The new deadline for vaping manufacturers to register their facilities and submit product listings is Oct. 12.
As we reported Wednesday, FDA Commissioner Scott Gottlieb announced on Twitter that the agency would postpone the deadline, due to the problems with the online registration system known as FURLS (FDA Unified Registration and Listing System).
“We know there are logon issues with #FDA website system that also allows tobacco firms to register with FDA before Sept 30th deadline,” Gottlieb wrote on Twitter. “Owing to website connectivity problems re tobacco registration, we’ll be implementing a short term extension to allow firms to register.”
The new deadline was announced in a post on the FURLS website.
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.
It’s not a substantial delay. Considering the millions of entries that need to be made in the FDA’s already strained database, vendors will likely still face challenges getting product listings completed by Oct. 12.
Our original article on this deadline has links vendors can use to get help completing this task.
And take advantage of the agency’s offer to “work with” any manufacturer who has technical problems with the website.
Will this mess ever be fixed?
The FDA’s Center for Tobacco Products never intended to honestly regulate this industry. Their plan, as written in the deeming regulations, has always been to drive the small vape companies out of business, leaving just the tobacco industry giants to deal with.
Now that thousands of small vaping businesses are trying to follow the rules and submit millions of products to the FDA, the agency is stuck. They can’t handle the volume of submissions, but they can’t say they weren’t ready either.
“The FDA Center for Tobacco Products has again shown itself to be unprepared to regulate the vapor products industry,” American Vaping Association President Gregory Conley told Vaping360.
“All along, the FDA has woefully underestimated the number of vapor products that would need to be registered,” he added. “This is yet another reason why Scott Gottlieb should make major reforms to how the FDA regulates smoke-free products.”
Until the agency replaces the intentionally impossible deeming rule requirements with a sensible system of standards that protects consumers and allows for innovation, this process will continue to be one disaster after another.