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Modified Risk Tobacco Products

 

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Overview 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
  1. Request an Industry Account Manager (IAM) account to establish a 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
  • 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

Resources

Publicly 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 Status
Swedish 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 Order
22nd Century Group Inc. VLN® King, VLN® Menthol King May 18, 2020 FDA-2019-N-0994 February 14, 2020 Modified Risk Granted Order
U.S. Smokeless Tobacco Company Copenhagen Classic Snuff May 13, 2022 FDA-2018-N-3261 February 6-7, 2019 Modified Risk Granted Order
R.J. Reynolds Tobacco Company Camel Snus December 30, 2020 FDA-2017-N-4678 September 13-14, 2018 Withdrawn
Philip Morris Products S.A.

IQOS Tobacco Heating System

 February 24, 2020 FDA-2017-D-3001 January 24-25, 2018 Modified Risk Granted Order
Swedish 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. 31, 2023:

  FY 2011-2020 FY21 FY22 FY23 FY24 to-date Total To-Date
Modified Risk Granted Orders 12 0 3 1 0 16
Modified Risk Denial Orders 0 0 0 0 0 0
Refuse to Accept 10 0 0 0 0 10
Refuse to File 6 5 0 0 0 11
Withdrawn by Applicant 5 0 0 6 0 11
Total 33 5 3 7 0 48

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.

     

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