# Premarket Tobacco Product Applications and Recordkeeping Requirements
> **Food and Drug Administration** · Final rule. · Published 2021-10-05 · Effective 2021-11-04 · 86 FR 55300
## Document
- **Document number:** 2021-21011
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 86 FR 55300
- **CFR reference:** 21 CFR 1100
- **Publication date:** 2021-10-05
- **Effective date:** 2021-11-04
- **HHS docket:** Docket No. FDA-2019-N-2854
## Abstract

The Food and Drug Administration (FDA, the Agency, us, or we) is issuing a final rule that sets forth requirements for premarket tobacco product applications (PMTAs) and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. The rule will help ensure that PMTAs contain sufficient information for FDA to determine whether a marketing granted order should be issued for a new tobacco product. The rule codifies the general procedures FDA will follow when evaluating PMTAs and creates postmarket reporting requirements for applicants that receive marketing granted orders. The rule also requires tobacco product manufacturers to keep records establishing that their tobacco products are legally marketed, such as documents showing that a tobacco product is not required to undergo premarket review or has received premarket authorization.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2021/10/05/2021-21011/premarket-tobacco-product-applications-and-recordkeeping-requirements)
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