U.S. Compliance Support for Foreign Dietary Supplement Manufacturers
Planning to supply dietary supplements to the United States?
Foreign manufacturers must meet stringent U.S. compliance requirements before entering one of the world’s most highly regulated markets. At DietarySupplements.pro, we specialize in helping international companies navigate FDA, FSVP, and import documentation requirements to ensure your supplements are market-ready.
Why U.S. Compliance Matters
- • Consumer Trust: Showcase that your supplements are safe, high-quality, and trustworthy.
• Market Access: Avoid costly detentions, import refusals, and recalls.
• Retail Readiness: U.S. retailers and online platforms require proper documentation before listing your products.
• Brand Protection: Compliance protects your reputation and builds credibility with consumers and regulatory agencies.
Essential U.S. Compliance Documents for Supplement Imports
- Each of these documents plays a critical role in proving that your supplements meet U.S. regulatory standards:
| Document | Purpose |
|---|---|
| FDA Facility Registration Certificate | Legally register your manufacturing site with the U.S. FDA—mandatory before manufacturing or exporting to the U.S. |
| Hazard Analysis / HACCP Plan | Identify and manage risks to ensure FDA inspection readiness and importer verification. |
| Certificate of Analysis (COA) | Lab reports verifying identity, potency, and purity for each batch. |
| Product Specification Sheet | Detailed supplement composition, dosage, and quality standards. |
| Microbial / Heavy Metal Testing Reports | Verification of safety against U.S. limits for contaminants like lead and mercury. |
| FDA-Compliant Product Label | Ensure labels meet all U.S. FDA disclosure and format requirements. |
| Supplement Facts Panel | Accurate nutritional information displayed in FDA-approved format. |
| Import Prior Notice to FDA | Advance notification to the FDA for each incoming shipment—required for customs clearance. |
| Commercial Invoice | Full transaction details to facilitate customs processing and valuation. |
| Packing List | Itemized list to match physical shipment—supports efficient customs inspections. |
| Country of Origin Certificate | Confirm manufacturing origin—critical for labeling and trade compliance. |
| Bill of Lading / Airway Bill | Transportation documents required for freight movement and customs verification. |
| Marketing / Website Claims Compliance | Review and align product claims to FDA and FTC guidelines—avoid enforcement actions. |
| Third-Party GMP Audit Report | Prove your facility’s compliance with Good Manufacturing Practices (21 CFR 111). |
| GMP / ISO 22000 / FSSC 22000 Certificates | Strengthen credibility with third-party food safety certifications. |
| Product Listing in FDA's DSLD (Optional) | Voluntary listing to enhance transparency and consumer trust. |
| Structure/Function Claim Disclaimer | Mandatory disclaimer placement for structure/function claims under 21 CFR §101.93. |
| Recall / Complaint History (if requested) | Maintain transparency with documented safety history for FSVP inspections. |
Understanding FSVP: Foreign Supplier Verification Program
- The Foreign Supplier Verification Program (FSVP) is a legal requirement under FSMA for all foreign dietary supplement suppliers.
Key FSVP components include:
- • U.S. Agent: Your FDA-registered point of contact for inspections and communication.
• Written FSVP Plan: Hazard analysis and supplier evaluations.
• Qualified Individual (FSVPQI): Certified personnel to manage FSVP requirements.
• Supplier Verification Activities: COA reviews, audits, lab testing, and certifications.
• Importer Identification: Correct importer listing in every U.S. customs entry.
Understanding FSVP: Foreign Supplier Verification Program
- Ensure your shipment is U.S.-ready by:
- • Verifying document completeness and accuracy.
• Reviewing all labels and Supplement Facts Panels for compliance.
• Coordinating with your U.S. importer and customs broker.
• Preparing for inspection to prevent costly delays.
Ready to Export Your Supplements to the U.S.?
- DietarySupplements.pro provides:
- • Expert U.S. compliance guidance.
• Comprehensive document preparation and review.
• Full FSVP support for foreign dietary supplement manufacturers.
