GroundRules
21 CFR 1107.48: Issuance of an order denying marketing authorization.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER K—TOBACCO PRODUCTS
- PART 1107—EXEMPTION REQUESTS AND SUBSTANTIAL EQUIVALENCE REPORTS
- Subpart D—FDA Review
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON