Hyman Phelps & McNamara, PC
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 also helps clients interpret and comment on the implementation of new requirements, such as those arising from the Food Safety Modernization Act.
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 his contributions were recognized through several team and individual awards. Mr. Carvajal serves on the Food and Dietary Supplements Committee of the Food and Drug Law Institute, and previously served as Chair of the Public Policy Outreach and Implementation Task Force of the Institute of Food Technologists. He is also a member of the European Food Law Association.
Diane B. McColl
Hyman Phelps & McNamara, PC
Diane B. McColl works with chemical and ingredient supplies companies, providing counsel on the regulation of their products in foods, dietary supplements, food contact articles, medical devices, cosmetics, and pharmaceuticals. She has advised clients on FDA and USDA regulatory issues for 30 years, helping manage products throughout their lifecycle. Ms. McColl's scientific and technical background from her former career as a pharmacist enhances her work with research and development teams. In particular, she is an expert on issues related to the development of new food ingredients. Because of her extensive industry knowledge of foods, dietary supplements, animal drugs and feeds, and OTC drugs and cosmetics, Ms. McColl often conducts due diligence for mergers and acquisitions.
Ms. McColl provides guidance on U.S. aspects of global regulatory strategies for novel food ingredients, including sweeteners, functional ingredients, processing aids, color additives, fermenting agents, and flavor modifiers. She also helps clients evaluate, develop, and defend product labeling and advertising, reviewing health and "structure/function" claims.
Ms. McColl joined Hyman, Phelps & McNamara in 1989, and today is one of the food and chemical industry's foremost experts on FDA and USDA regulatory issues. She serves on the Food Ingredient Expert Committee of United States Pharmacopoeia (USP), and past President of the International Society for Regulatory Toxicology and Pharmacy (ISRTP). Since 2010, Chambers USA has recognized Ms. McColl each year on its list of attorneys for "Food & Beverage: Litigation & Regulatory." In addition, she received a peer review rating of "AV Preeminent" by Martindale-Hubbell.
Paulette Gaynor, Ph.D.
Senior Regulatory Project Manager
Office of Food Additive Safety (OFAS)
U.S. Food and Drug Administration
Dr. Gaynor joined FDA in 1997, working as a consumer safety officer in the Office of Premarket Approval (the former office name for OFAS). Dr. Gaynor’s expertise includes the regulation of substances generally recognized as safe (GRAS) in food; and, she also serves as the contact for the GRAS notification program for human food. During her career at the FDA, Dr. Gaynor has coordinated the evaluation or review of regulatory submissions within the pre-market programs for GRAS notices, food additive petitions, and food contact notifications. In addition, Dr. Gaynor served as a member of agency work groups on health claims and obesity, as well as a member of government delegations to the Codex Alimentarius Commission. Prior to joining the FDA, Dr. Gaynor conducted postdoctoral research on aspects of lipid metabolism at the University of Michigan and then at the National Institutes of Health. Dr. Gaynor received her undergraduate degree in biological sciences, with a concentration in biochemistry, from Cornell University and her doctorate degree in food science from Rutgers University.