Export Certificates for Foods and Cosmetics:
Questions and Answers

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• What are FDA export certificates (certificates of free sale, etc.)?

  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:

  • Certificates of Free Sale are certificates (not pertaining to a particular production lot or export consignment) that state that the particular product(s) is produced in the United States, that it is marketed in the United States, and that the particular manufacturer has no unresolved enforcement actions pending before or taken by FDA. These certificates may be isuued by FDA-CFSAN or by State governmental authority.

• Which countries require an export certificate and for which products?

  For a list of Export Certificate requirements by country, please visit http://www.fas.usda.gov

• What information do I need to provide when requesting an export certificate?

  See the application (available in PDF) for specific requirements for foods. In general, each request should be accompanied by:

  1. *original label(s) electronic file, or for new products where labels have yet to be printed, send detailed draft version(s)
  2. additional information, if needed, to identify the product(s),
  3. *adequate identification of the manufacturer of each product,
  4. submission of a Product List (supplied by the requester) to accompany each certificate (required only by the Office of Cosmetics and Colors)
  5. information on where the certificate should be sent, and
  6. the following statement:

     "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."

  * Not required by the Office of Cosmetics and Colors. For further information, please visit their website: Exporting Cosmetics.

• Is there a fee for obtaining an export certificate?

  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.

• How long will it take before I receive the certificate and how long is it valid?

  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.