Ricardo Carvajal Director 202-737-4586
Ricardo Carvajal

Overview

Ricardo Carvajal works with manufacturers and marketers of conventional foods and dietary supplements on a wide 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, and those applicable to the production and marketing of hemp and its derivatives.  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 an 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

Education & Admissions

Education

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

Admissions

District of Columbia

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.

Honors & Awards

  • Best Lawyers, 2023, 2024
  • 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

Speaking Engagements

  • ACI’s 8th Advanced Summit on Food Law Regulation, Compliance and Litigation, The Future is Finally Now for Cell-Cultivated Proteins: How to Harness Innovation While Mitigating Compliance Risks, April 30-May 1, 2024
  • AHPA Regulatory Congress, The claims they are a-changin, November 14, 2023
  • CHPA Regulatory Scientific & Quality Conference, Best Practices for Complaint Handling and AER Reporting  and Mission Imposter:  Protecting the Supply Chain and Product Integrity, September 18-20, 2023
  • Panelist, ACI’s Legal, Regulatory & Compliance Forum on Dietary Supplements, It’s a Matter of Interpretation:  What Can the Industry Glean About the Future of Dietary Supplement Regulation Based on Recent FDA Activity, June 28-29, 2023
  • Moderator, FDLI Food and Dietary Supplement Safety and Regulation Conference (Virtual), Panel: The Use of Bioactive Substances in Food and Dietary Supplements, March 23-24, 2023
  • FDLI Course: Introduction to Food Law and Regulation, Food Safety: Current Good Manufacturing Practices and Related Requirements; Unintended Components/Contaminants of Food, March 21-22, 2023
  • FEMA Fall Symposium, Dietary Supplement Regulation: Fact vs Fiction, October 24-26, 2022
  • FDLI Lunch and Learn, Practicing Food Law Today: What You Must Know, September 27 2022 (Virtual)
  • FDLI Food Advertising, Labeling, and Litigation Conference, Food and Dietary Supplements Legislation, Regulation, and Litigation: Key Developments Over the Past Year, September 28-29, 2022
  • FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law; Panel Moderator: CFSAN Breakout Session, June 14-15, 2022
  • ACI Virtual Dietary Supplements Legal Regulatory & Compliance Conference, Defining a ‘Dietary Supplement’ as Intended by DSHEA: Examining Questions Surrounding Synthetic Botanical Constituents, Drug Exclusions, and Other Inconsistent Interpretations of the Dietary Supplement Definition, June 23-24, 2020
  • European Food Law Association Codex Alimentarius and its importance in the current regulatory debate, From a programme to an international body: Codex Alimentarius evolution and its current challenges, October 10, 2019
  • Dietary Supplements Regulatory Summit, DSHEA Turns 25 – A Reflection, May 14, 2019
  • GMA Sciences Forum, Learning Lab Session 3: Spark your Imagination: Cannabis in the CPG Industry, March 26-27, 2019
  • 2018 IFT Food Policy Impact,  GRAS Guidance and Lawsuits, February 6, 2018
  • 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, Panel Moderator, New Food Ingredients: US and EU Requirements and Strategic Considerations, May 4-5, 2017
  • GMA Science Forum, A Look Back and A Look Forward – What Does the Future Hold for the Food Industry, April 18-20, 2017
  • Webinar, Navigating FDA’s 2016 NDI Draft Guidance: Expert Overview and Analysis, September 17, 2016
  • American Bar Association, 6th Annual  Food and Supplements Conference, June 14, 2016
  • Eating Insects Detroit Conference, U.S. Regulation of Insect-Derived Foods: Past, Current, and Future, May 26, 2016
  • Corn Dry Milling Conference, Food Safety Modernization Act, Update, May 19, 2016