Court Orders Further Postponement of FDA Graphic Cigarette Warnings

FDA | Graphic Cigarette Warnings

The following update was provided by the National Association of Tobacco Outlets (NATO).

On May 21, 2021, the U.S. District Court for the Eastern District of Texas issued an order further postponing the effective date of the U.S. Food and Drug Administration’s (FDA) graphic cigarette health warning rule by another 90 days from April 14, 2022 to July 13, 2022. A copy of the court order accompanies this bulletin. In addition, the order also states that “any other obligation to comply with a deadline tied to the effective date of the rule” is also postponed for an additional 90 days.

Based on this additional language in the order, the FDA should be issuing a guidance announcement also postponing for another 90 days the preferred filing deadline for manufacturers, wholesalers, and retailers to submit cigarette health warning rotational plans to the agency. Each manufacturer, wholesaler, and retailer that creates its own cigarette advertisements is required to file a plan with the FDA which sets forth the schedule for rotating the eleven graphic cigarette health warnings on cigarette advertisements. The agency had strongly encouraged industry members to submit their cigarette health warning rotational plans by June 14, 2021 to allow sufficient time for the plans to be reviewed and considered for approval. Now, that preferred filing deadline for cigarette health warning rotational plans should be September 13, 2021.