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The F.D.A.’s New Cigarette Warnings Are Disturbing. See for Yourself.

WASHINGTON — The corpse is gone.

So are the grief-stricken woman, the rotting teeth and the man struggling to smoke despite a hole in his windpipe.

Nine years after the Food and Drug Administration first proposed graphic images as warnings on cigarette packs but was thwarted by tobacco companies in a successful court battle, the agency announced on Thursday that it is finally issuing a new set.

Each of the 13 proposed warnings would cover the top half of a cigarette pack, to be used in rotation by manufacturers along with a variety of updated statements about the health risks of smoking.

“When you look at the current warnings on the side of cigarette packs, they are virtually invisible,” said Mitchell Zeller, who runs the F.D.A.’s tobacco division, in a call with media on Thursday. “The diseases embedded in these images will improve public understanding of the negative consequences of cigarette smoking.”

They feature photos involving lung and bladder cancers, diabetes, a chest incision scar from heart surgery, blackened lungs, a bulging tumor on a woman’s neck, an underweight infant and a man slumped on a bed who may be dealing with erectile dysfunction.

“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,” said Dr. Norman Sharpless, the acting F.D.A. commissioner, in a news release.

ImageCreditU.S. Food and Drug Administration

It was initially unclear whether the big tobacco companies would fight the latest proposals. R.J. Reynolds Tobacco, which led the earlier court fight, said it was studying the F.D.A.’s suggestions, which will not become final until next year.

“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,” said Neassa Hollon, a spokeswoman for the company.

In an email, Bonnie Herzog, managing director of equity research with Wells Fargo, said she expected that the industry would eventually challenge the proposals in court.

The warnings are required under the Tobacco Control Act, which Congress passed in 2009. The agency unveiled its first choices in 2010, featuring colorful — and gruesome — pictures to wrap around the top half of cigarette packages and also on 20 percent of the surface area of advertisements.

A year later, the F.D.A. whittled its final selection to nine images. Public health advocates loved them, but tobacco companies fiercely objected. A group sued the F.D.A., and in 2012 convinced an appeals court that these specific graphic images violated its First Amendment rights of free speech. Altria, the nation’s largest tobacco company, was not part of the lawsuit.

The court ordered that the warnings be purely informational, not aimed at scaring smokers, nudging them to quit or imposing an ideology.

ImageCreditCanadian Cancer Society

The ruling was a huge setback for the F.D.A., which has spent the ensuing years trying to devise a set of warning labels that would be a strong deterrent. While the agency lagged in offering alternatives, scores of other nations required extremely graphic images of smoking-related damage — some that were so grotesque they would failed the standard set by the appeals court in the United States.

Eric Lindblom, a former F.D.A. tobacco lawyer, said the agency hadn’t tried very hard. “The F.D.A. lawyers, the health and human services lawyers, the Department of Justice lawyers, they are all scared of any F.D.A. issue that raises First Amendment issues because they lost big, and they don’t want to lose again,” he said.

Now a director at Georgetown’s O’Neill Institute for National and Global Health Law, Mr. Lindblom praised the agency’s new strategy, of creating what he called a safety net with several options in case a few warnings were rejected in court.

The United States was the first nation to require warnings on cigarettes, but they have not been updated since 1985. Cigarette companies are permitted to rotate four warnings about lung and heart disease and cancers, and pregnancy complications. One says that cigarette smoke contains carbon monoxide, but does not explain why that is dangerous. The National Academy of Medicine has called the current warnings “woefully deficient.”

Much has changed since the 1980s, with smoking rates declining significantly. But even though the rate decreased to 13.8 percent last year from 21 percent in 2005, there are still nearly 38 million smokers in the country. According to the Centers for Disease Control and Prevention, about 480,000 people die from smoking-related illnesses in the United States each year, and smoking remains the nation’s leading cause of preventable death.

Secondhand smoke can also be lethal, and is especially dangerous for children. A C.D.C. report this week said that from 2013 through 2016, more than 35 percent of nonsmoking youths aged 3 to 17 were exposed to secondhand tobacco smoke.

ImageCreditvia U.S. Food and Drug Administration

The 13 new warnings describe in greater detail how smoking damages the body. One notes that smoking causes cataracts, which can lead to blindness. Others note the possibility of getting diabetes or reduced blood flow to the limbs, which can result in amputation.

In a 2019 report, the World Health Organization said warning labels “are most effective when they are pictorial, graphic, comprehensive, and strongly worded.” More than 91 countries have adopted what the organization considers strong labels, which cover at least half of the package. These include warnings about impotence — featuring sad-looking couples in bed — and magnified images of rotten teeth and cataract-covered eyeballs. Another 22 countries require graphic warnings that cover 30 percent of the pack, according to the organization.

Several published studies found mixed smoker reactions to the initial nine proposed labels. A February 2016 study published by University of Illinois researchers in the journal Communication Research suggests that graphic images could backfire, with smokers viewing the lurid images as “a threat to their freedom, choice or autonomy.”

Researchers at the University of North Carolina, Chapel Hill said in June 2016 that 40 percent of participants in their study said they were more likely to consider quitting after exposure to the graphic images, compared with 34 percent with the text warning. And a study led by Cornell University researchers found that graphic warnings in cigarette advertisements reduced the appeal of cigarette brands among youth relative to social cue advertisements with the Surgeon General’s warnings. Neither graphic nor text warnings influenced people’s beliefs about the health risks of smoking.

But public health organizations still pushed for them. In 2016, a coalition including the American Academy of Pediatrics, the American Cancer Society, the American Lung Association and others, sued the agency for taking too long to offer revised labels.

In March, a federal court ruled in the groups’ favor, noting that the F.D.A. had “unlawfully withheld,” and “unreasonably delayed” action to require the graphic warnings. Judge Indira Talwani set a deadline of Thursday, Aug. 15 for the agency to issue a draft, and March 15 of next year to finalize them.

Dennis Henigan, vice president of legal and regulatory affairs for the Campaign for Tobacco-Free Kids, was part of the coalition urging for updated warnings.

“Young people regard themselves as immortal, immune from some of the hazards of life,” Mr. Henigan said. “We think that images like these will deepen their understanding that this is not some abstract danger, that if they become addicted to cigarettes, these dire consequences are very likely.”


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