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Preparing a PMTA & PMTA Decisions

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. 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 that 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 a review, the application must comply with the PMTA format requirements (per 21 CFR 1114.7(b)). It must:

PMTA Decisions

PMTA Resources

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