FDA Export Certificate - Certificate of Free Sale

FDA Certificates for food, dietary supplement and cosmetics

Foreign business and governments often asked for FDA certificates for products exporting form the U.S. FDA is issuing a certificate of free sale also known as FDA export certificate, to US firms that manufacture food, dietary supplements, cosmetics and food additives. The certificate indicates that the product is marketed in the U.S. or eligible for export and the manufacturer has no pending enforcement action before FDA.

The “Certificate to a Foreign Government” is available for conventional foods, food additives, food contact substances, and infant formula that meet the applicable requirements of the FD&C Act for marketing in the United States. This certificate states, among other things that a product (or products) may be marketed in and legally exported from the United States. The fee for this certificate is $175 for the first certificate, $155 for the second certificate for the same products(s) issued in response to the same request, and $100 for each subsequent certificate for the same product(s) issued in response to the same request.

The “Certificate of Exportability” is available for conventional foods, food additives, food contact substances, and infant formula products that cannot be legally marketed in the United States but that meet the requirements of section 801(e) of the FD&C Act and may be legally exported. This certificate states that a product (or products) meet(s) the requirements of section 801(e)(1) of the FD&C Act and may be legally exported. The fee for this certificate is $175 for the first certificate, $155 for the second certificate for the same products(s) issued in response to the same request, and $100 for each subsequent certificate for the same product(s) issued in response to the same request.

The “Certificate of Free Sale” is available only for dietary supplements, medical foods, and foods for special dietary use. FDA does not charge a fee for this certificate.

The "Certificate for Cosmetics" is issued for products that meet the definition of a cosmetic under section 201(i) of the FD&C Act (21 U.S.C. 321(i)). FDA does not issue these certificates for products marketed with drug claims, such as cleansers with acne treatment claims. The fee for this certificate is $10 per certificate.

FDA Fees for the above certificates may change, please visit the FDA export certificate website for the most recent fee schedule

Liberty Management Group Ltd. assists food, dietary supplement and cosmetic manufacturers in FDA export certificate application requirements.


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