---
kind: "section"
citation: "21 C.F.R. § 1107.10"
title: "21"
number: "1107.10"
heading: "Scope."
url: "https://uscodex.org/cfr/21/1107.10"
---

# §1107.10. Scope.

- (a) Subparts [B](/cfr/21/subpartB.md) through [E](/cfr/21/subpartE.md) of this part apply to a substantial equivalence report (or an SE Report) for a new tobacco product, other than “premium” cigars as defined in [§ 1107.12](/cfr/21/1107.12.md), that has:
  - (1) Characteristics different from a predicate tobacco product and for which information is submitted to demonstrate it is not appropriate to regulate the product under section [910(b)](/cfr/21/910.md?p=b) and [(c)](/cfr/21/910.md?p=c) of the Federal Food, Drug, and Cosmetic Act because the new tobacco product does not raise different questions of public health or
  - (2) **The same characteristics as a predicate tobacco product.**
- (b) These subparts set forth procedures and requirements for the submission to FDA of an SE Report under sections [905](/cfr/21/905.md) and [910](/cfr/21/910.md) of the Federal, Food, Drug, and Cosmetic Act; the basic criteria for establishing substantial equivalence; and the general procedures FDA will follow when evaluating submissions.

## 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.