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U.S. Department of Health and Human Services

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Cumulative Number of Product 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.

Alternately, a manufacturer may submit a substantial equivalence report demonstrating that its new tobacco product is substantially equivalent to a predicate tobacco product, as defined in the Tobacco Control Act. The Substantial Equivlance provision of the Tobacco Control Act requires nothing of manufacturers of unaltered tobacco products which were commercially available on February 15, 2007.

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/A7,028
Nov 2018N/A7,091
Dec 2018N/A7,189
Jan 2019N/A7,216
Feb 2019N/A7,249
Mar 2019N/A7,286
Apr 2019N/A7,324
May 2019N/A7,362
Jun 2019N/A7,400
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 7,400

Total number of product submissions 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.

Alternately, a manufacturer may submit a substantial equivalence report demonstrating that its new tobacco product is substantially equivalent to a predicate tobacco product, as defined in the Tobacco Control Act. The Substantial Equivlance provision of the Tobacco Control Act requires nothing of manufacturers of unaltered tobacco products which were commercially available on February 15, 2007.

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

FY 2019 YTD: TBD

Total number of product applications 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
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TimeTargetNumber
Oct 2018N/A144
Nov 2018N/A51
Dec 2018N/A32
Jan 2019N/A56
Feb 2019N/A184
Mar 2019N/A56
Apr 2019N/A103
May 2019N/A52
Jun 2019N/A100
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 778

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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