FDA launches new export certification program to make trade easier

03 Sep 2018 --- The US Food and Drug Administration is helping to facilitate trade between the US and foreign partners with the launch of its new export certification program for specific FDA-regulated food products which includes fees for issuing new export certifications to US-based manufacturers or exporters of these products.

Export certification under the Federal Food, Drug & Cosmetic Act (FD&C Act) provides US exporters with another tool to facilitate exports to countries that import food products from America.

“We anticipate that this new export certification will facilitate trade by assisting US food exporters in fulfilling importing country requirements for FDA certification of FDA-regulated food products,” said FDA Commissioner Scott Gottlieb. 

“While American food standards are among the most stringent in the world, the FDA recognizes that some US 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 specific 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 US$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.

Prior to the launch of this new certification program, the FDA issued other types of certifications for exported foods. However, new export certification will implement the FSMA amendment. 

The new export certification program for foods is intended to be complementary to export certification for foods currently issued by other US government agencies. 

As the FDA launches its new export certification program for foods, the arrangements currently in place for specific food commodities with other US government agencies will remain the same. 

The federal agency will continue to coordinate and work with other government agencies on export certification and will partner in interagency consultations for any new requests from foreign governments to ensure the needs of US exporters are met and will continue to issue the current “Certificate of Free Sale” for dietary supplements, medical foods and foods for particular nutritional uses.

The FDA will begin issuing and collecting fees for the new export certificates starting October 1, 2018.