Back to: FDA Pre-Existing Tobacco Product (PTP) Determination Program
Abstract
This webinar series from the Center for Tobacco Products (CTP) explains the US Food and Drug Administration’s (FDA) voluntary pre-existing tobacco product (PTP) determination program. A PTP is defined as a tobacco product that was commercially marketed in the United States as of February 15, 2007, including those in test markets. This crucial date distinguishes PTPs from new tobacco products, which generally require prior FDA authorization through pathways like substantial equivalence (SE) reports or pre-market tobacco product applications (PMTAs) to be legally marketed. In contrast, a PTP does not require such prior authorization. The term “grandfathered tobacco product” was updated to PTP on August 19, 2022, while retaining the same definition. Submitting a PTP status determination request to FDA is voluntary. A PTP determination can facilitate the review of SE reports if the product also qualifies as a predicate product, and may assist during manufacturing inspections. However, a PTP that was solely in test markets as of February 15, 2007, cannot serve as a predicate in an SE report. The FDA maintains a searchable database of legally marketed tobacco products, including PTPs, which is updated monthly. This program helps regulated entities understand the specific classification and regulatory pathway for their tobacco products.