FDA Implements New Warnings for Cigarette Packages and Advertisements

The U.S. Food and Drug Administration (FDA) issued a final rule to require new health warnings on cigarette packages and in cigarette advertisements, which 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. Beginning June 18, 2021, the new health warnings will be required to appear prominently on cigarette packages and in advertisements, occupying the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent 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.

The warnings focus on serious health risks 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 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.

The set of 11 required warnings are based on the full results of 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 photorealistic 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 ow, which can cause erectile dysfunction.
• WARNING: Smoking reduces blood ow 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, FDA has issued a guidance to accompany the final rule titled “Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide” for industry to assist small businesses in understanding and complying with the rule.