Food and Drug Administration
Food and Drug Administration's Categorical Exclusions (opens in new tab)Categorical Exclusion
§25.35 Tobacco product applications.
Exclusion Text
(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;
Disclaimer
This CE Explorer tool is not an authoritative source and creates no rights or obligations. When using the CE Explorer Tool, Federal agencies and stakeholders should review the relevant agency's NEPA procedures for information about how to apply the CE, including any limitations or potential extraordinary circumstances, and to ensure that a CE is current and applicable to a given proposed action. For ease of use, a link to each agency's NEPA procedures and CEs is provided along with the text of the CE. To adopt and use another agency's categorical exclusion, an agency must follow the steps described in section 109 of NEPA, 42 U.S.C. 4336c.
