FDA requires new health warnings for cigarette packages and advertisements

The U.S. Food and Drug Administration issued a final rule to require new health warnings on cigarette packages and in cigarette advertisements. The warnings feature textual statements with photo-realistic color images depicting some of the lesser-known, but serious health risks of cigarette smoking, including impact to fetal growth, cardiac disease, diabetes and more.

“The 11 finalized cigarette health 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,” said Mitch Zeller, J.D., director of FDA’s Center for Tobacco Products. “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. Additionally, research shows substantial gaps remain in the public’s knowledge of the harms of cigarette smoking, and smokers have misinformation 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.”

Beginning June 18, 2021, these new cigarette health warnings will be required to appear prominently on cigarette packages and in advertisements, occupying the top 50% of the area of the front and rear panels of cigarette packages and at least 20% of the area at the top of cigarette advertisements. Once implemented, the new warnings must be randomly and equally displayed and distributed on cigarette packages and rotated quarterly in cigarette advertisements.

As the FDA outlined in the proposed rule issued last year, the agency undertook a science-based approach to develop and evaluate the new cigarette health warnings. These warnings focus on serious health risks that are less known by the public as being negative health consequences of smoking. For example, current smokers have been found to have almost four times the risk of bladder cancer as never smokers, and it has been estimated that smoking is responsible for 5,000 bladder cancer deaths in the U.S. each year — yet research shows the public has limited awareness of bladder cancer as a consequence of smoking.

While the proposed rule put forward 13 warnings for consideration, the FDA finalized a set of 11 required warnings for the final rule based on the full results of the FDA’s consumer research studies, the relevant scientific literature, public comments submitted to the proposed rule docket and other legal and policy considerations. The final cigarette health warnings each consist of one of the following textual warning statements paired with an accompanying photo-realistic image depicting the negative health consequences of smoking:

• 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.
• 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 cataracts, which can lead to blindness.

In addition, the FDA has issued a guidance to accompany the final rule. The “Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide” guidance for industry will assist small businesses in understanding and complying with the final rule.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.