Modified Risk Tobacco Products
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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.
- Questions and Answers about Modified Risk Tobacco Products
- Draft Guidance: Modified Risk Tobacco Products Applications
- Final Rule: Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products
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|
|General Snus/Swedish Match USA, Inc.||May 13, 2019||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.||February 11, 2019||FDA-2017-D-3001||January 24-25, 2018|
|Camel Snus/ R.J. Reynolds Tobacco Company||May 13, 2019||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.
For applications noted with “TBD” under the “Comment Period Closes” column, there is no deadline for public comment at this time. There may be conflicting deadlines posted on regulations.gov and federalregister.gov. While we cannot control how information is displayed on those websites, the dockets for those applications 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.
As of May 24, 2017:
|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|
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.