Hyman Phelps and McNamara
 
Ricardo Carvajal
Director
Photo of Ricardo Carvajal

(202) 737-4586
rcarvajal@hpm.com
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Practice Areas
Foods and Dietary Supplements
Enforcement
Advertising and Promotion
OTC Drugs and Cosmetics

Education
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 fewer 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
•  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
•  Corn Dry Milling Conference, Food Safety Modernization Act Update, May 19, 2016
•  CRN Regulatory Summit - The regulation of dietary supplements under DSHEA, RC Speech: The regulation of dietary supplements under DSHEA, May 5, 2016
•  GMA Science Forum - A Look Back and A Look Forward: What Does the Future Hold for the Food Industry?, RC 4/20 Panelist: A Look Back and A Look Forward: What Does the Future Hold for the Food Industry?, April 18-21, 2016
•  GMA Legal Conference: Setting the Bar for Foods, Beverage & Consumer Goods Law, Co-Speaker: FSMA Update, February 23-25, 2016
•  Tulane Environmental Law and Policy Summit, 2/19 Panel: Genetically Engineered Salmon, February 19, 2016
•  NAD and CARU Annual Conference, The Art of Reconciliation: Laws, Guidance, Standards, and Norms and their Role in Advertising Claims., September 28, 2015
•  National Advertising Division Annual Conference and Children's Advertising Review Unit Annual Conference, [RC 9/28 Moderator: “The Art of Reconciliation: Laws, Guidance, Standards, and Norms and their Role in Advertising Claims”], September 28-30, 2015
•  CLE Telephone Seminar on the Food Safety Modernization Act, 2-hour CLE telephone seminar that will provide an overview of the Food Safety Modernization Act and its anticipated impact on food businesses., October 16, 2014
•  A Workshop on GRAS Determinations for the International Society of Regulatory Toxicology and Pharmacology (, Diane McColl hosted A Workshop on GRAS Determinations for the International Society of Regulatory Toxicology and Pharmacology ("ISRTP"), October 13-14, 2014
•  FDLI - Is the GRAS Process Broken?, Is the GRAS Process Broken?, July 23, 2014
•  IFT Annual Meeting & Food Expo, Recent product, ingredient, and technology developments, and their potential business impact, June 21-24, 2014
•  ABA - 2014 Section of Litigation Food & Supplements Fourth Annual Workshop, June 5, 2014
•  Latin American Food Congress 2014: The 2nd annual Latin American Food & Beverage Industry Conference, March 4-6, 2014
•  FDLI - About FOOD WEEK 2014, February 10 - 13, 2014
•  Panelist for Litigation Roundtable, Understanding criminal prosecution of food and supplement companies (and their corporate officers) under the Food Drug and Cosmetic Act: Best practices to avoid becoming the next Jensen Farms, December 12, 2013
•  The New York Academy of Sciences: Nanomedicines - Addressing the Scientific and Regulatory Gap, Panelist for session on Global Regulation of Nanomedicines: Can We Harmonize the Guidelines?, November 21, 2013
•  FDLI Webinar - EU vs. US Health Claim Regulation, Regulation of US Health Claims, November 20, 2013
•  The Food, Drug, & Cosmetic Division of the American Society for Quality 24th West Coast Conference, Panelist for the session "Update on Dietary Supplements & FSMA"., November 8, 2013
•  Food, Drug, & Cosmetic Division of American Society for Quality 23rd West Coast Conference, Preventive Controls and Foreign Supplier Verification: Focus on Dietary Ingredients and Supplements, October 4, 2013
•  AACC International Annual Meeting, Presenting as part of a symposium titled "Food Safety in the Global Supply Chain: Facts vs. Myths", September 29- October 2, 2013
•  Institute for Food Safety and Health Annual Meeting, FSMA and Foreign Supplier Verification: Impact on Industry, September 17 - 18, 2013
•  Food Safety Summit Expo and Conference, Moderator and presenter for session titled "Impact of the US Food Safety Modernization Act on International Regulatory Policies and Trade", April 30 - May 2, 2013
•  FDLI Annual Conference, Moderator for breakout session titled "Dietary Supplements/Cosmetics/Food: Nanotechnology at a Crossroads", April 23 - 24, 2013
•  Real-World Implications of United States v. Caronia, January 31, 2013
•  Food Chemical News Conference - The Impact of FSMA on Food Importing, Food Import and FSMA Preventive Controls, December 4, 2012
•  The Food, Drug & Cosmetic Division of the American Society for Quality 23rd West Coast Conference  Dietary Supplement Global Strategies, Panel member for "Compliance Challenges" and "Enforcement Hot Topics", September 14, 2012
•  Dietary Phosphorus Consensus Conference, Phosphorous Labeling in the U.S. - Regulatory Considerations, June 26, 2012
