FDA-Issued Certificate of Free Sale Processing Services
Helping You Access International Markets with Confidence
We provide streamlined, project-based assistance in obtaining a Certificate of Free Sale (CFS)—a key document that proves your product is legally sold and distributed in the United States, in compliance with the U.S. federal regulations, and are eligible for export to foreign markets. From application setup to document submission, we manage the process end-to-end, saving you time and avoiding regulatory errors.
Who This Is For
This service is ideal for manufacturers, brand owners, private labelers, or exporters seeking to sell products in international markets and who require formal proof that their products are freely sold in the United States. Common product categories include:
- • Cosmetics and personal care items
- • Dietary supplements
- • Foods for special dietary use
Scope of Services
1. Product Eligibility Verification
- • Review submitted documentation for completeness and consistency with the regulations
- • Verify regulatory compliance based on the product type (e.g., 21 CFR for food, dietary supplements, or cosmetics; FTC labeling rules)
- • Review applicable regulatory databases (e.g., FDA, CFSAN, or other federal agency guidance) to confirm the product category is permitted for sale in the U.S.
- • Check for warning letters, import alerts, or enforcement actions involving the product or company, if publicly available
- • Confirm that the product is currently distributed or intended for commercial sale in the U.S. (client must provide evidence such as screenshots, invoices, or distribution records if not yet widely marketed)
2. Documentation Collection and Review
Collect and assess all documentation required for the certificate application, including but not limited to:
- • Company and point of contact information
- • Facility information
- • Business license or company registration certificate
- • Facility process category (e.g., manufacturing, exporting, distribution, shipping)
- • Valid manufacturing license (if applicable)
- • Product information (i.e., product name, description, packaging, expiration date, value of goods, quantity to country of destination)
- • Shipping information (e.g., container/seal number, means of transport, place of loading, point of entry)
- • Product formulation and labeling details
- • GMP certification (e.g., ISO 22716, 21 CFR Part 111/117, or equivalent)
- • Country of Destination
- • Number of certificates to be requested
- • Product HTS Code (if applicable)
- • Certificate of Compliance or Marketing Authorization (if available)
- • Attestation Letter
- • Facility identifiers: FDA Establishment Identifier (FEI), Food Facility Registration (FFR), DUNS Number (if applicable)
3. FDA Industry Systems (FIS) Setup and Management
- • Register a new FIS account for the client’s facility
- • Set up access to the CFSAN eCATS portal
- • Enter the required facility and contact information
- • Facilitate linking of account to the client’s food facility registration system
- • Enter the required information for certificate issuance
4. Application Filing and Monitoring
- • Submit application via CFSAN eCATS
- • Coordinate payment of FDA fees (if applicable; paid by the client)
- • Track status of the submission and provide real-time updates
- • Respond to any requests for clarification or additional documents
5. Certificate Issuance and Verification
- • Receive the official Certificate of Free Sale
- • Review for accuracy and confirm alignment with import destination requirements
- • Forward original or digital copy to the client
Deliverables
- • Submission confirmation from the FDA portal
- • Ongoing status updates during review
- • Final issued Certificate of Free Sale
Pricing and Timeline
Service Fee: $690.00 per product
Timeline: 15 to 20 business days
Add‑on Services
- • FDA Label Compliance Review — starts at $750 per product
- • FDA Facility Registration (FFR) + DUNS Number Registration + U.S. Agent — $750 per facility;
- • HTS Code Classification Assistance — starts at $99 per product
Ready to Export With Confidence?
Let us take care of the paperwork so you can focus on global growth.
Contact us today to begin your Certificate of Free Sale application.
Services provide assessment and/or submission facilitation based on the available documentation to facilitate compliance per applicable regulations, but does not constitute assured regulatory approval, nor does it guarantee market acceptance, regulatory clearance, or product sales in the target market.