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U.S. Department of Health and Human Services

Tobacco Products

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MRTP Draft Guidance Documents 

 

Summary of MRTP Applications

 Pre-May 2014May 2014June 2014July 2014Total to Date
Refuse to Accept20002
Refuse to File40004
No Marketing Orders00000
Marketing Orders00000
Withdrawals10001


MRTP Applications Currently Under Scientific Review

StatusProduct /CompanyApplicationOpen Comment PeriodRegulations.gov Docket #TPSAC Meeting Date/InfoTPSAC Meeting Materials
FiledSwedish Match North AmericaView FilesUntil Monday, February 23, 2015, 11:59 PM ETFDA-2014-N-1051--

 

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.