FDA Proposes New Cigarette Warning Labels

New Warning Labels Would Be Larger and More Graphic

Medically Reviewed by Laura J. Martin, MD on November 10, 2010
From the WebMD Archives

FDA proposed cigarette warning labels Nov. 10, 2010 --The FDA is proposing new cigarette warning labels that will be larger and more visible on cigarette packages and in advertisements in an effort to reduce the number of tobacco-related illnesses and deaths.

The proposed images are graphic: a thin, sickly patient in bed, a breastfeeding mother blowing smoke in the baby’s face, a corpse, and a smoker injecting a cigarette in the arm like a hypodermic needle.

The proposal was announced today at a news conference by Health and Human Services Secretary Kathleen Sebelius and FDA officials. "Today marks an important milestone in protecting our children and the health of the American public," Sebelius said.

“The existing warning labels on cigarette packs have not been updated in 25 years, so this is very good timing,” FDA Commissioner Margaret Hamburg said at a second news conference Wednesday elaborating on the proposal. “Some of the images, I am sure you will agree, are very, very powerful -- and that is the point. We need to make sure anyone considering smoking, particularly kids, fully appreciate the consequences of cigarette use.”

The agency is considering 36 different images and will study the effectiveness of them with consumers before choosing the ones to accompany the nine warning statements.

Each year, tobacco kills 443,000 Americans, and 30% of cancer deaths are related to tobacco. Each day, 4,000 youths try smoking, according to the FDA.

The FDA is exerting its new power to regulate tobacco products under the Family Smoking Prevention and Tobacco Control Act, which requires the agency to issue final regulations on the warning labels by June 22, 2011. Public comments are being accepted through Jan. 9, 2011. By October 2012, cigarettes can’t be sold without the new warning labels.

The proposed new labeling was applauded by some experts and was met with skepticism and criticism by others, who aren't sure stronger labels will convince hard-core smokers to quit.

Proposed New Cigarette Warning Labels

Among the proposed labels, all beginning with the word "WARNING" in capital letters:

  • Cigarettes are addictive.
  • Tobacco smoke can harm your children.
  • Cigarettes cause fatal lung disease.
  • Cigarettes cause cancer.
  • Cigarettes cause strokes and heart disease.
  • Smoking during pregnancy can harm your baby.
  • Smoking can kill you.
  • Tobacco smoke causes fatal lung disease in nonsmokers.
  • Quitting smoking now greatly reduces serious risks to your health.

The nine health warnings would be required to appear on the upper portion of the front and rear panels of a cigarette package and take up at least the top half of the panels, according to the FDA.

Reactions to New Cigarette Warning Labels

The proposal for stronger warning labels was applauded by the American Association for Cancer Research.

But Len Horovitz, MD, an internist and lung specialist at Lenox Hill Hospital in New York City, is skeptical that the new labels will convince smokers to give up tobacco. "I will ask my patients [who smoke] what is on the side of the pack and most don't know," he tells WebMD. Even if the labels are larger and more graphic, he says, "I don't know if they will really help."

What does work? "The best approach is when your patient comes in and you uncover the irrationality of what they are doing," he says. "The motivation to stop smoking comes from the patient, hopefully, with some cheerleading from a doctor or health care professional. Nagging [by a partner] doesn't work, although sometimes a child will be very compelling. A child will say something like 'I want you to be around when I am getting married.'"

Fear doesn't work, he says, and may backfire. "Showing gruesome pictures can also cause anxiety in a smoker and they will go out and smoke more. I've seen enough of the psychology of smoking to know it's not a rational process."

John Banzhaf III, professor of public interest law at George Washington University and executive director of Action on Smoking and Health, an organization devoted to antismoking efforts, calls the label program "'too little, too late."

Banning smoking is a better approach, Banzhaf tells WebMD. He says the federal government should ban smoking at all institutions that accept Health and Human Services grants, for instance. Financial incentives to quit like a smoker premium surcharge and higher taxes would also do more to curb smoking than the label proposal, he says.

Tobacco Industry Response

The tobacco industry views the new warnings as unnecessary and questions their legality. “We are currently reviewing the 140-page notice issued today by the FDA regarding warning labels on cigarette packaging," says David Howard, a spokesman for the R.J. Reynolds Tobacco Company. “It is important to note that the legality of requiring larger and graphic warnings is part of our lawsuit that is currently pending in the 6th Circuit Court of Appeals. A hearing on the matter is expected to occur sometime next year.”

R.J. Reynolds and other tobacco companies filed the suit earlier this year against the FDA and the U.S. Department of Health and Human Services. Among the points in the legal brief is that “These new warnings are not necessary to address any information deficit on the part of the American public.”

With the graphic and new warning taking up so much space on the package, the companies also argue little space will be left for marketing messages describing the products.

Show Sources


News conference, FDA.

News release, FDA.

Len Horovitz, MD, pulmonary specialist, Lenox Hill Hospital, New York City.

John Banzhaf III, JD, professor of public interest law, George Washington University; executive director, Action on Smoking and Health, Washington, D.C.

Kathleen Sebelius, secretary, Health and Human Services.

Margaret Hamburg, commissioner, FDA.

David Howard, spokesman for R.J. Reynolds Tobacco Company.

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