Overview of PMTAs

A Premarket Tobacco Product Application (PMTA) can be submitted by any person for any new tobacco product seeking an FDA marketing order, under section 910(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act. A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health. In order to reach such a decision and to authorize marketing, FDA considers (per section 910(c)(4)), among other things: 

• Risks and benefits to the population as a whole, including people who would use the proposed new tobacco product as well as nonusers;
• Whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available
• Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available; and
• The methods, facilities, and controls used to manufacture, process, and pack the new tobacco product. 

In 2021, FDA finalized a final PMTA rule that describes the required content, format and review of PMTAs. For FDA to complete a substantive review of a PMTA, the application must include the information described in the final rule. 

Preparing a PMTA 

• A PMTA includes (per section 910(b)(1)): 
  • Full reports of all information published or known to, or which should reasonably be known to, the applicant concerning investigations which have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products.
  • Full statement of the components, ingredients, additives, and properties, and of the principle or principles of operation.
  • Full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and when relevant, packing and installation.
  • An identifying reference to any tobacco product standard, if applicable. If so, either:
    • Adequate information to show that such aspect of such tobacco product fully meets such tobacco product standard, or
    • Adequate information to justify any deviation from such standard
  • Samples of the tobacco product as required
  • Specimens of proposed labeling
  • Additional applicable required items per the final rule Refuse to Accept Procedures for Premarket Tobacco Submissions
• FDA has interpreted these statutory requirements in the PMTA Final Rule, under which a PMTA must contain the following sections (per 21 CFR 1114.7):
  • General information  
  • Descriptive information  
  • Product samples  
  • Labeling and description of marketing plans 
  • Statement of compliance with 21 CFR part 25  
  • Summary  
  • Product formulation  
  • Manufacturing  
  • Health risk investigations  
  • The effect on the population as a whole  
  • Certification statement
• To facilitate review, the application must comply with the PMTA format requirements (per 21 CFR 1114.7(b)). It must:
  • Be submitted using the appropriate FDA forms
    • FDA 4057 – Premarket Tobacco Product Application (PMTA) Submission
    • FDA 4057a – Premarket Tobacco Product Application Amendment and General Correspondence Submission
      • Fact Sheet – Amendment Tips: Completing Form FDA 4057a
    • FDA 4057b – Premarket Tobacco Product Application Product Grouping Spreadsheet [Last updated: April 28, 2022]
  • Contain a comprehensive index (i.e., a listing of files and data associated with those files)
  • Contain a table of contents
  • Be well-organized and legible
  • Be written in English (see 21 CFR 1114.7(b) for requirements related to documents that have been translated from another language into English)
  • Be submitted in an electronic format that FDA can process, read, review, and archive, unless FDA has granted a waiver.

Did You Know?

FDA regulations require individual environmental assessments to be submitted for each individual tobacco product.

• How to Submit a PMTA 
  1. Request an Industry Account Manager (IAM) account to establish CTP Portal account, if your company does not already have an IAM.
  2. Prepare your submission electronically using FDA's eSubmitter software and the eSubmitter template “CTP Transmittal Form.”
  3. Submit online via the CTP Portal. 
     Note: The CTP Portal provides more functionality than the ESG, and CTP recommends using the CTP Portal. However, if you already have an ESG WebTrader account, you may use it to submit documents to CTP. Watch this video for an overview of the CTP Portal and its functionality. 
     
     Applicants may request a waiver from FDA to submit a PMTA in a format other than electronically. Waivers will be granted if use of electronic means is not reasonable for the applicant.
• Amendments can also be submitted using these instructions.  Any amendment must include, among other things, the appropriate form and specify the submission tracking number(s) of the PMTA. If responding to a deficiency (including requests), follow the instructions as outlined in your deficiency letter. Find tips for completing Form FDA 4057a, and watch this video to get help finding your submission tracking number in the CTP Portal.

Grouping PMTA Submissions 

• The final PMTA rule outlines how a manufacturer might submit one premarket tobacco product application for multiple products as a grouped submission such as e-liquids in varying sizes, nicotine strengths and/or flavor combinations. 
• To identify and provide information for each product contained in a grouped submission, applicants should use the Product Grouping Spreadsheet (xlsm 80 KB) [Last updated: April 28, 2022]. 
• FDA intends to consider information on each product in a grouped submission as a separate, individual application.  
• Content specific to each product in a grouped submission will need to be clearly specified.  

Importantly, each product in a grouped submission is still treated as an individual product application. FDA regulations still require individual environmental assessments to be submitted for each individual tobacco product. 

PMTA Review Process 

• Presubmission Meetings: A voluntary formal meeting between the applicant and FDA to discuss a planned PMTA submission for a tobacco product. For more information, see Meetings with Industry and Investigators.
  • Output
    • Meeting granted letter or
    • Meeting denial letter
    • Meeting minutes letter (if meeting is granted and held)
• Acceptance Review: An administrative review that ensures the product falls under Center for Tobacco Products jurisdiction and confirms that the statutory and regulatory requirements of an application are met based upon Section 910 of the FD&C Act and the criteria set forth in § 1114.27(a)(1).
  • Output
    • Acceptance letter or
    • Refuse to accept (RTA) letter
• Filing Review:   A threshold determination of whether the application contains sufficient information to permit a substantive review. FDA may refuse to file a PMTA if any of the criteria in § 1114.27(b)(1) apply.
  • Output
    • Filing letter or
    • Refuse to file (RTF) letter
• Substantive Review: FDA evaluation of the scientific information and data in an application, as well as recommendations from the Tobacco Product Scientific Advisory Committee (TPSAC), if the application was referred.
  • Output
    • Deficiency letter: Additional information is needed to complete scientific review. The letter will specify the number of days an applicant has to respond.
    • Environmental information request letter: FDA made a scientific decision to issue a marketing granted order; however, the applicant is required to provide information for environmental considerations before a marketing granted order can be issued. 
• Action:
  • Output includes
    • Marketing granted order letter or
    • Marketing denial order letter
• Postmarket Requirements: Requires applicants to establish and maintain records and make reports that FDA requires as necessary to determine or facilitate a determination of whether there may be grounds to withdraw or temporarily suspend a marketing granted order. Postmarket reporting requirements for all products that receive a marketing granted order are set forth in § 1114.41 and FDA may require additional reporting under the terms of a marketing granted order.