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Jonathan L. Koenig, Arnold & Porter, LLP, Associate
Jonathan “Jack” Koenig litigates complex matters arising under consumer protection and environmental laws. Mr. Koenig also advises clients on regulatory compliance issues, including with respect to consumer product labeling regulations, California’s recycling regimes, California’s unique toxics and labeling law (Proposition 65), environmental contamination cleanup programs, OSHA standards, and other consumer protection and environmental laws and regulations.
Mr. Koenig previously served as a prosecutor for the Navajo Nation Office of the Prosecutor, where he regularly tried cases.
Mr. Koenig graduated from Harvard Law School with honors in 2011, where he served as an Editor of the Harvard Civil Rights--Civil Liberties Law Review. While a law student, he also worked as an intern for the Honorable Joseph F. Battalion of the United States District Court for the District of Nebraska. Prior to law school, Mr. Koenig served in the United States Army.
Anthony Pavel, Cargill, Senior Food LawyerTony is Cargill Inc.’s Senior Food Lawyer responsible for food and feed law across Cargill’s North American businesses. Prior to joining Cargill, Tony was the Deputy Chair of the FDA Practice at Morgan Lewis & Bockius, served as General Counsel and Secretary to the Enzyme Technical Association, and as the past Chair of the Institute of Food Technologist's Food Laws and Regulations Division. During his undergraduate and legal studies, he worked for a food HACCP consulting business. Tony has been named one of the leading food lawyers in the US by Chambers and Partners and Law360.
Christopher A. Cole, Crowell & Moring LLP, Partner
Christopher Cole is the co-chair of Crowell & Moring's Advertising & Product Risk Management Group in the Washington, D.C. office, which was named as a Law360 Practice Group of the Year for Consumer Protection in 2013.
Chris practices complex commercial litigation and is well-known for defending companies accused of false advertising and deceptive or unfair trade practices. He handles investigations and litigation before the Federal Trade Commission (FTC) and other agencies. And, he has successfully resolved dozens of matters before the National Advertising Division (NAD) and the National Advertising Review Board (NARB), where he has achieved some of the most notable results for his clients in that forum over the last decade. As part of his work for advertisers, Chris regularly advises regarding the development, substantiation, approval, and defense of advertising campaigns. Chris also handles many other types of cases, including consumer class actions, unfair competition, intellectual property, commercial litigation, and government enforcement proceedings.
Chris's clients include some of the world's leading companies in industries such as food and beverages, media and telecommunications, and consumer products. He frequently represents companies that have difficult product development, reputational, and marketing concerns that require multifaceted regulatory or litigation solutions.
Chris has been ranked among the top false advertising litigators in the country for many years by Chambers & Partners, which has in various editions quoted clients who have described him as a "superstar," "incredibly responsive," "outstanding," "cost-conscious," "hard-working," and have said that he "gets to the heart of the concept quickly and understands the advertising motivation in relation to the law."
He is a vice-chair of the American Bar Association's Section of Antitrust Committee on Advertising Disputes and Litigation and an editor of the ABA's major treatise on Consumer Protection Law and Developments.
Devon Wm. Hill, Keller and Heckman LLP, Partner
Devon 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.
John D. Graubert, Covington & Burling LLP, Partner
John Graubert is a partner in the firm’s Washington office. He 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 is co-chair of the firm’s Advertising and Consumer Law practice group and an Adjunct Professor at the Georgetown University Law Center.
From 1998-2008, Mr. Graubert served as Principal Deputy General Counsel (including short stints as 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). Mr. Graubert received the A. Leon Higginbotham Award and the Award for Distinguished Service.
Sarah Roller, J.D., R.D., M.P.H, Kelly Drye & Warren LLP, Partner
Sarah Roller, J.D., R.D., M.P.H., is a partner in the firm’s Washington, D.C. office and chair of the Food and Drug Law practice. She focuses her practice on the representation of U.S. and global companies and industry trade organizations 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 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. In addition to ensuring that product formulations and ingredients meet Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) and other applicable safety requirements, Ms. Roller leverages her multidisciplinary background in law, human nutrition, food science and public health to ensure that product benefit claims disseminated through labeling, print and Web advertising, social marketing and other promotions are adequately substantiated by scientific evidence. Ms. Roller also 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.
Specifically, 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, functional foods, dietary supplements, cosmetics, ingredients, packaging and related emerging technologies, including irradiation, biotechnology, cloning and nanotechnology. She represents clients in legal, policy and enforcement matters arising before federal and state governmental bodies, including the U.S. Congress, FDA, Federal Trade Commission (FTC), USDA, and the Department of Health and Human Services (DHHS). She also advises global companies regarding the production, importation, distribution and marketing of food products and components and the associated regulatory issues involved at the international, federal and state levels.
Ms. Roller determines the adequacy of scientific evidence to substantiate product benefit claims, and defends clients when the adequacy of claim substantiation is challenged by governmental bodies, competitors or consumers. She represents clients in connection with FDA enforcement matters, including warning letters, inspections, product seizures and import detentions, and advises clients in conducting product recalls, whether self-initiated or performed at the request of the FDA. In addition, she counsels clients in litigation matters in which product safety, marketing practices and promotional claims are challenged under federal or state laws.
