FDA requires new health warnings, images for cigarette packages

The FDA has issued a final rule requiring new health warnings on cigarette packages and in cigarette advertisements that include textual statements and photo-realistic color images depicting some of the lesser-known but serious health risks of cigarette smoking, according to a press release.

These risks, the agency noted, include impact on fetal growth, cardiac disease, diabetes and more.

The decision finalizes the FDA’s proposed rule from August. The proposed rule originally called for 13 warnings, but the FDA settled on 11 required warnings for the final rule based on full results of the agency’s consumer research studies, the relevant scientific literature, public comments submitted during the proposed rule docket and other legal and policy considerations. Each warning consists of one of the following textual statements with an accompanying photo-realistic image depicting the negative health consequences of smoking:

• WARNING: Tobacco smoke can harm your children.

The FDA has issued a final rule requiring new health warnings on cigarette packages and in cigarette advertisements that include textual statements and photo-realistic color images depicting some of the lesser-known but serious health risks of cigarette smoking, according to a press release.

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• 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, according to the release.

“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,” Mitch Zeller, JD, director of FDA’s Center for Tobacco Products, said in the release. “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.”

The ruling is set to take effect June 18, 2021. At that time, the FDA will require cigarette packages and advertisements to prominently display the new health warnings so that they occupy the top 50% of the area in the front and rear panels of cigarette packages and at least 20% of the area at the top of cigarette advertisements. The new warnings must be randomly and equally displayed and distributed on cigarette packages and rotated quarterly in cigarette advertisements, according to the release.