Regulatory Status of PHOs and General Food Additive Petition Requirements Webinar

Faculty

Mical Honigfort, Ph.D., Supervisory Consumer Safety, U.S. Food and Drug Administration, Office of Food Additive Safety, Division of Petition Review received her BA in chemistry from Washington and Jefferson College and her PhD in polymer chemistry from the University of Akron.  Dr. Honigfort started at FDA/CFSAN as a Consumer Safety Officer in the Office of Food Additive Safety/Division of Petition Review in 2002 and became a group supervisor in 2012.  During her time at FDA, she has managed the review of food and color additive petitions and worked on a variety of issues related to food ingredient safety.

Andrew Zajac, Ph.D., Division Director, U.S. Food and Drug Administration, Office of Food Additive Safety, Division of Petition Review has been the Director of the Division of Petition Review in FDA’s Office of Food Additive Safety since 2006.  This division has primary responsibility at FDA for the review of petitions for food additives, including sources of radiation used to treat food, and petitions for color additives used in FDA regulated products.  He has been at FDA for more than 22 years and has worked on a wide variety of food ingredient and food packaging regulatory issues.  Prior to becoming a division director, he was a consumer safety officer and a group supervisor at FDA.  He is also a Commissioned Corps officer in the U.S. Public Health Service with the rank of Captain, and has more than 27 years of uniformed service, including five years as a U.S. Army officer.  Captain Zajac is a biomedical engineer by training.  

Ricardo Carvajal, M.S., J.D., Director, Hyman, Phelps & McNamara PC, provides FDA and FTC regulatory counseling and litigation support to manufacturers and marketers of foods (including dietary supplements and medical foods), cosmetics, and OTC drugs. He has substantial experience with all food and dietary supplement issues, including recalls, Reportable Food Registry issues, and GMP and HACCP compliance issues. He also has substantial experience with labeling and advertising issues, including those that arise from the use of health, nutrient content, structure/function, and disease claims. Mr. Carvajal counsels product developers on regulatory strategy, including requirements pertaining to self-determinations of GRAS status and determinations of new dietary ingredient status. He also serves on due diligence review teams for major acquisitions and initial public offerings, and provides expert opinions on FDA regulatory matters. He has particular expertise in the regulation of products derived through biotechnology and nanotechnology.

From 2002 to 2007, Mr. Carvajal served as Associate Chief Counsel in FDA's Office of Chief Counsel, where his work was recognized with several individual and team awards. He currently serves on the Editorial Advisory Board for the Food and Drug Law Institute Monographs, and served as Chair of the Public Policy Outreach and Implementation Task Force of the Institute of Food Technologists.

Mr. Carvajal holds a J.D. from Northwestern University School of Law and an M.S. in Biology from the University of Michigan. He is admitted to practice in the District of Columbia.