---
kind: "section"
citation: "21 C.F.R. § 1107.48"
title: "21"
number: "1107.48"
heading: "Issuance of an order denying marketing authorization."
url: "https://uscodex.org/cfr/21/1107.48"
---

# §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.

## Notes

### Source

Source: 86 FR 55275, Oct. 4, 2021, unless otherwise noted.

### Authority

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

### Source

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