Modified Risk Tobacco Products
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MRTP Draft Guidance Documents
- Draft Guidance for Industry: Modified Risk Tobacco Products Applications (2012): Addresses topics related to submitting MRTP applications, including suggestions for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 post-market surveillance and studies.
- Draft Guidance for Industry and Staff: Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products (2009): Discusses a preliminary timetable for review of applications for MRTPs. Pending further guidance or rulemaking, FDA intends to issue a decision on an MRTP application within 360 days of its receipt by FDA.
Summary of MRTP Applications
|Pre-May 2014||May 2014||June 2014||July 2014||Total|
|Refuse to Accept||2||0||0||0||2|
|Refuse to File||4||0||0||0||4|
|No Marketing Orders||0||0||0||0||0|
MRTP Applications Currently Under Scientific Review
|Status||Product/Company||Application||Open Comment Period||Regulations.gov Docket #||TPSAC Meeting Date/Info||TPSAC Meeting Materials|
|Filed||Swedish Match North America||View Files||Closed Monday, February 23, 2015, 11:59 PM ET||FDA-2014-N-1051||April 9-10, 2015||View Materials|
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.
April 9-10, 2015 TPSAC Meeting Notice Q&A: Modified Risk Tobacco Products 2013 TPSAC Meeting Materials and Information Less Risky Tobacco Product? Only if the Science Says So Protecting the Public Health through Tobacco Regulation
- Public Workshop: Scientific Evaluation of Modified Risk Tobacco Product (MRTP) Applications (August 2011) [ARCHIVED]
- Scientific Standards for Studies on Modified Risk Tobacco Products (Institute of Medicine, December 2011)