FSVP (Foreign Supplier Verification Programs)
Administered by FDA
Regulatory FrameworkAudit Scope
Importer obligation under FSMA, 21 CFR Part 1 Subpart L: importers covered by the rule must develop a separate FSVP for each food and each foreign supplier, verifying the food is produced in line with applicable U.S. safety standards. For dietary supplements, 21 CFR 1.511 sets modified requirements along several pathways; under § 1.511(c) verification keys on whether the supplier's processes and procedures provide the same level of public health protection as those required under 21 CFR Part 111, rather than on documentary proof of literal Part 111 compliance. Part 111 itself does reach imports — 21 CFR 111.1(a) covers a dietary supplement that is imported or offered for import. Coverage is not universal: 21 CFR 1.501 exempts several categories, including juice and seafood from HACCP-compliant suppliers, certain alcoholic beverages, food imported for research or personal consumption, U.S. food exported and returned unprocessed, and USDA-regulated meat, poultry, and egg products.
What It Proves
A vendor citing FSVP is stating that, where it acts as a covered FSVP importer, it maintains the supplier-verification program 21 CFR Part 1 Subpart L requires, developed per food and per foreign supplier, with records available to FDA on request.
What It Does Not Prove
FSVP is a LEGAL REQUIREMENT for covered importers, not a certification, and there is no certificate or public registry to verify the claim. Does NOT cover every import: 21 CFR 1.501 exempts categories such as juice and seafood from HACCP-compliant suppliers, certain alcoholic beverages, and USDA-regulated meat, poultry, and egg products, and dietary supplements follow modified requirements under 21 CFR 1.511. Does NOT mean FDA has audited or approved the importer or its foreign suppliers. Does NOT apply to domestically manufactured products or ingredients. Does NOT substitute for the foreign manufacturer's own 21 CFR Part 111 cGMP compliance.
How Vendors Report It
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