LAKEVILLE, Minn. — On May 21, the U.S. District Court for the Eastern District of Texas issued an order further postponing the effective date of the FDA’s graphic cigarette health warning rule by another 90 days to July 13, 2022. This follows the court’s Dec. 2 order, which postponed the implementation date of the FDA’s new graphic cigarette warnings for cigarette packages and advertisements to April 14, 2022.
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 is anticipated to be extended to Sept. 13, 2021, in accordance with the court’s order.
The postponement is the latest ruling by the court in R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration, filed on April 3, by R.J. Reynolds Tobacco Co., several other manufacturers and five retailers to invalidate both the FDA’s rule for these new text and graphic cigarette health warnings and Congress’s requirement that the FDA mandate these warnings under the Family Smoking Prevention and Tobacco Control Act.
The lawsuit remains ongoing, as does another lawsuit, filed by Philip Morris USA Inc. and Sherman Group Holdings, LLC. The legal claims made in the two suits include violations of the First Amendment to the U.S. Constitution, violations of the act, and failure by the FDA to conform to rulemaking requirements. These issues remain to be decided as these cases go forward.
Thomas A. Briant is the executive director of NATO, a tobacco retailing association based in Lakeville, Minn. Reach him at email@example.com.