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                Premarket Tobacco Product Applications

Premarket Tobacco Product Applications

                        Preparing and Submitting a Premarket Tobacco Product Application
          FDA Tobacco Product Application Tips - Premarket Tobacco Product Applications
          Premarket Tobacco Product Marketing Granted Orders Home
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          Preparing and Submitting a Premarket Tobacco Product ApplicationPremarket Tobacco Product Applications Preparing and Submitting a Premarket Tobacco Product Application
  
  	
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How Do I Prepare a Standard Premarket Tobacco Product Application (PMTA)?
	How Do I Prepare Supplemental PMTAs and Resubmissions?
	How Do I Prepare an Amendment?
	How Do I Submit PMTAs and Amendments?
	Resources to Help With Preparing and Submitting a PMTAPremarket tobacco product applications (PMTAs) must meet the content and format requirements described in the final PMTA rule: Premarket Tobacco Product Applications and Recordkeeping Requirements. Requirements for PMTAs include, among other things, submitting the appropriate FDA forms:

Form FDA 4057 – Premarket Tobacco Product Application (PMTA) Submission
	Form FDA 4057b – Premarket Tobacco Product Application Product Grouping SpreadsheetForm FDA 4057b allows applicants to submit one PMTA for multiple products—such as e-liquids in varying sizes, nicotine strengths, or flavor combinations—as a grouped submission. Each product in a grouped submission is considered a separate, individual application and must include its own individual environmental assessment. Applicants should keep in mind that the content specific to each product in a grouped submission needs to be clearly specified.

How Do I Prepare a Standard Premarket Tobacco Product Application (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 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, the application must comply with the PMTA format requirements (per 21 CFR 1114.7(b)). It must:
	Be submitted using the appropriate FDA forms
		Form FDA 4057 – Premarket Tobacco Product Application (PMTA) Submission 
			Get tips for completing Form FDA 4057
			Form FDA 4057b – Premarket Tobacco Product Application Product Grouping Spreadsheet 
			Get tips for completing Form FDA 4057b
		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 waiverHow Do I Prepare Supplemental PMTAs and Resubmissions?

In certain instances, it may be appropriate for an applicant to submit supplemental PMTAs or resubmissions.

According to the PMTA rule, Premarket Tobacco Product Applications and Recordkeeping Requirements, **a supplemental PMTA**:

May be submitted in situations where an applicant is seeking authorization for a new tobacco product that is a modified version of a previously authorized tobacco product
	May be submitted for modifications of a previously authorized tobacco product in order to demonstrate compliance with a tobacco product standard under section 907 of the FD&C Act
	Allows the applicant to cross-reference applicable content from the previously submitted PMTA that received the marketing granted order
	Must include a section containing full descriptions, data, and information of each modification to the new product, comparisons to the original product version, and a concluding summary of how the new product meets the requirements to receive a marketing granted orderAccording to the PMTA rule, **a resubmission**:

May be submitted to address application deficiencies following the issuance of a marketing denial order
	May be for the same tobacco product which FDA issued a marketing denial order or a new tobacco product that results from modifications to the product necessary to address the deficiencies outlined in the marketing denial order
	Allows the applicant to cross-reference content from the previously submitted PMTA that received the marketing denial order
	Must include a section that lists and provides a separate response to each deficiency, including all data and information necessary to complete each responseBoth supplemental PMTAs and resubmissions must include the following required FDA forms:

Form FDA 4057 – Premarket Tobacco Product Application (PMTA) Submission

	Get tips for completing Form FDA 4057
	Form FDA 4057b – Premarket Tobacco Product Application Product Grouping Spreadsheet
	Get tips for completing Form FDA 4057bHow Do I Prepare an Amendment?

When submitting a PMTA, applicants are expected to submit all required information, as outlined in section 910(b)(1) of the FD&C Act and 21 CFR Part 1114, to allow FDA to determine whether it should authorize the marketing of a new tobacco product. However, additional information may be needed for FDA to complete its review of a PMTA, so applicants are allowed to submit amendments to a pending application.

FDA may, at any time after it receives and before it acts on an application, request an applicant submit additional information so the agency can complete its review of a PMTA. Similarly, an applicant may choose to submit an amendment with additional information on their own. Amendments may include information like a new study that is relevant to the PMTA, clarifications, or a transfer in ownership of the PMTA.

Among other things, amendments must include:

Form FDA 4057a – Premarket Tobacco Product Application Amendment and General Correspondence Submission

	Get tips for completing Form FDA 4057a
	The submission tracking number (STN) assigned to the application 
	Learn how you can find your STN online.
	A certification statement, as required by 21 CFR 1114.9(a) and described in 21 CFR 1114.7(m)To submit an amendment, follow the standard PMTA submission instructions. If responding to a deficiency (including requests), follow the instructions as outlined in your deficiency letter.

How Do I Submit PMTAs and Amendments?

Request an Industry Account Manager (IAM) account to establish a CTP Portal account, if your company does not already have an IAM.
	Prepare your submission electronically using FDA's eSubmitter software and the eSubmitter template “CTP Transmittal Form.”
	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. Watch this video for an overview of the CTP Portal and its functionality.*
	Applicants may request a waiver from FDA to submit a PMTA in a format other than electronically. Waivers will be granted if use of electronic means is not reasonable for the applicant.Resources to Help With Preparing and Submitting a PMTA

Webpage with tips for completing PMTA forms
	Tobacco Compliance Webinars for Manufacturers to provide assistance with marketing applications for tobacco products
	Video with information on using the CTP Portal
	The CTP Office of Small Business Assistance (OSBA) is available to help industry understand and comply with FDA’s tobacco laws and regulationsResource to submit and reference tobacco product master files:

Some applicants may also benefit from review of information about referencing Tobacco Product Master Files (TPMF) in applications to market.Guidance to help applicants design and conduct tobacco product perception and intention (TPPI) studies:

Principles for Designing and Conducting Tobacco Product Perception and Intention StudiesGuidance for preparing and submitting a PMTA for electronic nicotine delivery systems (ENDS) and other e-cigarettes:

Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS) (2019)Past public meetings:

2019 Deemed Tobacco Product Applications – A Public Meeting includes many presentations relevant to PMTA preparation, submission, and review
	2018 Tobacco Product Application Review Public Meeting has many presentations relevant to PMTA preparation, submission, and review

                                                                                  Content current as of:
      09/07/2023
              
              
Regulated Product(s)
		 TobaccoPremarket Tobacco Product Applications

          
                        Preparing and Submitting a Premarket Tobacco Product Application
          FDA Tobacco Product Application Tips - Premarket Tobacco Product Applications
          Premarket Tobacco Product Marketing Granted Orders
 
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