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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.
Articles / Publications
Retailers on the Radar of FDA Under the Family Smoking Prevention and Tobacco Control Act,
November/December 2009
The Family Smoking Prevention and Tobacco Control Act: An Overview,
December 2009
Seeing Red Over "Green" - The Fight Over "Organic", "Natural", and "Sustainable",
May 2009
Dermatologic Therapy,
May 9, 2009
FDA'S Implementation of FDAAA'S Food-Related Provisions: A Work in Progress,
January 2009
Surprise!...That Food Is Now a Drug,
October 2008
What is Natural?,
September 2008
Dietary Supplement GMPs: Legal Perspectives,
September 2008
Food Allergens: Legal Requirements,
September 2008
Cosmetics Labeling and Process for Assigning INCI Names,
July 2008
FDA Nutrition Labeling Requirements,
July 2008
Voluntary Labeling Claims,
July 2008
The Battle Over rbST Labeling Comes to a Draw. Next Up, Animal Clones,
May 2008
FDAAA § 912 - A Fundamental Shift in the Dividing Line Between Foods and Drugs,
April 2008
As Nanotech Goes to Market, What Lessons Can We Draw From Biotech?,
April 2008
FDA Regulation of Nanotechnology: What Are the Rules of the Road?,
February 2008
Food, Dietary Supplements, and Cosmetics,
December 2007
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