Food and Drug Branch Export Document Program
The export market, for California produced foods, drugs, and medical devices has increased significantly. Many countries require the submission of export documents issued by the California Department of Public Health before importation of California manufactured products is permitted. These documents certify that the manufacturer and its products are subject to the health standards required by the Department, and that the Department does not object to the sale of the products in California or the shipment of the products to other countries. The Department understands that exporters need these documents quickly to avoid shipping delays and unnecessary storage costs.
The California Health and Safety Code provides mechanisms to assure that adequate resources are available to provide California exporters with timely export documents. Effective July 1, 1993, this new law establishes a one-time fee of $101.71 plus an hourly charge of $80 (a minimum charge of $25) to review and process export and distributor certificates. A flat fee of $15 is charged for an official copy of a license, permit, registration, or certificate of manufacture. Please click here to download a copy of this application. PLEASE NOTE NEW ADDRESS: California Department of Public Health, Food and Drug Branch MS-7602, 1500 Capitol Avenue, Suite 72-436 , Sacramento, CA 95814.
The Department considers two primary factors in deciding whether an export document should be issued. First, the system of manufacture and quality control used to produce the products must be adequate; this is determined during our inspections of manufacturers, distributors, and wholesalers. Second, the products must be properly labeled; this is determined by a review of product labeling at the time of export document request. This review must be done at the time of the request because product labeling is typically not reviewed during the inspection process, and because existing products are being relabeled and new products introduced into the market place on a continual basis.
Our goal is to issue export documents within 15 working days of request receipt. All export document requests must be made using the linked application form and submitted to our office with the appropriate fee. If you have any questions, please contact the Export Document Processor at (916) 650-6500 or e-mail to the link above.
As of July 1, 2001, the California Department of Public Health, Food and Drug Branch (FDB), Export Certificate Program upgraded the Export Document Application procedure to better serve industry and facilitate trade in California.
For the new program to run smoothly, beginning July 1, 2003, the Department will no longer accept the old application form, as it does not interface properly with the new program, which has been tested and validated. Enclosed is the current application, which can also be accessed on-line in the future using this link: http://www.cdph.ca.gov/pubsforms/forms/CtrldForms/cdph8582.pdf.
All applicants must submit labels of the products they are exporting along with their applications and check or checks (if requesting notary). For applications submitted without labels, the Department will make one follow-up contact to request labels be submitted. If labels are not submitted within two weeks, the application will be returned. If you have more then 10 products listed on your application please email your list of products to FDBINFO@cdph.ca.gov in the MS Excel format for faster processing time.
Due to time constraints, phone calls can not be made to verify inconsistent information provided on the application. If we find discrepancies on your application, it will be returned to you for correction, and your certificate will not be issued until the corrections have been received.
The fee for each certificate is $25 and any certificates requiring special verbiage not consistent with the standard wording will cost $80 each.
If you have any questions, please contact the Export Desk Manager at (916) 650-6500.