---
kind: "section"
citation: "21 C.F.R. § 1107.44"
title: "21"
number: "1107.44"
heading: "FDA action on an SE Report."
url: "https://uscodex.org/cfr/21/1107.44"
---

# §1107.44. FDA action on an SE Report.


After receipt of an SE Report, FDA will:

- (a) Refuse to accept the SE Report for review if it does not comply with [§ 1107.18](/cfr/21/1107.18.md) and [§ 1105.10](/cfr/21/1105.10.md) of this chapter;
- (b) Request additional information as provided in [§ 1107.40(d)](/cfr/21/1107.40.md?p=d);
- (c) Issue a letter administratively closing the SE Report if it is not possible to make a determination on an SE Report;
- (d) Issue a letter canceling the SE Report if FDA finds the SE Report was created in error;
- (e) Issue an order as described in [§ 1107.46](/cfr/21/1107.46.md) finding the new tobacco product to be substantially equivalent and in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act; or
- (f) Issue an order as described in [§ 1107.48](/cfr/21/1107.48.md) denying marketing authorization because the new tobacco product is:
  - (1) Not substantially equivalent to a tobacco product commercially marketed (other than for test marketing) in the United States on February 15, 2007, or
  - (2) **Not in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act.**

## 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.