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  1. Labeling and Warning Statements for Tobacco Products

Cigarette Health Warnings

Required Warnings for Cigarette Packages and Advertisements (Additional Materials; Reopening of the Comment Period) 

FDA has reopened the comment period for the “Required Warnings for Cigarette Packages and Advertisements” proposed rule published on Aug. 16, 2019. When finalized, this rule would require new cigarette health warnings on cigarette packages and in advertisements to promote greater public understanding of the negative health consequences of smoking. FDA is placing additional materials in the docket and reopening the public comment period for 15 days to allow comment on the additional materials. 

Submit comments on the additional materials and proposed rule by Nov. 27, 2019.


On this page:


About the Proposed Rule

The proposed rule, “Required Warnings for Cigarette Packages and Advertisements,” would require, once finalized, new health warnings on cigarette packages and in advertisements to promote greater public understanding of the negative health consequences of smoking.

The 13 proposed warnings, which feature text statements accompanied by photo-realistic color images depicting some of the lesser-known health risks of cigarette smoking, stand to represent the most significant change to cigarette labels in 35 years.

When finalized, this rule will fulfill FDA’s statutory mandate under the Family Smoking Prevention and Tobacco Control Act and enhance other important initiatives the agency is undertaking to advance the health of America’s families. 

Read the proposed rule.


Proposed Warnings

Interactive Cigarette Health Warning

Use your mouse to rotate this 3D image of one of FDA’s new proposed cigarette health warnings to see what it would look like on a cigarette package. You can also download this interactive image, and share it on your digital space. 

Thirteen Proposed Cigarette Health Warnings*

A rectangular cigarette health warning with a white background and black text that reads: “WARNING: Tobacco smoke can harm your children.” To the right of the text is a photorealistic illustration showing the head and shoulders of a young boy (aged 8-10 years) wearing a hospital gown and receiving a nebulizer treatment for chronic asthma resulting from secondhand smoke exposure. The warning is surrounded by a black outline.
A rectangular cigarette health warning with a white background and black text that reads: “WARNING: Smoking during pregnancy stunts fetal growth." Above the text is a photorealistic illustration showing an infant with low birth weight resulting from stunted fetal growth due to maternal smoking during pregnancy. The infant is laying on a medical scale, and the digital display on the scale reads four pounds. The warning is surrounded by a black outline.
A rectangular cigarette health warning with a white background and black text that reads: "WARNING: Smoking causes age-related macular degeneration, which can lead to blindness." To the right of the text is a photorealistic illustration depicting a closeup of an older man (aged 65 years or older) who has age-related macular degeneration caused by cigarette smoking. The man is receiving an injection in his right eye to prevent additional vessel growth. The warning is surrounded by a black outline.

 

A rectangular cigarette health warning with a white background and black text that reads: “WARNING: Smoking causes bladder cancer, which can lead to bloody urine.” To the right of the text is a photorealistic illustration showing a gloved hand holding a urine specimen cup containing bloody urine resulting from bladder cancer caused by cigarette smoking. The warning is surrounded by a black outline.
A rectangular cigarette health warning with a white background and black text that reads: "WARNING: Smoking reduces blood flow to the limbs, which can require amputation." Above the text is a photorealistic illustration showing the feet of a person who had several toes amputated due to tissue damage resulting from peripheral vascular disease caused by cigarette smoking. The warning is surrounded by a black outline.
A rectangular cigarette health warning with a white background and black text that reads: "WARNING: Smoking causes cataracts, which can lead to blindness." To the right of the text is a photorealistic illustration depicting a closeup of the face of a man (aged 65 years or older) who has a cataract caused by cigarette smoking. The man's right pupil is covered by a large cataract. The warning is surrounded by a black outline.

 

A rectangular cigarette health warning with a white background and black text that reads: "WARNING: Smoking causes COPD, a lung disease that can be fatal." To the right of the text is a photorealistic illustration showing gloved hands holding a pair of diseased, darkened lungs removed from a smoker with COPD. The warning is surrounded by a black outline.
A rectangular cigarette health warning with a white background and black text that reads: "WARNING: Smoking causes COPD, a lung disease that can be fatal." Next to the text is a photorealistic illustration showing a man receiving oxygen support because he has COPD caused by cigarette smoking. The illustration shows the head and neck of a man (aged 50-60 years) who has a nasal canula under his nose supplying oxygen; the oxygen tank is behind his left shoulder. The warning is surrounded by a black outline.
A rectangular cigarette health warning with a white background and black text reads: "WARNING: Smoking can cause heart disease and strokes by clogging arteries."  Next to the text is a photorealistic illustration of a chest of a man (aged 60-70 years) wearing an open hospital gown who recently underwent surgery to treat heart disease caused by smoking. . A large, recently-sutured incision running down the middle of his chest and is undergoing post-operative monitoring. The warning has a black border.

 

A rectangular cigarette health warning with a white background and black text that reads: “WARNING: Smoking causes head and neck cancer.” To the right of the text is a photorealistic illustration showing the head and neck of a woman (aged 50-60 years) who has neck cancer caused by cigarette smoking. The woman has a visible tumor protruding from the right side her neck just below her jawline. The warning is surrounded by a black outline.
A rectangular cigarette health warning with a white background and black text that reads: "WARNING: Smoking causes type 2 diabetes, which raises blood sugar." Above the text is a photorealistic illustration depicting a personal glucometer device being used to measure the blood glucose level of a person with type 2 diabetes caused by cigarette smoking. The digital display reading of 175 mg/dL and a notation on the glucometer indicate a high blood sugar level. The warning is surrounded by a black outline.
A rectangular cigarette health warning with a white background and black text that reads: “WARNING: Tobacco smoke causes fatal lung disease in nonsmokers." To the right of the text is a photorealistic illustration showing gloved hands holding a pair of diseased lungs containing cancerous lesions from chronic secondhand smoke exposure. The warning is surrounded by a black outline.

 

A rectangular cigarette health warning with a white background and black text that reads: "WARNING: Smoking reduces blood flow, which can cause erectile dysfunction." Next to the text, a photorealistic illustration shows a man with erectile dysfunction due to smoking. The man (aged 50-60 years) sits on a bed, leaning forward, with an elbow on each knee. His head is tilted down with his forehead pressed into hand. Behind him on the bed, his female partner looks away. The warning has a black border.
 

 

*These warnings are protected by copyright. For more information regarding permitted uses of these warnings contact AskCTP@fda.hhs.gov.


Background

The Family Smoking Prevention and Tobacco Control Act (TCA) 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 TCA. 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, FDA conducted comprehensive research and development activities in support of a new cigarette health warning proposed rule to satisfy the requirements of the TCA 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 2019 directing FDA to publish the new proposed rule by August 2019 and issue a final rule in March 2020. FDA issued the new cigarette health warnings proposed rule on August 15, 2019. 


Additional Resources