Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter K - Tobacco Products |
Part 1114 - Premarket Tobacco Product Applications |
Subpart B - Premarket Tobacco Product Applications |
§ 1114.5 - Application submission.
Latest version.
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§ 1114.5 Application submission.
An applicant may submit a PMTA to demonstrate that a new tobacco product meets the requirements to receive a marketing granted order. A new tobacco product may not be introduced or delivered for introduction into interstate commerce under this part until FDA has issued a marketing granted order for the product.