The Food and Drug Administration proposed a rule requiring cigarette packs to feature graphic health warnings, including color photos of smoking-related illnesses.
Similar health warnings are required on cigarette boxes in other countries but aren’t mandatory in the U.S., where tobacco companies successfully sued to block them. While adult smoking rates have declined in recent decades, the Centers for Disease Control and Prevention estimate that 480,000 Americans die from cigarette smoking every year.
“Given that tobacco use is still the leading cause of preventable disease and death in the U.S., there’s a lot at stake to ensure the public understands these risks,” said Acting FDA Commissioner
in a statement Thursday.
The FDA’s proposed graphic labels would represent the biggest overhaul of cigarette-health warnings in more than three decades. The proposal is also a test of the rule-making clout of the agency, after its previous effort to implement pictorial warnings was quashed.
In 2012, a group of tobacco companies convinced an appeals court that the agency’s proposed images violated their First Amendment rights. That group included Reynolds American Inc. but not
the U.S. cigarette market leader.
Since 1984, labels describing the dangers of smoking have been contained in a small box with black-and-white text. But the 2009 law that gave the FDA regulatory authority over tobacco required the agency to issue new rules for color warnings on cigarette packs.
The FDA’s original proposal for these graphic warnings included images of a body on an autopsy table and a man exhaling cigarette smoke through a hole in his throat. The newly proposed warnings include a large tumor on a woman’s neck and a pair of feet with amputated toes. One warning says: “Smoking causes bladder cancer, which can lead to bloody urine,” accompanied by a photo of a specimen cup filled with reddish liquid.
The latest proposal calls for the warning messages to occupy the top half of the front and rear panels of cigarette packages and at least 20% of the top of cigarette advertisements.
Altria, maker of industry-leading Marlboro cigarettes, said it has been expecting such a move. “We seek to work constructively with the agency, and we are reviewing the proposed rule,” a spokesman said.
Newport maker British American Tobacco PLC is also reviewing the FDA’s latest proposal, a spokeswoman 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,” the spokeswoman said.
Health warnings first appeared on cigarette packages in 1966 and were most recently updated in 1984 to include the Surgeon General’s warnings that appear on packages and in advertisements today. The FDA argues those text-based messages are too small and less effective than messages with images.
In their legal challenge, the tobacco companies argued the agency’s original graphic warnings didn’t achieve the government’s stated intent of conveying health risks and rather were aimed at evoking shock and disgust. The original warnings also included a smoking cessation hotline, which was outside their scope.
The new warnings use more detailed language—warning about specific cancers, rather than cancer in general—and describe some of the lesser-known health risks of smoking, such poor circulation, cataracts and macular degeneration.
The agency will now seek public comment on the proposal. The warnings would be required to appear on packages and in advertisements 15 months after a final rule is issued.
U.S. cigarette sales have been falling for decades, and the decline has accelerated in recent years as smokers have switched to e-cigarettes. Tobacco giants such as Altria have been able to offset the declines and preserve profits through price increases while also investing in alternative products.
Earlier this year, the Marlboro maker paid $12.8 billion for a 35% stake in Juul Labs Inc., a startup whose sleek, nicotine-packed vaporizers lead a surging e-cigarette market.
The FDA in 2017 launched a regulatory overhaul of tobacco products with the aim of encouraging cigarette smokers to switch to less harmful products such as e-cigarettes. As part of that overhaul, the agency has said it intends to mandate a reduction of nicotine in cigarettes to nonaddictive levels, but such a move is years away from being implemented.
—Saabira Chaudhuri contributed to this article.
Write to Jennifer Maloney at firstname.lastname@example.org
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