§ 1114.5 Application submission.
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Title 21 CFR: Food and Drugs › Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › Part 1114: PREMARKET TOBACCO PRODUCT APPLICATIONS › Subpart B: Premarket Tobacco Product Applications › § 1114.5: § 1114.5 Application submission.
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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.
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