FDA Implements Prior Notice of Imported Food Final Rule
The U.S. Food and Drug Administration (FDA) implemented its “Prior Notice of Imported Food Final Rule” on May 6, 2009, as announced in a CFSCAN Constituent Update posted on the fda.gov Web site. The final rule amended the existing Prior Notice Interim Final Rule (PN IFR) contained in CFR Part I, Subpart I, which had been in effect since December 12, 2003. The PN IFR required that FDA receive prior notice of food imported into the U.S. The final rule revises the IFR in only a few key areas.
For importers of food into the U.S., the most significant areas of change are as follows:
- In contrast to the IFR, the final rule requires the identity of the manufacturer for all entry types, including In-Transit and Transportation and Exportation entries.
- The final rule adds a definition for “manufacturer” and provides an alternative for identifying the manufacturer when the registration number is not known. In addition to the name of the manufacturer, the prior notice submitter must submit either: (a) the registration number of the facility associated with the article of food; or (b) the full address of the site-specific facility and reason why no registration number is being provided.
Specifically, the following reason codes listed in the Interim Final Rule (IFR) compliance policy guide (CPG) will not be accepted on or after May 6, 2009:
- G Individual Gift – label name address in lieu of registration number
- I Samples – Quality Assurance, research or analysis purposes only
- J U.S. Manufacturing facility that is not required to register
- L Unable to determine identity of the manufacturer - providing identity of manufacturer’s headquarters
- M Unable to determine identity of manufacturer or headquarters - providing invoicing firm’s identity
- O Gift Pack for non-business purposes – providing single prior notice and identity of packer
Questions should be directed to the Prior Notice Center at 1.866.521.2297.
For more information, please visit the FDA Web site.