# 21 CFR § 1114.5: Application submission

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.5

## Section

- **Citation:** 21 CFR § 1114.5
- **Heading:** Application submission
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER K—TOBACCO PRODUCTS > PART 1114—PREMARKET TOBACCO PRODUCT APPLICATIONS > Subpart B—Premarket Tobacco Product Applications

## 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 CFR § 1114.1 § 1114.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.1.md)
- [21 CFR § 1114.3 § 1114.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.3.md)
- [21 CFR § 1114.5 § 1114.5 Application submission.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.5.md)
- [21 CFR § 1114.7 § 1114.7 Required content and format.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.7.md)
- [21 CFR § 1114.9 § 1114.9 Amendments.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.9.md)
- [21 CFR § 1114.11 § 1114.11 Withdrawal by applicant.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.11.md)
- [21 CFR § 1114.13 § 1114.13 Change in ownership of an application.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.13.md)
- [21 CFR § 1114.15 § 1114.15 Supplemental applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.15.md)
- [21 CFR § 1114.17 § 1114.17 Resubmissions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.17.md)
- [21 CFR § 1114.25 § 1114.25 Communication between FDA and applicants.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.25.md)
- [21 CFR § 1114.27 § 1114.27 Review procedure.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.27.md)
- [21 CFR § 1114.29 § 1114.29 FDA action on an application.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.29.md)
- [21 CFR § 1114.31 § 1114.31 Issuance of a marketing granted order.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.31.md)
- [21 CFR § 1114.33 § 1114.33 Issuance of a marketing denial order.](https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.33.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-1114.5. Check the current official text before relying on it. Not legal advice.