Section 911 of the Federal Food, Drug and Cosmetic (FD&C) Act, as amended by the Tobacco Control Act, gives FDA responsibility to establish rigorous criteria that must be met before the agency can issue an order authorizing the marketing of a modified risk tobacco product (MRTP).
FDA can issue an order authorizing the marketing of a product only if the evidence submitted in the application meets the requirements of Section 911, including, among other things, showing 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 not permanent; it is for a fixed period of time that will be specified in the order. To continue to market a modified risk tobacco product after the set term, a company would need to seek renewal of the order and FDA would need to determine that the findings continue to be satisfied.
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, it will provide an opportunity for an informal hearing as required under the law.
MRTP Draft Guidance Documents
- Draft Guidance for Industry: Modified Risk Tobacco Products Applications (2012): Addresses topics related to submitting MRTP applications, including suggestions for organizing and submitting an application to FDA; what types of scientific studies and analyses could be submitted; and what information could be collected through postmarket surveillance and studies.
Summary of MRTP Applications
|Pre-May 2014||May 2014-
|Refuse to Accept||2||0||0||2|
|Refuse to File||4||0||0||4|
|No Marketing Orders||0||0||0||0|
|Status||Product/Company||Application||Open Comment Period||Regulations.gov Docket #||TPSAC Meeting Date/Info||TPSAC Meeting Materials|
|Filed||Swedish Match North America, Inc||View Application Files
||Closed August 31, 2015*||FDA-2014-N-1051||April 9-10, 2015||View TPSAC Materials|
*The comment period for these originally-filed applications closed on February 23, 2015. FDA reopened the period for public comment on amendments made to the MRTPAs submitted by Swedish Match North America, Inc. FDA will consider all comments on the amendments received by August 31, 2015. FDA cannot guarantee consideration of comments received after that date.
Comment on an MRTP application
MRTP applications currently under scientific review are available in full for download at the links above.
To provide comments on a publicly-available MRTP application, go to Regulations.gov and submit data, research, or other information related to the application through the date when the associated docket closes.
FDA intends to make filed MRTP applications available for comment for 180 days on Regulations.gov. Please note, however, that it will be more likely that the FDA is able to consider your comments before referring the applications to the Tobacco Products Scientific Advisory Committee if you submit your comments in the first 90 days of the comment period.
- Issue Snapshot: Modified Risk Tobacco Products (PDF - 161KB)
Q&A: Modified Risk Tobacco Products 2013 TPSAC Meeting Materials and Information Less Risky Tobacco Product? Only if the Science Says So
- Scientific Standards for Studies on Modified Risk Tobacco Products (Institute of Medicine, December 2011)