FDA Appeals Block on Cigarette Warning Labels

Nov. 30, 2011 — -- The U.S. Food and Drug Administration has appealed a federal judge's order that blocked graphic warnings about the dangers of smoking on cigarette packages.

In November, U.S. District Judge Richard Leon ruled that cigarette companies would likely win their battle against the FDA's mandatory requirement that graphic images of cigarette-induced diseases and death by smoking would be displayed on the top half of the pack. Leon said the images went too far.

In June, the FDA unveiled the final nine graphics that were scheduled appear on cigarette packs by 2012, including images of a man smoking from a tracheotomy hole, and rotting teeth with short one-line facts such as "cigarettes cause cancer."

"We want to make a difference and help people who are smoking stop smoking and discourage people who haven't taken up the habit yet," FDA commissioner Margaret Hamburg told ABC News.

Leon blocked the labels until after the lawsuit was resolved between cigarette companies and the FDA.

The images mark the most dramatic change a single pack has undergone in more than 25 years. The agency will require all manufacturers to use the labels on all U.S. sold cigarettes by Oct. 22, 2012. The Obama administration submitted its appeal Tuesday.

Although intended to warn smokers of the fatal consequences of cigarette smoking, the images created by the FDA are arguably tame in comparison to other countries such as Canada or Australia, said Dr. Eden Evins, associate professor of psychiatry at Harvard Medical School.

"This is truth," Evins said. "This isn't hyped up fear, and it hasn't gone far enough."

The FDA first introduced 36 jarring labels in November 2010, which were aimed at escalating efforts to motivate smokers to quit. The labels represented the agency's exercise of its new authority over tobacco products and the most significant change in cigarette warnings since companies were forced to add the mandatory surgeon general's warning in 1965.

Previous studies suggest that graphic health warnings displayed in other countries worked better than text warnings to motivate smokers to quit, and nonsmokers not to start.

The United States was the first country to require health warnings on tobacco products. But it is now playing catchup to more than 30 countries that already require large, graphic cigarette warnings.

Images used on cigarette packs in countries such as Canada are so disturbing that some smokers buy covers for their cigarette packs to block out the images.

While "the stronger the better" when it comes to motivating smokers to quit, according to Dr. Mary O'Sullivan, director of the smoking cessation program at St. Luke's-Roosevelt in New York, the images do offer straightforward messages of the fatal consequences.

Since many Americans are not used to seeing jarring images on their labels, the new campaign may prove comparable to other countries that display more gruesome images, O'Sullivan said.

"One of the problems our society faces is that we don't have an illness idea about nicotine addiction," said Dr. Mary O'Sullivan, director of the smoking-cessation program at St. Luke's-Roosevelt in New York. "But that's the story, suffering."

While some experts such as Evins and Sullivan believe the images will pack a heavier punch to smokers than the current warning labels, some health communication experts wonder how long the proposed fear-based messages will work.

"The point of putting these pictures is the shock value and research tells us shock value on its own rarely works," said Timothy Edgar, associate professor and graduate program director of health communication at Emerson College in Boston.

Most Americans already know that smoking is dangerous; the message that the FDA is trying to convey, Edgar said. But visualizing the harms associated with smoking will inform many who might find it hard to quit.

"I don't think people do know that one in every two smokers will die from smoke-related illnesses," Evins said.

The new package warnings are part of an FDA proposal under the Family Smoking Prevention and Tobacco Control Act, which requires that cigarette packages and advertisements have larger and more visible graphic health warnings. While the graphics might dissuade some smokers at the start of the campaign, the communication tactic might not spur many to kick the habit for good, if at all, Edgar said.

"I think people are still going to have a hard time saying, 'Yes, that's me on that label,'" he said. "There's a physical addiction involved in this as well. It's not an absolute choice for many who smoke."

Federal regulators and health experts have warned for decades that cigarettes are deadly. But Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, called the ramped-up measures "a timely and much-needed shot in the arm."

"The current warnings are more than 25 years old, go unnoticed on the side of cigarette packs and fail to effectively communicate the serious health risks of smoking," Myers said.

Experts Suggest Anti-Smoking Policy

The intended message will more likely reach younger adults, or those who might have just picked up the habit, said Joy Schmitz, professor of psychiatry and behavioral sciences at the University of Texas medical school in Houston."It might give them pause for concern or contemplation as to their choice of smoking when they see the pretty dramatic scene on the packages," Schmitz said.

But evidence suggests that for message to be effective in the long run, it must not only communicate the danger but also offer ways to help change behavior, Emerson College's Edgar said.

"Simply showing someone that there is a severe outcome or they're personally responsible is not enough. They need to know there's something they can do about it," he said.

Schmitz agreed.

"It needs to be combined with the anti-smoking policies, restricting smoking in the environment, as well as promoting effective evidence-based smoking cessation treatments that are available," she said.

Leading cancer groups, including the American Cancer Society, approached the FDA early on in the development of the labels and "were adamant about including the 800-Quit-Now number," said Thomas Glynn, director of cancer science and trends at the American Cancer Society.

"To be most effective, these labels need to be paired with an action," Glynn said.

The FDA indicated that the number would be included in the label design.

Although smoking rates have declined overall since the 1960s, health officials noted, that rates have leveled off in the past decade. About 21 percent of U.S. adults, and nearly 20 percent of high school students smoke cigarettes, according to the Centers for Disease Control and Prevention.