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."