The U.S. Food and Drug Administration (FDA) recently announced a new export certification program, along with the fees that will be assessed, for certain FDA-regulated food products. The fees will apply to products, such as produce, grains, processed foods, food additives, color additives, food contact substances, and infant formula.

“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,” explained FDA Commissioner Scott Gottlieb, M.D, in an announcement about the new export certification program.

By way of background, 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. The law also authorized FDA to charge up to $175 for each certification. The FDA Food Safety Modernization Act (FSMA) of 2011 added foods to the listed of covered products.

FDA announced the fees that it will assess for issuing the export certificates for food in the September 4, 2018 Federal Register. The fee for the first certificate will be $175, the fee for the second certificate for the same product(s) issued in response the same request will be $155, and a $100 fee will be assessed for subsequent certificates issued for the same product(s) in response the same request. FDA will begin issuing and collecting fees for the new export certificates on October 1, 2018.

Prior to the launch of this new certification program, the FDA issued other types of certifications for exported foods, such as “Certificate of Free Sale” for dietary supplements, medical foods and foods for special dietary uses. FDA will continue these programs. In addition, FDA’s new export certification program for foods is intended to be complementary to export certification for foods currently issued by other U.S. government agencies.