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, specifically focusing on the agency’s review process for standalone PTP requests. A PTP is a tobacco product commercially marketed in the United States on February 15, 2007, which means it does not require prior FDA authorization for marketing. Upon receiving a submission, FDA conducts an initial review, issuing an acknowledgement letter if accepted. However, a submission may receive an unable to accept (UTA) letter for issues like failing to provide separate submissions for each product, or an unable to review (UTR) letter for errors such as missing information or non-English evidence. During the detailed review, FDA examines the product name, description, evidence of commercial marketing, and test marketing statement consistency. The agency frequently sends a Request for Information (RFI) letter to clarify inconsistent information, vague descriptions, inadequate evidence, or insufficient linking of evidence to the product, typically allowing 30 days for a response. Submitters may also amend or withdraw their submissions at any point. After completing its review, FDA issues a final determination: the product is PTP (either predicate eligible or not), or FDA is unable to determine PTP status due to insufficient information. Determined PTPs are added to the FDA’s searchable database of legally marketed tobacco products.