21 CFR § 1114.5 - Application submission.

---
identifier: "/us/cfr/t21/s1114.5"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1114.5 - Application submission."
title_number: 21
title_name: "Food and Drugs"
section_number: "1114.5"
section_name: "Application submission."
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"
---


# 1114.5 Application submission.

An applicant may submit a PMTA to demonstrate that a new tobacco product meets the requirements to receive a marketing granted order. A new tobacco product may not be introduced or delivered for introduction into interstate commerce under this part until FDA has issued a marketing granted order for the product.