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Mr. Carvajal provides FDA regulatory counseling to manufacturers and marketers of foods, drugs, devices, and cosmetics. He has substantial experience with regulatory issues pertaining to foods, including dietary supplements. He has worked on GMP and HACCP compliance issues, and on a wide array of labeling compliance issues, including those that arise from the use of health, nutrient content, structure/function, and disease claims. He also has experience with drug, medical device, and cosmetics issues. He has worked on due diligence review teams for major acquisitions and initial public offerings, helped manufacturers to determine the regulatory status of products, and provided advice on labeling, advertising, and promotion issues. He has particular expertise in the regulation of products derived through biotechnology and nanotechnology. From 2002 to 2007, he served as Associate Chief Counsel in FDA's Office of Chief Counsel, where his work was recognized with several individual and team awards. He is an active member of the Food and Drug Law Institute and the Institute of Food Technologists. He 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. Mr. Carvajal is a native of New Orleans, Louisiana.
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