Hyman Phelps and McNamara
Ricardo Carvajal
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(202) 737-4586
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Practice Areas
Foods and Dietary Supplements
Advertising and Promotion
OTC Drugs and Cosmetics

J.D., Northwestern University School of Law
M.S., Biology, University of Michigan

Bar Admissions
District of Columbia

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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.

Related Experience
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.

Veterinary Drugs
• Works with animal biotechnology companies to develop and implement their regulatory strategy.

Professional Affiliations
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 more articles
•  Ready or Not, CRISPR and Gene Editing Have Arrived and Are Here to Stay,  September 2016

•  HP&M Files Comments on Draft NDI Guidance; Request Withdrawal and Reissuance Reflecting DSHEA Intent,  December 2011

•  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

Speaking Engagements    -    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

Blog Posts    -    see fewer 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
•  Coalition of Consumer Advocates Challenges FDA’s GRAS Notification Final Rule,  May 26, 2017
•  To Reduce Regulatory Burdens, Citizen Petition Asks FDA to Permit Interstate Sales of Raw Milk,  May 10, 2017
•  Interagency Food Safety Analytics Collaboration Issues New Strategic Plan,  March 31, 2017
•  FDA SOT Colloquium Explores Determination of Adversity in Food Chemical Safety Evaluations,  March 21, 2017
•  How to Name that Food: The Good Food Institute Petitions FDA for Clarity,  March 8, 2017
•  FDA’s Draft Guidance on Listeria monocytogenes (In Case You Missed It),  February 14, 2017
•  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
•  HHS OIG’s Odd Take on Food Recalls,  June 22, 2016
•  FDA Rolls Out Sodium Reduction Initiative, and Salt Remains GRAS,  June 7, 2016
•  The Next Wave for Probiotics?,  April 25, 2016
•  Food Importers: Wake Up!,  March 23, 2016
•  District Court Dismisses PHO Lawsuit on Preemption Grounds,  March 15, 2016
•  48 Hours in New Orleans: Food Drugs, and Oh Right Law,  February 21, 2016
•  Something Fishy in the Appropriations Act: With GE Salmon A Side of Smoke and Mirrors,  February 18, 2016
•  Chipotle and FDA’s Reach,  February 11, 2016
•  For FSMA Consulting, It’s Buyer Beware,  January 24, 2016
•  Soy Protein and Coronary Heart Disease Health Claim Stands – For Now,  January 22, 2016
•  FDA Broadens Arsenal in Fight Against Kratom,  January 6, 2016
•  Question: What do Sodium Reduction, FOP Labeling, and Medical Foods Have in Common?,  December 16, 2015
•  A Meeting on Listeria With Potentially High Stakes,  December 2, 2015
•  Something Old, Something New: FDA’s Guidance Documents on Labeling of Genetically Engineered Foods – Including Salmon,  November 24, 2015