Premarket Tobacco Product Applications

On Jan. 19, 2021, the Premarket Tobacco Product Applications final rule and Substantial Equivalence final rule were displayed in the Federal Register, but did not publish. On Jan. 20, 2021 a memo from the White House Chief of Staff ordered the withdrawal of any rules that did not publish in the Federal Register by noon on that day. Therefore, these final rules have been withdrawn. The FDA will work closely with the new administration to advance appropriate regulations and policies that were withdrawn and are in line with the agency’s public health mission.

On this page:

Overview of Premarket Tobacco Product Applications (PMTAs)
Preparing a PMTA
PMTA Review Process
Reporting for PMTA
Resources

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, 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.

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 recommends the following structure:
- Cover letter and administrative information
- Table of contents
- Summaries
- Product Description and Manufacturing (if applicable)
- Nonclinical information (if applicable)
- Clinical - Product Impact on Individual Health (if applicable)
- Clinical - Product Impact on Population Health (if applicable)
- Environmental Impact
How to Submit a PMTA
- Online
  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.
- Submit by Mail: If you are unable to submit online, mail submissions to CTP's Document Control Center.
  Please note that the proposed rule for PMTA, when finalized, would require an applicant to submit a PMTA and all supporting and related documents electronically in a format that FDA can process, review, and archive. Applicants who cannot meet this requirement must request and receive a waiver from FDA before submitting a PMTA.
Amendments can also be submitted using these instructions. Any amendment should include: a cover letter with submission tracking number(s) of the PMTA in the subject line. If responding to a deficiency (including requests), follow the instructions as outlined in your deficiency letter.

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 Review¹: 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.

Reporting for PMTA

PMTA Resources

Additional Resources

References

_{1. Phase 2: Filing only applies to PMTA and Modified Risk Tobacco Product Applications (MRTPA).}