We’ve noticed that one byproduct of the new biennial Food Facility Registration requirement is stricter enforcement of registration rules when filing Prior Notice (PN). We have seen FDA cracking down on PN filings. In particular, FDA seems to be taking a close look at actual foreign Food Facility Registration number to make sure that the party

a.) is the actual manufacturer of the product or the facility that actually repacked the product.

b.) has authority to register the Food Facility with FDA.

We have seen two cases already where FDA questioned the authenticity and validity of the Food Facility Registration number of the foreign food facility. In both cases, FDA eventually refused the goods. The products had to be either exported or destroyed.

Keep in mind that the refusal of the product occurs at the time of filing of the PN. This is different from a typical FDA hold that occurs at the time of Customs entry submission. With a hold during the filing of PN, Customs cannot release the goods either. The goods end up sitting at the port accumulating storage charges while the issue is resolved. Most importers are used to being able to receive and hold their shipments while waiting for FDA to release goods. This is not the case with an FDA hold at the PN level.

My recommendation to the importing community is if the shipper is NOT the actual manufacturer OR the repacker of the food product, you MUST get the Food Facility Registration number and information of the actual manufacturer or repacker. FDA has on occasion accepted the name and address of the manufacturer / repacker without the Food Facility Registration number ONLY if the that manufacturer / repacker has already registered with FDA using that same name and address. Unfortunately, there is no system of verifying this with FDA without actually submitting the entry to FDA. This ends up being a great risk. You don’t know if the name address is listed with FDA until you submit the entry. I don’t believe this is a risk that most importers will find worth taking. Therefore it behooves the importer to get the actual FDA Food Facility Registration number of the foreign manufacturer / repacker.

Let me know if you have any questions or comments.

-Jimmy Ting

jimmyting@gwlcorp.com