What are FDA export certificates (Certificate of Free Sale)?
Certificate of Free Sale are certificates (not pertaining to a particular production lot or export consignment) that indicate that the particular product(s) is marketed in the United States or eligible for export, and that the particular manufacturer has no unresolved enforcement actions pending before or taken by FDA. These certificates may be issued by FDA-CFSAN or by a State governmental authority.
Which countries require an export certificate and for which products?
For a list of Export Certificate requirements by country, please visit the links under USDA Food Export Certificate Database.
What information do I need to provide when requesting an export certificate?
Step-by-step instructions are available on the FDA website for filing electronic applications.
Is there a fee for obtaining an export certificate?
Certificates issued by CFSAN for food, food additives, seafood, dietary supplements, and cosmetics cost $10. You will receive a bill for the amount due along with the completed certificates.
For export certificates for human or animal drugs, biologics and devices issued under section 801(e)(4) of the Act, the agency may charge a fee of up to $175 if the certificate is issued within 20 government working days from the time a complete request is received. This fee may vary depending on the product type, but will not exceed $175.
How long will it take before I receive the certificate and how long is it valid?
Certificates for food, dietary supplements, cosmetics, and food additives may take up to 3-8 weeks, depending on work load and regulatory status of the products and /or the company. Processing of a certificate cannot begin until all requested documents have been received.
FDA Export Certificates
The links below contain contact information for FDA food related Export Certificates. Also included below, are the PDF and online application forms for food and dietary supplement Export Certificates.
USDA Food Export Certificate Database
The United States Department of Agriculture (USDA) provides information on state-issued export certificates and a directory of state authorities. USDA’s Foreign Agricultural Service provides the Food and Agricultural Import Regulations and Standards (FAIRS) reports on foreign countries' export certificate requirements.
Association of Food and Drug Officials (AFDO)
AFDO maintains a listing of contact information of state and local regulatory officials invovled with food, animal feed, animal health, and food defense.