21 C.F.R. § 1114.39

Postmarket changes.

Last amended: 2021Year: 2026Length: 84 wordsOfficial source

Cite as 21 C.F.R. § 1114.39 (2026)

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.
Cross-references to the CFR
1114.151114.7
21 C.F.R. § 1114.39: Postmarket changes. | Justis AI