Ricardo Carvajal, J.D., Director, Hyman, Phelps & McNamara PC
Ricardo Carvajal provides FDA and FTC regulatory counseling and litigation support to manufacturers and marketers of foods (including dietary supplements and medical foods), cosmetics, and OTC drugs. He has substantial experience with all food and dietary supplement issues, including recalls, Reportable Food Registry issues, and GMP and HACCP compliance issues. He also has substantial experience with labeling and advertising issues, including those that arise from the use of health, nutrient content, structure/function, and disease claims. Mr. Carvajal counsels product developers on regulatory strategy, including requirements pertaining to self-determinations of GRAS status and determinations of new dietary ingredient status. He has particular expertise in the regulation of products derived through biotechnology and nanotechnology. From 2002 to 2007, Mr. Carvajal served as Associate Chief Counsel in FDA's Office of Chief Counsel. He currently serves on the Editorial Advisory Board for the Food and Drug Law Institute Monographs, and served as Chair of the Public Policy Outreach and Implementation Task Force of the Institute of Food Technologists.
Mr. Carvajal holds a J.D. from Northwestern University School of Law and an M.S. in Biology from the University of Michigan. He is admitted to practice in the District of Columbia.
John Graubert, Partner, Covington & Burling LLP, Washington Office
John Graubert has more than 30 years of experience in a wide range of antitrust and consumer law matters including merger and non-merger government investigations and enforcement actions, private antitrust litigation, and counseling in the US and in conjunction with the firm’s counsel in Europe and Beijing. In recent years his practice has concentrated on Federal Trade Commission proceedings in both competition and consumer protection areas, as well as matters concerning the Consumer Financial Protection Bureau. Mr. Graubert served as co-lead counsel for POM Wonderful in FTC administrative litigation challenging advertising. Mr. Graubert is co-chair of the firm’s Advertising and Consumer Law practice group, an Adjunct Professor at the Georgetown University Law Center, and a Vice-Chair of the Federal Civil Enforcement Committee of the ABA Antitrust Section. From 1998-2008, Mr. Graubert served as Principal Deputy General Counsel and Acting General Counsel at the Federal Trade Commission. At the FTC, Mr. Graubert managed all litigation, legal counsel, policy studies, and administrative functions within the Office of General Counsel. He also advised the Commission and agency staff on antitrust and consumer protection matters and administrative law. He was involved in dozens of litigated matters for the Commission, including FTC v. Swedish Match, et al. (D.D.C. 2000) and FTC v. Schering-Plough, et al. (11th Cir. 2005).
Joseph A. Levitt, Partner, Hogan Lovells US LLP
Joseph A. Levitt is a 25-year veteran of the U.S. Food and Drug Administration (FDA). He focuses on the development and implementation of legislative and regulatory policy regarding the manufacture and marketing of food, drugs and medical devices and how to work effectively with the FDA and related agencies. Joe also brings in-depth knowledge to a wide range of matters, including food and drug safety, biotechnology, labeling, advertising, and bioterrorism. For six years, from February 1998 through December 2003, Joe served as Director of the FDA's Center for Food Safety and Applied Nutrition (CFSAN), where he led successful efforts to modernize food safety regulation and enhance the security of the U.S. food supply. He also initiated a revitalization of FDA's nutrition program. During his FDA tenure, Joe also helped streamline the new drug review process and launch the agency's food labeling initiative. Additionally, he served as Deputy Director for Regulations and Policy at the FDA's Center for Devices and Radiological Health. He began his FDA career in the Office of Chief Counsel. Since joining Hogan & Hartson in January 2004, Joe counsels numerous food, drug and device companies and trade associations regarding compliance with federal laws and regulations. Joe has been directly engaged in all phases of the Food Safety Modernization Act, from development through implementation.
