As the result of a court order, a premarket submission must be made to FDA’s Center for Tobacco Products (CTP) by Sept. 9 for all deemed new tobacco products currently on the market (See statement on separate court decision regarding premium cigars).
For many months, FDA has been strongly encouraging manufacturers to submit their materials before the deadline. FDA is beginning to receive many of these applications; to date, the agency has received submissions for thousands of different products, many of which were submitted in just the last two weeks.
As FDA begins the work of processing these submissions, staff have identified items that have slowed down the processing time. Many of the PDF files do not have “text recognition” enabled, making it harder for staff to search the submissions for specific information, such as:
Additionally, FDA has received more paper submissions to-date than the agency would have expected; these take longer to process and move to scientific review. Although it is not always required, FDA recommends electronic submissions in order to more efficiently transmit and receive applications. For most submissions—including premarket review applications—companies may use the FDA e-Submitter tool to package files and information and then transmit those files via the CTP Portal, which will indicate the transmission to FDA was successful.
If you are unable to submit online, please mail or deliver submissions to be received by CTP’s Document Control Center (DCC) no later than 4:00 pm (EDT) September 9, 2020. We recommend you use a carrier who will provide tracking and delivery receipt. FDA does not accept applications via email. All applications must be received by 4:00 PM EDT on Sept. 9, 2020. The DCC accepts multiple forms of mixed media such as thumb drives, CDs, DVDs, and external hard drives.
For more information and tips, follow @FDATobacco on Twitter and visit FDA’s webpage on preparing and submitting deemed tobacco product applications.
U.S. Food & Drug Administration – September 3, 2020.