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U.S. Department of Health and Human Services

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Cumulative number of Exemption from SE 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 tobacco product that is modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, may be considered for exemption from demonstrating substantial equivalence if certain conditions are met. (Section 905 (j)(3)).

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/A219
Nov 2018N/A240
Dec 2018N/A313
Jan 2019N/A328
Feb 2019N/A355
Mar 2019N/A366
Apr 2019N/A380
May 2019N/A420
Jun 2019N/A488
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 488

Cumulative number of Exemption from SE 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FDA issued an Order letter, issued a Refuse-to-Accept letter or the application was withdrawn by the applicant.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/A184
Nov 2018N/A194
Dec 2018N/A204
Jan 2019N/A214
Feb 2019N/A299
Mar 2019N/A315
Apr 2019N/A325
May 2019N/A353
Jun 2019N/A375
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 375

Total number of Exemption from SE Applications received or filed 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 tobacco product that is modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, may be considered for exemption from demonstrating substantial equivalence if certain conditions are met. (Section 905 (j)(3)).

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/A16
Nov 2018N/A21
Dec 2018N/A73
Jan 2019N/A15
Feb 2019N/A27
Mar 2019N/A11
Apr 2019N/A14
May 2019N/A40
Jun 2019N/A68
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 285

Total number of Exemption from SE 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/A1
Nov 2018N/A10
Dec 2018N/A10
Jan 2019N/A10
Feb 2019N/A85
Mar 2019N/A16
Apr 2019N/A10
May 2019N/A28
Jun 2019N/A22
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 192

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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