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# Rule on Premarket Tobacco Product Application Requirements
- URL: https://www.fdaweb.com/rule-on-premarket-tobacco-product-application-requirements/
- Published: 2021-01-21T12:00:00.000Z
- Updated: 2026-09-14T16:43:39.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148498

*Federal Register* notice: FDA has issued a final rule that outlines requirements for premarket tobacco product applications (PMTAs) and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. The rule is intended to 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. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-01212.pdf?ref=fdaweb.com).