21 CFR 1114.39
§ 1114.39 Postmarket changes.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 1114.39, § 1114.39 Postmarket changes, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91551
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Full text
A marketing granted order authorizes the marketing of a new tobacco product in accordance with the terms of the order. Prior to the introduction or delivery for introduction into interstate commerce of a new tobacco product that results from modification(s) to the product, an applicant must submit a new PMTA under § 1114.7 or a supplemental PMTA under § 1114.15 and obtain a marketing granted order for the new tobacco product, unless the new tobacco product can be legally marketed through another premarket pathway.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.