Back to: FDA Pre-Existing Tobacco Product (PTP) Determination Program
Abstract
This webinar details the US Food and Drug Administration’s (FDA) voluntary pre-existing tobacco product (PTP) determination program, focusing on how to prepare and submit a standalone request for PTP status. A PTP is defined as any tobacco product, including those in test markets, that was commercially marketed in the United States on February 15, 2007. This distinction is critical because PTPs do not require prior FDA authorization for marketing, unlike new tobacco products [conversation history]. For a submission, FDA recommends providing adequate information, including the tobacco product’s full name as commercially marketed on that specific date, its unique characteristics such as package type, flavor, and product type, and demonstrating it was not exclusively marketed in a test market if it is intended to serve as a predicate product. Each tobacco product requires a separate electronic submission, ideally through the CTP portal. Submissions should include a signed test marketing statement from a responsible official and adequate dated evidence, such as invoices, to demonstrate commercial marketing on or around February 15, 2007. Inconsistent naming of the product throughout the submission or insufficient evidence of commercial marketing are common reasons for the FDA to issue a request for information (RFI). This program helps regulated entities understand the specific classification and regulatory pathway for their tobacco products [conversation history].