The Business of Alt Protein: Navigating FDA’s Pre-Market Food Ingredient Evaluation Programs
Webinar description
Join GFI and the FDA for a seminar on how to navigate the agency’s pre-market food ingredient evaluation programs, including the generally recognized as safe (GRAS) Notification Program, and the food and color additive petition programs. During this webinar, you’ll hear directly from the FDA about:
- The Federal Food, Drug, & Cosmetic Act (FD&C Act) as it pertains to ingredients added to conventional food
- An understanding of the pre-market review processes for food and color additive petitions (FAPs and CAPs), including timelines and FDA’s safety review of FAPs and CAPs
- An understanding of GRAS and FDA’s GRAS Notification Program, including an understanding of what GRAS means, common misconceptions about GRAS, and an overview of the GRAS Notification Program, including timelines and FDA’s safety evaluation of GRAS notices
- The “how, when, and whys” of engaging with FDA regarding your food ingredient
- Frequently asked questions
Meet the speaker
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.
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