---
kind: "section"
citation: "21 C.F.R. § 1114.5"
title: "21"
number: "1114.5"
heading: "Application submission."
url: "https://uscodex.org/cfr/21/1114.5"
---

# §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.


## Notes

### Authority

Authority: 21 U.S.C. 371, 374, 387a, 387i, 387j; Pub. L. 117-103, 136 Stat. 49.

### Source

Source: 86 FR 55412, Oct. 4, 2021, unless otherwise noted.