U.S. FDA announces new export certification program for certain food products

USA – 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.

According to FDA, the fees will apply to products, such as produce, grains, processed foods, food additives, color additives, food contact substances, and infant formula.

“The FDA Food Safety Modernization Act (FSMA) of 2011 authorizes us to charge fees to cover our costs associated with issuing export certificates for food.

This notice provides the fee schedule for issuing these certificates and the basis for the fees.

We have not previously exercised our FSMA authority to collect fees for export certificates issued for food for human consumption,” a statement from the announcement read.

This notice focuses on the fees to be assessed with respect to export certificates issued by the Center for Food Safety and Applied Nutrition (CFSAN) for food for human Start Printed Page 44891consumption, with the exception of dietary supplements, medical foods, and foods for special dietary use.

This notice applies to foods such as produce, grains, processed foods, food additives, color additives, food contact substances, generally regarded as safe ingredients, infant formula, and all other foods not specifically excluded.

Dietary supplements, medical foods, and foods for special dietary use are excluded from this notice.

“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 US$175 for each certification, as the FDA Food Safety Modernization Act (FSMA) of 2011 added foods to the listed of covered products.

FDA also 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 US$175, the fee for the second certificate for the same product(s) issued in response the same request will be US$155, and a US$100 fee will be assessed for subsequent certificates issued for the same product(s) in response the same request.

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.

FDA added that the fee for all subsequent certificates for the same product(s) issued in response to the same request reflects reduced FDA costs for preparing those certificates.

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