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 helps clients interpret and comment on the implementation of new requirements, such as those arising from the Food Safety Modernization Act. He also has expertise in FDA's regulation of bioengineered plants and animals.
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 he counseled the agency on a variety of rulemaking and enforcement activities and policy initiatives. Mr. Carvajal has served on the Food and Dietary Supplements Committee and the Global Committee of the Food and Drug Law Institute, and as Chair of the Public Policy Outreach and Implementation Task Force of the Institute of Food Technologists. He is also a member of the American Bar Association nd 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.
• Works with animal biotechnology companies to develop and implement their regulatory strategy.
Food and Drug Law Institute
Institute of Food Technologists
American Bar Association
European Food Law Association
Awards & Recognition
• Chambers USA, Food & Beverages, 2017, 2016, 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 fewer 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
• Retailers on the Radar of FDA Under the Family Smoking Prevention and Tobacco Control Act,
• The Family Smoking Prevention and Tobacco Control Act: An Overview,
• Seeing Red Over "Green" - The Fight Over "Organic", "Natural", and "Sustainable",
• Dermatologic Therapy,
May 9, 2009
• FDA'S Implementation of FDAAA'S Food-Related Provisions: A Work in Progress,
• Surprise!...That Food Is Now a Drug,
• What is Natural?,
• Dietary Supplement GMPs: Legal Perspectives,
• Food Allergens: Legal Requirements,
• Cosmetics Labeling and Process for Assigning INCI Names,
• FDA Nutrition Labeling Requirements,
• Voluntary Labeling Claims,
• The Battle Over rbST Labeling Comes to a Draw. Next Up, Animal Clones,
• FDAAA § 912 - A Fundamental Shift in the Dividing Line Between Foods and Drugs,
• As Nanotech Goes to Market, What Lessons Can We Draw From Biotech?,
• FDA Regulation of Nanotechnology: What Are the Rules of the Road?,
• Food, Dietary Supplements, and Cosmetics,
see more speaking engagements
• EFLA EU-US Food Law Conference 2017, September 28, 2017
• ACI Conference on Dietary Supplements, FSMA Update: What Dietary Supplement Manufacturers Need to Know Now, June 26-28, 2017
• FDLI Annual Conference, New Food Ingredients: US and EU Requirements and Strategic Considerations, May4-5, 2017
• GMA Science Forum, A Look Back and A Look Forward – What Does the Future Hold for the Food Industry, April 18-20, 2017
• GRAS Final Rule Webinar, September 15, 2016
see more blog entries
• FDA Finalizes Guidance on Mosquito-Related Products (Including Genetically Engineered Mosquitoes),
October 24, 2017
• Could The Delaney Clause Rear Its Head Yet Again?,
October 5, 2017
• FDA Releases Food Safety Plan Software,
August 22, 2017
• Deregulatory Agenda Notwithstanding, the Enforcement Side of the House is Open for Business,
July 27, 2017
• GMO Labeling And The ANPRM That Wasn’t,
June 29, 2017