U.S. Food and Drug Administration announced its new export certification program for certain FDA-regulated food products and fees it will assess for issuing new export certifications to U.S.-based manufacturers or exporters of these products. Export certification under the Federal Food, Drug & Cosmetic Act (FD&C Act) provides U.S. exporters another tool to facilitate exports to countries that import food products from the U.S.
In 1996, Congress added a new statutory provision to the FD&C Act that stated any person who exports a drug, animal drug or device may request the FDA certify in writing that the exported product meets certain requirements, and that the FDA shall issue such a certification within 20 days upon a showing that the product meets those requirements. The law also authorized the FDA to charge up to $175 for each such certification. However, this provision did not include FDA-regulated foods. When Congress passed the FDA Food Safety Modernization Act (FSMA) in 2011, it added foods to the list of covered products.
The FDA’s new export certification will implement the FSMA amendment. Prior to the launch of this new certification program, the FDA issued other types of certifications for exported foods.
The FDA’s export certification program for foods is intended to be complementary to export certification for foods currently issued by other U.S. government agencies. As the FDA launches its new export certification program for foods, the arrangements currently in place for certain food commodities with other U.S. government agencies will remain the same.
The FDA has and will continue to coordinate and work with other U.S. government agencies on export certification and will partner in interagency consultations for any new requests from foreign governments to ensure the needs of U.S. exporters are met.
The FDA will continue to issue the current “Certificate of Free Sale” for dietary supplements, medical foods and foods for special dietary uses.
