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U.S. Department of Health and Human Services

About FDA

Total number of information request letters sent to regular 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.

Information is current as of February 28, 2013

Fiscal Year - 2013

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TimeTargetNumber
Oct 2012N/A56
Nov 2012N/A201
Dec 2012N/A93
Jan 2013N/A613
Feb 2013N/A6
Mar 2013N/ATBD
Apr 2013N/ATBD
May 2013N/ATBD
Jun 2013N/ATBD
Jul 2013N/ATBD
Aug 2013N/ATBD
Sep 2013N/ATBD

FY 2013 YTD: 969

Number of information request letters sent to SE provisional report submitters in the month

Tracking against this measure began in December 2012

Dictionary: TBD

Fiscal Year - 2013

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Tracking against this measure began in December 2012

TimeTargetNumber
Dec 2012N/A1,305
Jan 2013N/A591
Feb 2013N/A118
Mar 2013N/ATBD
Apr 2013N/ATBD
May 2013N/ATBD
Jun 2013N/ATBD
Jul 2013N/ATBD
Aug 2013N/ATBD
Sep 2013N/ATBD

FY 2013 YTD: 2,014

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.