What happens if someone does not follow the Prior Notice pre-filing time limits and attempts to obtain release of their BTA covered merchandise from CBP prematurely?

For BTA covered merchandise, the FDA must authorize release or some other action prior to CBP processing.  CBP Officers may not release BTA covered merchandise without FDA approval.  Anyone attempting to gain premature release (termed “untimely filing ” by the FDA) of goods that have not been processed by the FDA for BTA purposes, will find their merchandise held at the port until the FDA completes their BTA review.   The act of “untimely filing” may also subject violators to significant civil monetary penalties issued by CBP.