StacksVerified U.S. regulatory reference

21 CFR §1107.48

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)General. FDA will issue an order that the new tobacco product cannot be marketed if FDA finds that:
    1. (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. (2)The new tobacco product is not in compliance with the Federal Food, Drug, and Cosmetic Act.
  2. (b)Basis for order. The order will describe the basis for denying marketing authorization.