GroundRules
21 CFR 1114.5: Application submission.
Where this section sits in the code
- 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
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON