Country of Origin Certificate – Required for Customs & Labeling Compliance
A Country of Origin Certificate verifies the country where your dietary supplement is manufactured, processed, or assembled. While not required by the FDA, it is mandated under 19 CFR Part 134 by U.S. Customs and Border Protection (CBP) for imported goods—and is often essential for labeling, trade compliance, and platform requirements.
Who Needs It?
- • Foreign Manufacturers & Exporters shipping dietary supplements to the U.S.
• U.S. Importers & Distributors managing customs documentation
• Amazon FBA & Retail Sellers needing country declarations on packaging
• Private Label Brands selling across global markets or applying for certifications
Why It’s Required:
- • Required by U.S. CBP for all imported goods entering the U.S.
• Must match the label’s country of origin statement
• Used in customs classification, tariff assessment, and port clearance
• Requested by eCommerce platforms, retailers, and international buyers
What’s Included:
- • Country of Origin Certificate Drafting
• Manufacturer/Processor Details Formatting
• Tariff Code Cross-Reference (if needed)
• Origin Statement for Label & Documentation Alignment
• Final Certificate in Editable + PDF Format
• Optional Custom Wording for Trade Agreements or Buyer Requests
What’s Included:
- • FDA Facility Registration (New or Renewal)
• U.S. Agent Appointment (for foreign facilities)
• Registration Confirmation and Number
• Biennial Renewal Reminders & Monitoring
• FDA Compliance Guidance & Support
Pricing:
| Service | Standard Price | Support360 Member Price (50% Off) |
|---|---|---|
| Country of Origin Certificate Setup | $150 | $75 |
- Support360 Members save 50% on all customs documentation services, including Country of Origin Certificates, Commercial Invoices, and Packing Lists.
Non-Compliance Can Lead To:
- • Shipment delays or rejections at U.S. ports
• Labeling issues or FTC violations
• Amazon or Walmart takedowns for incomplete origin details
• Missed trade benefits under origin-based agreements (e.g., USMCA)
