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December Update on the FDA Registration And Prior Notice Regulations

December 4, 2003

With the December 12, 2003, implementation of the FDA’s Registration & Prior Notice Regulations fast approaching, we provide the following summary of developments in the implementation of the new requirements.

Broker Contracts

Customs Brokers who perform as U.S. Agents and/or as Registering Agents for foreign food facilities may wish to incorporate liability provisions into their contractual agreements to manage the private issues of liability arising from such services. For further information please contac George R. Tuttle, III at (415) 288-0428.

CBP’s Interim Procedures

CBP has published guidance on Interim Procedures, which will be in effect on December 12, 2003, relating to imported food products subject to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. In the initial phase, the CBP and FDA will focus on education of the trade community and, accordingly, will not hold merchandise for reasons of inadequate Prior Notice (except where there exists an identified bioterrorist threat). In a timeline still to be developed, the CBP will later phase in partial enforcement for egregious violations, to be followed, finally, by full enforcement of the regulations. The CBP advises that questions concerning the entry and release of imported food products should be addressed to the following CBP staffers:

Jim Swanson
(202) 927-0966

Tom Heffernan
(202) 927-1185

FDA Food Codes Published

The FDA has published its table of FDA food codes corresponding to HTSUS codes. These FDA codes apply to prior notice submitted via both the ABI system and the FDA's Prior Notice System Interface.

FDA Guidance Publications

The FDA has published concise summaries of the interim final rules on Registration and Prior Notice. These summaries are more detailed than the FDA’s prior fact sheets, and are capable of being emailed or faxed to foreign food facilities.

Additional background information, FDA Registration, and Prior Notice Regulations can be found at our BTA Information Page.

Please contact Stephen Spraitzar at (415) 288-0427 if you have any questions regarding the FDA Bioterrorism Act or other Customs law matters.

Stephen Spraitzar 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 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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