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FDA Reviewing Applications for Food and Cosmetics Export Certificates

Wednesday, April 15, 2015
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is inviting comments through May 15 on forms used to request export certificates for U.S.-manufactured food and cosmetic products.

Some foreign countries require manufacturers of FDA-regulated products to provide an export certificate for the products they wish to export to that country. A certificate of free sale is a certificate (not pertaining to a particular production lot or export consignment) that indicates that the particular product 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 the FDA. The FDA’s Center for Food Safety and Applied Nutrition issues such certificates for food, food additives, seafood, dietary supplements and cosmetics. Interested persons may request a certificate by using the electronic CFSAN certificate application process or by submitting paper forms FDA 3613d for cosmetic products or FDA 3613e for food products.

The following information is requested on Form FDA 3613d: name of and contact information for the requester; name of and contact information for the exporting company (if different from requester); a designation of the type of certificate requested (general or product-specific); if product-specific, a list of the exact brand names of the products; the contact person, company name and address where the requested certificate should be sent; and the name and account number (if applicable) of the requester’s preferred carrier for delivery of the certificate. Finally, Form FDA 3613d requires the requester’s signature, the name and title of the person signing the form, and the date signed.

The following information is requested on Form FDA 3613e: name of and contact information for the manufacturer, as well as the manufacturer’s state license or registration number; name of and contact information for the exporting company (if different from manufacturer), as well as the exporting company’s state license or registration number; a description of the shipment, including the product, the common name, the manufacturer and a description or additional comments; the name of the country to which the requester of the certificate intends to ship the product; the contact person, firm name and address where the requested certificate should be sent; and the name and account number (if applicable) of the requester’s preferred carrier for delivery of the certificate. Form FDA 3613e requires the requestor to submit an original or copy of the applicable product label or labels. Finally, Form FDA 3613e requires the submitter’s signature, the name and title of the person signing the form, and the date signed.

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