21 CFR § 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.