Modified Risk Tobacco Products
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- Draft Guidance: Modified Risk Tobacco Products Applications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
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|
|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*||June 18, 2018***||FDA-2017-N-4678||TBD|
* FDA is making these applications available for public comment in accordance with applicable laws. Due to the large size of these MRTP applications, FDA will post the application documents on a rolling basis as they are redacted.
** On November 21, FDA issued a notice in the Federal Register extending the comment period for the Philip Morris Products S.A. MRTP applications. At this time, there is no deadline for public comment on these applications. Once all documents from these MRTP applications, including amendments, are posted, FDA intends to issue another notice in the Federal Register announcing when the comment period will close, which will be at least 30 days from the date the last application documents are posted.
*** There is currently a 180-day public comment period for the R.J. Reynolds Tobacco Company MRTP applications, which we plan to extend, if necessary, to provide additional time for comment as further materials are received and posted.
Summary of MRTP Application Actions
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.