Businesses looking to export food, dietary supplements, or cosmetics manufactured in the US may be required to present an export certificate from the FDA. This certificate represents the FDAs official attestation concerning a product’s regulatory or marketing status, based on available information at the time FDA issues the certificate (including, as appropriate, attestations provided by the person seeking the certificate). The FDA does not issue certificates for products manufactured outside of the U.S.
Depending on your product, there are different types of certificates you may apply for (Certificate fees vary):
Certificate for Cosmetics- For products that meet the definition of a cosmetic under section 201(i) of the FD&C Act (21 U.S.C. 321(i)).
Certificate to a Foreign Government- 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.
Certificate of Exportability- 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.
Certificate of Free Sale- is available only for dietary supplements, medical foods, and foods for special dietary use.
*Important note* Issuance of a certificate by the FDA does not preclude FDA from taking appropriate regulatory action against a product covered by the certificate.
Bustos Law Group is available to assist businesses in the application for export certificates.