FDA Import Alter 99-41 "Detention Without Physical Examination of Human and Animal Foods Imported from Foreign Suppliers..."

by Importers Who Are Not in Compliance with the Requirements of the Foreign Supplier Verification Program (FSVP) Regulation"

Reason for Alert:

Section 805 of the FD&C Act (21 U.S.C. 384a) requires each importer of food to perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the
importer is produced in compliance with the requirements of section 418 (21 U.S.C. 350g) (regarding hazard analysis and risk-based preventive controls) or section 419 (21 U.S.C 350h)(regarding
standards for produce safety) of the FD&C Act, as appropriate; and that the food is not adulterated under section 402 or misbranded under section 403(w).

The Foreign Supplier Verification Programs for Food Importers (FSVP) regulation (21 CFR part 1 subpart L) defines "importer" as the "U.S. owner or consignee" of an article of food that is being offered
for import into the United States. If there is no "U.S. owner or consignee" of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or
consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer for purposes of the FSVP regulation. (21 CFR 1.500)

The FSVP regulation defines "U.S. owner or consignee" as the person in the United States who, at the time of U.S. entry, either owns the food, has purchased the food, or has agreed in writing to
purchase the food. (21 CFR 1.500)

If there is no "U.S. owner consignee" of an article of food at the time of U.S. entry, the article of food may not be imported into the United States unless the foreign owner or consignee has
appropriately designated a U.S. agent or representative as the FSVP importer. (21 CFR 1.509(b)) Read More→

https://www.accessdata.fda.gov/cms_ia/importalert_1160.html