By Charles Breen, Independent Advisor for FSMA
On August 31, 2018, FDA announced a new voluntary export certification option for certain foods as authorized under FSMA, similar to that available for qualified pharmaceuticals and medical devices. This new export certification program and its associated fees will allow the agency to collect up to $175 for export certifications for food for human consumption, with the exception of dietary supplements, medical foods, and foods for special dietary use. The issuance and collection of these fees begin October 1, 2018, and are in effect for two new types of food certificates, the “Certificate to a Foreign Government” and “Certificate of Exportability.”
Prior to this announcement, CFSAN issued only a “Certificate of Export” for seafood, food additives, and food contact substances and a “Certificate of Free Sale” for foods other than seafood, dietary supplements, infant formula, medical foods, and foods for special dietary use.
Per the FDA’s Constituent Update, the “Certificate to a Foreign Government” will be available for products that meet the applicable requirements of the FD&C Act and will certify that a product (or products) may be marketed in and legally exported from the United States. The “Certificate of Exportability” will be available for export only products and will certify that a product or products meet(s) the requirements of section 801(e)(1) of the FD&C Act and may be legally exported. FDA anticipates that the new certificates will help facilitate exports by assisting industry in fulfilling importing country requirements for certification by FDA of FDA-regulated food products.
Requests for written export certification for FDA regulated products are common from foreign customers or foreign governments. In the case of food products, FDA provides, though does not require, written certification for exports in the form of certificates and lists of eligible exporters for specific products or destinations. Those U.S. companies which export foods are required to follow U.S. laws and regulations as well as those specific to the countries the products are being exported to. It is important to note that laws vary across countries and FDA does not provide any guidance for laws outside of the U.S. that companies must follow.
Most CFSAN export certificates may be obtained by completing an online application through the FDA Unified Registration and Listing Systems (FURLS) Certificate Application Process (CAP). These take several weeks to process with no expedited review option. Some foreign governments require the additional step of verifying the export certificate via apostille or authentication from the U.S. Department of State or, in cases where the certificate was issued after April 2016, a unique Certificate ID, printed in the top left corner of every certificate, may be used to independently verify whether the export certificate was issued by FDA.
EAS offers U.S. import assistance as well as assistance for companies exporting product to foreign countries via the application of a certificate of export as well as obtaining