21 CFR 1107.48
§ 1107.48 Issuance of an order denying marketing authorization.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 1107.48, § 1107.48 Issuance of an order denying marketing authorization, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91524
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Full text
(a) General. FDA will issue an order that the new tobacco product cannot be marketed if FDA finds that:
(1) The information submitted in the SE Report does not establish that the new tobacco product is substantially equivalent to a predicate tobacco product that was commercially marketed (other than for test marketing) in the United States on February 15, 2007; or
(2) The new tobacco product is not in compliance with the Federal Food, Drug, and Cosmetic Act.
(b) Basis for order. The order will describe the basis for denying marketing authorization.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.