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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter K - Tobacco Products |
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Part 1107 - Exemption Requests and Substantial Equivalence Reports |
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Subpart D - FDA Review |
§ 1107.48 - Issuance of an order denying marketing authorization.
Latest version.
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§ 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.