The FDA Thursday proposed the most significant change to cigarette warning labels in 35 years, requiring that graphic colored images depicting the health hazards of smoking cover the top half of all cigarette packs and at least a fifth of the surface of advertisements.
The agency has been trying for decades to bring U.S. warning labels in line with standards in other nations. The United States was tied for last in a world ranking of the size of warning labels on cigarette packs, in a recent report. In many countries, tobacco packages feature photographs of blackened lungs, or people missing jaws due to cancer surgery. U.S. labels contain a surgeon general’s warning text that critics say is outdated.
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The rule must be finalized by March and would go into effect 15 months later, FDA officials said. Commenters have two months to offer suggestions on the rule.
The 13 images that FDA would require cigarette packages to bear will depict some of the lesser-known but serious health risks of smoking, said acting Commissioner Ned Sharpless.
“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” they are unaware of, Sharpless said on a call with reporters. The FDA has been researching how to shape the package messages for six years, said Mitch Zeller, head of FDA’s Center for Tobacco Products.
Tobacco is the leading cause of disease and death in the United States. Each year it’s responsible for 480,000 premature deaths and $300 billion in health care and lost productivity costs, FDA said.
Studies abroad have found the graphic labels are effective in encouraging smokers to quit and curbing the numbers of new users. Currently about 34.3 million U.S. adults and nearly 1.4 million U.S. youths smoke cigarettes.
A federal judge in September ordered the agency to issue a final rule by next March, after a previous attempt was struck down in 2012 for violating the First Amendment.
A 2016 lawsuit demanding the rule was brought by a group of pediatricians, public health and medical groups, including the Campaign for Tobacco-Free Kids, the American Cancer Society, American Academy of Pediatrics and the Truth Initiative.
“The proposed rule is a critical and long-overdue step forward in the nation’s battle against tobacco use,” said Dennis Henigan of the Campaign for Tobacco-Free Kids. “The tobacco industry cannot be allowed to further delay these necessary warnings.”
The FDA released sample images that included a pale-looking child with an oxygen mask and the warning, “Tobacco smoke can harm your child,” and a man with a long scar on his chest with the message, “Smoking can cause heart disease and strokes by clogging arteries.”
The new warnings are an “enormous public health opportunity to expand public understanding of the risks of cigarette smoking,” said Sharpless. HHS and the White House were “very supportive of our efforts,” he said.
FDA is confident the proposed rule will stand up to further legal challenges, said Zeller. The agency employed extensive consumer research to come up with the most informative messages and images. “We took the time to do thorough research to get this right,” he said.