Regulations last checked for updates: Mar 13, 2025

Title 21 - Food and Drugs last revised: Feb 25, 2025
§ 1114.39 - Postmarket changes.

A marketing granted order authorizes the marketing of a new tobacco product in accordance with the terms of the order. Prior to the introduction or delivery for introduction into interstate commerce of a new tobacco product that results from modification(s) to the product, an applicant must submit a new PMTA under § 1114.7 or a supplemental PMTA under § 1114.15 and obtain a marketing granted order for the new tobacco product, unless the new tobacco product can be legally marketed through another premarket pathway.

authority: 21 U.S.C. 371,374,387a,387i,387j; Pub. L. 117-103, 136 Stat. 49
source: 86 FR 55412, Oct. 4, 2021, unless otherwise noted.
cite as: 21 CFR 1114.39