ALEXANDRIA, Va.—The U.S. District Court for the Eastern District of Texas again has issued an order to postpone the effective date of required warnings on cigarettes until April 9, 2023, according to the U.S. Food and Drug Administration (FDA). The order was the result of the case of R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al.
Any obligation to comply with a deadline tied to the effective date is similarly postponed, according to the FDA, but the FDA encourages entities to submit cigarette plans as soon as possible but no later than June 10, 2022.
In March 2020, the FDA issued a final rule requiring cigarette health warnings on cigarette packaging and advertisements. In October 2019, NACS filed a letter on the proposed rule on graphic warning labels on cigarette packages.
The final rule requires cigarette manufacturers to include graphic health warnings on cigarette packaging and advertisements. According to the final rule, “new cigarette health warnings must appear prominently on packages and in advertisements, occupying the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent of the area at the top of cigarette advertisements.”
In addition, retailers of cigarettes are responsible for ensuring those health warnings are visible to the public and unobscured. In terms of packaging requirements, retailers of cigarettes will not be in violation of the final rule if the cigarette packaging: (1) contains a warning; (2) is supplied to the retailer by a licensed manufacturer or distributor; and (3) is not altered by the retailer. However, retailers are responsible for ensuring that the health warnings are visible on packages and unobscured by stickers, sleeves or other materials.
Retailers will not be in violation of the advertisement requirements if that retailer receives the advertisements from a cigarette manufacturer or distributor. However, if retailers are creating the advertisements, then they must ensure the health warnings meet the new requirements. In all cases, however, the retailer is liable if the retailer publicly displays an advertisement that does not contain a warning or if that warning has been altered by the retailer in a material way or is obscured from view.
In the proposed rule, FDA would have required retailers to submit plans for the random and equal display of the required warnings for cigarette packages and required retailers to rotate the warnings in advertisements quarterly. In its letter to the agency, NACS raised concerns with this proposal given that retailers have no control over how manufacturers display and distribute the health warnings, nor do retailers create the advertisements. In response, the FDA explains in the final rule that retailers selling cigarettes would not be required to submit a plan for packaging, as long as the cigarette packaging: (1) contains a warning; (2) is supplied to the retailer by a tobacco manufacturer or distributor; and (3) is not altered by the retailer in a way material way.
This is the fourth time the agency has delayed the rule’s effective date. In May 2020, the U.S. District Court for the Eastern District of Texas agreed to a postponement until Oct. 16, 2021, because of the COVID-19 pandemic. In January 2021, the order was postponed to January 14, 2022, and in August 2021, order was postponed to Oct. 11, 2022.
The new requirement for graphic warning labels on cigarette packs was initially slated to take effect June 18, 2021.
More details on the rule, as well as the new effective date and recommended date for submission of cigarette plans, can be found on the FDA website.