August 16, 2019

FDA on Thursday unveiled 13 proposed graphic warning labels about the health risks of smoking that, if finalized, would appear on the packaging of all cigarettes sold in the United States.

Where the new warning labels will appear

If finalized, the 13 images would be required to would cover half of the fronts and backs of all cigarette packs and at least 20% of the area at the top of all cigarette advertisements. The new warning labels still must undergo public comment, but under a court order, they must be finalized by March 15, 2020. The labels are expected to begin appearing on cigarette packaging in 2021.

One of the images features a photo of a woman with a large lump on her neck and text that says, "WARNING: Smoking causes head and neck cancer." Another shows a pair of feet with missing toes and text that says, "WARNING: Smoking reduces blood flow to the limbs, which can require amputation."

According to FDA, the proposed graphic warnings are intended to be more noticeable and easier to understand than the current warnings on cigarette packs. More than 91 countries have adopted strong warning labels that cover at least half of cigarette packs.

Why the labels may face a battle in court

Congress in 2009 first directed FDA to create graphic warning labels for cigarette packages, but after FDA in 2011 released its initial batch of proposed images, the agency was sued by five tobacco companies that argued the proposed labels violated their First Amendment rights.

An appeals court ruled in favor of the tobacco companies, saying the required warnings should be purely informational and should not attempt to scare smokers, encourage them to quit, or impose an ideology on them.

FDA said it would issue new regulations and warning labels following the lawsuit, but it was sued in 2016 by health groups arguing the agency wasn't moving fast enough to comply with the law. A federal court ruled in favor of the group in March.

While further legal challenges over the new warning labels are expected, Mary Rouvelas, senior counsel for the American Cancer Society Cancer Action Network, said FDA has stronger standing than it did in 2011.

"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."

Reaction

Ned Sharpless, acting FDA commissioner, said in a statement, "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."

Mitchell Zeller, director of FDA's Center for Tobacco Products, said the current warning labels on cigarette packs have become "virtually invisible," and that these new warnings "are critical to promote greater understanding of the risks associated with cigarette smoking."

In a joint statement, a number of health organizations, including the American Cancer Society, American Heart Association, American Lung Association, and the American Academy of Pediatrics, said the new proposed warnings "are a dramatic improvement over the current text-only warnings that have become stale and unnoticed. They are supported by extensive scientific evidence, and they will help the United States catch up to the 120-plus countries that have adopted this best-practice strategy to reduce tobacco use and save lives."

According to Noel Brewer, a professor of health behavior at the University of North Carolina's Gillings School of Global Public Health, research shows these types of graphic warning labels can be effective.

Brewer and other researchers in North Carolina studied almost 2,000 smokers over a four-week period and found those exposed to graphic warning labels on cigarette packs were more likely to try to stop smoking.

"This is what happened over a period of four weeks. Imagine what happens over months or even years," Brewer said. "Smoking is the deadliest behavior we engage in; more people die from smoking than from anything else."

A spokesperson for R.J. Reynolds Tobacco Company, which was part of the 2011 lawsuit against FDA, said the company is "carefully reviewing" the latest proposal.

"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 spokesperson said (Hellmann, The Hill, 8/15; Siddons, Roll Call, 8/15; Bever, Washington Post, 8/15; Kaplan, New York Times, 8/15; FDA proposal, Federal Register, 8/16).

Topics