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U.S. Department of Health and Human Services

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Cumulative number of Modified Risk Tobacco Product (MRTP) Applications received since Program Inception

Dictionary: The Tobacco Control Act requires manufacturers of new or modified tobacco products to submit a premarket application and obtain a market authorization order before they market their products. To introduce a new or modified tobacco product, an applicant must submit an application to FDA providing information on the product sufficient to allow the agency to determine that an order authorizing the product’s introduction is appropriate for the protection of the public health.

A modified risk tobacco product is a tobacco product that is sold or distributed for use to reduce harm and the risk of tobacco-related disease associated with commercially marketed tobacco products. You can legally market a modified risk tobacco product only after FDA issues an order permitting its marketing (Section 911(g)).

Additional information about premarket review requirements for tobacco products can be found on the Tobacco Products - Product Requirements, Marketing and Labeling.

Information is current as of June 30, 2019. CTP began tracking this measure FY15 Q4.

Fiscal Year - 2019

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TimeTargetNumber
Oct 2018N/A38
Nov 2018N/A38
Dec 2018N/A40
Jan 2019N/A40
Feb 2019N/A40
Mar 2019N/A40
Apr 2019N/A40
May 2019N/A42
Jun 2019N/A42
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 42

Cumulative number of MRTP Application Closed since Program Inception

FDA issued an Order letter, issued a Refuse-to-Accept letter or the application was withdrawn by the applicant.

Fiscal Year - 2019
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TimeTargetNumber
Oct 2018N/A21
Nov 2018N/A21
Dec 2018N/A21
Jan 2019N/A21
Feb 2019N/A21
Mar 2019N/A21
Apr 2019N/A21
May 2019N/A21
Jun 2019N/A21
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 21

Total number of Modified Risk Tobacco Product (MRTP) Applications received in the month

Dictionary: The Tobacco Control Act requires manufacturers of new or modified tobacco products to submit a premarket application and obtain a market authorization order before they market their products. To introduce a new or modified tobacco product, an applicant must submit an application to FDA providing information on the product sufficient to allow the agency to determine that an order authorizing the product’s introduction is appropriate for the protection of the public health.

A modified risk tobacco product is a tobacco product that is sold or distributed for use to reduce harm and the risk of tobacco-related disease associated with commercially marketed tobacco products. You can legally market a modified risk tobacco product only after FDA issues an order permitting its marketing (Section 911(g)).

Additional information about premarket review requirements for tobacco products can be found on the Tobacco Products - Product Requirements, Marketing and Labeling.

Fiscal Year - 2019

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TimeTargetNumber
Oct 2018N/A0
Nov 2018N/A0
Dec 2018N/A2
Jan 2019N/A0
Feb 2019N/A0
Mar 2019N/A0
Apr 2019N/A0
May 2019N/A2
Jun 2019N/A0
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 4

Total number of MRTP Closed in the month

FDA issued an Order letter, issued a Refuse-to-Accept letter or the application was withdrawn by the applicant.

Fiscal Year - 2019
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2018N/A0
Nov 2018N/A0
Dec 2018N/A0
Jan 2019N/A0
Feb 2019N/A0
Mar 2019N/A0
Apr 2019N/A0
May 2019N/A0
Jun 2019N/A0
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 0

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.

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