The U.S. Food and Drug Administration (FDA), citing the Family Smoking Prevention and Tobacco Control Act, issued a rule on March 17 requiring 11 new health warnings on cigarette packs, cartons and ads, consisting of text warning statements accompanied by graphic color images.

This was the second such set of warnings, as the first set was overturned as unconstitutional by an appellate court, which sent them back to the FDA to create new compliant warnings. These new warnings would have been required by the FDA beginning June 18, 2021.