Changing COLA from exemption to certificate of label approval

[bradocaster]

Has anyone changed a label from exemption to cert. of label approval? I'd like to do that with all of our products and wondered how long the process will take.

Thanks,

Brad

[dhdunbar]

I have no experience with this, but will take a flier and assume that you go into the stack just like everyone else. I assume that if it is a product for which you have to have pe-COLA analysis, i.e., a formula, that you have that already, but if it is a label that requires pre-COLA analysis, and if I you do not have it, then add the time for formula approval to the time for label approval.

TTB processes labels in the order received. As of 7/2 they are processing label approvals received on 5/15 and formulas received on 4/30. So, unless they make some improvements in the processing times, you are guaranteed that even flawless formulas are backed up 63 days and labels 48 days, because the web site says that unless you submitted before the date shown, TTB has not looked at your application. That means that they cannot have taken any action on it.

Here is the curious part of TTB's statistics: TTB says that formulas are averaging 63 days and the labels 47 days before they are approved or rejected. But how can that be the case, if they are not even first looking at the formula for 63 days and the COLA app for 48 days? Assuming that some formulas and labels have problems and that the applicants get a chance to correct them before rejection, then either the vast majority get corrected within one day, allowing TTB to approve or reject, on average, on the same day it first looks at the application, or the average days figure is misstated. Or maybe it is just the confluence of two trend lines. Who knows?

In any case, you know that if you submitted the formula 4/30, you have a built in wait of 63 days plus whatever time it takes for TTB to approve after they first look at it, and 48 days if you submitted the COLA in mid -May. These are moving differences, so that does not say how long a wait you will have if you submit today, and the averages are both moving and suspect, so it's Nike time, "Just do it." What will be will be.