FDA Issues Final Rule To Require New Cigarette Health Warnings

(UNDATED) – FDA issued a final rule to require new health warnings on cigarette packages and in cigarette advertisements to promote greater public understanding of the negative health consequences of cigarette smoking.

The eleven warnings feature text statements accompanied by photo-realistic color images depicting some of the lesser-known, but serious health risks of cigarette smoking, including impact on fetal growth, cardiac disease, and diabetes.

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 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 warnings must be randomly and equally displayed and distributed on cigarette packages and rotated quarterly in cigarette advertisements.

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