The U.S. District Court for the Eastern District of Texas issued an order March 2, postponing the effective date of the Food and Drug Administration’s (FDA) graphic cigarette health warning rule by 90 days from Jan. 14, 2022, to April 14, 2022. 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 National Association of Tobacco Outlets (NATO) has asked the FDA for guidance on whether the agency will also be postponing for 90 days the preferred filing deadline of March 16, 2021, for manufacturers, wholesalers, and retailers to submit cigarette health warning rotational plans.
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 11 different graphic cigarette health warnings on cigarette packages and/or cigarette advertisements. The agency had strongly encouraged industry members to submit their cigarette health warning rotational plans by March 16, 2021, to allow sufficient time for the plans to be reviewed and considered for approval.
When the same U.S. District Court issued an order on Dece.2, 2020, initially postponing the effective date of the FDA’s graphic cigarette health warning regulations by 90 days to Jan.14, 2022, the agency then also postponed the preferred filing date for the cigarette health warning plans by 90 days to March 16, 2021, because this earlier order contained the same language postponing for 90 days “any other obligation to comply with a deadline tied to the effective date of the rule.”
NATO will update members when the FDA responds to NATO’s inquiry.