The USFDA has proposed new health warnings on cigarette packets; this is the most significant change in 35 years
The U.S. Food and Drug Administration has proposed new health warnings on cigarette packages and in advertisements to promote greater public understanding of the negative health consequences of smoking.
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. 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.
“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. 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 FDA Commissioner Ned Sharpless, M.D.
He added: “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. Given that tobacco use is still the leading cause of preventable disease and death in the U.S., there’s a lot at stake to ensure the public understands these risks. We remain committed to educating the public, especially America’s youth, about the dangers associated with using cigarettes and other tobacco products.”
About 34.3 million U.S. adults and nearly 1.4 million U.S. youth (aged 12-17 years) currently smoke cigarettes. Despite years of progress in tackling the leading cause of preventable disease and death in the United States, tobacco use — largely cigarette smoking and secondhand smoke exposure — kills about 480,000 Americans every single year. In fact, smoking kills more people each year than alcohol, HIV, car accidents, illegal drugs, murders and suicides combined, and over 16 million Americans alive today live with disease caused by cigarette smoking. Tobacco use also costs more than $300 billion a year in direct health care costs and lost productivity.
About 34.3 million U.S. adults and nearly 1.4 million U.S. youth (aged 12-17 years) currently smoke cigarettes. Despite years of progress in tackling the leading cause of preventable disease and death in the United States, tobacco use — largely cigarette smoking and secondhand smoke exposure — kills about 480,000 Americans every single year
Health warnings first appeared on cigarette packages in 1966 and were most recently updated in 1984 to include the Surgeon General’s warnings that appear on packages and in advertisements today. However, research shows that these warnings have become virtually invisible to both smokers and nonsmokers — not attracting much attention and not leaving a very memorable impression of the risks of smoking. As outlined in the proposed rule today, 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. Additionally, research shows substantial gaps remain in the public’s knowledge of the harms of smoking, and smokers have misinformation regarding cigarettes and the products’ negative health effects.
To address these gaps in public understanding, the FDA undertook a science-based approach to develop and evaluate the new proposed cigarette health warnings announced today. These warnings focus on serious health risks — such as bladder cancer, diabetes, erectile dysfunction and conditions that can cause blindness — that are lesser-known by the public as being negative health consequences of smoking. For example, current smokers have been found to have almost four times the risk of bladder cancer as never smokers, and it has been estimated that smoking is responsible for 5,000 bladder cancer deaths in the United States each year — yet research shows the public has limited awareness of bladder cancer as a consequence of smoking.
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.
“Cigarette packages and advertisements can serve as an important channel for communicating health information to broad audiences that include both smokers and nonsmokers. In fact, daily smokers potentially see warnings on cigarette packages more than 5,100 times per year, and all members of the public, including adolescents, are exposed to cigarette advertisements in print and digital media, as well as in and around stores where cigarettes are sold,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “The FDA undertook a comprehensive, science-based research and development process, and took the necessary time to get these new proposed warnings right by developing distinct and clear messages about the negative health consequences of smoking. We are especially encouraged that the research we conducted on these new proposed warnings demonstrated they would lead to improved understanding among both youth and adults, smokers and nonsmokers.”
