21 CFR § 1107.48 - Issuance of an order denying marketing authorization.

---
identifier: "/us/cfr/t21/s1107.48"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1107.48 - Issuance of an order denying marketing authorization."
title_number: 21
title_name: "Food and Drugs"
section_number: "1107.48"
section_name: "Issuance of an order denying marketing authorization."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "K"
subchapter_name: "TOBACCO PRODUCTS"
part_number: "1107"
part_name: "EXEMPTION REQUESTS AND SUBSTANTIAL EQUIVALENCE REPORTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 371, 374, 387e(j), 387i, 387j; Pub. L. 117-103, 136 Stat. 49."
regulatory_source: "76 FR 38974, July 5, 2011, unless otherwise noted."
cfr_part: "1107"
---


# 1107.48 Issuance of an order denying marketing authorization.

(a) *General.* FDA will issue an order that the new tobacco product cannot be marketed if FDA finds that:

(1) The information submitted in the SE Report does not establish that the new tobacco product is substantially equivalent to a predicate tobacco product that was commercially marketed (other than for test marketing) in the United States on February 15, 2007; or

(2) The new tobacco product is not in compliance with the Federal Food, Drug, and Cosmetic Act.

(b) *Basis for order.* The order will describe the basis for denying marketing authorization.