International supplement brands importing into the United States under FDA's Foreign Supplier Verification Program (FSVP) rule (21 CFR Part 1, Subpart L) generally need two distinct forms of support: an eligible U.S.-based FSVP importer identified at customs entry, and technical regulatory support (acting as or supporting the FSVP Qualified Individual) to evaluate the foreign supplier, establish specifications, and compile the verification records FDA inspects.
Blue Ocean Regulatory provides the technical and regulatory advisory support to build and maintain your FSVP compliance program, evaluate foreign manufacturer cGMP compliance, and prepare your product specifications and labels. Because Blue Ocean Regulatory is based in Canada, we do not act as the U.S. FSVP importer or U.S. agent of record; brands without their own U.S. entity must designate a separate eligible U.S. party for that role.
Separating the Two FSVP Roles
Many international founders and customs brokers conflate the legal entity listed at entry with the technical specialist who builds the verification file. Under 21 CFR § 1.500 and 21 CFR § 1.511 (the modified FSVP requirements for dietary supplements), those responsibilities work differently:
- The FSVP Importer (must be located in the United States): The FSVP importer is the U.S. owner or consignee of the dietary supplement at the time of U.S. entry. If there is no U.S. owner or consignee at the time of entry, the foreign brand must designate a U.S. agent or representative as the FSVP importer, confirmed in a signed statement of consent (21 CFR § 1.500). This party's name, U.S. address, email, and DUNS number are transmitted at customs entry, and they hold legal responsibility for ensuring FSVP obligations are met.
- The FSVP Qualified Individual / Regulatory Advisor: Under 21 CFR § 1.503, the technical verification tasks—establishing standard operating procedures (SOPs), reviewing the foreign manufacturer's compliance with 21 CFR Part 111 cGMP, verifying finished-product specifications (21 CFR § 111.70), and evaluating Certificates of Analysis (COAs)—must be performed by a Qualified Individual who has the education, training, or experience needed to perform those activities.
What Blue Ocean Regulatory Advises On—and Where You Need a Separate U.S. Party
When an international brand from Canada, the UK, the EU, or Australia prepares to sell dietary supplements in the United States, Blue Ocean Regulatory supports the technical and quality foundation of the FSVP program:
- Finished-Product Specifications & Testing Plans: Establishing written specifications for identity, purity, strength, composition, and contaminant limits under 21 CFR Part 111 so every imported lot has defensible release criteria.
- Foreign Supplier Evaluation & Dossier Compilation: Reviewing the foreign contract manufacturer's GMP audit reports, batch documentation, test methods, and COAs to assemble the technical FSVP file.
- FSVP Standard Operating Procedures (SOPs): Writing the brand's FSVP procedures for supplier approval, periodic re-evaluation, corrective actions, and recordkeeping so files can be produced promptly if FDA requests an inspection.
- U.S. Label & Claims Alignment: Reviewing packaging labels under 21 CFR Part 101 and marketing claims under the FTC Health Products Compliance Guidance before inventory ships.
How Your U.S. Corporate Footprint Affects Setup
- If your brand has an eligible U.S. entity or U.S. consignee: Your U.S. entity can serve as the FSVP importer at entry while Blue Ocean Regulatory builds the FSVP SOPs, specifications, and supplier verification files your team maintains.
- If your brand has no U.S. entity or U.S. consignee: You must engage a separate, eligible U.S.-located FSVP agent who consents in writing to act as the FSVP importer at customs entry. In that arrangement, Blue Ocean Regulatory prepares the technical compliance dossier, product specifications, and verification records that the U.S. FSVP agent requires before signing off on entry.
Preparing Before Your First Shipment Leaves the Facility
Many international brands only discover FSVP requirements when a customs broker asks for a DUNS number and FSVP importer designation while a shipment is already in transit—or after FDA places a shipment on detention. Confirming who will serve as your U.S.-located FSVP importer and assembling your 21 CFR Part 111 specifications and supplier verification records before production ships helps prevent avoidable border holds and retesting delays.