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MRTP Draft Guidance Documents
- Draft Guidance for Industry: Modified Risk Tobacco Products Applications (2012): Addresses topics related to submitting MRTP applications, including suggestions for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 December 14, 2016:
|Refuse to Accept||2||0||0||0||0||8||10|
|Refuse to File||0||4||0||0||0||0||4|
|Modified Risk Orders||0||0||0||0||0||0||0|
|Denial (In Whole/Part)||0||0||0||0||0||8||8|
|Response (In Whole/Part)||0||0||0||0||0||8||8|
|Withdrawn by Applicant||1||0||0||0||2||0||3|
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.
Perspective: Lessons Learned from the First Review of Modified Risk Tobacco Product (MRTP) Applications FDA takes action on applications seeking to market modified risk tobacco products
- 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)