FDA has proposed new health warnings for cigarette packages and advertisements that would include text statements, accompanied by photo-realistic color images, to promote greater public understanding of the negative health consequences of smoking. FDA encourages public comments related to the proposed warnings and other topics as described in the proposed rule through Oct. 15. After carefully considering public feedback and making revisions where appropriate, the agency will publish a final rule, including responses to comments received.

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act, or TCA), enacted in 2009, directed FDA to issue regulations requiring that cigarette packages and advertisements include new health warnings with text statements and color graphics depicting the negative health consequences of smoking. The TCA specified nine text statements, while giving FDA the authority to adjust the text of these statements if such a change would promote greater understanding of the risks of smoking.

FDA published a final rule in 2011 requiring health warnings with color graphics to accompany the nine TCA warning statements, but 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 for 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, FDA has been conducting comprehensive research and development activities, including multiple rounds of consumer research, in support of a new cigarette health warnings proposed rule.

FDA undertook an extensive process of scientific, legal, and regulatory analysis starting in 2013 in support of the proposed health warnings, including adjustments to some of the TCA text statements. The 13 proposed warnings cover a number of health conditions and include the following text statements:

• 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. (This statement is 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.

The “Required Warnings for Cigarette Packages and Advertisements” proposed rule, once finalized, would require every cigarette package and advertisement to prominently bear one of the new required warnings in keeping with certain requirements specified in the TCA.

For example, the warning would occupy the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent of the area at the top of cigarette advertisements.

Health warnings on cigarette packages can serve as prominent sources of health information for both smokers and nonsmokers. Daily smokers in the United States are potentially exposed to the cigarette warnings on packages over 5,100 times per year. And information on cigarette packages are potentially viewed by many others, including nonsmokers, as the packages are sometimes visible to others when a person is carrying them.^2,3,4

Filling a Critical Need

Despite declines in cigarette smoking rates in the United States over the past several decades, more than 34 million U.S. adults smoke,⁵ as do 1.4 million 12- to 17-year-olds.⁶ Cigarette smoking remains the leading cause of preventable disease and death in the United States and is responsible for 480,000 deaths a year^7,8 —more than are caused by HIV, illegal drug use, alcohol use, motor vehicle injuries, and firearm-related incidents combined.⁹ And more than 16 million Americans live with disease caused by smoking cigarettes.¹⁰ In addition to lung cancer, heart disease, and chronic obstructive pulmonary disease (COPD), smoking also causes many other serious health conditions.¹⁰ “Given the extreme risks cigarette smoking poses to the public health,” said Mitch Zeller, J.D., director of FDA’s Center for Tobacco Products (CTP), “new proposed warnings of this type are critical to promote greater public understanding of the risks associated with cigarette smoking.”

Health warnings have long appeared on cigarette packages but are far from adequate today to inform people about the health harms of cigarette smoking. These warnings first appeared on cigarette packages in 1966 and were most recently updated in 1984. For 35 years, cigarette packages and advertisements have carried one of the same four Surgeon General’s warnings, such as, “SURGEON GENERAL’S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, and May Complicate Pregnancy.” Research shows that today’s warnings have become virtually invisible^11,12,13,14 —failing to attract much attention or leave a memorable impression. Their unchanged content over decades, as well as their small size and lack of images, undermines the current warnings’ effectiveness in conveying relevant information about the negative health consequences of cigarette smoking.¹¹

Developing and Testing the 13 Proposed Cigarette Health Warnings

As described in detail in the proposed rule, FDA went through a lengthy process to develop and test the text statements and accompanying color images to ensure the proposed warnings would promote greater public understanding of the negative health consequences of smoking.

“FDA undertook a comprehensive, science-based research and development process to get these proposed warnings right by developing distinct and clear messages about the risks associated with cigarette smoking and exposure to secondhand smoke,” said CTP director Zeller.

Among its primary research and development steps, the agency carefully evaluated the public’s understanding of the health risks associated with smoking and conducted its own research on potential warning statements.

Evaluating the public’s understanding: Identifying knowledge gaps

Historically, public health messages about the risks from cigarette smoking, including longstanding warnings on cigarette packages and in advertisements, have focused on a limited number of health conditions such as lung cancer and addiction. And over time, public understanding of these health consequences has improved. However, FDA identified a great potential to educate the public about health conditions that are less known and less understood by the public to be caused by smoking.

