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Newsletter

Revised FDA Guidance on Prior Notice Submissions and Enforcement Policy

November 15, 2004

On November 3, 2004, a revised Compliance Policy Guide (CPG) was issued by the FDA, detailing new procedures for the transmission of Prior Notice (PN) for imported food products. The Guidance document also describes the FDA's approach to enforcement of the PN requirements. This latest revision, effective November 8, 2004, supersedes the previous versions of the Guidance document of August 2004.

For background on the Bioterrorism Act and Prior Notice Regulations, please see our previous newsletters on the subject:

The November Compliance Policy Guide attempts to provide brokers with additional flexibility in complying with the PN requirements.  

Registration Number Substitutes

Particularly vexing for the trade community has been the issue of what options are available to a submitter/transmitter of Prior Notice information when the manufacturer's registration number is not known.

There may be any number of legitimate reasons that this might occur in an import transaction, including for example:

  • the food facility is out of business
  • the food facility is a restaurant or retail food establishment
  • shipment contains samples for quality assurance, or research/analysis
  • food was made at a U.S. manufacturing facility not required to register

The latest FDA guidance now allows PN to be submitted/transmitted without the registration number; however, the FDA asks that a "reason code" be submitted/transmitted to explain why the registration number is not available.  

In the place of the registration number, the FDA will allow the submitter/transmitter to designate the name, address, city and country of the facility that manufactured the food be provided.  

If neither the registration number nor the manufacturer's address is known, the PN can supply the name and address of the headquarters for the facility that manufactured the food.

If none of the forgoing information is known, the prior notice can provide the name and address of the invoicing company.  

In these instances, the FDA will undertake to research the facility itself, using this alternative information and, therefore, the agency cautions that it may take more time for the agency to determine whether the article of food is subject to being held under the Bioterrorism Act detention procedures.  

Express Courier Shipments

The FDA CPG now allows express PN filing on courier shipment to substitute a tracking number instead of the anticipated arrival information and/or planned shipment information. However, this exception only applies if the person submitting/transmitting the prior notice is not the express courier and the prior notice is submitted via the PNSI system.

This guidance appears intended to assist individuals importing non-commercial shipments of food product from abroad.

Under PNSI, the Advance Filing Period is Lengthened to 10 days

If submitted via the FDA's Prior Notice System Interface (PNSI), the PN may now be submitted/transmitted up to 10 days before the anticipated date of arrival. Programming limitations have not yet made this extended time frame possible for ABI system filings, which remain limited to five days before anticipated arrival.

The CPG also recommends that no regulatory action be taken for shipments that are sent for non-commercial purposes from a non-commercial shipper.

Holding Facilities. PNSI has been modified to include the location of the facility holding refused goods and allow any party to transmit that information.

Examples of these types of shipments include food in household goods, food purchased by a traveler and sent by that traveler to their U.S. address, or gifts purchased and shipped by an individual to another individual in the U.S. It is noted that the shipper must be an individual, so any of the above that is shipped by the commercial establishment from which the purchase was made rather than the individual themselves would not be eligible for the exception.

Additional details regarding all of the new revisions are available and can be accessed online.

If you have any questions on any of the issues raised in this newsletter, please contact George R. Tuttle, III at (415) 288-0428 or via email at geo@tuttlelaw.com.

George R. Tuttle, III is an attorney with the Law Offices of George R. Tuttle in San Francisco. The information in this article is general in nature and is not intended to constitute legal advice or to create an attorney-client relationship with respect to any event or occurrence, and may not be considered as such.

Copyright 2005 by Tuttle Law Offices.

All rights reserved. Information has been obtained from sources believed to be reliable. However, because of the possibility of human or mechanical error by our offices or by others, we do not guarantee the accuracy, adequacy, or completeness of any information and are not responsible for any errors, omissions, or for the results obtained from the use of such information.

 

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