On May 22, 2020, the U.S. Food and Drug Administration (FDA) announced two policies to provide temporary flexibility with respect to packaged foods formulation and labeling requirements during the COVID-19 pandemic. The agency’s guidance document is entitled “Temporary Policy Regarding Certain Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines” (“Guidance”). The Guidance details flexibility for manufacturers to make minor formulation changes and flexibility for vending machine operators regarding calorie information for foods sold in vending machines. Like the other guidance documents FDA has issued to provide labeling flexibility during the COVID-19 pandemic, this guidance is effective only for the duration of the public health emergency. We summarize the Guidance in this post.

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Photo of Elizabeth Fawell Elizabeth Fawell

Partner, Washington, D.C.

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…

Partner, Washington, D.C.

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, D.C.

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.…

Senior Associate, Washington, D.C.

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 Mary Lancaster Mary Lancaster

Associate, Washington, D.C.

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…

Associate, Washington, D.C.

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.