The public has a limited understanding of smoking-related health consequences such as impotence; stroke; gangrene; conditions that cause blindness, such as cataracts; emphysema and chronic bronchitis; bladder cancer and other cancers besides lung cancer; and the effects of secondhand smoke on nonsmoking adults and children. “As a cancer doctor and researcher, I am well aware of the staggering toll on the public health from cigarettes,” said Acting FDA Commissioner Ned Sharpless, M.D. “They cause cancer, heart disease, stroke, emphysema, and other medical problems. And they also cause a number of less-known smoking-related risks that youth and adult smokers and nonsmokers may simply not be aware are connected with tobacco products, such as diabetes, blindness, and erectile dysfunction.” Looking at bladder cancer as an example, the public has limited understanding of bladder cancer as a consequence of smoking, although current smokers have been found to have almost four times the risk of this type of cancer compared to those who have never smoked,¹⁵and smoking is responsible for an estimated 5,000 bladder cancer deaths in the United States each year.¹⁶

These health harms are among a long list of the negative health effects of cigarette smoking. In identifying the negative health effects to include in its proposed cigarette health warnings, FDA considered evidence from the Surgeon General’s reports, the preeminent source regarding whether cigarette smoking and exposure to secondhand smoke are causally related to specific negative health consequences.

Identifying warning statements that promote greater public understanding of smoking’s negative health consequences

FDA conducted its own extensive research to develop and test revised warning statements about the risks associated with cigarette smoking that were developed to focus on these less-known health consequences of smoking. The agency’s process involved:

• Evaluating the TCA text statements to consider whether to propose revising those statements to promote greater public understanding of the risks associated with cigarette smoking.
  
  FDA conducted a large consumer research study to determine which, if any, revised warning statements promote greater public understanding of the risks associated with cigarette smoking when compared to the TCA statements. The agency used the findings from this consumer research study to select a set of text warning statements, to be paired with accompanying color images, for further testing.
   
• Developing color images depicting the negative health consequences of cigarette smoking to accompany the text statements.
  
  In parallel with its research on which text statements to include in the proposed warnings, FDA undertook a rigorous, multi-step process to develop, test, and refine color images depicting the negative health consequences of cigarette smoking to accompany the statements. Studies of health warnings have shown that messages with vivid features, such as images, make a message more noticeable, easier to understand, and easier to remember.^17,18 These types of health warnings therefore aid understanding among individuals with diverse backgrounds who have gaps in their knowledge of the negative health consequences of smoking.
  
  Based on a review of relevant information, including communication science research and other scientific studies, FDA determined that text warning statements paired with factually accurate, closely aligned (“concordant”) photographs or photo-realistic images (images that resemble photographs) of specific health conditions, presented in a realistic and objective way, would be most likely to advance the government’s interest in promoting public understanding of the health risks associated with cigarette smoking. The agency used a photo-realistic illustration format for the images, rather than photographs, for several reasons, including that this format best allowed for depiction of specific features of the health conditions as described by the text warning statements.
   
• Developing and testing text-and-image pairings to determine which warnings would promote greater public understanding of the negative health consequences of cigarette smoking.
  
  After the photo-realistic images were created, FDA paired text warning statements with concordant images for evaluation through a series of focus groups around the United States. Based on feedback received in these focus groups, the agency made further refinements and completed text-and-image pairings for additional testing. FDA then conducted a final consumer research study that compared 16 potential cigarette warnings (text-and-image pairings) to the current 1984 Surgeon General’s warnings to inform the agency’s selection of 13 cigarette health warnings for the proposed rule.

Advancing the Government Interest

The proposed warnings—which, when finalized, would represent the most significant change to cigarette labels in 35 years—provide an enormous public health opportunity to address substantial gaps in the public’s knowledge of the health risks of cigarette smoking, and fulfill FDA’s responsibilities under the Tobacco Control Act. FDA’s intensive, science-based research and development process, including its consumer research studies, showed the proposed cigarette health warnings will advance the government’s interest in promoting greater public understanding of the negative health consequences of cigarette smoking. “We are encouraged,” Mitch Zeller stated, “that the research we conducted on these new proposed warnings demonstrated they would lead to improved understanding among both youth and adults and both smokers and nonsmokers.” FDA’s extensive research also ensured that the warnings proposed are factually accurate, and that the images correspond closely with the text warning statements.