The Food and Drug Administration (FDA) issued a proposed rule to require new health warnings on cigarette packages and in advertisements.

“The proposed warnings, which feature photo-realistic color images depicting some of the lesser-known, but serious health risks of cigarette smoking, stand to represent the most significant change to cigarette labels in more than 35 years,” the FDA said.

When finalized, this rule would fulfill a requirement in the Family Smoking Prevention and Tobacco Control Act and complement additional important work the FDA is undertaking to advance the health of America’s families.

“With these new proposed cigarette health warnings, we have an enormous public health opportunity to fulfill our statutory mandate and increase the public’s understanding of the full scope of serious negative health consequences of cigarette smoking,” said Acting FDA Commissioner Ned Sharpless. “We remain committed to educating the public, especially America’s youth, about the dangers associated with using cigarettes and other tobacco products.”

The proposed new warnings, each comprising a text statement and corresponding photo-realistic image in full color, include:

• WARNING: Tobacco smoke can harm your children.
• WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
• WARNING: Smoking causes head and neck cancer.
• WARNING: Smoking causes bladder cancer, which can lead to bloody urine.
• WARNING: Smoking during pregnancy stunts fetal growth.
• WARNING: Smoking can cause heart disease and strokes by clogging arteries.
• WARNING: Smoking causes COPD, a lung disease that can be fatal. (paired with two different images)
• WARNING: Smoking reduces blood flow, which can cause erectile dysfunction.
• WARNING: Smoking reduces blood flow to the limbs, which can require amputation.
• WARNING: Smoking causes type 2 diabetes, which raises blood sugar.
• WARNING: Smoking causes age-related macular degeneration, which can lead to blindness.
• WARNING: Smoking causes cataracts, which can lead to blindness.

New cigarette health warnings, once finalized, would appear prominently on cigarette packages and in advertisements, occupying the top 50% of the area 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 be required to appear on packages and in advertisements 15 months after a final rule is issued.

The proposed rule will be open for public comments for 60 days through Oct. 15.

Among other things, the FDA is seeking comments on the proposed cigarette health warnings and how many warnings should be selected for the final rule. Given the degree of public and stakeholder interest in this area, the FDA is also seeking proposals for alternative text and images, as well as scientific information to support a finding that the alternative text and images would advance the government interest in promoting greater public understanding of the negative health consequences of smoking.