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FDA’s Quiet Reorganization of the Office of Food Additive Safety Begins Today

  • Before the Food and Drug Administration (FDA) took it down this morning, the website for the Office of Food Additive Safety (OFAS) showed three divisions for (1) Food Additive Petitions (FAPs) and Color Additive Petitions (CAPs), (2) Food Contact Notifications (FCNs), and (3) Biotechnology and Generally Recognized as Safe (GRAS) notifications.  Since the last reorganization of the Center for Food Safety and Human Nutrition (CFSAN) in 2002, these three divisions within OFAS have each had assigned teams for handling all industry submissions for new food and food-contact clearances.

  • Through informal communications with FDA regarding another issue, we were told that the Division of Biotechnology and GRAS Notifications will merge with the Division of FAPs and CAPs as of today, May 13, 2019.  The Division of FCNs will remain largely unchanged.  Further, we understand there will be an entirely new Division of Science and Technology made up of three teams responsible for special projects, biotechnology issues, and environmental reviews.  Presumably, the OFAS website will be back online shortly reflecting the new organization.

  • This major reorganization was briefly mentioned (in a single bullet listing OFAS as an office to undergo proposed reorganization) within a March 21, 2019 letter from former FDA Commissioner Scott Gottlieb to FDA staff regarding larger, multidepartment reorganization efforts.  FDA has not broadly announced these organizational changes in the divisions handling food ingredient submissions, which will include significant shifts of personnel to new positions with granular changes in employees’ responsibilities.  With FDA employees moving to different areas and taking on new responsibilities, we would not be surprised if there are some administrative delays.

© 2019 Keller and Heckman LLP


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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...