U.S. Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless, M.D., and Deputy Commissioner for Food Policy and Response Frank Yiannas recently issued a public statement on steps to usher the U.S. into a new era of smarter food safety (the Statement). The Statement reflects on the evolution of our food system from an “around the corner” network to one that is “around the world.” It posits the next 10 years will see more innovation in the food sphere than the past 20. As such, the agency is looking to augment its food safety work such as implementing FDA Food Safety Modernization Act (FSMA) requirements and its use of technologies such as whole genome sequencing and the GenomeTrackr Network, by leveraging, among other things, the use of new and emerging technologies to create “a more digital, traceable, and safer system.” The Statement announces two new FDA initiatives – one an artificial intelligence pilot program for imported foods review, the other a “Blueprint for the New Era of Smarter Food Safety.” The agency will seek stakeholder input through a public meeting later this year on the Blueprint, addressing the key areas traceability, digital technologies, and evolving business models. In brief, the agency views the new era of smarter food safety as one that is “people-led, FSMA-based, and technology-enabled.”

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Photo of Elizabeth Fawell Elizabeth Fawell

Partner, Washington, DC

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.

Photo of Mary Lancaster Mary Lancaster

Mary Lancaster provides practical guidance on complex regulatory issues to help food and beverage companies in all segments of the industry achieve their business goals.

Mary advises clients on Food and Drug Administration (FDA) and United States Department of Agriculture (USDA) compliance with current good manufacturing practice (cGMP), advertising and labeling compliance, and food safety issues that arise throughout the entire food supply chain. She also advises on enforcement actions and drafts comments on proposed regulations and agency guidance. Mary also has experience with matters in front of the Federal Trade Commission’s Bureau of Consumer Protection.

Prior to law school, Mary was a legal assistant at a Washington, D.C. law firm, where she assisted lawyers in white-collar investigations, pharmaceutical class action litigations, and federal habeas petitions for death row inmates.