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As of June 18, 2021, the 11 new warnings must be displayed prominently, filling the top half of cigarette packages on both front and back and at least 20% of the area at the top of ads.
The warnings include text and photo-realistic color images depicting some of the lesser-known, but serious health risks of cigarette smoking, including impaired fetal growth, heart disease, diabetes and more.
The warnings "represent the most significant change to cigarette labels in more than 35 years and will considerably increase public awareness of lesser-known, but serious negative health consequences of cigarette smoking," Mitch Zeller, director of FDA's Center for Tobacco Products, said in an agency news release.
For example, current smokers have almost four times the risk of bladder cancer as never-smokers, and smoking is responsible for an estimated 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.
"Research shows that the current warnings on cigarettes, which have not changed since 1984, have become virtually invisible to both smokers and nonsmokers, in part because of their small size, location and lack of an image," Zeller said.
Research also shows substantial gaps remain in the public's knowledge of smoking's harms and that smokers are misinformed about cigarettes and their negative health effects.
"The new cigarette health warnings complement other critical FDA actions, including outreach campaigns targeted to both adults and youth, to educate the public about the dangers associated with using cigarettes, as well as other tobacco products," Zeller said.
Thirteen warnings were considered. The 11 new ones were selected based on consumer research and public comments, scientific literature and other factors, according to the FDA.
The messages all begin with WARNING, followed by:
- Tobacco smoke can harm your children.
- Tobacco smoke causes fatal lung disease in nonsmokers.
- Smoking causes head and neck cancer.
- Smoking causes bladder cancer, which can lead to bloody urine.
- Smoking during pregnancy stunts fetal growth.
- Smoking can cause heart disease and strokes by clogging arteries.
- Smoking causes COPD, a lung disease that can be fatal.
- Smoking reduces blood flow, which can cause erectile dysfunction.
- Smoking reduces blood flow to the limbs, which can require amputation.
- Smoking causes type 2 diabetes, which raises blood sugar.
- Smoking causes cataracts, which can lead to blindness.
-- Robert Preidt
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