The U.S. Food and Drug Administration (FDA) recently announced it will be holding a full-day public meeting on September 27, 2019, to address “Horizontal Approaches to Food Standards of Identity Modernization.” As explained in more detail below, FDA’s “horizontal” approach to standards reform would look at amending wide groups of standards rather than evaluating standards on a case-by-case basis. Requests to make oral comments are due by September 12th and in-person attendees should register by September 20th. Written comments are due by November 12, 2019, and can be submitted to FDA docket number FDA-2018-N-2381-1371.

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Photo of Steve Steinborn Steve Steinborn

Partner, Washington, DC

Steven Steinborn literally wrote the book on food labeling as a principal author of the U.S. Department of Agriculture’s (USDA) labeling guide. On top of that, he offers clients 28 years of experience in guiding informed business decisions, taking into account food laws and other regulations, as well as the environment in which companies operate. Representing food processors, restaurant chains, foodservice operators, ingredient suppliers, and trade associations, Steven focuses on advertising, labeling, and food safety. He is also a strong advocate in enforcement matters brought by the Federal Trade Commission, the Food and Drug Administration, the USDA, and state regulators as well.

From small start-ups to established international brands, Steven understands the dynamics of the food industry. He brings this knowledge to bear on cutting-edge issues ranging from claim substantiation to potential food safety situations. He is also regularly consulted in bringing and defending competitor challenges, and represents companies before the Better Business Bureau’s National Advertising Division. Keenly aware of the current litigation climate, Steven works closely with marketers in exploring all avenues to reach important business objectives.

Beyond the food industry, Steven routinely advises consumer product companies on reporting and potential recall situations arising under the jurisdiction of the Consumer Product Safety Commission. His practice covers a diverse range of industries, including children’s toys, household appliances, infant products, gas grills, furnaces, consumer electronics, computers, printers, handheld devices, and child-resistant packaging.

Steven is a frequent speaker on innovation and legal compliance and has authored numerous articles on a range of subjects, from the latest developments in the regulation of genetically engineered foods to important developments that impact food advertising.

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.