Diane B. McColl, Director, Hyman, Phelps & McNamara PC
Diane B. McColl graduated cum laude with a B.S. in Pharmacy from the University of South Carolina in 1976. Ms. McColl practiced pharmacy in Tennessee and South Carolina until 1984, when she earned a law degree from the University of South Carolina. She joined Hyman, Phelps & McNamara in 1989. Ms. McColl is admitted to the bars of Texas and the District of Columbia. Ms. McColl is a member of the USP Food Ingredient Expert Committee. She is president of the International Society of Regulatory Toxicology and Pharmacology, and is a professional member of the Institute of Food Technologists. In 30 years of legal practice, Ms. McColl has advised the manufacturers and marketers of conventional foods, medical foods, dietary supplements, food and color additives, and new food ingredients on compliance with the regulatory requirements for these products. She has helped develop global regulatory strategies for numerous novel food ingredients, including sugar alcohols, bulk sweeteners, processing aids, color additives and flavoring agents. She also has assisted with the preparation of food additive petitions, notifications for “generally recognized as safe” (GRAS) food ingredients, notifications for new dietary ingredients for dietary supplements and requests for “threshold of regulation” exemptions for substances used in productions of food packaging materials. In addition, Ms. McColl has assisted in evaluating, developing, and defending the labeling and advertising materials for such products. She’s also provided guidance on issues such as health claims, nutrient content claims, nutrition labeling and “structure/functions” claims.
Sarah Roller, J.D., R.D., M.P.H., Partner, Kelly Drye & Warren LLP
Sarah Roller is chair of the firm’s Washington, D.C. office Food and Drug Law practice. She focuses her practice on the representation of U.S. and global companies in addition to industry trade organizations. Particularly, those engaged in the development, manufacture, import, export, distribution and marketing of foods, beverages, dietary supplements, functional foods, nutraceuticals, medical foods, cosmetics, medicines, and other personal health care and wellness products;both domestically and abroad. Ms. Roller assists companies in the development of legal risk management strategies and compliance programs designed to minimize risk at the outset and avoid the costly setbacks associated with regulatory enforcement. She ensures that product formulations and ingredients meet Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) and other applicable safety requirements.
Ms. Roller also leverages her multidisciplinary background in law, human nutrition, food science and public health to ensure that product benefit claims disseminated through labeling, print/Web advertising, social marketing and other promotions are adequately substantiated by scientific evidence. Ms. Roller has experience representing clients in complex legal, policy and enforcement matters before federal and state agencies, providing integrated counseling services spanning the legal, regulatory and legislative arenas. Ms. Roller provides legal advice, strategic counsel and recommendations to clients relating to the production, distribution, importation, marketing and recall of food and beverage products. She also provides advice relating to functional foods, dietary supplements, cosmetics, ingredients, packaging and related emerging technologies; including irradiation, biotechnology, cloning and nanotechnology.
Trenton Norris, Senior Partner, Arnold & Porter LLP
Trenton Norris works in the firm's San Francisco and Silicon Valley offices, litigates complex scientific and technical disputes in the areas of consumer protection, advertising, product liability, product safety, environmental, and food law. Mr. Norris' clients are primarily manufacturers and retailers of everyday products and services. His cases have involved diverse products, technologies, and industries, including dietary supplements, cosmetics, restaurants, hotels, amusement parks, plumbing products, medical devices, soft drinks, glassware, snack foods, vaccines, home electronics, paints, motor vehicles, pharmaceuticals, and batteries. He often works with trade associations and joint defense groups in these industries. Mr. Norris represents clients regarding federal, state, and local regulation of consumer products and services, with an emphasis on reporting and labeling requirements. Common issues in Mr. Norris' matters are preemption, commercial speech, interstate commerce, citizen enforcement, jurisdiction, and class action requirements. Common opponents are state attorneys general, local district attorneys, state regulatory agencies, and citizens groups. Mr. Norris has advised and defended hundreds of companies regarding California's unique toxics and labeling law, Proposition 65, and California's expansive consumer protection laws. Mr. Norris served as the top legislative aide to a US Senator on appropriations, environmental, and transportation issues (1987-89). He was Editor of the Harvard Law Review (1990-92). He headed Arnold & Porter LLP's San Francisco and Silicon Valley offices from 2008 to 2013, and he regularly speaks to law students concerning the economics of law practice.
