Law Library

U.S. Food and Drug Administration
Center for Food Safety & Applied Nutrition
Industry Affairs Staff Brochure
February 1995


 

      Procedure for Obtaining

             Certificates for Export of Foods and Cosmetics

 

 

Q.  What are Certificates of Export?

 

A.  Certificates of Export generally indicate that the product can

be freely sold in the United States and that there are no known

safety concerns about the product or the company that manufactures

it.  Such certificates are not guarantees and are usually issued

only when a country or a foreign company requests them.

 

Q.  What are the U.S. Food and Drug Administration's required

provisions for issuing Certificates?

 

A.  FDA will issue Certificates provided the firm and the

product(s) meet the requirements of 801 (e) of the Federal Food,

Drug, and Cosmetics Act as follows:

 

(1) accords to the specifications of the foreign purchaser,

 

(2) is not in conflict with the laws of the country to which it is

intended for export,

 

(3) is labeled on the outside of the shipping package that is

intended for export, and

 

(4) is not sold or offered for sale in domestic commerce.

 

 

Q.  What should I include when requesting a Certificate?

 

A.  Each request MUST be accompanied by an original label or a

legible facsimile and sufficient information about any unusual

ingredient for each product for which a certificate is requested so

the reviewer can make a proper evaluation; AND a check for $10.00

per certificate, made payable to the U.S. Food and Drug

Administration.

 

 

Q.  Where should I write to receive Certificate?

 

A.  The U.S. Food and Drug Administration's Center for Food Safety

and Applied Nutrition now have five office that process requests

for Certificates of Export.

 

When mailing you 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

 

Request for exports of cosmetic 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 exprots 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 supplement, 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?

 

A.  It will take approximately four weeks to respond to Certificate

requests.

 

 

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: February 1995

 


01/17/1997