---
kind: "section"
citation: "21 C.F.R. § 25.35"
title: "21"
number: "25.35"
heading: "Tobacco product applications."
url: "https://uscodex.org/cfr/21/25.35"
---

# §25.35. Tobacco product applications.


The classes of actions listed in this section are categorically excluded and, therefore, normally do not require the preparation of an EA or an EIS:

- (a) Issuance of an order finding a tobacco product substantially equivalent under [section 910(a)(2)(B)](/cfr/21/910.md?p=a-2-B) of the Federal Food, Drug, and Cosmetic Act;
- (b) Issuance of an order finding a tobacco product not substantially equivalent under [section 910(a)](/cfr/21/910.md?p=a) of the Federal Food, Drug, and Cosmetic Act, denial of a request for an exemption under [21 CFR part 1107](/cfr/21/part1107.md) from the requirement of demonstrating substantial equivalence, issuance of an order under [section 910(c)](/cfr/21/910.md?p=c) of the Federal Food, Drug, and Cosmetic Act that a new tobacco product may not be introduced or delivered for introduction into interstate commerce, or issuance of an order under [section 911](/cfr/21/911.md) of the Federal Food, Drug, and Cosmetic Act that a modified risk tobacco product may not be introduced or delivered for introduction into interstate commerce;
- (c) Rescission or temporary suspension of an order authorizing the marketing of a new tobacco product under [section 910](/cfr/21/910.md) of the Federal Food, Drug, and Cosmetic Act;
- (d) Rescission of an order authorizing the marketing of a modified risk tobacco product under [section 911](/cfr/21/911.md) of the Federal Food, Drug, and Cosmetic Act; and
- (e) Rescission of an order granting an exemption request under [§ 1107.1](/cfr/21/1107.1.md) of this chapter.

## Notes

### Amendments

[80 FR 57535, Sept. 24, 2015]

### Authority

Authority: 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 Comp., p. 356-360.

### Source

Source: 62 FR 40592, July 29, 1997, unless otherwise noted.

### Amendments

[80 FR 57535, Sept. 24, 2015]