Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised); Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised final guidance for industry entitled "Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised)." This is a revision to the third edition of this final guidance, which issued in February 2021, and is intended to assist those required to submit cigarette plans for cigarette packages and cigarette advertisements by providing content, timing, and other recommendations related to those submissions. FDA is revising this guidance to reflect the May 21, 2021, court order that postponed the effective date of the final rule entitled "Tobacco Products; Required Warnings for Cigarette Packages and Advertisements" to July 13, 2022. Pursuant to the court order, this revised guidance strongly encourages entities to submit cigarette plans to FDA as soon as possible after publication of the final rule, and in any event, by the recommended submission date, which is currently September 13, 2021.