May 7, 2025
FDA Pre-Existing Tobacco Product (PTP) Determination Program
About This Course
In August 2022, FDA updated the term “grandfathered tobacco product” to “pre-existing tobacco product.” A pre-existing tobacco product is any tobacco product (including those products in test markets) that was commercially marketed in the United States as of February 15, 2007. The FDA interprets “as of” to mean “on” that date. Pre-existing tobacco products are regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and do not require premarket authorization to be legally marketed.
FDA’s Center for Tobacco Products (CTP) pre-existing tobacco products (PTP) determination program webinar series covers in detail various topics pertaining to the PTP determination program. The webinar series includes the following:
- In Part 1, CTP explains what a pre-existing tobacco product is in reference to preparing a voluntary pre-existing tobacco product status determination request.
- In Part 2, CTP outlines how to submit a Pre-Existing Tobacco Product Status Determination Request to CTP.
- In Part 3, CTP describes the process for agency review of a pre-existing tobacco product status determination request and possible outcomes.
Resources
- CTP Updates “Grandfathered Tobacco Product” Term to “Pre-Existing Tobacco Product”
- Guidance: Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007
- Memo: Unique Identification of Tobacco Products
- Substantial Equivalence Marketing Orders: Information provided within these orders may also contain information on predicate products that are also pre-existing tobacco products
- Q&A: Tobacco Product Review and Evaluation and Pathways to Market
- For specific questions about your existing pre-existing tobacco product submissions, please contact [email protected]. Be sure to reference the assigned STN in the inquiry.