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Elizabeth B. Fawell

Counsel
Washington, D.C.

Elizabeth B. Fawell

Elizabeth Fawell navigates the detailed, and often complex, regulatory issues confronting food companies and helps them understand both the rules and various risks involved so that they can make informed business decisions. Elizabeth works with every segment of the food industry, including manufacturers, distributors, retailers, restaurants, and food service operators; and their trade associations.

Elizabeth's work on behalf of food industry clients with the Food Safety Modernization Act (FSMA) since its inception and her understanding of Hazard Analysis Critical Control Point (HACCP) systems provides her with the experience and perspective needed as she counsels clients on how to comply with new requirements under the law. Elizabeth is a Preventive Controls Qualified Individual (PCQI) and has completed the FSPCA PCQI training.

Elizabeth knows how laws, regulations, and guidance documents are developed, interpreted, and enforced. Her extensive knowledge enables clients to prevent and respond to enforcement actions such as Warning Letters, Import Alerts, and agency investigations. She helps clients in determining whether an RFR is necessary and whether a recall is warranted. If so, she helps manage the recall to minimize business impacts. Elizabeth provides real-time advice during factory inspections, helps clients prepare 483 responses, and drafts inspection manuals. She also assists clients in lawfully and creatively promoting their products; such as the development of labels, claims, and website and promotional campaigns. Elizabeth also supports clients in advertising disputes and with responses to FTC and Attorney General investigations.

Elizabeth helps clients stay informed of and ahead of public policy issues and develops strategies for effective advocacy before regulators. She also counsels clients on compliance with Consumer Product Safety Commission (CPSC) safety standards, testing and certification requirements, and reporting obligations.

Elizabeth is a member of the Food and Dietary Supplements Committee of the Food and Drug Law Institute.

Representative Experience

Counseled food manufacturer on responding to an FDA Inspectional Observations Form 483 and avoiding enforcement action.

Advising major food companies on compliance with FSMA preventive controls and supply chain requirements.

Advised several companies on CPSC reporting requirements and avoided a recall in multiple instances.

Education and admissions

Education

  • J.D., Order of the Coif, Northwestern University School of Law, 2005
  • B.A., Princeton University, 1998

Memberships

  • Member, Food and Drug Law Institute, Food and Dietary Supplements Committee
  • Member, Maryland Bar Association

Bar admissions and qualifications

  • District of Columbia
  • Maryland

Latest thinking and events

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