The Business of Alt Protein: Navigating FDA’s Pre-Market Food Ingredient Evaluation Programs

Stephanie (Stiffy) A. Hice, Ph.D.

Regulatory Review Scientist and Microbiology Reviewer, Division of Food Ingredients, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, U.S. FOOD AND DRUG ADMINISTRATION

Originally from Milwaukee, WI, Dr. Stiffy Hice received their BS in Biological Science, with minors in Printmaking and Psychology, from the University of Tulsa in 2014; and their PhD in Food Science and Technology with a certificate in Food Safety and Defense from Iowa State University in 2019. After graduating from Iowa State University, Dr. Hice joined the U.S. Food and Drug Administration (FDA) in 2019 as a Regulatory Review Scientist and Microbiology Reviewer in the Division of Food Ingredients (DFI) within the Office of Food Additive Safety (OFAS). Dr. Hice has managed the review of numerous Generally Recognized as Safe (GRAS) notices—with particular emphasis on microbial-derived ingredients, bacteriophage preparations and live microbial cultures—as well as approval of direct food additive and color additive petitions that have been submitted to the Center for Food Safety and Applied Nutrition (CFSAN) at FDA. As a Regulatory Review Scientist, one of Dr. Hice’s primary duties is managing both GRAS evaluation teams and petition review teams. Many submissions have robust regulatory and scientific considerations, which must be evaluated to: (1) issue a response letter regarding the safety conclusions made by the submitter of a GRAS notice, or (2) approve a food or color additive in response to a petition. As a Microbiology Reviewer, Dr. Hice is charged with evaluating the microbiological safety of ingredients intended for use in conventional foods. Dr. Hice is also a member of several workgroups, including the Cultured Meat Premarket Consultation Working Group and the DFI Infant Formula Working Group.