{"data":{"id":"us/21-cfr-1107.48","jurisdiction":"us","citation":"21 CFR 1107.48","heading":"Issuance of an order denying marketing authorization.","body":"(a) General. FDA will issue an order that the new tobacco product cannot be marketed if FDA finds that:\n(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\n(2) The new tobacco product is not in compliance with the Federal Food, Drug, and Cosmetic Act.\n(b) Basis for order. The order will describe the basis for denying marketing authorization.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER K—TOBACCO PRODUCTS","PART 1107—EXEMPTION REQUESTS AND SUBSTANTIAL EQUIVALENCE REPORTS","Subpart D—FDA Review"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"eaefaaefce9507ebbe7657f8d5aa8def2d92a0cde86235947d1ffbad3419f42f","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-1107.46","next":"us/21-cfr-1107.50"},"notice":"GroundRules: Original legal text. Not legal advice."}