ADVERTISING AND PROMOTION PRESCRIPTION DRUGS AND BIOLOGICS CONTROLLED SUBSTANCES PDMA AND STATE LICENSING OTC DRUGS AND COSMETICS MEDICAL DEVICES IN VITRO DIAGNOSTIC DEVICES FOODS AND DIETARY SUPPLEMENTS ANIMAL DRUGS AND FEEDS TISSUE PRODUCTS PRODUCT JURISDICTION AND COMBINATION PRODUCTS HEALTH CARE FEDERAL TRADE COMMISSION CONSUMER PRODUCT SAFETY COMMISSION TOBACCO TRAINING PROGRAMS ENFORCEMENT OTHER MATTERS FIRM NEWS CURRENT DEVELOPMENTS IN THE LAW CONFERENCES Ricardo Carvajal (202) 737-4586 RCarvajal@hpm.com Download Vcard Secretary: Cora Seballos (202) 737-4598 cseballos@hpm.com + Articles / Publications + Blog Postings - Speaking Engagements 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.   Speaking Engagements   IFT 2010 Annual Meeting and Food Expo,  July 17 - 20, 2010   Labeling Requirements and Implications for Foods Marketed in the U.S. and Food Regulation: Evolutionary changes in revolutionary times   North American Millers' Association 2010 Division Meeting,  March 2010   FDA Under the Obama Administration   Unither Nanomedical and Telemedical Technology Conference,  February 23 - 26, 2010   Keynote Speaker   FDLI Introduction to Food Law and Regulation Annual Conference,  January 26, 2010   Food Safety: Unintended Components/Contaminants of Food   Product Labeling and Process,  November 19, 2009   Personal Care Products Council   American Society for Nanomedicine Inaugural Conference,  October 24, 2009   FDA's Regulation of Nanotechnology: Current Controversies and Potential Impacts on Nanomedicine   NanoBiotech 2009,  October 19, 2009   ACI FDA Boot Camp,  September 16, 2009   Spotlight on Nanotechology   FDLI's Webinar Series on Issues and Implementation of the Food and Drug Administration Amendments Act of 2007,  September 10, 2009   Reportable Food Registry   Thompson Publishing Webinar,  August 25, 2009   Family Smoking Prevention and Tobacco Control Act   IFT Annual Meeting and Food Expo,  June 5 - 9, 2009   Instructor on food labeling and presenter on GRAS determinations and the use of "natural" claims   FDA Fellows - Introduction to Food Law and Regulation,  May 26 - 27, 2009   ACI Nanotechnology Law Webinar,  May 19, 2009   The Essential Guide to the Legal & Regulatory Aspects of Nanotechnology   FDLI webinar: What is Natural?,  April 8, 2009   Industry perspectives on the use of "natural" claims in the labeling of foods, including recent court cases and challenges brought before the National Advertising Division regarding advertisers' use of the claim. Also addressed was the question of whether "natural" claims are preempted under the FDCA. A recording of the webinar can be purchased here.   IFT FLDR mid-year meeting,  April 3, 2009   FDA's implementation of the food-related provisions of the FDA Amendments Act of 2007 (namely the prohibition in FDCA section 301(ll) on the addition of "drugs" to food, and the requirement in section 417 that FDA institute a Reportable Food Registry)   Nanotechnology Workshop at the ACI FDA Boot Camp,  March 31, 2009   An introduction to the science of nanotechnology, an overview of the National Nanotechnology Initiative, and a review of FDA's regulatory approach to products derived through nanotechnology.   ABA Audioconference: Hot Topics in Food Law II,  February 10, 2009   Differences between FDA's regulation of contaminants and its regulation of unsafe food additives and an update of the controversy surrounding the use of bisphenol A in food contact articles.   FDLI Dietary Supplements Conference,  January 29 - 30, 2009   Formulation and Review of Structure/Function Claims and Health Claims for Dietary Supplements Emerging Topics, which addressed section 301(ll) of the FDCA, regulation of dietary supplement/OTC combination products, and Proposition 65 issues. A recording of the conference presentations can be purchased here.   INCI Nomenclature Workshop for the Personal Care Products Council,  October 20, 2008   IFT Webinar: What is Natural?,  September 25, 2008   Food, Drug, & Cosmetic Division of the American Society for Quality 19th West Coast Conference,  September 19, 2008   Dietary Supplements GMPs: Are We Ready? Legal Update   Personal Care Products Council Webinar,  July 10, 2008   Product Labeling & Process for Assigning Ingredient Names   IFT Annual Meeting,  June 27 - July 1, 2008   Co-instructor for the Food Labeling Short Course and organizer for the symposium and roundtable "What is Natural?"   NanoBioNexus Conference,  April 10, 2008   Clearing the US and EU Regulatory Path to Product Approval - "What Similarities and Differences Exist and How Can Companies Manage the Hurdles?"   114th International Association of Operative Millers Conference & Expo,  April 2010   The FDA's Direction and Management's Responsibility in Food Safety