21 CFR 1107.44
§ 1107.44 FDA action on an SE Report.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 1107.44, § 1107.44 FDA action on an SE Report, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91522
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Full text
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 and § 1105.10 of this chapter;
(b) Request additional information as provided in § 1107.40(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 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 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.