Premarket of Tobacco Product Application (PMTA)

What is PMTA? 

  • A premarket tobacco application (PMTA) is an application that must be reviewed and approved by the Food and Drug Administration before a new tobacco product can be legally marketed in the United States. The first PMTA, and only to date, was approved by US FDA on November 10, 2015, when the FDA authorized the marketing of eight Swedish Match North America Inc. snus smokeless tobacco products (to be marketed under the brand name “General”).

Overview of PMTAs

Any person can submit a Premarket Tobacco Product Application (PMTA) 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; and
  • 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 

Preparation of the Premarket Tobacco Product Applications (PMTAs)

How to Prepare PMTA  Application

  • Under the FD&C Act, 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
  • 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, your application must comply with the PMTA format requirements (per 21 CFR 1114.7(b)). Your application must:
    • Be submitted using the appropriate FDA forms
      • FDA 4057 – Premarket Tobacco Product Application (PMTA) Submission 
      • FDA 4057a – Premarket Tobacco Product Amendment and General Correspondence Submission 
      • FDA 4057b – Premarket Tobacco Product Application Product Grouping Spreadsheet 
    • 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.
  • How to Submit a PMTA 

0.              Request an Industry Account Manager (IAM) account to establish CTP Portal account if your company does not already have an IAM.

1.                Prepare your submission electronically using FDA’s eSubmitter software and the eSubmitter template “CTP Transmittal Form.”

2.               Submit online via the CTP Portal. 
Applicants may request a waiver from FDA to submit a PMTA in a format other than electronically. Waivers will be granted if the use of electronic means is not reasonable for the applicant.

 

 

PMTA Review Process

PMTA Review Process work flow

  • Pre-submission Meetings: A voluntary formal meeting between the applicant and FDA to discuss a planned PMTA submission for a tobacco product. 
    • Output
      • Meeting granted letter or
      • Meeting denial letter
      • Meeting minutes letter (if the 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 a 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
  • Post-market 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. Post-market 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.
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