Self-Determined GRAS Webinar

Faculty

Dr. Antonia (Toni) Mattia, Division Director of Biotechnology and GRAS Notice Review, Food and Drug Administration earned a Ph.D. degree in pharmacology at the University of Maryland, Baltimore, MD in 1985. Dr. Mattia joined the FDA in 1991 following time spent conducting research at the University of Maryland and the University of Arizona. Since joining FDA, Dr. Mattia has participated in the safety assessment of food ingredients and contaminants as a toxicology reviewer, team leader and supervisor in the Office of Food Additive Safety in FDA’s Center for Food Safety and Applied Nutrition (CFSAN). Since the mid-90s, Dr. Mattia has also participated in food ingredient safety assessments internationally as a member and invited scientist serving the FAO/WHO Joint Expert Committee on Food Additives. Currently, Dr. Mattia is the Director of the Division of Biotechnology and GRAS Notice Review in CFSAN’s Office of Food Additive Safety. In this position, Dr. Mattia has oversight of FDA’s GRAS Notification Program and Biotechnology Consultations. In addition, she is responsible for post-market technical evaluations, including consideration of scientific as well as regulatory issues, for ingredients added directly to food and plants bioengineered for food uses.

Richardo Carvajal, J.D., Associate, 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.