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U.S. Department of Health and Human Services

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Cumulative number of Substantial Equivalance (SE) Provisional reports received (1)

Dictionary: New tobacco products may not be legally marketed in the United States unless FDA has issued an order permitting their marketing. However, if a new tobacco product was both commercially marketed after February 15, 2007 but before March 22, 2011 and a Substantial Equivalence Report was submitted by March 22, 2011, then this new tobacco product may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent to an appropriate predicate product. (Section 905(j))

Information is current as of March 31, 2014

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A3,517
Nov 2012N/A3,517
Dec 2012N/A3,517
Jan 2013N/A3,517
Feb 2013N/A3,517
Mar 2013N/A3,517
Apr 2013N/A3,517
May 2013N/A3,517
Jun 2013N/A3,517
Jul 2013N/A3,517
Aug 2013N/A3,517
Sep 2013N/A3,517

FY 2013 Cumulative Total: 3,517

Footnotes

  • (1) The number of applications reported as received (in a given month) may be revised due to subsequent unbundling of applications submitted with multiple products and if applications are re-categorized. The numbers reported for June 2013 have been updated as of June 25, 2013

Total number of SE Provisional reports received in the month

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A0
Nov 2012N/A0
Dec 2012N/A0
Jan 2013N/A0
Feb 2013N/A0
Mar 2013N/A0
Apr 2013N/A0
May 2013N/A0
Jun 2013N/A0
Jul 2013N/ATBD
Aug 2013N/ATBD
Sep 2013N/ATBD

FY 2013 Total: 0

Number of information request letters sent to SE Provisional report submitters 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 Equivalence 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 CTP website

Monthly total of information request letters sent. Each submission is reviewed for completeness. Letters will be sent to manufacturers advising them of missing information in their submissions.

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A0
Nov 2012N/A0
Dec 2012N/A1,323
Jan 2013N/A450
Feb 2013N/A109
Mar 2013N/A328
Apr 2013N/A202
May 2013N/A226
Jun 2013N/A166
Jul 2013N/A16
Aug 2013N/A1
Sep 2013N/A0

FY 2013 Total: 2,821

Total number of SE Provisional scientific reviews initiated (assigned technical lead) in the month

Dictionary: Monthly total of number of SE Provisional submissions assigned to a scientific lead (proxy for initiating scientific review).

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A0
Nov 2012N/A0
Dec 2012N/A0
Jan 2013N/A0
Feb 2013N/A0
Mar 2013N/A0
Apr 2013N/A0
May 2013N/A41
Jun 2013N/A0
Jul 2013N/A0
Aug 2013N/A0
Sep 2013N/A0

FY 2013 Total: 41

Cumulative number of SE Provisional orders issued

Dictionary: Cumulative total of number of SE Provisional product submissions reviewed and determined to be substantially equivalent to a predicate product.

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A0
Nov 2012N/A0
Dec 2012N/A0
Jan 2013N/A0
Feb 2013N/A0
Mar 2013N/A0
Apr 2013N/A0
May 2013N/A0
Jun 2013N/A0
Jul 2013N/A0
Aug 2013N/A0
Sep 2013N/A0

FY 2013 Total: 0

Total number of SE orders issued during the month

Monthly total of number of Provisional product submissions reviewed and determined to be substantially equivalent to a predicate product.

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A0
Nov 2012N/A0
Dec 2012N/A0
Jan 2013N/A0
Feb 2013N/A0
Mar 2013N/A0
Apr 2013N/A0
May 2013N/A0
Jun 2013N/A0
Jul 2013N/A0
Aug 2013N/A0
Sep 2013N/A0

FY 2013 Cumulative Total: 0

Cumulative number of Non-Substational Equivalence (NSE) Provisional orders issued

Dictionary: Cumulative total of number of Provisional products reviewed and issued a not substantially equivalent order which will result in the products being removed from the market.

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A0
Nov 2012N/A0
Dec 2012N/A0
Jan 2013N/A0
Feb 2013N/A0
Mar 2013N/A0
Apr 2013N/A0
May 2013N/A0
Jun 2013N/A0
Jul 2013N/A0
Aug 2013N/A0
Sep 2013N/A0

FY 2013 Cumulative Total: 0

Total number of NSE Provisional orders issued during the month

Monthly total of number of Provisional products reviewed and issued a not substantially equivalent order which will result in the products being removed from the market.

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A0
Nov 2012N/A0
Dec 2012N/A0
Jan 2013N/A0
Feb 2013N/A0
Mar 2013N/A0
Apr 2013N/A0
May 2013N/A0
Jun 2013N/A0
Jul 2013N/A0
Aug 2013N/A0
Sep 2013N/A0

FY 2013 Total: 0

Cumulative Number of SE Provisional Reports withdrawn

Dictionary: Cumulative total number of SE Provisional reports withdrawn by tobacco product manufacturers.

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A22
Nov 2012N/A22
Dec 2012N/A23
Jan 2013N/A24
Feb 2013N/A25
Mar 2013N/A25
Apr 2013N/A55
May 2013N/A99
Jun 2013N/A99
Jul 2013N/A104
Aug 2013N/A114
Sep 2013N/A117

FY 2013 Cumulative Total: 117

Number of SE Provisional reports withdrawn during the month

Monthly total number of SE Provisional reports withdrawn by tobacco product manufacturers.

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A0
Nov 2012N/A0
Dec 2012N/A1
Jan 2013N/A1
Feb 2013N/A1
Mar 2013N/A0
Apr 2013N/A30
May 2013N/A44
Jun 2013N/A0
Jul 2013N/A5
Aug 2013N/A10
Sep 2013N/A3

FY 2013 Total: 95

Glossary

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.