Cargo Systems Messaging Service

CSMS #50999050 - Food and Drug Administration (FDA) Receiving Contradicting FSVP ACE Data Elements

FDA has been receiving a significant volume of Partner Government Agency (PGA) lines containing human and animal food products, to include dietary supplements, with conflicting data elements associated with the Foreign Supplier Verification Program (FSVP). Specifically, these lines contain both the Entity Role Code FSV (Foreign Supplier Verification Program Importer) in PG19, and an Affirmation of Compliance Code to indicate the product is exempt from FSVP; FSX (Product is Exempt from FSVP requirements) and/or RNE (Product is for R&E (Research and Evaluation), therefore exempt from FSVP requirements) in PG23.

Refer to PG19 and PG23 in the ‘Food Commodity Combined’ and the ‘Non-PN Food Commodity or PN Requirements Previously Met’ sections in the FDA Supplemental Guide for ACE FSVP requirements.

ACE logic will be deployed in the future to prevent transmission of these contradicting data elements. Meanwhile, filers are encouraged to correct this contradicting information as soon as possible.

Software vendors are encouraged to prevent the transmission of Entity Role Code FSV and the exemption Affirmations of Compliance (FSX or RNE) on a single PGA line to avoid this confusion for future entries.

For questions related to FDA ACE requirements contact FDA ACE Support at ACE_Support@fda.hhs.gov, Monday-Friday, 8AM-8PM Eastern.

For questions related to FDA’s FSVP requirements for human and animal food products, contact the Food Safety Modernization Act (FSMA) Technical Assistance Network (TAN) via https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-technical-assistance-network-tan.