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U.S. Compliance Support for Foreign Dietary Supplement Manufacturers

Supplying dietary and food supplements to the United States?

Foreign manufacturers must meet strict U.S. compliance requirements before entering this highly regulated market. At Consultare Inc. Group, we specialize in helping international companies navigate the complexities of FDA, FSVP, and U.S. import documentation to ensure full regulatory readiness.

Why U.S. Compliance Matters

• Consumer Safety and Trust: Assures buyers that your supplements are free of contaminants and misleading claims.
• Legal Access: Helps avoid detentions, import refusals, or costly recalls due to non-compliance.
• Market Entry: Several U.S. retailers and e-commerce platforms require proper documentation before listing your products.
• Brand Protection: Helps protect your reputation by demonstrating compliance with FDA regulations.

Key U.S. Compliance Documents for Dietary Supplement Imports

Each document below plays a critical role in demonstrating that your dietary or food supplements are safe, legal, and market-ready for U.S. distribution.
  • FDA Facility Registration Certificate
    • - Your manufacturing site must be registered with the U.S. FDA.
    • - Confirms your facility is recognized as a legal entity involved in supplement production.
    • - Required before manufacturing or shipping products to the U.S.
  • Hazard Analysis or HACCP Plan
    • - A documented plan identifying potential biological, chemical, or physical hazards.
    • - Confirms your facility is recognized as a legal entity involved in supplement production.
    • - Required for FDA inspection readiness and importer verification.
  • Certificate of Analysis (COA)
    • - Lab-verified results for identity, potency, purity, and safety.
    • - Used by U.S. importers to verify product compliance with FDA standards.
    • - Must cover each product batch shipped.
  • Product Specification Sheet
    • - A detailed description of the supplement’s ingredients, dosage, and physical properties.
    • - Helps ensure consistent product quality.
    • - A key part of the U.S. importer’s documentation review process.
  • Microbial / Heavy Metal Testing Reports
    • - Laboratory results showing compliance with U.S. safety thresholds.
    • - Focus on contaminants like lead, arsenic, cadmium, and mercury.
    • - Often required prior to clearance or product approval.
  • FDA-Compliant Product Label
    • - Must include required disclosures, ingredient listing, and manufacturer details.
    • - Non-compliant labels can result in border detentions.
  • Supplement Facts Panel
    • - Standard FDA panel displaying nutrients, servings, and active components.
    • - Mandatory for all U.S.-sold supplements.
    • - Formatting and accuracy are strictly enforced.
  • Import Prior Notice to FDA
    • - An electronic submission to FDA before the product arrives at a U.S. port.
    • - Must be completed accurately and timely to avoid entry refusal.
    • - Required for all dietary supplement imports.
  • Commercial Invoice
    • - Details the nature of the transaction, including declared value, product description, and buyer details.
    • - Used for customs clearance and valuation.
    • - Helps ensure transparency and trade compliance.
  • Packing List
    • - A shipment summary that lists all goods, their quantities, and packaging format.
    • - Must match physical goods to avoid inspection delays.
    • - Supports customs verification and logistics tracking.
  • Country of Origin Certificate
    • - Declaration of where the product was produced or processed.
    • - May affect U.S. labeling requirements.
    • - Commonly reviewed by importers and CBP.
  • Bill of Lading / Airway Bill
    • - A logistics document showing the origin, destination, and carrier details of the shipment.
    • - Required for all ocean or air freight shipments.
    • - Used in customs processing and shipment tracking.
  • Marketing / Website Claims Compliance
    • - Proof that all marketing, advertising, and website content follows U.S. law.
    • - Must avoid unapproved health claims or misleading language.
    • - A core part of brand and compliance review by the FTC and FDA.
  • Third-Party GMP Audit Report
    • - An audit certification from a recognized third-party body.
    • - Demonstrates adherence to Good Manufacturing Practices (21 CFR 111).
    • - Often requested by major retailers, distributors, and online platforms.
  • GMP / ISO 22000 / FSSC 22000 Certificates
    • - Certificates confirming the facility operates under recognized food safety and quality systems.
    • - Enhances credibility and supports FSVP importer verification.
    • - While not mandatory, strongly recommended.
  • Product Listing in FDA's DSLD (Optional)
    • - Voluntary listing in the Dietary Supplement Label Database.
    • - Increases product visibility and transparency for U.S. consumers and regulators.
    • - Can build brand trust in the U.S. market.
  • Structure/Function Claim Disclaimer
    • - A mandatory disclaimer for supplements that make non-disease claims (e.g., “supports digestion”).
    • - Required under 21 CFR §101.93.
    • - Must be placed properly on the product label to avoid FDA enforcement.
  • Recall / Complaint History (if requested)
    • - Records of prior recalls or consumer complaints maintained by the manufacturer.
    • - Reviewed during FSVP inspections and U.S. importer evaluations.
    • - Must be available upon request to demonstrate transparency.

    FSVP Requirements: What Foreign Manufacturers Must Know

    The Foreign Supplier Verification Program (FSVP) is a legal requirement under the U.S. Food Safety Modernization Act (FSMA). If you are a foreign manufacturer, your U.S. importer is responsible for verifying your compliance—but you must provide supporting documentation.

    Key FSVP Components Include:

  • U.S. Agent (for Foreign Facility)
    • - Your official FDA contact for communication and inspections.
  • Written FSVP Plan
    • - Hazard analysis, safety evaluations, and monitoring.
  • Qualified Individual (FSVPQI)
    • - Person responsible for the FSVP’s development.
  • FSVP Supplier Verification Activities
    • - Audits, COAs, testing, and certifications
  • Importer Identification for Entry Filings
    • - Must be accurate to avoid delays
    •

    Ensuring Readiness Before Shipping to the U.S.

    Foreign suppliers should conduct a final compliance check before export:
    • • Verify document completeness and accuracy
    • • Confirm label and Supplement Facts Panel format
    • • Align all materials with your U.S. importer and customs broker
    • • Be inspection-ready to avoid shipment detentions

    Ready to Export Your Supplements to the U.S.?

    FSVPServices.com offers expert compliance guidance, document review, and FSVP support for foreign dietary and food supplement manufacturers. Our team ensures your products are U.S.-ready from the start. 📩 Email us at: info@consultareinc.com 📞 Call us: +1-202-982-3002

    Build Your Brand. Grow With Us.

    Get Started: Contact us at info@consultareinc.com or submit your request via our online form.