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FDA Compliance Summary Information Regarding Prior Notice of Imported
Food Shipments
The Public Health and Bioterrorism Preparedness and Response
Act of 2002 (Bioterrorism Act), Section 307, added Section
801(m) to the Federal Food, Drug, and Cosmetic Act to require
that FDA receive prior notice for food imported or offered
for import into the United States. In the preamble to the
interim final rule published October 10, 2003, FDA stated
that it would provide a transition period, during which it
would emphasize education on prior notice requirements to
help industry better comply with the regulation.
A Compliance Policy Guide was issued in December 2003 to provide
guidance on the agency’s strategy for enforcing and
achieving compliance with the interim final rule. During the
initial period, FDA is providing industry and the public with
summary information about the level of compliance with the
prior notice requirements, including data on the types of
errors in submitted prior notices. This information will also
be analyzed to help FDA take appropriate enforcement action
when necessary. Information of interest to industry and other
members of the public falls into two categories:
- Information of general interest about the number and
types of prior notices that are being filed, and which
systems are being used to submit them.
- Information about
the degree of compliance with the prior notice requirements.
Information on both
types is included in the accompanying charts. This
first posting of summary information describes prior notice
submissions
received during the first two months after the interim
final rule became effective
December 12, 2003. It provides a high level
summary of the current pattern of submissions,
and identifies the biggest areas of concern. As the transition
period progresses,
FDA expects to provide more detailed information that will specifically
target key areas that require attention.
For more information, see www.cfsan.fda.gov/~pn/pnsum.html.
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