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
Fiscal Year - 2013
FY 2013 YTD: 257
Number of information request letters sent to provisional report submitters in the month
Fiscal Year - 2013
FY 2013 YTD: 246
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.