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Conditionally Approved COLAs

Conditionally approved COLAs have started appearing on some label applications in COLAs online. Please note that conditionally approved is NOT a final status, it requires action on the part of the submitter.

The new status was developed to streamline the label approval process by allowing the TTB, under limited circumstances, to propose changes to the information that was entered in COLAs online in order to make it consistent with the label submitted. Once notified via email of the status changes there is a seven day period to review the proposed changes and either accept or decline them. If accepted, the status of the application will automatically change to approved with no further review required by the TTB. If you decline any of the changes or do not respond within seven days the system will automatically change the status to Needs Correction and you will be provided with directions on what needs to be fixed before your COLA can be approved.

Source: TTB, September 2019