Food Importers Face FSVP Deadline, May 30, 2017

Attention food importers! The May 30 deadline to comply with FDA’s Foreign Supplier Verification Programs (FSVP) is mandatory and right around the corner.

The Food Supplier Verification Program (FSVP) rule is intended to be a flexible, risk-based program to verify that foreign suppliers are producing their food in compliance with processes that meet the FDA’s standards for preventive controls and safety.

Unsure if are subject to FSVP?  Just follow FDA’s Am I Subject to FSVP Flowchart.

Under FSVP, an importer must:

  • Determine the known or reasonably foreseeable hazards with each food;
  • Evaluate the risks posed by a food, based on the hazard analysis, and the foreign supplier’s performance;
  • Use the evaluation of the risk posed by an imported food and supplier’s performance to approve suppliers and determine appropriate supplier verification activities;
  • Conduct supplier verification activities;
  • Conduct corrective actions.

Most of the time, the FSVP Importer will be the Importer of Record (IOR). When there is a non-U.S. resident IOR, the FSVP Importer will be the U.S. buyer (or a U.S. entity who has agreed, in writing, to purchase the food product and meet the FSVP requirements). Importers must advise their Customs broker who will serve as the FSVP for each shipment.

A Customs broker or other intermediary is not to be shown as the FSVP importer, as Customs brokers do not meet the definition of a U.S. owner or purchaser with a financial interest in the imported food takes responsibility for the safety of the food product as outlined above.

Starting with Customs entries filed May 30, 2017:

If you are not subject to the FSVP requirements, you must provide this information to your Customs broker in writing showing an Affirmation of Compliance code “FSX” for FSVP Exempt or “RNE” for Research and Evaluation.

If you are subject to FSVP, you must provide your Customs broker in writing for each line entry of food product offered for importation into the United States the following information:

  • Legal business name and address
  • Email address
  • Unique Facility Identifier (UFI) recognized as acceptable by the FDA (The Food and Drug Administration has formally recognized the Data Universal Numbering System (DUNS) number as an acceptable UFI under the Foreign Supplier Verification Program.)

When the FDA program code is FOO under industries (01-46, 48, 49, 50, 52, 54, 69, 70, 71 or 72) and the processing code is one of the following shown below, FSVP details are mandatory.

FOO – Food* Processing Codes:

  • NSF – Natural State Food
  • PRO – Processed Food
  • FEE – Animal Feed
  • DSU – Dietary Supplement
  • ADD – Additives and Colors

For the onboarding period, FDA will temporarily allow the submission of “UNK” (Unknown) as the syntax for the DUNS number for the FSV Importer.  “UNK” should only be used if the nine-digit, site-specific DUNS number is not available at the time the entry is transmitted. Customs will be issue a message later to indicate when UNK will no longer be accepted.

The National Customs Brokers & Forwarders Association of America (NCBFAA) sent a letter to the Food and Drug Administration’s Office of Enforcement and Import Operations dated April 10th expressing concern from importers over the readiness and understanding of the FSVP requirements.

For further information, please visit the FDA following resources:

If you have any questions or comments, please contact us at compliance@shapiro.com