Procedure for Obtaining Certificates for Export of Foods and Cosmetics
Q. What are Certificates of Export?
A. The Certificate of Export will generally indicate that the product(s) is regulated by the Food and Drug Administration (FDA) and that they are not at this time the subject of any enforcement action by the FDA. Such certificates are not guarantees nor a certification of the product's safety and quality. They are issued at the request of a domestic (US) company.
Q. What are the U.S. Food and Drug Administration's required provisions for issuing Certificates?
A. FDA will issue Certificates assuming the product meets the requirements of 801(e) of the Federal Food, Drug, and Cosmetics Act as follows:
- accords to the specifications of the foreign purchaser,
- is not in conflict with the laws of the country to which it is intended for export,
- is labeled on the outside of the shipping package that is intended for export, and
- the particular shipment is not sold or offered for sale in domestic commerce.
Q. What should I include when requesting a Certificate?
A. Each request should be accompanied by:
- an original label or, if no labels have been printed, a detailed draft version of the current label,
- sufficient information for each product for which a certificate is requested so the reviewer can properly identify the product
- adequate identification of the actual manufacturer of each product
- 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 of the United States Code which makes it a criminal offense to knowingly and willfully make a false and fraudulent statement or to make or use a false document in any matter within the jurisdiction of a department or agency of the United States or to knowingly and willfully falsify, conceal, or cover up by any trick, scheme or device a material fact in any matter within the jurisdiction of a department or agency of the United States"
Q. Where should I write to receive a Certificate?
A. The U.S. Food and Drug Administration's Center for Food Safety and Applied Nutrition now has five offices that process requests for Certificates of Export. When mailing your request, include the specific office address as indicated below:
Office Address
U.S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
200 C Street, S.W.
Washington, DC 20204
- Requests for exports of cosmetics and colors:
- Office of Cosmetics and Colors, HFS-100
- Requests for exports of food grade chemicals and food additives:
- Office of Premarket Approval, HFS-200
- Requests for exports of all standardized and related foods excluding seafood:
- Office of Plant and Dairy Foods and Beverages, HFS-300
- Requests for export of all seafood:
- Office of Seafood, HFS-400
- Requests for export of all dietary supplements, vitamins, minerals and herbal preparations, infant formulas, and medical foods:
- Office of Special Nutritionals, HFS-450
Q. When should I expect receipt of the Certificate? Is there a cost involved?
A. It will take approximately four to six weeks to respond to certificate requests. There is a charge of $10.00 per certificate, for which you will be billed separately.
- Industry Activities Staff (HFS-565)
- Center for Food Safety and Applied Nutrition
- Food and Drug Administration
- Public Health Service
- Department of Health and Human Services
- 200 C St. S.W.
- Washington, DC 20204
*Industry Activities Staff Brochure, July 1997 1997-SEP-04
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