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Brian Sylvester Weighs In on FDA’s New Food Export Certificate Program

Inside Health Policy’s FDA Week
September 10, 2018

Brian P. Sylvester, special counsel in Wiley Rein’s Food, Drug and Medical Device and Consumer Product Regulation practices, was quoted by Inside Health Policy’s FDA Week in a September 6 article concerning the U.S. Food and Drug Administration’s (FDA) recently announced food export certificate program.

Mr. Sylvester noted that the new program echoes existing FDA certifications programs tailored to exports of pharmaceuticals and medical devices. In the context of food, he explained that “many foreign governments seek official assurance that products exported to their countries may be marketed in the U.S. or meet specific U.S. regulations” and noted that “an FDA export certificate may be relied upon by foreign governments as a key tool in this regard.”

He further noted that this new certification program is “meant to complement existing export certificates for food such as the ‘Certificate of Export’ for seafood, food additives and food contact substances”, as well as the ‘Certificate of Free Sale’ for foods other than seafood, dietary supplements, infant formula, medical foods, and foods for special dietary use.”

While clarification is still needed on certain points — such as whether companies violating FDA safety rules will lose their export certificates — Mr. Sylvester predicted that additional guidance may be forthcoming to supplement the program description recently added to FDA’s website. For now, he said the certificates generated from this new program will facilitate “and perhaps boost” trade by allowing exporters to assure foreign governments that their products are officially up to U.S. standards.

To read the article, click here (subscription required).