|
May 2007
Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply an "export certificate" for products regulated by the Food and Drug Administration (FDA). An export certificate contains information about a firm's regulatory status. For example:
For a list of Export Certificate requirements by country, please visit http://www.fas.usda.gov
See the application (available in PDF) for specific requirements for foods. In general, each request should be accompanied by:
"The requester hereby presents and acknowledges that the company is aware that in making this request the company is subject to the terms and provisions of Title 18, Section 1001, United States Code which makes it a criminal offense to falsify, conceal, or cover up a material fact; make any material false, fictitious, or fraudulent statement or representation; or make or use any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry."
Certificates isued 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. Animal feed export certificates are issued by the Center for Veterinary Medicine and cost $10. 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.
FDA-issued export certificates are generally valid for two (cosmetics, dietary supplements, foods) or three years (food additives which includes all color certificates).
Certificates for human and animal drugs, biologics and devices are issued within 20 government working days.
Certificates for food, feed, 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.
Certificates for seafood are usually expedited more quickly than processed foods and may be issued within a few days.