OFW - Key Persons
Job Titles:
- Senior Regulatory & Technical Advisor
Angie is a seasoned food safety expert with over 30 years of experience in the meat and poultry industry. At OFW, she tackles food safety challenges for clients, drawing on her extensive background leading regulatory and safety teams at major processors, such as Cargill, Smithfield, and Kraft Foods.
Throughout her career, Angie has focused on mitigating risks from foodborne pathogens such as Shiga toxin-producing E. coli (STEC), Salmonella, and Listeria monocytogenes. She has pioneered innovative detection and prevention strategies and played a key role in industry-wide efforts to shape federal food safety regulations.
Job Titles:
- Supervisory Regulatory Specialist
April specializes in compliance with FDA labeling regulations, particularly with respect to food and dietary supplement products. She assists clients with other aspects of FDA compliance as well, including:
Reviewing product claims to ensure conformance with the applicable marketing category.
Resolving detentions through means such as communicating with Compliance Officers on clients' behalf; drafting and submitting a Form 766 Request to Recondition; and arranging for third-party laboratory testing of product, as applicable.
Petitioning FDA to remove firms from import alert.
Applying for inclusion on an FDA Export List.
Fulfilling applicable registration and listing requirements.
Drawing on four decades of experience in private practice and as an attorney for the Food and Drug Administration, Arthur advises business entities and associations on regulatory matters within the jurisdiction of the Department of Health and Human Services, including in particular the FDA. He also has extensive experience in trade association governance and related issues.
Job Titles:
- Supervisory Regulatory Specialist
As a Policy Advisor in Washington, D.C., Ben translates complex policy issues into effective federal strategies for clients. His current focus on food, agriculture, cannabis, international trade, and drug policy is underpinned by strategic successes across public and private sectors, making him adept at navigating the complexities of Capitol Hill.
Before advising clients at OFW, Ben refined his strategic skills at Booz Allen Hamilton, where he developed multi-year strategic plans for the U.S. Navy and advised on organizational design, change management, and human capital strategy for DoD clients. Prior to that, Ben excelled in business transformation at IBM's Global Business Services, including reshaping logistics for a multinational dairy manufacturer.
A University of Michigan graduate with a degree in Political Science and Entrepreneurship, Ben combines political insight with business acumen. He has consulted for startups, facilitated substantial venture capital funding, and ranked 6th nationally in sales, all enhancing his strategic capabilities.
Job Titles:
- Senior Regulatory Advisor
Brian Ravitch has a thorough knowledge of FDA regulatory laws, practices, and procedures in the area of food and feed programs. As a Senior Regulatory Advisor, he has concentrated in the areas of Import Compliance, Foreign Supplier Verification Program (FSVP), Seafood HACCP, and Hazard Analysis Risk-based Preventive Controls. Brian began his 39-year career in the Federal Government with the Department of Commerce, NOAA, and National Marine Fisheries, having extensive knowledge of tuna fisheries. Fourteen years later, he continued government service with the U.S. Food and Drug Administration (FDA) in Import Field Operations. While at FDA, he took opportunities to expand his depth of knowledge and experience, including eight years as an Import Compliance Officer, a Specialist in Seafood HACCP, and ended his career in December 2019 as one of seven National Program Headquarters' Experts in the Office of Food and Feed Operations Branch. As a leading Food Program Expert, Brian worked closely with the Center for Food Safety and Applied Nutrition (CFSAN) and the Office of Regulatory Affairs (ORA) Field Operations to accomplish the agency's mission, including conducting domestic and international inspections. He provided technical support to field investigators in the areas of inspections, analytical, technical/evidence, and scientific data. As a Food Program Expert, Brian was a headquarters' authority on import operations and inspectional techniques in the area of food and feed, serving as an instructor and focal point for authoritative guidance to field operations. Brian was instrumental in developing and implementing the Foreign Supplier Verification Program (FSVP), serving as a Subject Matter Expert for the agency.
Bruce has three decades of experience advising businesses and associations on FDA and FTC regulatory matters involving food labeling, advertising, and safety. His practice includes resolution of competitive disputes, class action cases, responses to FDA regulatory proposals, and enforcement matters.
Mr. Durkin specializes in food safety regulation by the FDA with more than twenty-five years' experience working directly with the produce industry. He has led the firm's practice in Drug Enforcement Administration issues and works before both the Animal and Plant Health Inspection Service and the Agricultural Marketing Service, among other USDA agencies.
Denise is a bilingual Spanish-speaking attorney who has exclusively practiced Customs and International Trade Law since admission to the Florida Bar in 2017. Cross-trained in federal regulatory matters involving all forty-two plus federal agencies, Denise primarily specializes in U.S. Customs and Border Protection (CBP) and U.S. Food and Drug Administration (FDA) matters.
