FDA Seeks Public Comment on Cigarette Warning Labels

Angel Abcede, Senior Editor/Tobacco, CSP

cigarettes warning

WASHINGTON -- The content of warning labels for cigarettes has resurfaced as an area of renewed study. The U.S. Food and Drug Administration (FDA) is opening a public-comment period with an online survey to consider the effectiveness of the labels, the agency announced.

In a posting dated Sept. 14, the FDA said it would assess the text in warning statements for cigarettes to see if changes would “promote greater public understanding of the negative health consequences of cigarette smoking.”

To do so, it will initiate an online study to involve 1.2 million people who fall into categories that include adolescents who are current cigarette smokers, adolescents who are susceptible to the initiation of cigarette smoking, young adults who are current cigarette smokers and older adults who are current smokers.

Over the years, warning labels—more specifically graphics on labels—have become a topic of public debate.

Here are a few details of the new study …

Current warnings

smoking cigarette

A control group of study participants will view and comment on the effectiveness of these nine warning statements that the FDA uses:

  • WARNING: Cigarettes are addictive.
  • WARNING: Tobacco smoke can harm your children.
  • WARNING: Cigarettes cause fatal lung disease.
  • WARNING: Cigarettes cause cancer.
  • WARNING: Cigarettes cause strokes and heart disease.
  • WARNING: Smoking during pregnancy can harm your baby.
  • WARNING: Smoking can kill you.
  • WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
  • WARNING: Quitting smoking now greatly reduces serious risks to your health.

Potential new warnings


Here is a list of revised statements the FDA will put before test participants:

  • WARNING: Smoking causes mouth and throat cancer.
  • WARNING: Smoking causes head and neck cancer.
  • WARNING: Smoking causes bladder cancer, which can lead to bloody urine.
  • WARNING: Smoking during pregnancy causes premature birth.
  • WARNING: Smoking during pregnancy stunts fetal growth.
  • WARNING: Smoking during pregnancy causes premature birth and low birth weight.
  • WARNING: Secondhand smoke causes respiratory illnesses in children, like pneumonia.
  • WARNING: Smoking can cause heart disease and strokes by clogging arteries.
  • WARNING: Smoking causes COPD [or chronic obstructive pulmonary disease], a lung disease that can be fatal.
  • WARNING: Smoking causes serious lung diseases like emphysema and chronic bronchitis.
  • 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.

Graphic images

cigarette warning

In its announcement post, the FDA responded to comments it previously received about adding graphic images to the warning-label test. Three comments suggested that the textual warning statements should be evaluated together with accompanying images because the effects of the final cigarette graphic-warning labels will be a combination of the effects of both the text and images.

The FDA declined the suggestion at this time. "This current phase of the research, which includes the study proposed here, is an effort by FDA to collect data concerning revised, textual-warning statements that may later be used with new images as part of cigarette graphic-health warnings," it said. "In the future, FDA will conduct research pairing warning statements with images."