Last week, the U.S. District Court for the Eastern District of Texas issued an order to postpone the effective date of the “Required Warnings for Cigarette Packages and Advertisements” final rule. The new effective date of the final rule is Jan. 9, 2023.
The postponement order emerged from the case of R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al., No. 6:20-cv-00176. Pursuant to the court order, any obligation to comply with a deadline tied to the effective date is similarly postponed.
For example, FDA strongly encourages entities to submit cigarette plans (as required by 21 CFR 1141.10(g)) as soon as possible, and in any event by March 12, 2022.
In March 2020, FDA finalized the “Required Warnings for Cigarette Packages and Advertisements” rule, establishing 11 new cigarette health warnings, consisting of textual warning statements accompanied by color graphics, in the form of concordant photorealistic images, depicting the negative health consequences of cigarette smoking. These new required warnings depict some of the lesser-known, but serious health risks of smoking.
FDA has also published the “Required Warnings for Cigarette Packages and Advertisements – Small Entity Compliance Guide” to help small businesses understand and comply with the final rule.
For FDA to approve a cigarette plan for cigarette packaging, the plan must provide that all of the required warnings are randomly displayed during each 12-month period on each brand of the product, displayed on each brand of the product in as equal a number of times as is possible during each 12-month period, are randomly distributed in all areas of the United States in which the product is marketed, and must ensure that all of the required warnings will be displayed by the manufacturer, distributor, or retailer at the same time.
For FDA to approve a cigarette plan for cigarette advertising, the plan must provide that all of the required warnings are rotated quarterly in alternating sequence in advertisements for each brand of cigarettes.