Regulators say the current warnings are virtually invisible and the new ones would represent the most significant update to cigarette labels in more than 35 years.
"With these new proposed cigarette health warnings, we have an enormous public health opportunity to fulfill our statutory mandate and increase the public's understanding of the full scope of serious negative health consequences of cigarette smoking," acting FDA Commissioner Ned Sharpless said Thursday on a call with reporters.
The warning labels would cover the top half of the front and back of cigarette packs and at least 20% of the top of cigarette ads. Comments will be accepted for the next 60 days and will be considered before FDA publishes a final rule in the spring, which tobacco companies are almost certain to challenge.
Congress mandated the FDA to issue graphic health warnings on cigarette packs "depicting the negative health consequences" as part of the 2009 Tobacco Control Act. Federal courts struck down the agency's first attempt to finalize a rule, saying the FDA violated the First Amendment.
Mitch Zeller, director of the FDA's Center for Tobacco Products, said the FDA "learned a lot" from that first attempt and "took the time through the research to get this right."
"If we are sued after we issue a final rule, we strongly believe that this will hold up under any legal challenges under the First Amendment, under our statute or under administrative procedure," he said on a call with reporters.
Reynolds American, one of the five companies that sued the FDA, in a statement said "we firmly support public awareness of the harms of smoking cigarettes, but the manner in which those messages are delivered to the public cannot run afoul of the First Amendment protections that apply to all speakers, including cigarette manufacturers."
Altria, the largest U.S. cigarette manufacturer and maker of Marlboro cigarettes, in a statement said its approach to the proposed rule will be "constructive" and that it will "carefully review the proposed rule and its implications to our businesses and submit comments."
More than 120 countries display pictures on cigarette packs to show the harmful health effects of smoking cigarettes. Studies suggest this makes people more aware of the risks and encourages smokers to quit. U.S. cigarette warning labels have not been updated since 1984.
Even though smoking rates have hit record lows in the U.S., 34.3 million adults — or 14% of adults — still smoke, according to the Centers for Disease Control and Prevention. Cigarette smoking kills more than 480,000 Americans every year, and more than 16 million Americans are living with a disease caused by smoking, according to the CDC.
The agency tried to require graphic warning labels in 2011. It chose nine images, including one of a man smoking through a tracheotomy hole in his heart and one with a man on an autopsy table with chest staples.
Five tobacco companies — R.J. Reynolds, Lorillard, Commonwealth Brands, Liggett Group and Santa Fe Natural — sued the FDA that year. A federal judge sided with the companies, saying the warnings violated the First Amendment. A federal appeals court affirmed the decision, saying the FDA had not provided "a shred of evidence" proving the labels would "directly advance its interest in reducing the number of Americans who smoke."
However, a separate ruling upheld the FDA's authority to require graphic warning labels. The FDA in 2013 said it would go back and issue new regulations. But by 2016, it had not announced anything, so eight public health groups sued.
A federal judge decided the FDA had "unlawfully withheld" and "unreasonably delayed" action to require graphic warnings. She ordered the FDA to issue a proposed rule by Aug. 15, 2019 and a final rule by March 15, 2020. The new rule would go into effect 15 months after it is issued.
Dennis Henigan, Campaign for Tobacco-Free Kids' director of legal and regulatory affairs, said public health groups "fully expect there will be a court battle over the new rule."
He added, "Filing suit is not the same as winning."