How to Obtain a Certificate of Free Sale for Companies in California

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).

Foreign governments require that the Certificate of Free Sale is issued by a federal, state, city office or a non-governmental association.  Listed below are the three options for California exporters to obtain a Certificate of Free Sale. It is essential that you verify with your overseas customer/importer whether the Certificate of Free Sale must be issued by a government agency, or if a chamber or industry association-issued certificate will be acceptable.

This information is intended for companies located in California. To find information specific to your state, please contact your local office: http://export.gov/usoffices/index.asp

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OPTION 1 – Chambers of Commerce and Industry Associations

Irvine Chamber of Commerce

https://www.greaterirvinechamber.com

http://www.irvineglobalmarkets.com/irvine-global/exporting/certificate-of-free-sale/?item=7085

Tel: (949) 660-9112

North Orange County Chamber of Commerce

www.nocchamber.com

Tel: (714) 871-3100

Costa Mesa Chamber of Commerce

http://www.costamesachamber.com/

Tel: (714) 885-9090

ICMAD (for cosmetics and personal care products)

https://www.icmad.org/programs/certificates-of-free-sale

Please check with the organizations above to confirm documentation requirements, fees, and wait times. Chambers and industry groups typically require the following to issue a CFS:

1. Proof that the products are made in the United States, usually by providing a written declaration from the manufacturer.

2. Copies of invoices showing the sale to a U.S. customer for each product that requires a CFS. They may be required to be dated within the last 12 months, and the product names on the invoice must be the same as how they will appear on the CFS certificate.

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OPTION 2 – STATE OF CALIFORNIA

California Department of Public Health – Food and Drug Branch

https://www.cdph.ca.gov/Programs/CEH/DFDCS/Pages/FDBPrograms/ExportDocumentProgram.aspx

Please check with the CDPH for required documents, fees, and wait times. CDPH submissions require a specific form, and there is a new online document request process which requires a one-time registration fee in addition to individual document fees. There is an additional fee for documents that require notarization.

Products covered: Food, Drugs, Cosmetics, Medical Devices

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OPTION 3 - U.S. FOOD AND DRUG ADMINISTRATION (FDA)

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.

Next Steps:

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

Cosmetics and Colors Certificate Export Application

Does my product qualify as a Cosmetic product?

For other applications please Click here for the list of FDA Contacts (contacts at bottom of page)

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)

Recorded Webinar of FDA’s Center for Devices and Radiological Office of Compliance

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. (exportcert@cdrh.fda.gov) 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.

Next Steps: Please click here for details on how to obtain a certificate for unapproved medical devices.

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

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