Tobacco Products

Modified Risk Tobacco Products

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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MRTP Draft Guidance Documents

  • Draft Guidance for Industry: Modified Risk Tobacco Products Applications (2012): Addresses topics related to submitting MRTP applications, including suggestions for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 Application Actions

As of May 24, 2017:

 2011201220132014201520162017Total
Refuse to Accept200008010
Refuse to File04000004
Modified Risk Orders00000000
Denial (In Whole/Part)00000808
Response (In Whole/Part)00000808
Withdrawn by Applicant10002025
Total3400224235

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.


MRTP Application Actions (Orders, Denials, and Responses)

On December 14, 2016, the FDA denied Swedish Match North America, Inc.'s request to remove one warning label required to be displayed on all smokeless tobacco products and issued a response letter related to the company's requests to remove or revise two other required warnings. More information on MRTP application actions is available.


MRTP Applications Currently Under Scientific Review

Status  Product/Company Application Comment Period ClosesRegulations.gov Docket #TPSAC Meeting Date/Info
FiledIQOS system with Marlboro Heatsticks/Philip Morris Products S.A.View Application Files*December 12, 2017**FDA-2017-D-3001TBD

* Due to the large size of these applications, FDA will post the application documents in batches on a rolling basis as they are redacted in accordance with applicable laws.
** FDA is making the applications available for public comment through December 12, 2017, which is 180 days from the opening of the public docket on June 15, 2017. However, if fewer than 30 days remain in the comment period when the final batch of application materials is posted, FDA will issue a notice in the Federal Register extending the comment period.

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 at least until FDA makes a decision on the applications and will post any additional amendments to FDA’s website on an ongoing basis. Please note 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 early in the comment period (e.g., at least 60 days in advance of the TPSAC meeting).

 

Page Last Updated: 06/14/2017
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