The Food and Drug Administration is proposing new health warnings on cigarette packages and in advertisements that would include photo-realistic color images of serious but lesser-known health risks of smoking.

The proposed warnings are to help “promote greater public understanding of the negative health consequences of smoking,” and would be the most significant change to cigarette labels in more than 35 years, the agency said Thursday.

“As a cancer doctor and researcher, I am well aware of the staggering toll inflicted on the public health by tobacco products, which cause cancer, heart disease, stroke, emphysema and other medical problems,” said Acting FDA Commissioner Ned Sharpless. “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.”

Tobacco use is still the leading cause of preventable disease and death in the U.S., killing about 480,000 Americans each year, according to the federal agency.

The FDA says about 34 million U.S. adults and more than 1 million U.S. youth (aged 12-17 years old) currently smoke cigarettes.

Health warnings first appeared on cigarette packages in 1966, undergoing the most recent update in 1984 to include the Surgeon General’s warnings that are on packages and in advertisements today.

But research shows the warnings are “virtually invisible” to consumers and do not leave a memorable impression of the risks of smoking, the FDA said.

There are also substantial gaps in the public’s knowledge of the negative health effects of smoking, research shows.

To address these issues, the FDA is proposing 13 cigarette health warnings that would be paired with a photo-realistic colored image:

• Tobacco smoke can harm your children.

• Tobacco smoke causes fatal lung disease in nonsmokers.

• Smoking causes head and neck cancer.

• Smoking causes bladder cancer, which can lead to bloody urine.

• Smoking during pregnancy stunts fetal growth.

• Smoking can cause heart disease and strokes by clogging arteries.

• Smoking causes COPD, a lung disease that can be fatal. (Paired with two different images.)

• Smoking reduces blood flow, which can cause erectile dysfunction.

• Smoking reduces blood flow to the limbs, which can require amputation.

• Smoking causes Type 2 diabetes, which raises blood sugar.

• Smoking causes age-related macular degeneration, which can lead to blindness.

• Smoking causes cataracts, which can lead to blindness.

The new finalized health warnings would cover the top half of the front and rear panels of cigarette packages and at least 20% of the area at the top of cigarette advertisements. The warnings would have to appear on packages and in advertisements 15 months after a final rule on the warnings is issued.

The proposed rule on the new health warnings will be open for public comment for 60 days or until Oct. 15.

The FDA is welcoming comments on proposed cigarette health warnings, labels to be selected for the final rule, alternative text and images for warnings, and scientific information to support the alternatives.

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