New graphic health warnings proposed for cigarette packages

OAKLAND, Calif. - Health risk warnings on cigarette packages stand to change – and become far more graphic – for the first time in more than 35 years. 

The new proposed warnings would include more specific health risks alongside colorful pictures of people impacted by smoking-related diseases.

A picture of bloody and bruised feet missing toes warns that smoking reduces blood flow to the limbs, which can require amputation.

A picture of a sick child with an oxygen mask warns that tobacco smoke can harm your children.

And a picture of a man with seemingly serious eye problems warns that smoking causes cataracts, which can lead to blindness.

The FDA on Thursday unveiled 13 new graphic health warnings in all. 

“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,” said acting U.S. Food and Drug Administration Commissioner Dr. Ned Sharpless.

Health warnings first appeared on cigarette packages in 1966 and were updated in 1984 to include the Surgeon General’s warning that “smoking causes lung cancer, heart disease, emphysema and may complicate pregnancy.” 

However, the U.S. Food and Drug Administration says research shows that the warnings have become “virtually invisible” to both smokers and nonsmokers. The reasons: the type is small, there’s no accompanying pictures and the warning is on the side of the cigarette package. 

“The unchanged content of these health warnings, as well as their small size, location and lack of an image, severely impairs their ability to convey relevant information about the negative health consequences of cigarette smoking in an effective way to the public,’’ the FDA said in a statement Thursday. 

The negative health consequences are many. 

Smoking kills more people each year than alcohol, HIV, car accidents, illegal drugs, murders and suicides combined, according to the FDA.

What’s more, more than 16 million Americans live with diseases caused by cigarette smoking. Tobacco use — largely cigarette smoking and secondhand smoke exposure — kills about 480,000 Americans every year. Tobacco use is the leading cause of preventable disease and death in the U.S.

The FDA said the new warnings would fulfill a requirement in the Family Smoking Prevention and Tobacco Control Act, which requires the warnings, and add to the work the agency is doing to advance the health of America’s families. 

“Cigarette packages and advertisements can serve as an important channel for communicating health information to broad audiences that include both smokers and nonsmokers,’’ said Mitch Zeller, director of the FDA’s Center for Tobacco Products, adding that daily smokers may see warnings on cigarette packages more than 5,100 times a year.

The new health warnings, once finalized, would be featured on the top half of both the front and back of cigarette packages. The warnings would also appear on a top area of cigarette advertisements.  

Work to improve warnings has not been without challenges. 

In 2011, the FDA finalized nine warning statements with color graphics that spelled out the negative health consequences of smoking. Several tobacco companies challenged the warnings in court and a year later the U.S. Court of Appeals of the District of Columbia ruled that the information violated the First Amendment. In 2013, the federal government decided not to seek further review of the court’s ruling.

Over the last six years, the FDA says it has done comprehensive research and development to draw up the new proposed cigarette health warnings and meet the requirements of both the Tobacco Control Act and the law. 

Earlier this year and following a lawsuit filed by several public health groups, a judge in the U.S. District Court for the District of Massachusetts issued an order directing the FDA to finalize the warnings by March of next year.