Due to intermittent outages of the FDA’s Unified Registration and Listing System
(FURLS), FDA is extending the compliance deadline for registration and product listing for persons who owned or operated domestic manufacturing establishments engaged in the manufacture of newly deemed tobacco products prior to August 8, 2016, and continued to own or operate such establishments(s) on or after August 8, 2016. The FDA is extending this compliance deadline to provide manufacturers with additional time to submit the tobacco registration and product listing information required under Section 905 of the FD&C Act.
FDA now does not intend to initiate enforcement action against these operators and owners with respect to registration and listing under section 905 of the FD&C Act provided that the submissions are received by FDA on or before Thursday,
October 12, 2017. Due to the anticipated increase in the number of registrants and
number of products to be listed as the compliance deadline approaches, we encourage
you to register as soon as possible to ensure that your registration is processed before
the new compliance deadline.
If you have any questions or need assistance in registering or listing your products,
please send an email to FDA at [email protected] . We request
you include “IT Questions” in the subject line and provide the following information in the body of the email:
• Name of the Owner or Operator of the establishment
• Name and Address of the establishment
• Phone number- so FDA staff can personally assist you, if needed
• Best time to call and speak to the Owner or Operator of the establishment
If you are not able to register and list by October 12, 2017 due to technical difficulties with FURLS, please contact us by October 12, 2017 and we will work with you to address any technical problems.