21 CFR 1114.5
§ 1114.5 Application submission.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 1114.5, § 1114.5 Application submission, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91535
- Permanent ID
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.