PMTA STATUS

What is a “PMTA” application?

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.

What is FLIQ’s PMTA current status?

SUBSTANTIVE REVIEW – click here to view our acceptance letter

FLIQ’s PMTA application has been accepted by the FDA, advancing us to the review process. The following is FLIQ’s progress:

   Pre Submission Meeting
   Acceptance
   Review
   Action
   Postmarket Reporting

About the 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 § 1105.10.
  • Output
    • Acceptance letter or
    • Refuse to accept (RTA) letter
• Filing Review:   A preliminary scientific review that ensures the application contains all the items under Section 910(b)(1).
  • 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 make a marketing authorization decision. Applicants have 180 days to respond to this type of letter.
    • Environmental information request letter: FDA made a scientific decision to support a marketing order; however, the applicant is required to provide information for environmental considerations before a marketing order can be issued.
• Action:
  • Output
    • Marketing order letter or
    • No marketing order letter
• Postmarket Reporting: 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.