FDA Instructs ABI Filers on Avoiding Certain Prior Notice Rejects
U.S Customs and Border Protection (CBP) has issued a message from the Food and Drug Administration (FDA) to all ABI filers of prior notice (PN) data for imported food, in order to instruct filers on how to avoid certain PN rejects which began in August 2004 when the FDA implemented additional PN edits.
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According to FDA, the leading cause of rejects is the failure to submit PN data when required. The second leading cause is inappropriate disclaiming of PN when the food product requires PN.
In this message, FDA discusses three PN reject problems involving (i) FDA product codes, (ii) U.S. goods returned, and (iii) expired or cancelled PN confirmation numbers.
(FDA's message also contains easy-to-interpret definitions of FDA flags FD0 to FD4 (and "no flag"), and reiterates the three ways PN can be submitted (neither of which is summarized below).
FDA Product Codes
Since there is not always a simple relationship between FDA product codes and Harmonized Tariff Schedule (HTS) codes, FDA states its OASIS system is programmed to edit for PN based on the FDA product code submitted.
As a result, a number of situations exist where filers are submitting an entry and are not providing PN data, or are transmitting a disclaim "PND" Affirmation of Compliance Code, but the FDA product code requires PN.
In those cases, the FDA is sending a reject back to ABI and ultimately the filer receives a line level reject with a reason code.
FDA states that most FDA product codes are straightforward; however, there are some industry codes where certain FDA product codes require PN (and will cause a reject if not sent) and other FDA product codes do not require PN, as follows:
Industry 50. In the case of Industry 50, the PN requirements are only applicable to two product codes:
- --01 color for foods, drugs and cosmetics (FD&C) (certified)
- --01 color for food (not certified)
Industry 54. For Industry 54, the PN requirement is determined by the product code subclass. The following subclasses require PN:
| The following subclasses do not require PN: | |
| D | human N/RX 1 ingredient |
| E | human N/RX combined ingredient |
| F | human RX 1 ingredient |
| G | human RX combined ingredient |
| I | investigational |
| N | animal N/RX drug |
| R | animal RX drug |
U.S. Goods Returned. FDA states that it has also seen many rejects for no PN submitted for articles of food with U.S. Goods Returned tariff classifications.
FDA states that if products that fall under 9801.00.1097 (Other American Goods Returned) are not subject to PN, a "PND" disclaimer is required. (See ITT's Online Archives or 09/29/04 news, 04092913 for BP summary of the FDA flag for Other American Goods Returned (9801.00.1097) changing to FD3 (PN may be required or disclaimed) from FD1 (PN may be required).
If the product requires PN, FDA states that the FDA country of production (US) does not change this requirement, and the failure to send PN data will result in a FDA reject.
Expired or Cancelled PN Confirmation Number. According to FDA, another cause of FDA rejects is the use of an expired or cancelled PN confirmation number (PNC). FDA states that if you receive this reject, the filer must contact the submitter of the PN to determine why it was expired or cancelled. In either case, new PN must be filed. The entry would then have to be corrected using the ABI other government agency correction (CP) transaction with the correct, current PN confirmation numbers.
CBP Admin Message 04-2171 (dated 10/07/04), available at http://www.brokerpower.com/cgi-bin/adminsearch/admmsg.view.pl?article=2004/2004-2171.ADM