Ms. Calle is uniquely positioned to assist foreign and domestic businesses, manufacturers, distributors, importers, and exporters as she has extensive experience in a range of import compliance, regulatory compliance, and administrative enforcement matters involving the U.S. Department of Homeland Security (DHS), the U.S. Environmental Protection Agency (EPA), Alcohol and Tobacco Tax and Trade Bureau (TTB), the Federal Trade Commission (FTC), the Consumer Product Safety Commission (CPSC), the Federal Communications Commission (FCC), the U.S. Department of Agriculture (USDA), and other federal organizations.
Job Titles:
- Principal, USDA Practice Head
Dr. Teitel advises clients on regulatory matters where medicine and the law converge, especially relating to medical devices. He accomplishes this by leveraging his experience in medicine, the medical device business, and regulatory law.
Eric helps clients achieve their business and humanitarian goals in food and agriculture with the U.S. Congress and regulatory agencies including USDA, FDA, EPA, and USTR. His more than 20 years of experience in complex legislation and regulation spans nutrition assistance programs, food & beverage industry, animal health industry, production agriculture, and international trade & diplomacy.
Job Titles:
- Principal, Litigation Practice Head
Job Titles:
- Managing Principal, FDA Food Practice Head and Digital Health Practice
Mason advises businesses on laws and regulations surrounding the manufacture, marketing, promotion, and distribution of FDA regulated products. Mason also provides counsel to trade associations and commodity groups that include FDA regulated industry and advises business on transactional matters concerning FDA regulations and related requirements.
Mason routinely provides advice surrounding FDA regulated products, including:
FDA product applications and approvals
FDA facility registration
FDA and USDA enforcement and administrative matters (warning letters, complaints for injunctive relief and consent decrees, citizen petitions, and trade complaints)
Promotion and advertising compliance
Compliance with Federal Anti-Kickback Statute, Sunshine Act, CAN-SPAM, HIPAA, and other laws that may apply to advertising and promotion of FDA-regulated products
Legislative and regulatory policy strategy, including comments on relevant rule making and agency guidance
Import and export requirements (import alerts, holds, detentions, refusals, and other Customs and Border Protection requirements)
Labeling, formulation, and ingredients (food additives and GRAS petitions)
Food Safety Modernization Act
False Claims Act defense
Practice Areas
National Organic Program
Jay provides clients with strategic advice on government affairs and communications matters mainly in the agriculture/food and public health sectors. His more than 45 years of agricultural trade association experience has focused principally on agricultural, environmental and health regulation matters.
Job Titles:
- Principal, Litigation Practice Head
Jennifer brings to her practice a unique knowledge of litigation and regulation in both practice and theory. Previously a litigation partner at a complex litigation firm in the areas of mass torts, securities, consumer protection, and antitrust, Jennifer developed a specialty in litigation involving regulated industries. She played an active role investigating and litigating science issues, including trial, in the Vioxx multi-district litigation and the Engle tobacco litigation, litigated a nationwide class action against Mercedes Benz USA from class certification to settlement, and administered the class settlements in four statewide antitrust class actions against Microsoft.
Prior to joining Olsson Frank Weeda, Jennifer was selected by the Institute of Medicine and FDA for a highly competitive fellowship in regulatory science. While at FDA, she drafted agency guidances and conducted legal analysis of proposed regulations under the Administrative Procedure Act and the Constitution, including First Amendment issues pertaining to warning and label requirements and due process concerns. Her analysis of these issues is published in the preamble of the deeming rule.
Jennifer also brings extensive experience in law and economics. A former doctoral fellow at the RAND Corporation, Jennifer is a coauthor of the legal textbook Class Action Dilemmas - Pursuing Public Goals for Private Gain, the culmination of a multi-year, multi-disciplinary study of class actions. She also co-authored a major study of asbestos litigation presented to the judicial committees of the United States Senate and House of Representatives. Jennifer's quantitative skills, including multivariable statistics, are particularly valuable in cases involving regulated products and class allegations.
Jessica's experience in the compliance industry has allowed her to gain proficiency in working with a number of regulatory agencies. She routinely provides clients support with navigating the requirements of organizations like the FDA, USDA, FWS, AAFCO, and various state-level governing bodies.
Job Titles:
- Principal, Customs & Trade Practice Head
As the head of the firm's Customs & Trade practice group, Jessica uses her decades of experience to provide guidance to importers and others regarding all aspects of Customs and international trade laws and regulations, including tariff classification and valuation, country of origin determinations, antidumping and countervailing duty issues, Customs detentions, seizures, fines, penalties, and forfeitures, and product marking and labeling. Jessica has particular expertise in the area of the U.S. prohibition on importation of goods made in whole or in part with forced labor (19 U.S.C. ยง 1307) and the Uyghur Forced Labor Prevention Act (UFLPA). While much of her practice focuses on assisting clients in the food and agriculture, dietary supplements, medical devices, and pharmaceutical industries, Jessica has routinely represented clients of all industry types.
Her primary areas of focus include:
Job Titles:
- Principal Attorney, USDA Practice Head
John Dillard draws on his extensive practical and legal experience to provide knowledgeable and effective regulatory and litigation counsel to OFW Law's USDA- and FDA-regulated food and agriculture clients. He also serves as General Counsel to several trade associations in the food and agriculture sector.
