On September 27, 2019 the U.S. Food and Drug Administration (FDA) hosted a public meeting to gather information from stakeholders on changes the agency could make to existing standards of identity (SOIs), particularly changes that could be made across categories of standardized foods (i.e., “horizontal” changes), to provide flexibility for the development of healthier foods and facilitate innovation. Though FDA primarily was in listening mode during the meeting, comments by agency representatives suggested FDA’s commitment to SOI modernization. In particular, the agency encouraged stakeholder comments to the docket, indicating interest in highly-detailed proposals for establishing horizontal approaches to SOIs that eliminate barriers to improvements in product nutrition profiles, spur innovation, and provide flexibility to allow emerging technology to reach consumers while ensuring sufficient transparency. Written comments are due by November 12, 2019, and can be submitted to FDA docket number FDA-2018-N-2381-1371. This memorandum provides a high-level summary of the agency statements and stakeholder comments made during the meeting.

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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 Veronica Colas Veronica Colas

Senior Associate, Washington, DC

Veronica Colas counsels clients on the regulations and policy issues affecting food companies from farm to table. She represents all segments of the food industry, including manufacturers, retailers, restaurants, and food service companies, as well as their trade associations.
Veronica provides clear advice and practical solutions for compliance with labeling, advertising, and safety regulations from the Food and Drug Administration (FDA), U.S. Department of Agriculture, and Consumer Product Safety Commission.

A core part of Veronica’s practice is helping clients develop new products, label claims, advertising materials, and promotional campaigns, with a keen awareness of today’s litigation environment. She has a deep understanding of both current and forthcoming food labeling and production requirements, from nutrition and menu labeling, to the regulatory issues surrounding genetically engineered foods and organic food production.

Veronica also has significant experience in helping clients navigate regulatory enforcement challenges, such as Warning Letters, import detentions, and investigations by the Federal Trade Commission, Department of Justice, Congress, and state Attorneys General. She works closely with trade associations and food companies to craft comments and develop strategies in response to agency rulemaking and other public policy issues. She is a frequent speaker and contributor to industry publications.

Photo of Leigh Barcham Leigh Barcham

Associate, Washington, DC

Leigh Barcham provides business-oriented legal and policy solutions to food and agriculture companies and trade associations. She advises clients on state and federal regulatory issues that may arise throughout the entire food production line from farm to table. Leigh also guides clients in consumer products industries as they navigate federal advertising laws and regulations.
When she joined Hogan Lovells, Leigh brought with her more than five years of public policy experience. A part-time student by night and a law clerk by day, Leigh worked throughout law school at a firm in Washington, D.C., focusing on legislation and federal regulation affecting the energy industry. Before law school she served as a policy analyst for international affairs and climate change at the White House Council on Environmental Quality.