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FDA Releases New Resources for Tobacco Product Applicants

September 7, 2023

FDA’s Center for Tobacco Products (CTP) has launched new resources to help applicants navigate the FDA tobacco product application process. Specifically, CTP is offering a new webpage with more in-depth information on how to complete the three required Premarket Tobacco Product Application (PMTA) forms to submit and amend pending applications.

Over the last few years, CTP has received more than 26 million PMTAs and made determinations on 99% of those applications. Based on this experience and communications with applicants, CTP has developed the new online resources, which includes easy-to-access tips to help applicants submit in the future.

For example, CTP has received questions about what forms must be included in a PMTA and how to populate them. To address these questions, CTP created a new webpage that shares information for correctly completing:

  • Form FDA 4057 – Premarket Tobacco Product Application (PMTA) Submission
  • Form FDA 4057a – Premarket Tobacco Product Application Amendment and General Correspondence Submission
  • Form FDA 4057b – Premarket Tobacco Product Application Product Grouping Spreadsheet

These new online resources are part of CTP’s ongoing efforts to enhance the center’s efficiency, effectiveness, and transparency in response to recommendations from an independent external evaluation led by the Reagan-Udall Foundation. These latest resources build on tips CTP provided earlier this year for applicants preparing amendments to pending PMTAs.  

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