FDA orders graphic warnings on cigarettes packs, ads

LOS ANGELES — In the first major change to cigarette packaging in a quarter-century, the Food and Drug Administration (FDA) said Wednesday it will require graphic warning labels that cover half a package's front and rear and the top 20 percent of all cigarette ads.

The labels will feature either drawings or photos illustrating graphically the dangers associated with smoking and will be accompanied by text stating that smoking is addictive or that it kills. The pictures feature such things as a diseased lung, a corpse and a man smoking a cigarette through a tracheotomy tube. Regulators hope they will be sufficiently frightening to keep young people from beginning to smoke and to strengthen the will of those who are attempting to quit.

"We want to make sure every person who picks up a pack of cigarettes knows exactly what the risk is they are taking," Health and Human Services Secretary Kathleen Sebelius said at a news conference.

Regulations now require only a written warning on the edge of the cigarette pack and a similar small warning at the bottom of ads.

"There is no question but that strong graphic warning labels work" and that, in particular, they influence kids, said Stanton Glantz, a tobacco-control expert at the University of California, San Francisco. "Right now we have the weakest warning labels in the world. Now we will be right up there tied for the strongest."

The FDA is looking at 36 different potential labels, which can be viewed at www.fda.gov/cigarettewarnings. The agency will select nine by June 22, 2011, and cigarette manufacturers must begin putting them on packages and advertising by Sept. 22, 2011. By Oct. 22, 2011, manufacturers will no longer be able to distribute cigarettes that do not bear the new warnings.

Federal agencies have been concerned that smoking rates, which declined from about 42 percent in 1965 to just under 21 percent in 2004, have remained flat since then.

"Every day, 4,000 young people try cigarettes for the first time and 1,000 continue to smoke," Sebelius said.

Tobacco use causes at least 18 cancers, not just lung cancer, according to the American Association for Cancer Research. Smoking also plays a major role in the onset of cardiovascular disease. An estimated 450,000 Americans die prematurely as a result of smoking-related disease every year and 8 million suffer chronic diseases at a cost to the economy of nearly $200 billion annually.

The goal of the new actions by the Department of Health and Human Services is to bring the smoking rate down to 12 percent by 2020.

A key step was the passage of "historic legislation" in June 2009 that, for the first time, gave the FDA power to regulate tobacco products. Since then, the agency has taken a number of steps, including banning the practice of giving out free samples, halting advertising in youth-oriented magazines, and banning misleading terms such as "light," "low-tar" and "mild" from advertising.

Medicare also has changed its rules so that smoking-cessation products are available to any beneficiaries who want them, not just those who have lung disease, as was the previous practice.