•  ABA Section of Litigation Food & Supplements Second Annual Workshop, Panel on "The Impact of the Food Safety Modernization Act on the Food Industry", June 12, 2012
•  FDLI's Food Week Conference, Moderator for the Labeling and Advertising session, January 23 - 26, 2012
•  IFT Food Policy Impact Conference, Navigating Today's Labeling Requirements&And What's Coming Up, December 1, 2011
•  IFT Food Policy Impact: Short Course, Co-instructor: Labeling Requirements and Implications for Foods Marketed in the U.S., November 29 - 30, 2011
•  ASQ Food, Drug, and Cosmetic Division's 22nd West Coast Conference on Dietary Supplement Challenges: cGMPs, Analytical, FSMA, NDI, and More, "Food Safety Modernization Act Implementation Update" and "New Dietary Ingredients", September 30, 2011
•  ACI Food Safety Regulatory Compliance Summit, The Reportable Food Registry One Year Later: Best Practices for Reporting Events While Minimizing Exposure to Government Investigation or Private Litigation, June 15 - 16, 2011
•  IFT Annual Meeting,
  • Nutrition Labeling Requirements for FDA
  • Nutrition Labeling Requirements
  • Nutrient Content, Structure/Function and Health Claims
  • Other Claims: Production, Processing, and Marketing
  • Create and Evaluate Your Own Food Label
  • The Legal Aspects of Food Allergen Labeling and Control
, June 11 - 14, 2011
•  ABA's First Annual Workshop on Food and Supplements, Co-moderator for the session on the impact of the Food Safety Modernization Act, February 17, 2011
•  FDLI Food Week, Introduction to Food Law and Regulation, Unintended Components/Contaminants of Food, January 24 - 27, 2011
•  Personal Care Products Council Webinar, Product Labeling, Assignment Processes and Global Harmonization of INCI Names, December 2, 2010
•  FDLI Enforcement and Litigation Conference, Food and Dietary Supplements Breakout Session., October 12 - 13, 2010
•  IFT 2010 Annual Meeting and Food Expo, Labeling Requirements and Implications for Foods Marketed in the U.S. and Food Regulation: Evolutionary changes in revolutionary times, July 17 - 20, 2010
•  North American Millers' Association 2010 Division Meeting, FDA Under the Obama Administration, March 2010
•  Unither Nanomedical and Telemedical Technology Conference, Keynote Speaker, February 23 - 26, 2010
•  FDLI Introduction to Food Law and Regulation Annual Conference, Food Safety: Unintended Components/Contaminants of Food, January 26, 2010
•  Product Labeling and Process, Personal Care Products Council, November 19, 2009
•  American Society for Nanomedicine Inaugural Conference, FDA's Regulation of Nanotechnology: Current Controversies and Potential Impacts on Nanomedicine, October 24, 2009
•  NanoBiotech 2009, October 19, 2009
•  ACI FDA Boot Camp, Spotlight on Nanotechology, September 16, 2009
•  FDLI's Webinar Series on Issues and Implementation of the Food and Drug Administration Amendments Act of 2007, Reportable Food Registry, September 10, 2009
•  Thompson Publishing Webinar, Family Smoking Prevention and Tobacco Control Act, August 25, 2009
•  IFT Annual Meeting and Food Expo, Instructor on food labeling and presenter on GRAS determinations and the use of "natural" claims, June 5 - 9, 2009
•  FDA Fellows - Introduction to Food Law and Regulation, May 26 - 27, 2009
•  ACI Nanotechnology Law Webinar, The Essential Guide to the Legal & Regulatory Aspects of Nanotechnology, May 19, 2009
•  FDLI webinar: What is Natural?, 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., April 8, 2009
•  IFT FLDR mid-year meeting, 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), April 3, 2009
•  Nanotechnology Workshop at the ACI FDA Boot Camp, 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., March 31, 2009
•  ABA Audioconference: Hot Topics in Food Law II, 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., February 10, 2009
•  FDLI Dietary Supplements Conference, 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., January 29 - 30, 2009
•  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, Dietary Supplements GMPs: Are We Ready? Legal Update, September 19, 2008
•  Personal Care Products Council Webinar, Product Labeling & Process for Assigning Ingredient Names, July 10, 2008
•  IFT Annual Meeting, Co-instructor for the Food Labeling Short Course and organizer for the symposium and roundtable "What is Natural?", June 27 - July 1, 2008
•  NanoBioNexus Conference, Clearing the US and EU Regulatory Path to Product Approval - "What Similarities and Differences Exist and How Can Companies Manage the Hurdles?", April 10, 2008
•  114th International Association of Operative Millers Conference & Expo, The FDA's Direction and Management's Responsibility in Food Safety, April 2010


Blog Posts    -    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