Devon Wm. Hill, Partner, Keller and Heckman LLP
Devon Wm. Hill joined Keller and Heckman in 1996. Mr. Hill's practice focuses on assisting clients with the regulatory issues involved in the global marketing of new products. Specifically, Mr. Hill focuses on compliance and testing issues surrounding the regulation of food, cosmetics, and food and drug packaging materials in the United States and Europe. Mr. Hill has experience in dealing with the compliance of food and drug packaging in most of the other countries of the world that have established regulatory systems. In addition, Mr. Hill advises clients on issues surrounding the regulation and approval of pesticides and antimicrobials under the Federal Insecticide, Fungicide, and Rodenticide Act and the European Union's new Biocides Directive. Prior to attending law school, Mr. Hill obtained his Masters Degree in Chemistry and worked as a research chemist and in industry. Mr. Hill uses this background to assist clients in navigating often-inseparable scientific and legal issues.
Anthony "Tony" Pavel, Partner, Morgan Lewis & Bockius, LLP
Anthony "Tony" Pavel provides regulatory counseling to clients on food, drug, and cosmetic and medical device products in the firm’s FDA practice. He has a broad range of experience with issues involving product claims in labeling, advertising, and other promotional material, as well as clinical research and substantiation issues, and regulatory strategies for functional foods and dietary supplements. Mr. Pavel also assists clients with novel food and color additive petitions, food packing and labeling, Food Contact Notifications and secondary food additives (packaging, processing aids), food safety compliance, HACCP, SSOPs, GMPs, and GRAS self-affirmations and notifications. Additional areas of his work include the National Organic Program, recall and market withdrawal strategies, import detentions, seizures, and alleged food tampering. Mr. Pavel assists clients with the preparation of FDA submissions, including 510(k) premarket notifications, premarket approval applications, as well as recalls and market withdrawals, adverse event reports, and product listings and establishment registrations. He works with clinical laboratories, manufacturers, and distributors of medical device and laboratory equipment, advising them on all areas of regulatory compliance, including Laboratory Developed Tests /CLIA, clinical kitting, and regulatory/marketing strategy. Mr. Pavel also has experience with regulatory issues involving clinical trials, eHealth, and telemedicine. Mr. Pavel earned his J.D. from Loyola University of Chicago School of Law in 2001, where he was a staff editor of the Loyola Consumer Law Review and interned with the Illinois Attorney General's Health Care Bureau. He earned his B.S., with honors, from the University of Western Ontario, Canada, in 1998. He is proficient in Hungarian.
Mr. Pavel is admitted to practice in the District of Columbia and Maryland.
Bert Rein, Partner, Wiley Rein LLP
Bert Rein is a founding partner of the firm, is widely recognized as a leading antitrust and commercial litigator and international law expert. He has been recognized by Legal Times as a “Visionary” and Washington's "Leading Food and Drug Lawyer," and named by Corporate Counsel as one of the "Best Lawyers in America" for excellence in business and commercial litigation, communications, and antitrust law. His Constitutional litigation includes First Amendment and Preemption challenges to regulatory initiatives and tort law expansions. Mr. Rein successfully represented petitioner Abigail Fisher in Fisher v. University of Texas, a constitutional challenge to the university's race-based admission policies that was argued before the Supreme Court of the United States in 2012. Mr Rein Successfully represented Shelby County, Alabama in its challenge to the constitutionality of the renewal of the preclearance provisions of the Voting Rights Act that was argued before the Supreme Court of the United States in 2013. Mr. Rein’s professional experience includes: Special Assistant to the Under Secretary of State (1969-1970) and Deputy Assistant Secretary of State for Economic and Business Affairs (1970-1973), U.S. Department of State; Reagan Administration Transition Teams for the U.S. Department of Justice and Federal Trade Commission (1981);and Director, National Chamber Litigation Center (1992-Present).
