FDA helps facilitate trade between U.S. and foreign trading partners with new export certification program for food

FDA News Release

• For Immediate Release: August 31, 2018

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Today the 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.

“We anticipate that this new export certification will facilitate trade by assisting U.S. food exporters in fulfilling importing country requirements for FDA certification of FDA-regulated food products,” said FDA Commissioner Scott Gottlieb, M.D. “While American food standards are among the most stringent in the world, the FDA recognizes that some U.S. trading partners seek additional assurance that imported food products are produced under applicable requirements, and may request specific language or product information on export certificates. The new export certification program will continue FDA’s efforts to help facilitate American global exports and boost our nation’s economy.”

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.

The FDA will begin issuing and collecting fees for the new export certificates starting Oct. 1, 2018. For more information, see the Federal Register Notice.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics,