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Overview of Modified Risk Tobacco Product (MRTP) Applications
	Preparing an MRTP Application
	MRTP Application Review Process
	Performance and Reporting
	Resources
	Publicly Available MRTP Application Materials
	Summary of MRTP Application ActionsOverview of MRTP Applications

A modified risk tobacco product (MRTP) application can be submitted by any person for a proposed MRTP seeking an FDA modified risk order, under section 911 of the Federal Food, Drug, and Cosmetic (FD&C) Act. An order permitting the sale of an MRTP refers to a single specific product, not an entire class of tobacco products (e.g., all smokeless products). An MRTP application must demonstrate that the product will or is expected to benefit the health of the population as a whole.

By law, FDA must make MRTP applications available (except information regarding trade secrets or otherwise confidential, commercial information) for public comment and also refer MRTP applications to the Tobacco Product Scientific Advisory Committee (TPSAC).

In order to reach a decision to authorize marketing of a proposed MRTP, FDA must consider under section 911(g)(4):

the relative health risks to individuals of the tobacco product that is the subject of the application;
	the increased or decreased likelihood that existing users of tobacco products who would otherwise stop using such products will switch to the tobacco product that is the subject of the application;
	the increased or decreased likelihood that persons who do not use tobacco products will start using the tobacco product that is the subject of the application;
	the risks and benefits to persons from the use of the tobacco product that is the subject of the application as compared to the use of products for smoking cessation approved as medical products to treat nicotine dependence; and
	comments, data, and information submitted by interested persons.Preparing an MRTP Application

An MRTP application includes (as required by Section 911(d) of the FD&C Act):

	A description of the proposed tobacco product and any proposed advertising and labeling
		Conditions for using the tobacco product
		Formulation of the tobacco product
		Sample product labels and labeling
		All documents (including underlying scientific information) relating to research findings conducted, supported, or possessed by the tobacco product manufacturer relating to the effect of the product on tobacco-related diseases and health-related conditions.
		Data and information about how consumers actually use the tobacco product
	An MRTP application must also contain the information specified by 21 CFR § 1105.10 for it to be accepted for review (see the final rule Refuse to Accept Procedures for Premarket Tobacco Submissions).
	The following structure can help facilitate review:
	Cover Letter and Administrative Information
		Table of Contents
		Summaries
		Product Description and Manufacturing
		Nonclinical (if applicable)
		Clinical – Product Impact on Individual Health (if applicable)
		Clinical – Product Impact on Population Health (if applicable)
		Environmental Impact**How to Submit an MRTP Application**

**Online**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.**Submit by Mail**:
	If you are unable to submit online, mail submissions to CTP's Document Control Center
	**Amendments**
	Amendments can be submitted using the above instructions. The amendment should include a cover letter that includes the submission tracking number(s) of the corresponding MRTP application in the subject line. If responding to a deficiency (including requests), follow the instructions as outlined in your deficiency letter.MRTP Application Review Process

MRTP Application Review Process
**Pre-submission Meetings**: A voluntary formal meeting between the applicant and FDA to discuss a planned MRTP application submission for a tobacco product (recommended to follow the Meetings with Industry and Investigators guidance).

	Output
		Meeting granted letter,
			Meeting denial letter, or
			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 the criteria set forth in 21 CFR § 1105.10.
	Output
		Acceptance letter or
			Refuse to accept (RTA) letter
	**Filing Review**1: A preliminary scientific review that ensures the application contains the items required under Section 911(d) of the FD&C Act.
	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), public comments, and other information made available to the agency.
	Output
		Deficiency letter: Additional information is needed to make a modified risk authorization decision. FDA generally intends to give applicants 180 days to respond to this type of letter.
			Environmental information request letter: FDA made a scientific decision to support a modified risk order; however, the applicant is required to provide information for environmental considerations before a modified risk order can be issued.
	**Final Action**:
	Output
		Modified Risk Order letter or
			No Modified Risk Order letter
	**Postmarket Reporting**: Requires under section 911(g)(2)(C) or 911(i) (as applicable), among other things, applicants to conduct surveillance and postmarket studies to determine the impact of the modified risk order on consumer perception, behavior, and health, to allow FDA to review the accuracy of the determinations upon which the modified risk order was based.
	**Renewal**: Under section 911(g)(2)(C)(i) or 911(h)(4) (as applicable) An FDA order permitting marketing of an MRTP is valid only for the fixed time period specified in the order and is not permanent. To continue marketing an MRTP after the set term, the company may submit a new MRTP application for FDA to determine that the product still satisfies the requirements in section 911.
	**Withdrawal**: Applicants may withdraw a pending MRTP application at any time but should promptly notify FDA in writing of such a decision. If, at any time, FDA determines that any of the grounds for withdrawal in section 911(j) apply, including a determination that the applicant, based on new information, can no longer make the demonstrations required under section 911(g) for a modified risk order, FDA is required to withdraw the order. Before FDA withdraws an MRTP order, the agency will provide an opportunity for an informal hearing as required by law per section 911(j).**Performance and Reporting**

