FDA’s graphic warning rule’s future seems uncertain as court postpones effective date yet again.
The US District Court for the Eastern District of Texas postponed the effective date of the US Food and Drug Administration’s (FDA) required warnings for cigarette packages and advertisements final rule again, this time to January 9, 2023.
In March 2020, FDA finalized the rule, which requires implementing 11 new health warnings (both text statements and graphic color images) on cigarette packs, cartons, and ads, but it was challenged by several lawsuits. This is the third effective date for this rule; the first was January 14, 2022 which was postponed to April 14, 2022. This postponement was the result of a lawsuit by R.J. Reynolds and other manufacturers and retailers on April 3 last year to invalidate the rule and Congress’s requirement that FDA mandate the warnings. A similar lawsuit by Philip Morris USA and Sherman Group Holdings, owned by Altria Group, against FDA sought the same resolution. The latest postponement to the effective date is a result of the R.J. Reynolds case against FDA.
Pursuant to the court order, any obligation to comply with a deadline tied to the effective date is similarly postponed, but FDA recommends that companies submit their cigarette plans which include a schedule for rotating the 11 warnings on cigarette packages or advertisements, by March 12, 2022, if they create or produce their own cigarette advertisements.