Title 21

SECTION 25.35

25.35 Tobacco product applications.

§ 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) of the Federal Food, Drug, and Cosmetic Act;

(b) Issuance of an order finding a tobacco product not substantially equivalent under section 910(a) of the Federal Food, Drug, and Cosmetic Act, denial of a request for an exemption under 21 CFR part 1107 from the requirement of demonstrating substantial equivalence, issuance of an order under section 910(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 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 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 of the Federal Food, Drug, and Cosmetic Act; and

(e) Rescission of an order granting an exemption request under § 1107.1 of this chapter.

[80 FR 57535, Sept. 24, 2015]

---