Posted June 13, 2019
COLAs Online will soon include a new status, Conditionally Approved. This feature will further streamline the label approval process by allowing us, under limited circumstances, to propose changes to the information you entered in COLAs Online in order to make it consistent with the label you submitted with your application. You will be able to accept or decline our proposed changes.
Which Application Fields are Involved?
The Conditional Approval process will allow specialists to propose changes to the following fields on the application:
In many cases, we could approve COLA applications except for the fact that the information entered in these fields is not consistent with the label submitted with the application.
For example, the application may include a misspelling of the brand name that appears on the label, or there is a wine appellation on the label that wasn’t entered in the application. In such cases, a label specialist will now be able to use COLAs Online to propose changes to the application to make it consistent with the label and return it to you in Conditionally Approved status.
Accepting or Declining Proposed Changes
Conditionally Approved is not a final status; it requires action on your part. Once you are notified by email, you’ll have 7 days to review the proposed changes and either accept or decline them.
- If you agree with all of our proposed changes, select ACCEPT. The status of your application will automatically change to Approved. No further action on your part or review on our part will be necessary.
- If you disagree with one or more of the proposed changes, select DECLINE. The status of your application will automatically change to Needs Correction, and you can correct the inconsistencies yourself.
If you believe the original entries were correct, or want to provide additional information to the specialist, you may explain why you declined the changes using the Notes to Specialist field.
- If you don’t take action within 7 days after the application is put into Conditionally Approved status, the status will automatically change to Needs Correction.
Additional Information About the New Conditionally Approved Status
We will never make changes your actual label; we will only propose changes to the information entered in the application to make it consistent with your label. If we note something on your label that needs to be changed, we will return the application to you in Needs Correction status so you can make the changes.
A specialist will only propose changes to the application if it is clear from the label what information should be entered on the form. If the brand name of the product is not clear, for example, the specialist will send the application back to you in Needs Correction status.
In addition, a specialist will only propose changes to the application if the rest of the application and the label could be approved. For example, if the brand name entered on the form contains a typo and the label does not include the Health Warning Statement, the specialist will return the application for correction rather than proposing changes to the brand name field and asking you to fix the label.
How We Expect This Process Will Help
We expect that the Conditionally Approved process will help make the label approval process faster for you and for us.
Currently, when we return an application for these types of changes and you return it to us, your application goes back into the queue and is reviewed again.
If your application is in Conditionally Approved status and you agree with the proposed changes, you will have an approved application from the moment you click ACCEPT. Other than reviewing TTB’s changes, there is no additional work associated with the Conditionally Approved status.
If you have any questions or feedback concerning the Conditionally Approved status, please contact the Alcohol Labeling and Formulation Division (ALFD) at 866-927-2533, or use our ALFD Contact Form.
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