When Will FDA’s Graphic Warning Rule Take Effect?

ASK PHILIP MORRIS –

Nov. 2021 – The rule—initially slated to take effect June 18, 2021—would require 11 new textual, health warning statements accompanied by color, “photorealistic” images displayed on the top 50% of the front and rear panels of cigarette packs and top 20% of cigarette ads. The rule’s effective date, however, has been extended multiple times by court order and is currently set for October 11, 2022. So when might tobacco manufacturers need to start producing new cigarette packs and ads?

Our guess? Not right away. We’d wager the effective date will be extended yet again in mid-November.

Tobacco manufacturers have challenged FDA’s graphic-warning rule in federal courts in Texas and the District of Columbia. See R.J. Reynolds Tobacco Co. v. U.S. Food & Drug Admin., No. 6:20cv176 (E.D. Tex. Apr. 3, 2020); Philip Morris USA, Inc. v. U.S. Food & Drug Admin., No. 1:20cv1181 (D.D.C. May 6, 2020). And, in each case, the manufacturers have asked the court to postpone the effective date of the rule citing not only current challenges associated with the COVID-19 pandemic, but millions of dollars in compliance costs for package and ad replacements that would be unnecessary if they prevail. Thus far, the Texas court has been receptive of these arguments, granting R.J. Reynolds Tobacco Co.’s requests to postpone the rule’s effective date in May 2020, December 2020, March 2021, and May 2021. In August 2021, the court even acted on its own accord and postponed the date again to October 11, 2022—the current effective date.