Ms. Roller develops self-regulatory guidelines for food industry organizations with respect to product marketing practices and claim substantiation. She counsels clients with respect to food marketing practices directed to children and youth, and legal and policy developments surrounding obesity and diet-related public health concerns that are emerging at the international, federal and state levels.
Ms. Roller prepares citizen petitions, health claim petitions, health claim notifications, nutrient content claim petitions, temporary marketing permits, competitor complaints, model legislation, model rules, self-regulatory guidelines, briefing papers, testimony, press releases and other written and oral statements on behalf of client companies and trade organizations. She also communicates with the press and representatives of medical, scientific and public interest organizations.
In addition, Ms. Roller serves on medical, scientific and regulatory advisory boards providing strategic counsel to companies and trade organizations with respect to the development of new products and marketing initiatives.
A veteran of Capitol Hill, Ms. Roller previously spent five years working as a Life Sciences Policy Analyst for the U.S. Congress with the Congressional Research Service. She also previously served as a clinical research nutritionist with the Mt. Sinai Hypertension Trial conducted by Mt. Sinai Hospital and the University of Minnesota.
Steven B. Steinborn, Hogan Lovells US LLP, Partner
Steven 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 an experienced writer and frequent speaker on topics relating to food labeling and advertising. He also serves as an instructor for the Basic Food Law course sponsored by the Food Drug and Law Institute. 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.
Joe Levitt, Hogan Lovells US LLP, Partner
Joseph Levitt is a 25-year veteran of the U.S. Food and Drug Administration (FDA); he served as Director of FDA's Center for Food Safety and Applied Nutrition (CFSAN) for six years, from February 1998 through December 2003. Joe counsels numerous food companies and trade associations in food safety, labeling, and compliance matters and how to work effectively with the FDA, as well as on regulatory aspects of federal, state, and private litigation. He is particularly accomplished in helping companies that face significant compliance challenges with the FDA. He has superb knowledge of the FDA Food Safety Modernization Act (FSMA), including all phases of its development and implementation.
Joe's deep knowledge of the FDA is reflected in the many roles he held at the agency. While serving as FDA/CFSAN Director, Joe was involved in virtually all aspects of food regulation. In particular, 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 the FDA's nutrition program. Earlier in his FDA tenure, Joe functioned as the executive assistant to the commissioner, director of executive operations, chief of staff, and acting deputy commissioner in the Office of the Commissioner, where he 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, where he led efforts to implement safe medical device and mammography quality standards programs. He began his FDA career in the Office of Chief Counsel as a litigating attorney.
In the private sector, Joe has served on the Boards of Directors for the: Food and Drug Law Institute (FDLI); Food Allergy & Anaphylaxis Network (FAAN), recently rebranded as Food Allergy Research & Education, Inc. (FARE) (Board Chair, 2007); and FDA Alumni Association (Board Chair, 2012-14).
Joe has received numerous honors and awards in both the public and private sectors. Joe has repeatedly received a Top Tier ranking from Chambers USA for Food and Beverage lawyers. He also has been recognized as a BTI All-Star for excellence in client service. While at the FDA, Joe received three Presidential Executive Rank Awards as well as the HHS Distinguished Service Award, the HHS Secretary's Special Citation, the PHS Superior Service Award, the FDA Award of Merit (four times), the FDA Commissioner's Special Citation, and the FDA Equal Employment Opportunity Award. Joe has also received the FDLI Distinguished Service and Leadership Award, FDA Distinguished Alumni Award, and FDA Alumni Association Founders Award.
Joe received his bachelor's degree, magna cum laude, from Cornell University in 1975 and his J.D. degree, cum laude, from Boston University School of Law in 1978.
Ricardo Carvajal, Hyman, Phelps & McNamara, PC, Director
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 a member of the American Bar Association and the European Food Law Association.
Diane McColl, Hyman, Phelps & McNamara, PC, Director
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.
Shannon Cooksey, Vice President, Science Policy and Program Management
Shannon (Shana) Cooksey is the Vice President of Science Policy and Program Management at the Grocery Manufacturers Association (GMA) in Washington, D.C. GMA represents the world’s leading food, beverage, and consumer products companies. Shana is a globally recognized project manager, matching cutting edge science to food policy issues, and delivering expert scientific and technical assistance to the food and consumer product goods industry. At GMA, Mrs. Cooksey oversees all scientific program management activities, including managing all aspects of implementation of the Food Safety Modernization Act (FSMA) and all Ingredient Safety programs. In addition, she also provides leadership and execution of Program Management capabilities across the broad GMA organization and management of several important operational functions within the Science and Regulatory Affairs (SRA) department including budget oversight, strategic planning process, and logistical oversight of all scientific conferences, workshops and webinars. Prior to her role as Vice President, she supervised all laboratory operations at GMA and co-managed over 20 scientists and professional technical staff in the disciplines of chemistry, biochemistry, microbiology, processing technologies, packaging and product forensics.
Mrs. Cooksey holds Master of Science degree in Bio-Inorganic Chemistry from the University of New Mexico and a Bachelor of Arts in Chemistry and Biology from the University of Northern Colorado. She is a certified Project Management Professional (PMP), holds top certification in Microsoft Project, and is a professional Lean Six Sigma leader (green belt).
Karin Moore, Grocery Manufacturers Association, Senior 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.