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FDA Revises Two Guidances to Reflect Updated Agency Terminology

October 17, 2023

On Oct. 17, FDA released two revised final guidances to reflect updated terminology: 

  • “Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions” 
  • “Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007” 

In August 2022, FDA updated the term “grandfathered tobacco product” to “pre-existing tobacco product” on all the Center’s systems because it more clearly and appropriately describes these products. Additionally, the term “grandfathered” – when used to describe someone or something exempt from a new law or regulation – has its roots in 19th century racist voting laws, and updating the term reflects CTP’s commitment to diversity, equity, inclusion, and accessibility. 

A “pre-existing tobacco product” has the same definition as a grandfathered product: specifically, FDA considers a pre-existing tobacco product to mean a tobacco product that was commercially marketed in the United States as of Feb. 15, 2007. 

FDA also made other minor changes to the revised guidance documents to reflect additional updated terminology used in the substantial equivalence final rule, when appropriate. Details on these minor changes are described in the document history page included with each guidance; in brief, they relate to replacing the term “grandfathered” with “pre-existing tobacco product” and editorial changes to promote consistency throughout FDA’s guidances. 

Additionally, FDA is also announcing the withdrawal of two final guidances and a draft guidance that are no longer needed: 

  • Final guidance: “Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products”  
  • Final guidance: “Investigational Use of Deemed, Finished Tobacco Products That Were on the U.S. Market on August 8, 2016, During the Deeming Compliance Periods” 
  • Draft guidance: “Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product”  

FDA withdrew these guidances because they are now obsolete due to the issuance of the substantial equivalence final rule, or the end of the compliance period for deemed, finished tobacco products that were on the U.S. market on Aug. 8, 2016.  

Read the Revised Guidances

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