FDA Announces New Regular SE Reports to Immediately Enter Review Process
FDA is announcing that as of March 24, 2014, all "regular" Substantial Equivalence reports1 entered into FDA review immediately. These reports are for products not currently on the market. FDA has cleared the queue for regular SE reports entering the review process and now plans to initiate evaluation of new regular SE reports upon receipt. As a result, FDA is no longer issuing notification letters to applicants informing them of when their regular SE review will begin. Instead, applicants should expect that complete regular SE reports will undergo immediate, substantive review.
FDA would like to remind regulated industry that for a final determination of substantial equivalence, it is the applicant’s responsibility to ensure each SE report contains all information necessary to support a substantial equivalence finding. Any decision related to an applicant’s SE report will be based upon the information contained in its report and therefore the report must contain all of the information required by law. If SE reports are incomplete, FDA can refuse to accept them. In that instance, if an applicant chooses to re-submit its regular SE report with complete information, FDA currently intends to begin immediate SE review.
FDA would also like to note that the review process has concluded for 23.6% of the 981 regular SE Reports that were received before March 31, 2014. A review process may conclude through either issuance of an SE order, NSE order, or withdrawal of the application. These actions mean that no further review is required by FDA and only those products that receive an SE order may be marketed in the United States. While the process has concluded for nearly a quarter of regular SE reports, our work is ongoing with the remaining reports and the agency intends to reach decisions as expeditiously as possible.
Above all, FDA is committed to making sound, public health-based scientific decisions on the marketing of new tobacco products.
For more information on substantial equivalence decisions, visit FDA’s Tobacco Product Marketing Orders webpage.
1 “Regular” reports are for products that did not enter the market between February 16, 2007 and March 21, 2011, and for which an SE report was not submitted by March 22, 2011.