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

01, September 2018

The FDA has taken another concrete step towards facilitating exports to countries from the US. On August 31, the FDA announced a new export certification program for certain FDA-regulated food products that it will assess and permit to export. It will also assess and fix the fees from such companies that will be permitted to export to other markets from the US.

FDA Commissioner Scott Gottlieb said that with this certification, he hopes that federal trade will increase. The Federal Food, Drug & Cosmetic Act (FD&C Act)’s export certification is aimed at encouraging exports. The FDA will help exporters of food in the US fulfil importing country requirements for FDA certification of FDA-regulated food products. Current American food standards are considered among the most stringent in the world. Yet, a few trading partners ask for added assurance. Some of these requests include:

• Producing imported food products that meet applicable requirements
• Requesting specific language or product information on export certificates

Background

This latest export certification for food is in line with a new statutory provision to the FD&C Act, which the Congress added in 1996. Relating to any person who exports a drug, animal drug or device, this provision has the following features:

• The exporter could request that the FDA certify in writing that the exported product meets certain requirements
• The FDA shall issue such a certification within 20 days after ascertaining that the product meets those requirements
• This certification is priced at up to $175 each
• This FSMA amendment will be implemented by the FDA’s new export certification

The FDA will continue to issue the current “Certificate of Free Sale” for dietary supplements, medical foods and foods for special dietary uses. This new export certification program for foods by the FDA will not affect the arrangements currently in place for certain food commodities with other US government agencies, which will continue to remain what they are.

Initially, this provision did not include FDA-regulated foods. With the passage of the FDA Food Safety Modernization Act (FSMA) by the American Congress in 2011, foods were added to the list of covered products.

Before launching this new certification program, the FDA had been issuing other types of certifications for exported foods. This new FDA’s export certification program for foods is aimed at complementing export certification for foods currently being issued by other US government agencies.

The date for the start of issuance and collection of fees for the new export certificates is Oct. 1, 2018. The Federal Register Notice has more details.