2023-22976: Guidance Documents Referencing Pre-Existing Tobacco Products; Guidance for Industry; Availability; Withdrawal

Summary

The Food and Drug Administration (FDA) is announcing the availability of revised final guidances for industry entitled "Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions," and "Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007." Following the issuance of the final rules entitled "Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports" (SE) and "Premarket Tobacco Product Applications and Recordkeeping Requirements" (PMTA), FDA has made minor updates to these guidances for consistency with the terminology used in those rules. FDA is also announcing the withdrawal of the final guidances entitled "Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products," and "Investigational Use of Deemed, Finished Tobacco Products That Were on the U.S. Market on August 8, 2016, During the Deeming Compliance Periods," and a draft guidance entitled "Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product," which are obsolete due to the issuance of the SE final rule or the end of the compliance period for deemed, finished tobacco products that were on the U.S. market on August 8, 2016.

The agency’s own summary, as published.