Karin Moore, Grocery Manufacturers Association, Vice President and General Counsel
Ms. Moore directs the association’s federal and state litigation activity and provides legal counsel on numerous issues. Ms. Moore joins GMA from the Wine & Spirits Wholesalers of America (WSWA) where she was vice president and co-general counsel. At WSWA, her responsibilities included coordinating the association’s national litigation strategy, advising on regulatory issues facing wholesalers at both the state and federal levels, and serving on WSWA’s senior management team. Prior to joining WSWA, Moore was a counsel with O’Melveny & Myers’ Antitrust and Criminal Defense practice groups, where she focused on antitrust litigation, civil and criminal antitrust investigations, and federal and state cartel class actions. Prior to O’Melveny, she held a variety of positions with the U.S. Federal Trade Commission’s (FTC) Bureau of Competition, including counsel to the director and staff attorney with the Anticompetitive Practices Division. She holds a law degree from George Mason University School of Law and is vice-chair of the American Bar Association Section of Antitrust Law’s Trade, Sports and Professional Associations Committee.
Steven B. Steinborn, Partner, Hogan Lovells
Mr. Steinborn practices food and drug law with a focus on food labeling, advertising, and food safety. He works closely with food processors, restaurants, food service operators, and supermarkets with respect to compliance with nutrition and related labeling regulations. He routinely assists clients in enforcement proceedings before the U.S. Food and Drug Administration and the U.S. Department of Agriculture (USDA). Steven provides assistance to the firm’s trade association and company clients in fashioning comments and developing strategies in dealing with key rulemaking and other public policy issues. In recent years, his practice is increasingly focused on counseling companies that seek to promote the health benefits of traditional foods. Steven also advises food companies on a range of issues pertaining to the development of advertising, including the adequacy of substantiation and the express and implied terms conveyed by an advertisement. Steven has significant experience representing clients in enforcement matters before the U.S. Federal Trade Commission and has assisted in defending and initiating challenges against competitors. In addition, he advises food and other companies concerning games of chance and other promotional contests and awards to ensure compliance with an array of state laws. Steven’s practice also includes an emphasis on safety issues in connection with consumer products subject to the jurisdiction of the U.S. Consumer Product Safety Commission (CPSC). He routinely advises a variety of consumer products companies on compliance with the CPSC labeling and reporting requirements, and related product liability considerations. He has experience working with companies from diverse industries, ranging from gas grill manufacturers to toy companies, in enforcement proceedings before the CPSC. He also counsels companies with respect to a variety of different rulemaking and standard-setting activities at the CPSC, and similar activities undertaken by private organizations. Steven is a co-author of A Guide to Federal Food Labeling Requirements, a report commissioned by the U.S. Department of Health and Human Services and the USDA.
Anne Walsh, Director, Hyman Phelps & McNamara PC
Ms. Walsh joined the firm in January 2011 after serving as an Associate Chief Counsel with the U.S. Food and Drug Administration's Office of Chief Counsel from 2004 to 2010. Before then, she worked for several years at a major international law firm representing pharmaceutical and medical device clients. Ms. Walsh brings an invaluable perspective to the food and drug industry, having negotiated on both sides of the table on FDA-related matters.
Ms. Walsh has extensive knowledge of issues concerning health care fraud, off-label promotion, and clinical study fraud, with a particular emphasis on potential False Claims Act liability and exclusion by the HHS Office of Inspector General. She has helped companies comply with cGMP and reporting regulations, and has counseled clients in matters related to FDA inspections, seizure and injunction actions, warning letters, and recalls. She also advises clients facing enforcement and regulatory challenges in conducting internal investigations and risk assessment audits so that they can resolve regulatory issues and minimize litigation risks. Her litigation experience is comprehensive and diverse, from defending product liability claims in state court, bringing suit under the Lanham Act, prosecuting individuals and corporations in federal court, and suing FDA for violating the Administrative Procedure Act. At FDA, she worked closely with federal prosecutors and law enforcement agencies to investigate, negotiate, and litigate civil and criminal violations of the Federal Food, Drug, and Cosmetic Act. She also worked closely with FDA's Office of Regulatory Affairs, reviewing and advising Agency personnel on the legal sufficiency of Warning Letters and civil and criminal investigations. Ms. Walsh graduated from the College of William and Mary in 1994 with a B.A. in economics, and with a J.D. in 1997. She is admitted to practice law in New York and the District of Columbia.