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  1. Market and Distribute a Tobacco Product

Premarket Tobacco Product Applications

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What Are Premarket Tobacco Product Applications (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 Act (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
  • The methods, facilities, and controls used to manufacture, process, and pack the new tobacco product 

What Is the Final PMTA Rule?

In 2021, FDA finalized the 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. The rule also requires manufacturers to maintain records establishing that their tobacco products are legally marketed.

The final PMTA rule includes information on how to amend or withdraw an application, how FDA communicates with the applicant, and FDA's disclosure procedures. 

Preparing and Submitting a PMTA 

FDA has information and resources to help applicants prepare and submit PMTAs that meet the requirements outlined in the final PMTA rule. For example, applicants can learn more about:

  • What needs to be included in a PMTA
  • How to submit a PMTA
  • How to group PMTA submissions 
  • When to submit supplemental PMTAs, resubmissions, and amendments

Additionally, you can find tips for correctly completing PMTA forms.

PMTA Review Process 

PMTA Review Process work flow
  • 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 initial 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).
  • 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, as outlined in the PMTA final rule
  • Application 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.

In 2021, CTP held “A Conversation With the Center for Tobacco Products Office of Science” to help industry understand the FDA review process for marketing applications related to deemed tobacco products. 

PMTA Decisions

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