About FDA

Total number of information request letters sent to 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 November 30, 2012

• FY 2012
• FY 2013
• All

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

Fiscal Year - 2013

Time	Target	Number
Oct 2012	N/A	55
Nov 2012	N/A	191
Dec 2012	N/A	TBD
Jan 2013	N/A	TBD
Feb 2013	N/A	TBD
Mar 2013	N/A	TBD
Apr 2013	N/A	TBD
May 2013	N/A	TBD
Jun 2013	N/A	TBD
Jul 2013	N/A	TBD
Aug 2013	N/A	TBD
Sep 2013	N/A	TBD

FY 2013 YTD: 246