Import Alert 99-41

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 99-41
Published Date: 07/31/2019
Type: DWPE

Import Alert Name:

"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))

Guidance:

Divisions may detain, without physical examination, an article of human or animal food offered for import by an importer identified on the Red List of this import alert, for the food identified on the Red
List. Divisions may forward recommendations to the appropriate Center for additions to the Red List as follows:

Human food: Center for Food Safety and Applied Nutrition (CFSAN), Office of Compliance, Division of Enforcement
Animal food: Center for Veterinary Medicine (CVM), Office of Surveillance and Compliance, Division of Compliance

The Center will evaluate each recommendation to determine if DWPE under this import alert may be warranted.

An importer may be added to the Red List of this import alert because it appears that the importer is not in compliance with FSVP requirements for one or more foods. The specific food or foods from
a specific foreign supplier may be included on the Red List to identify the food or foods that are subject to DWPE when imported or offered for import by the identified importer. In some cases, an
importer may be subject to DWPE for all food that the importer imports if it appears that the importer is in violation of FSVP requirements for all such foods.

Even when an importer is not in compliance with FSVP requirements, the food and/or foreign supplier may nevertheless be in compliance with applicable requirements. Although the foreign supplier of
the food may be identified on the Red List within this import alert, this import alert does not apply to all food produced by the foreign supplier. The only food that may be subject to DWPE under this
import alert is the specified food when imported by the identified importer (but not when imported by other importers).

To request removal from the Red List of this import alert, the importer should submit information supporting their request to the FDA office identified in previous correspondence with the importer
relating to the FSVP violations. The importer should submit information to adequately demonstrate that the importer has resolved the conditions that gave rise to the appearance of the FSVP violation.

The purpose of this is to provide FDA with assurance that the importer is meeting the requirements of FSVP for future entries of the food from the foreign supplier. As appropriate, FDA may conduct a
follow-up inspection of the importer to determine whether the appearance of the FSVP violation has been removed.

The Division may submit a recommendation to DIO to remove the importer from the Red List. DIO will consult with the appropriate Center and the Division.

Because the appearance of the importer's FSVP violations causes the food to be subject to DWPE, the foreign supplier is not responsible for demonstrating that the conditions that gave rise to the
appearance of the violations have been resolved. Nevertheless, it is possible that foreign suppliers may contact FDA offices seeking information about removal from the Red List. If this occurs, the FDA
offices should direct the foreign suppliers to contact the relevant importers.

For questions or issues relating to import operations, please contact ORA/Division of Import Operations at (301) 796-0356 or send an email to FDAImportsInquiry@fda.hhs.gov.

For questions or issues relating to OASIS or PREDICT screening, please send an email to ORA DSS Import Systems Branch at oraoismsysimportsbranch@fda.hhs.gov.

Product Description:

Human and animal foods that are subject to the FSVP requirements.

PROBLEM: Failure to comply with FSVP requirements

Charge:

"The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it appears that the importer (as defined in section 805 of
the FD&C Act) is in violation of section 805."

OASIS Charge Code: FSVP VIO