21 CFR § 1114.39 - Postmarket changes.

---
identifier: "/us/cfr/t21/s1114.39"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1114.39 - Postmarket changes."
title_number: 21
title_name: "Food and Drugs"
section_number: "1114.39"
section_name: "Postmarket changes."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "K"
subchapter_name: "TOBACCO PRODUCTS"
part_number: "1114"
part_name: "PREMARKET TOBACCO PRODUCT APPLICATIONS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 371, 374, 387a, 387i, 387j; Pub. L. 117-103, 136 Stat. 49."
regulatory_source: "86 FR 55412, Oct. 4, 2021, unless otherwise noted."
cfr_part: "1114"
---


# 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.