Job Titles:
- Senior Regulatory Advisor
Kyla is a food lawyer who assists her clients at every stage of production and distribution. Kyla works with the OFW Law team to predict, direct, and respond to various federal laws and regulations. From farm to table, Kyla helps to mitigate risk and respond to challenges before and as they arise.
She brings a unique perspective gained from working with industry leaders as well as experience collaborating with federal and state agencies. Kyla's background spans corporate, governmental, and nonprofit sectors, equipping her to guide clients through complex regulatory landscapes and rapidly evolving challenges in the food and agriculture industries.
Michael is a Principal Attorney at OFW Law and heads the Food/Supplement Practice Team. He concentrates his efforts, and for over thirty years has counseled clients extensively, in food and dietary supplement regulatory matters, especially labeling and advertising, formulation, compliance and enforcement risk, and administrative procedures.
Job Titles:
- Attorney
- Principal
- Registered Patent Agent
Michael Goodman is a nationally recognized attorney and registered patent agent who advises clients on complex regulatory, transactional, and dispute matters in the FDA-regulated space. With nearly 20 years of combined industry and legal experience, Michael counsels startups and established multinational companies on the best, most efficient routes to bring regulated products to market and stay compliant.
His practice encompasses the full lifecycle of FDA-regulated products, including prescription and OTC drugs, medical devices, dietary supplements, cosmetics, and conventional foods. He is also a recognized expert in advising on kashrut-related food manufacturing issues. Michael regularly assists clients with regulatory strategy, product labeling and advertising review, health authority enforcement actions, and large-scale product recalls.
Before joining OFW, Michael served as in-house regulatory and GMP counsel at one of the world's largest pharmaceutical companies, where he guided global quality and regulatory teams through inspections, enforcement actions, major recalls, and health authority responses. Earlier in his career, Michael practiced at two Am Law 100 law firms, handling high-stakes FDA regulatory, enforcement, advertising, and product liability matters for major pharmaceutical, medical device, biotech, and dietary supplement companies.
He routinely advises on regulatory strategy, labeling and advertising compliance and claim substantiation, enforcement defense, product recalls, and negotiation of supply, manufacturing, and distribution agreements. Michael also regularly handles FDA regulatory diligence in mergers, acquisitions, private equity transactions, and public company filings.
Job Titles:
- Principal / Drug Practice Head
Phil helps clients navigate Capitol Hill and executive agencies on issues related to food and agriculture. He draws on more than 23 years experience with congressional budgets and annual appropriations as well as four years leading an executive branch trade agency whose 1,300 employees spanned the globe.
Rick Frank, a founding principal of OFW Law, served as the firm's Managing Principal for 38 years. Rick is a well-recognized expert on the labeling, advertising, and inspection and safety of food and drug products regulated by the FDA, USDA, and FTC, and is active in competitive labeling and advertising matters.
Job Titles:
- Principal, Customs & Trade Practice Head
Roger advises associations and individual clients on agricultural appropriations; Farm Bills; food assistance programs; international food aid and development programs; food safety issues; trade issues; and research programs. He has more than 30 years of experience on Capitol Hill, concentrating on these matters, having served as chief of staff to three House members and associate staff to the House Appropriations Committee.
Job Titles:
- Senior Regulatory & Technical Advisor
Stephen's expertise covers all areas of medical device law including:
Tom has broad and deep governmental and regulatory experience through nearly 30 years of federal service at the Federal Trade Commission, Consumer Financial Protection Bureau, and the United States Senate. He brings this experience to bear in providing critical informed advice and counsel to food and drug companies who have or may have matters before federal agencies and other parts of the federal government.
Job Titles:
- Senior Regulatory Advisor
Tom O'Donnell has 50 years of counseling and litigation experience. He focuses on all aspects of the import and export process, including tariff classification and valuation of imported merchandise, antidumping and countervailing duty issues, country of origin determinations, country of origin marking, free trade agreements, Customs penalties and seizures, Customs brokers issues, complex tariff provisions, import compliance programs, and intellectual property protection. As a Licensed Customs Broker, he is familiar with the details of the Customs entry process and how Customs operates. He litigates cases in the U.S. Court of International Trade and the U.S. Court of Appeals for the Federal Circuit. He makes representations to the Office of the U.S. Trade Representative and the congressional committees involved in international trade and tariff matters.
Job Titles:
- Principal / Drug Practice Head
Tish is a highly experienced counsel to drug, cosmetic, dietary supplement, and food companies with matters before the Food and Drug Administration, the Federal Trade Commission, and other federal agencies. In addition to counseling FDA-regulated entities, she has particular expertise aiding trade associations in their compliance strategies and crafting advocacy on behalf of members and is a highly regarded expert and frequent speaker on pharmaceutical supply chain security and cannabis.
Job Titles:
- Managing Principal, FDA Food Practice Head and Digital Health Practice Head