21 CFR 1107.48 - Issuance of an order denying marketing authorization.

Regulations last checked for updates: Nov 25, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024

View all text of Subpart D [§ 1107.40 - § 1107.50]

§ 1107.48 - Issuance of an order denying marketing authorization.

(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.

authority: 21 U.S.C. 371,374,387e,387i,387j; Pub. L. 117-103, 136 Stat. 49

source: 76 FR 38974, July 5, 2011, unless otherwise noted.

cite as: 21 CFR 1107.48