FDA proposes new required health warnings with color images for cigarette packages and advertisements to promote greater public understanding of negative health consequences of smoking

FDA News Release

• For Immediate Release: August 15, 2019

Today, the U.S. Food and Drug Administration issued a proposed rule to require 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. “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.

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.

Participants in the FDA's final consumer research study reported that the information provided by the 13 proposed cigarette health warnings was both new to them and that they learned something from the proposed warnings when compared to the current Surgeon General's warnings on cigarette packages and in advertisements. Based on the findings, 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.”

The Tobacco Control Act requires the agency to include new warning labels specifically on cigarette packages and in advertisements. In June 2011, the agency published a final rule requiring color graphics depicting the negative health consequences of smoking to accompany nine textual warning statements specified in the Tobacco Control Act. However, the final rule was challenged in court by several tobacco companies and was ultimately vacated in August 2012 after the U.S. Court of Appeals of the District of Columbia held that the rule violated the First Amendment. In March 2013, the federal government announced its decision not to seek further review of the court’s ruling.

Since that time, the FDA has been conducting comprehensive research and development activities in support of the new proposed cigarette health warning rule announced today in order to satisfy the requirements of the Tobacco Control Act based on — and within the limits of — both science and the law. 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 in March directing the agency to publish the proposed rule by August 2019 and issue a final rule in March 2020.

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.

In addition to the newly proposed cigarette health warnings, the FDA also continues to move forward on a number of separate measures to protect kids and significantly reduce tobacco-related disease and death as part of the agency’s comprehensive plan for tobacco and nicotine regulation.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.