Modified Risk Granted Orders**Resources**

Guidance
	Draft Guidance: Modified Risk Tobacco Products Applications
		Final Guidance: Use of “Light,” “Mild,” “Low,” or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products
	Tobacco Compliance Webinars for Manufacturers and Importers
	Reference Tools

	Guidance: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies
		Modified Risk Tobacco Product (MRTP) Application Review Process: Presentation from 2018 Tobacco Product Application Review Public Meeting
		Tobacco Product Application Review: Modified Risk Tobacco Product Applications: Presentation from 2018 Tobacco Product Application Review Public Meeting
		Information and Resources on Application Review Programs: Presentation from 2018 Tobacco Product Application Review Public Meeting
		CTP Electronic Submissions Standards and Activities: Presentation from 2018 Tobacco Product Application Review Public Meeting
		TPSAC Meetings on MRTP Applications
		Perspective: Lessons Learned from the First Review of Modified Risk Tobacco Product (MRTP) ApplicationsPublicly Available MRTP Application Materials

FDA makes redacted MRTP application materials available for public comment in accordance with applicable laws.2 Submit comments, including data, research, or other information to the regulations.gov docket associated with each set of MRTP applications before the comment period closes.

Company
			Product
			Comment Period Closes3
			Regulations.gov Docket #
			TPSAC Meeting Date/Info
			MRTP Application StatusSwedish Match USA, Inc.
			General Snus
			TBD
			FDA-2014-N-1051
			TBD
			Renewal - pending*Philip Morris Products S.A.
			IQOS 3 System Holder and Charger
			December 10, 2021
			FDA- 2021-N-0408-0001
			Refer to January 24-25, 2018, meeting materials
			Modified Risk Granted Order22nd Century Group Inc.
			VLN® King, VLN® Menthol King
			May 18, 2020
			FDA-2019-N-0994
			February 14, 2020
			Modified Risk Granted OrderU.S. Smokeless Tobacco Company
			Copenhagen Classic Snuff
			May 13, 2022
			FDA-2018-N-3261
			February 6-7, 2019
			Modified Risk Granted OrderR.J. Reynolds Tobacco Company
			Camel Snus
			December 30, 2020
			FDA-2017-N-4678
			September 13-14, 2018
			WithdrawnPhilip Morris Products S.A.
			IQOS Tobacco Heating System
			February 24, 2020
			FDA-2017-D-3001
			January 24-25, 2018
			Modified Risk Granted OrderSwedish Match USA, Inc.
			General Snus
			May 13, 2019
			FDA-2014-N-1051
			February 6-7, 2019
			Modified Risk Granted Order*Modified Risk Granted Order issued on October 22, 2019.

Sign up to receive email alerts when any MRTP application materials have been posted or check the application-specific webpages regularly for the latest available information.

Summary of MRTP Application Actions

*As of Dec. 1, 2022:*

2011-2020
			2021
			2022
			Total To-DateModified Risk Granted Orders
			12
			2
			1
			15Modified Risk Denial Orders
			0
			0
			0
			0Refuse to Accept
			10
			0
			0
			10Refuse to File
			6
			5
			0
			11Withdrawn by Applicant
			5
			0
			6
			11**Total**
			**33**
			**7**
			**7**
			**47**

*Note: The information above reflects the number of products subject to a particular action and/or letter. Individual letters may be issued for multiple products, and individual products may be subject to multiple actions.*

Additional Resources

Submit and Reference Tobacco Product Master Files
	Tobacco Control Act
	Refuse to Accept Procedures for Premarket Tobacco Product Submissions
	National Environmental Policy Act; Environmental Assessments for Tobacco Products
	Manufacturing
	Small Business Assistance for Tobacco Product Industry
	CTP OmbudsmanReferences
	Phase 2: Filing only applies to Premarket Tobacco Product Application (PMTA) and MRTP
	FDA will post the application materials, including current and future amendments, to the respective application-specific webpages after the materials are redacted.
	Applications with “TBD” have no deadline for public comments at this time. We cannot control how information is displayed on other websites, including regulations.gov and federalregister.gov, which may show conflicting deadlines. When all materials, including amendments, for a particular application are posted, FDA will announce a comment period closing date that will occur at least 30 days after the last application materials are posted.

                                                                                  Content current as of:
      11/30/2023
              
              
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