Emerging Issues Webinar: PHO's - What Are the Challenges That Lie Ahead?

FACULTY

Ricardo Carvajal, M.S., J.D.
Director
Hyman, Phelps & McNamara PC

Ricardo 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.


Diane B. McColl
Principal
Hyman, Phelps & McNamara P.C.


Ms. McColl graduated cum laude with a B.S. in Pharmacy from the University of South Carolina in 1976.  Ms. McColl practiced pharmacy in Tennessee and South Carolina until 1984, when she earned a law degree from the University of South Carolina. She joined Hyman, Phelps & McNamara in 1989. Ms. McColl is admitted to the bars of Texas and the District of Columbia. Ms. McColl is a member of the USP Food Ingredient Expert Committee. She is president of the International Society of Regulatory Toxicology and Pharmacology, and is a professional member of the Institute of Food Technologists. In 30 years of legal practice, Ms. McColl has advised the manufacturers and marketers of conventional foods, medical foods, dietary supplements, food and color additives, and new food ingredients on compliance with the regulatory requirements for these products. She has helped develop global regulatory strategies for numerous novel food ingredients, including sugar alcohols, bulk sweeteners, processing aids, color additives and flavoring agents. She also has assisted with the preparation of food additive petitions, notifications for “generally recognized as safe” (GRAS) food ingredients, notifications for new dietary ingredients for dietary supplements and requests for “threshold of regulation” exemptions for substances used in productions of food packaging materials. In addition, Ms. McColl has assisted in evaluating, developing, and defending the labeling and advertising materials for such products.  She’s also provided guidance on issues such as health claims, nutrient content claims, nutrition labeling and “structure/functions” claims.

 

Nga L. Tran, Dr.P.H., M.P.H., CIH
Principal Scientist
, Chemical Regulation & Food Safety
Exponent


Dr. Tran has more than 20 years of experience in exposure and risk assessment. Dr. Tran has extensive experience in evaluating the safety of foods and food ingredients, additives and contaminants, feed additives, cosmetics and consumer care products. She has provided technical support and prepared a variety of reports and submissions to regulatory authorities including Generally Recognized as Safe (GRAS) affirmation petitions to the FDA and food additive submissions to Health Canada, JECFA, and EFSA. Dr. Tran also has extensive experience in conducting scientific review for the substantiation of health claims. She has developed regulatory strategies for FDA-regulated products in support of product development and claims, pre-market approval and product defense.

Dr. Tran has extensive experience dietary exposure assessment and public health risk modeling. She has successfully applied risk apportionment models to evaluate contribution of dietary and lifestyle risk factors to diseases, such as dietary cholesterol and coronary heart diseases. She has developed systematic methods of evaluating beneficial effects of food and food ingredients for substantiation of health claims and developed models to quantify health benefits of GM crops. Dr. Tran has also worked extensively on risk ranking methodologies for a wide range of risk management purposes. Her work in the risk ranking arena has included the development of tools to prioritize food risks (both chemical and microbial), environmental health risk ranking framework for military deployments, risk based site selection model to prioritize U.S pharmaceutical manufacturing sites for cGMP inspection, and exposure and risk screening methodologies for consumer personal care products. Complementary to her risk assessment work, Dr. Tran also led the development of the peer review procedures for food safety risk assessments for FDA’s Center for Food Safety and Applied Nutrition (CFSAN).


Emilia C. Lonardo, Ph.D.
Consultant
Lonardo StatReg Associates, LLC.

Emilia C. Lonardo, Ph.D. brings over 35 years of professional experience and is currently a consultant at Lonardo StatReg Associates, LLC.   Dr. Lonardo joined the Grocery Manufacturers Association (2012 – 2015) as Vice President of Consumer Product Safety and Science Policy.  At GMA she led programs to modernize GRAS and manages emerging ingredient issues including partially hydrogenated oil/trans fat. Prior to joining GMA, she was Head of Regulatory Intelligence and Policy at Johnson & Johnson. Emilia also served as Global Head of Regulatory Strategy at Novartis Consumer Health, leading emerging issue management and product stewardship. Before that at the Exxon Corporation, she held the position of Sr. Toxicologist, assessing and ensuring product safety, and authoring food additive petitions. Earlier in her career, as a board certified Medical Technologist at the Cleveland Clinic, she supervised the Immunogenetics and Histocompatibility Laboratory. Dr. Lonardo received her Bachelor of Science degree in Biology from State University New York, Master of Science degrees in Immunology & Toxicology from Colorado State College, holds a Ph.D. from LaSalle University and a law degree.


Karin Moore
Vice President and General Counsel
Grocery Manufacturers Association


Ms. Moore directs the association’s federal and state litigation activity and provides legal counsel on numerous issues. Ms. Moore joins GMA from the Wine & Spirits Wholesalers of America (WSWA) where she was vice president and co-general counsel. At WSWA, her responsibilities included coordinating the association’s national litigation strategy, advising on regulatory issues facing wholesalers at both the state and federal levels, and serving on WSWA’s senior management team. Prior to joining WSWA, Moore was a counsel with O’Melveny & Myers’ Antitrust and Criminal Defense practice groups, where she focused on antitrust litigation, civil and criminal antitrust investigations, and federal and state cartel class actions. Prior to O’Melveny, she held a variety of positions with the U.S. Federal Trade Commission’s (FTC) Bureau of Competition, including counsel to the director and staff attorney with the Anticompetitive Practices Division. She holds a law degree from George Mason University School of Law and is vice-chair of the American Bar Association Section of Antitrust Law’s Trade, Sports and Professional Associations Committee.


Leon Bruner, DVM, Ph.D.,
Executive Vice President for Scientific and Regulatory Affairs and Chief Science Officer
Grocery Manufacturers Association. 

Dr. Bruner is a twenty-three year veteran of the consumer products industry. He has served in a variety of positions at The Procter & Gamble Company and The Gillette Company. Most recently, he served as director, environment, health and safety within Procter & Gamble’s Gillette organization. He previously served as vice president, Gillette environment, health and safety from 2000 to 2007.

During his professional career, Dr. Bruner has developed a strong reputation as an innovator who is able to apply strategic vision, critical thinking and first-class execution in pursuit of business goals. He is an internationally-recognized expert in the development and application of non-animal toxicity product testing methods, and is also an expert in product safety and regulatory compliance. He has written numerous peer-reviewed journal articles and several book chapters on those subjects.

Dr. Bruner holds a Doctor of Veterinary Medicine degree and a Ph.D. in pharmacology, both earned at Michigan State University. He also received his bachelor’s degree at Michigan State.