Ricardo Carvajal works with manufacturers and marketers of food and dietary supplements, OTC drugs, and cosmetics on a range of FDA, USDA, and FTC regulatory issues. Mr. Carvajal advises clients ranging from start-ups to multinational companies at all points in the supply chain, including bulk ingredient manufacturers, distributors of packaged goods, and retailers. He counsels clients on the regulatory status of ingredients and finished products, and provides advice on compliance with labeling and advertising requirements. He also helps clients interpret and comment on the implementation of new requirements, such as those arising from the Food Safety Modernization Act.
In enforcement matters, Mr. Carvajal counsels clients on managing inspections, responding to warning letters and other enforcement actions by federal and state regulators, and resolving import detentions. He also helps clients navigate product recalls and related corrective actions. Mr. Carvajal applies his subject matter expertise to corporate transactions, issuing opinions and conducting due diligence for acquisitions and IPOs.
Mr. Carvajal's approach to counseling clients draws on insights gained in his former role as Associate Chief Counsel at FDA, where his contributions were recognized through several team and individual awards. Mr. Carvajal serves on the Food and Dietary Supplements Committee of the Food and Drug Law Institute, and previously served as Chair of the Public Policy Outreach and Implementation Task Force of the Institute of Food Technologists. He is also a member of the European Food Law Association.
Foods and Dietary Supplements
• Evaluates the regulatory status of ingredients and guides the preparation of food additive petitions, GRAS self-determinations, and new dietary ingredient notifications.
• Provides counsel on compliance with GMP, HACCP, and preventive controls requirements, as well as on Reportable Food Registry issues and product recalls.
• Evaluates compliance with requirements applicable to health, nutrient content, and structure/function claims.
• Assists on the development and marketing of specialized products, such as medical foods.
• Advises on requirements applicable to products derived through emerging technologies, such as biotechnology and nanotechnology.
• Advises on the regulation of applicable to food contact substances.
Advertising and Promotion
• Advises clients on requirements pertaining to labeling and advertising claims in print and electronic media.
• Defends against challenges to claims by regulators, and represents clients in disputes arising through the National Advertising Division of the Council of Better Business Bureaus.
OTC Drugs and Cosmetics
• Helps companies interpret and comply with OTC monographs.
• Advises on the regulatory status of cosmetic ingredients, including color additives, and on the requirements applicable to promotional claims for cosmetic products.
Member of the Global Committee, FDLI, 2013-2015
Awards & Recognition
• Chambers USA, Food & Beverages, 2015, 2014
• Client Choice International, Product Liability, 2015, 2014
• The International Who's Who of Business Lawyers (Life Sciences), Regulatory Section, 2015 - 2016
Articles / Publications
see more articles
• Ready or Not, CRISPR and Gene Editing Have Arrived and Are Here to Stay,
• HP&M Files Comments on Draft NDI Guidance; Request Withdrawal and Reissuance Reflecting DSHEA Intent,
• On FDA And Food Ingredient Safety: Is The "Gras" Henhouse At Risk?,
December 3, 2010
• The Cost of Inadequate Substantiation,
November 5, 2010
• Publish and Perish: A Disturbing Trend in the European Union's Regulation of Nutrition Health Claims Made on Foods,
September / October 2010
see more speaking engagements
• GRAS Final Rule Webinar, September 15, 2016
• Navigating FDA’s 2016 NDI Draft Guidance: Expert Overview & Analysis, September 7, 2016
• ACI- CRN Dietary Supplements Conference, Roundup on FDA Rulemaking and Guidances Impacting the Dietary Supplements Industry, June 26, 2016
• American Bar Association Food & Supplements 6th Annual Workshop, RC Speech: Topic TBD, June 14, 2016
• Eating Insects Detroit, U.S. regulation of insect-derived foods: Past, current, and future, May 26, 2016
see more blog entries
• Will Any of FDA’s Recent Rules Wind Up On the Congressional Chopping Block?,
December 7, 2016
• FDA Updates Its Food Facility Registration Guidance,
November 9, 2016
• Draft Guidance Addresses Suppliers’ Disclosure of Uncontrolled Hazards in Foods ,
October 30, 2016
• FDA’s First Substantiation Guidance for a Conventional Food,
September 19, 2016
• GMO Labeling Bill Is A Pen Stroke Away From Becoming Law: What Comes Next?,
July 19, 2016