FDA proposes new, graphic warnings for cigarette packs and ads

A Food and Drug Administration photo illustration shows three  of the 13 proposed warnings.

The Food and Drug Administration has again published a proposed rule to "require color graphics depicting the negative health consequences of smoking be added to cigarette packages and in cigarette advertisements," Inside Health Policy's Beth Wang reports.

The warnings would be the first update to cigarette package warnings in more than 30 years. They were authorized by a 2009 law, but a tobacco-company lawsuit blocked FDA's first attempt.

Wang describes the proposed warnings:

“Tobacco smoke can harm your children,” with an image that shows the head and shoulders of a boy 8 to 10 years old, wearing a hospital gown and receiving a nebulizer treatment for chronic asthma.

“Tobacco smoke causes fatal lung disease in nonsmokers,” with an image showing gloved hands holding a pair of diseased lungs containing cancerous lesions.

“Smoking causes head and neck cancer,” with an image showing the head and neck of a woman 50 to 60 years old who has a tumor protruding from the right side of her neck, just below her jawline.

“Smoking causes bladder cancer, which can lead to bloody urine,” with an image of a gloved hand holding a specimen cup with bloody urine.

“Smoking during pregnancy stunts fetal growth,” with an image of an infant on a medical scale with a digital display reading 4 pounds.

“Smoking can cause heart disease and strokes by clogging arteries,” with an image of a 60- to 70-year-old man with a large, recently sutured incision in his chest as he undergoes monitoring.

“Smoking causes COPD, a lung disease that can be fatal.” There are two versions of the COPD warning. One will have an image of gloved hands holding a pair of diseased, darkened lungs removed from a smoker; the other will have an image of the head and neck of a 50- to 60-year-old man who has a nasal canula under his nose supplying oxygen, with the oxygen tank behind him.

“Smoking reduces blood flow, which can cause erectile dysfunction,” with an image of a 50- to 60-year-old man sitting on the edge of a bed and leaning forward with one elbow resting on each knee. The man’s head is tilted down with his forehead pressed into the knuckles of his right hand while his female partner sits behind him on the bed, looking in another direction.

“Smoking reduces blood flow to the limbs, which can require amputation,” with an image of feet with several toes amputated due to damage resulting from peripheral vascular disease caused by smoking.

“Smoking causes type 2 diabetes, which raises blood sugar,” with n image of a personal glucometer device showing a high blood sugar level.

“Smoking causes age-related macular degeneration, which can lead to blindness,” with the image of a senior man getting an injection in his right eye to prevent additional macular degeneration.

“Smoking causes cataracts, which can lead to blindness,” with the image of a man who is at least 65 years old who has a cataract covering his right pupil.

A lawsuit by public-health and anti-smoking advocates prompted FDA to issue the proposal, Wang notes: "The proposed warnings are required by law to be displayed on half the front and rear panels of cigarette packages, and on the top 20% of the area at the top of advertisements.

"This marks the second time FDA has issued a proposed rule to require graphic warnings on cigarette labels and advertisements," Wang notes. "The first rule was blocked in 2012 by the U.S. Court of Appeals for the District of Columbia in R.J. Reynolds Tobacco Company v. FDA, which argued the proposed rule violated the First Amendment by not justifying why there is a need to issue regulation on commercial speech. In March, however, a federal court ordered FDA to issue the proposed rule by Aug. 15, and a final rule by March 15, 2020."

The Family Smoking Prevention and Tobacco Control Act of 2009 "required nine new health warning statements to be included on cigarette packages and in cigarette advertisements, and it directed FDA to develop color graphics depicting the negative health consequences of smoking to accompany warnings," Wang notes. "After having their initial proposed rule rejected by the court in 2012, FDA undertook a research and development process to consider whether the TCA’s textual warning statements would promote greater public understanding of the risks associated with smoking. Through that process, FDA determined there was support to propose adjusting some of the TCA statements. FDA ended up with 16 statement-and-image pairings to test in a final quantitative consumer research study, which resulted in the 13 cigarette graphic health warnings listed in the proposed rule."