How to Obtain a Certificate of Free Sale for California Based Companies
Many countries require a Certificate of Free Sale, sometimes called a "Certificate for Export" or "Certificate to Foreign Governments." The certificate of free sale is evidence that goods, such as food items, cosmetics, biologics, or medical devices are legally sold or distributed in the open market, freely without restriction, and approved by the regulatory authorities in the country of origin (United States).
OPTION 1 - L.A. CHAMBER OF COMMERCE
Cost: $50 for members; $75 for non-members
Approximate Wait Time: 5-7 business days
The L.A. Chamber requires the following for a CFS:
1. For products that are manufactured in the United States you must be able to prove this by submitting a written declaration from the manufacturer (a written declaration from your company if you are the manufacturer) stating that the products are manufactured in the United States. (one time only).
2. For each product you would like listed on the Certificate of Free Sale, your company must submit copies of invoices showing the sale of each product to a U.S. customer. The invoices should be dated within the last 12 months and the product names must be the same as how they will appear on the certificate. Please note that if you have more than one product, we can list them all on one certificate, usually up to 20 (though we will still need copies of invoices showing the sale of each product to U.S. customers).
Next Steps: You can submit your request online or call the office if you have questions. Request your CFS from the L.A. Chamber here: http://www.lachamber.com/webpage-directory/global-initiatives/initiatives-certificatesoffreesale/
OPTION 2 – STATE OF CALIFORNIA
Products covered (only for products manufactured in California): Food, Seafood, Pet Food, Drugs, Cosmetics, Medical Devices
Cost: $25 (Additional $10 if Notarization is required – check with your importer or contact us for clarification)
Approximate Wait Time: 90 days *Please note wait times have decreased. Please inquire with the State of California
Next Steps: Submit Certificate of Free Sale Application from the State of California: http://www.cdph.ca.gov/pubsforms/forms/CtrldForms/cdph8582.pdf or contact the State of California Food and Drug Branch Export Office at 916-650-6519
OPTION 3 – WORLD TRADE CENTER DENVER
Products covered: approved products
Cost: $75 for nonmembers
Approximate Wait Time: 7 days
OPTION 4 - PERSONAL CARE PRODUCTS COUNCIL
Products covered: PCPC can issue certificate of free sale to members of the Personal Care Products Council for personal care products. This program includes legalization at the DC Consulate, State Department and the requesting country Embassy.
Cost: $575 for Rush; $375 for standard
Approximate Wait Time: 10-15 business days for rush: 3-5 weeks for standard
PCPC requires the following for a CFS:
1. REQUEST FORM: Required for All Certificate Requests. The request form must be completed in its entirety.
COMPANY AFFIDAVIT: An affidavit on company letterhead signed by the authorized company official. This document must be notarized. Companies are responsible for ensuring that all statements are accurate, true and objectively verifiable at the time they are made.
FORMULA STATEMENT: If required by the importing country, qualitative or quantitative formula statements for each product must be created as separate attachments. Hard copy only must be mailed to the PCPC. Please contact your distributor to find out whether or not the country requires a Formula Statement.
SHIPPING INFORMATION: Completed Pre-Paid Waybill Required. Please send completed pre-paid waybill with your request to the PCPC.
Next Steps: Visit http://www.personalcarecouncil.org/private/certificate-free-sale-program for more information.
OPTION 5 - U.S. FOOD AND DRUG ADMINISTRATION (FDA)
Products covered: The FDA provides Certificates of Free Sale (also called Export Certificates) for cosmetics, dietary supplements, infant formulas, medical foods (includes vitamins, minerals, amino acids, herbals), food additives, plant and dairy foods and beverages, seafood, EU Animal Health and specified risk (Specified Risk Materials of Bovine, Ovine and Caprine Origin Certificate), human or animal drugs, biologics, and medical devices (please see section below on Medical Devices).
Food, Food Additives, Seafood, Dietary Supplements, and Cosmetics (FDA)
Cost: Certificates issued by CFSAN for food, food additives, seafood, dietary supplements, and cosmetics cost $10.
Approximate Wait Time: Certificates for food, 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.
Submit the online application: https://www.access.fda.gov (select ‘FURLS Certificate Application Process’). You may need to create a NEW account before you can submit a new application.
Food Export Certificate Application Step-by-Step Instructions: http://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/ucm260332.htm
Does my product qualify as a Cosmetic product? http://www.fda.gov/cosmetics/internationalactivities/exporters/ucm129593.htm
For other applications please Click here for the list of FDA Contacts (http://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/ucm151486.htm)
Human or Animal Drugs, Biologics and Medical Devices (FDA)
Cost: For export certificates for human or animal drugs, biologics and devices, 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.
Next Steps: See the sections below for information on CFS for human or animal drugs, biologics and devices
Export of Legally Marketed Medical Devices (FDA)
While FDA does not place any restrictions on the export of Legally Marketed Devices, certain countries may require written certification that a firm or its devices are in compliance with U.S. law. In such instances FDA will accommodate U.S. firms by providing a Certificate for Foreign Government (CFG). These export certifications were formerly referred to as a Certificate for Products for Export or Certificate of Free Sale. The CFG is a self-certification process that is used to speed the processing of requests. Original certificates will be provided on special counterfeit resistant paper with an embossed gold foil seal.
Cost: CDRH requires an initial fee of $175 per certificate and $15 per certificate for additional certificate(s) issued for the same product(s) in the same letter of request. Original certificates will be provided on special counterfeit resistant paper with an embossed gold foil seal.
Next Steps: Please click here for full information. You will then submit your request for a CFG on form FDA-3613, Supplementary Information Certificate to Foreign Government Requests2. Questions regarding the CFG should be directed to the Office of Compliance, Export Certificate Team, at 301-796-7400. (firstname.lastname@example.org) or Leila Lawrence 240-276-0132
Export of Unapproved Medical Devices
The FDA implemented a new certification process referred to as a Certificate of Exportability (COE) to facilitate export of an unapproved medical device. Exporters applying for a COE are required to sign a statement indicating that they meet four criteria (see link below).
Cost: CDRH requires an initial fee of $175 per certificate and $15 per certificate for additional certificate(s) issued for the same product(s) in the same letter of request. Original certificates will be provided on special counterfeit resistant paper with an embossed gold foil seal. CDRH should to issue the certification within 20 days upon the firm's showing that the product meets the applicable requirements.
Food: Food Export Certificate Application Step-by-Step Instructions: http://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Exporting/ucm260332.htm Submit the online application: https://www.access.fda.gov (select ‘FURLS Certificate Application Process’). You may need to create a NEW account before you can submit a new application.
Cosmetics: Cosmetics and Colors Certificate Export Application Does my product qualify as a Cosmetic product?
Unregulated Medical Devices: Please click here
For other applications please Click here for the list of FDA Contacts (contacts at bottom of page)
Animal Feed and Animal Drugs Exporting Animal Feed and Animal Drugs Contact: Jeremy Robbi 240-276-9227
Human Drugs Certificate of a Pharmaceutical Product Contact: Betty McRoy 301-796-3218
Biologics More information on the exportation of Biologics Contact: Kimberly Cressotti 301-827-6201