Tobacco Products

Modified Risk Tobacco Products


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MRTP Overview

FDA can issue an order authorizing the marketing of a modified risk tobacco product (MRTP) only if the evidence submitted in the application meets the requirements of Section 911 of the Federal Food, Drug and Cosmetic (FD&C) Act. For example, an MRTP application musts demonstrate that the product will or is expected to benefit the health of the population as a whole.

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). In addition, 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 must seek renewal of the order, and FDA must determine that the product still satisfies the requirements in section 911.

If, at any time, FDA determines that it can no longer make the determinations required for an MRTP 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.


MRTP Applications Currently Under Scientific Review

Submit comments, including data, research, or other information related to the following publicly available MRTP applications before the comment period closes. 

Product/ Company Comment Period Closes Regulations.gov Docket # TPSAC Meeting Date/Info
Swedish Match North America Inc. TBD FDA-2014-N-1051 February 6-7, 2019
Copenhagen Snuff Fine Cut/U.S. Smokeless Tobacco Company TBD FDA-2018-N-3261 February 6-7, 2019
iQOS system with Marlboro HeatSticks/Philip Morris Products S.A. TBD FDA-2017-D-3001 January 24-25, 2018
Camel Snus/ R.J. Reynolds Tobacco Company TBD FDA-2017-N-4678 September 13-14, 2018

FDA is making these applications available for public comment in accordance with applicable laws. FDA will post the application materials, including current and future amendments, to the respective application-specific webpages on a rolling basis as the materials are redacted. You can sign up to receive email alerts when materials from any MRTP applications under scientific review have been posted or check the application-specific webpages regularly for the latest available information.

At this time, there is no deadline for public comment on these applications. There may be conflicting deadlines posted on regulations.gov and federalregister.gov. While we cannot control how information is displayed on those websites, the docket will remain open beyond any currently posted, specific closing dates. Once all materials for a particular set of MRTP applications, including amendments, are posted, FDA will announce when the comment period for those applications will close, which will be at least 30 days from the date the last application materials are posted. 


Summary of MRTP Application Actions

As of May 24, 2017:

  2011 2012 2013 2014 2015 2016 2017 Total
Refuse to Accept 2 0 0 0 0 8 0 10
Refuse to File 0 4 0 0 0 0 0 4
Denial (In Whole/Part) 0 0 0 0 0 8 0 8
Response (In Whole/Part) 0 0 0 0 0 8 0 8
Withdrawn by Applicant 1 0 0 0 2 0 2 5
Modified Risk Orders 0 0 0 0 0 0 0 0
Total 3 4 0 0 2 24 2 35

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.


See a full table with additional details on specific MRTP application actions. 

Page Last Updated: 12/10/2018
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