# 21 C.F.R. § 1114.5 (2026): Application submission

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P1114_S1114_5

## Section

- **Citation:** 21 C.F.R. § 1114.5 (2026)
- **Heading:** Application submission
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 1114: PREMARKET TOBACCO PRODUCT APPLICATIONS / Subpart B: Premarket Tobacco Product Applications / § 1114.5: § 1114.5   Application submission.

## Text

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.

## Nearby sections

- [21 C.F.R. § 1114.5 (2026) § 1114.5   Application submission.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1114_S1114_5.md)
- [21 C.F.R. § 1114.7 (2026) § 1114.7   Required content and format.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1114_S1114_7.md)
- [21 C.F.R. § 1114.9 (2026) § 1114.9   Amendments.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1114_S1114_9.md)
- [21 C.F.R. § 1114.11 (2026) § 1114.11   Withdrawal by applicant.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1114_S1114_11.md)
- [21 C.F.R. § 1114.13 (2026) § 1114.13   Change in ownership of an application.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1114_S1114_13.md)
- [21 C.F.R. § 1114.15 (2026) § 1114.15   Supplemental applications.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1114_S1114_15.md)
- [21 C.F.R. § 1114.17 (2026) § 1114.17   Resubmissions.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1114_S1114_17.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P1114_S1114_5. Check the current official text before relying on it. Not legal advice.