Ricardo Carvajal

Practice Areas

Ricardo works with manufacturers and marketers of foods (including dietary supplements) on a wide range of FDA, USDA, and FTC regulatory issues. He 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 electronic retailers. He counsels clients on the regulatory status of ingredients and finished products, including those produced through novel technologies. He advises on compliance with labeling and advertising requirements, and represents advertisers in challenges brought through the National Advertising Division. He also helps client manage and respond to inspections, adverse regulatory findings, and potential recall situations.

Career

Ricardo began his food regulatory career as an Associate Chief Counsel for Foods at the U.S. Food and Drug Administration, where he advised the agency on development of regulations and guidance documents, reviewed warning letters, and helped provide technical assistance on proposed legislation to Congress. Since joining Hyman, Phelps & McNamara in 2008, his practice has continued to focus primarily on food regulation.

Professional Memberships

Ricardo is member of the Food and Drug Law Institute and currently serves on its Board of Directors. He is also a member of the American Bar Association, the Institute of Food Technologists, and the European Food Law Association.

Publications

Publications include:  “FDA Deskbook: A Compliance and Enforcement Guide,” Practicing Law Institute, 2017 - 2024, contributing author.

 “History of EFLA ∙ EFLA’s Contributions to Comparative Law: A U.S. Perspective,” European Food and Feed Law Review, Volume 18 (2023), Issue 2, Pages 91 – 92.

 “The current understanding of the benefits, safety, and regulation of cannabidiol in consumer products,” Food Chem Toxicol 2021 Nov:157:112600 (co-author).

 “Regulation of Food Formulation, Manufacturing, Labeling, and Advertising: A Primer, Farm to Fork,” Food Law: A Practical Guide, American Bar Association, September 20, 2021.

 “Disclosure Under the National BE Standard for Dietary Supplements,” RAPS Regulatory Focus, June 30, 2021, co-author.

 “Perspective: Guiding Principles for the Implementation of Personalized Nutrition Approaches That Benefit Health and Function,” Advances in Nutrition 2020 Jan; 11(1): 25–34, co-author.

 “Ready or Not, CRISPR and Gene Editing Have Arrived and Are Here to Stay,” FDLI Update, July/August 2016, co-author.

 “Food Safety Regulations Applied to Traditional and Ethnic Foods,” Regulating Safety of Traditional and Ethnic Foods, 1st ed., Academic Press, 2015, co-author.

 “The Case in the USA: Safety Alerts and the Reportable Food Registry,” From Agricultural to Food Law: The New Scenario, Wageningen Academic Publishers, 2014.

 “A Primer on Food Law,” Handbook of Nutrition and Food, 3rd Ed., CRC Press, 2014.

 “On FDA And Food Ingredient Safety: Is The ‘GRAS’ Henhouse At Risk?,” Legal Backgrounder, Washington Legal Foundation, Vol. 25 No. 36, December 3, 2010, lead author.

 “The Cost of Inadequate Substantiation,” On the Front Burner, Food Chemical News, Vol. 52 No. 34, November 5, 2010, co-author.

 “Publish and Perish: A Disturbing Trend in the European Union’s Regulation of Nutrition Health Claims Made on Foods,” Food and Drug Law, Regulation and Education Update, Food and Drug Law Institute, September 2010, co-author.

 “GRAS Status of Food Ingredients in the U.S. – A Closer Look,” World of Food Ingredients, November 2009.

 “Drugs and other product choices,” Dermatologic Therapy, Vol. 22, 216–224 (2009), co-authored.

 “Seeing Red Over ‘Green’ – The Fight Over ‘Organic,’ ‘Natural,’ and ‘Sustainable,’” Business Law Today, American Bar Association, May 2009, lead author.

 “FDA’s Implementation of FDAAA’s Food-Related Provisions: A Work in Progress,” Food and Drug Law, Regulation and Education Update, Food and Drug Law Institute, January 2009, lead author.

 “Surprise!...That Food Is Now a Drug,” Food Technology Magazine, Institute of Food Technologists, October 2008, lead author.

 “The Battle Over rbST Labeling Comes to a Draw. Next Up, Animal Clones,” Thompson’s Guide to U.S. Food Labeling Law, May 2008.

 “FDA Amendments Act § 912 – A Fundamental Shift in the Dividing Line Between Foods and Drugs,” Insighter, Food and Drug Law Institute, April 2008, co-authored.

 “Food Labeling and Advertising: Much Ado About ‘Natural,’” Food and Drug Law, Regulation and Education Update, Food and Drug Law Institute, January/February 2008, co-authored.

 “Drugs, Dietary Supplements, and Functional Foods: Distinctions Without a Difference?” Life Sciences Newsletter, American Health Lawyers Association Life Sciences Practice Group, Fall 2007.

 “Risk Mitigation Strategies For Manufacturers of Nanomaterials,” Food and Drug Law, Regulation and Education Update, Food and Drug Law Institute, September/October 2007, co-authored.

 “New Food Labeling Requirements on the Horizon: The Food Allergen Labeling and Consumer Protection Act of 2004,” Food and Drug Law, Regulation, and Education Update, Food and Drug Law Institute, January/February 2005.

Languages Spoken

English and Spanish

Education