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COVID-19 Update: FDA and USDA Issue Memorandum of Understanding Regarding the Potential Use of the Defense Production Act with Regard to FDA-Regulated Food During the COVID-19 Pandemic

By Elizabeth Fawell, Brian Eyink & Christine Forgues on May 20, 2020
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The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) recently issued a Memorandum of Understanding (MOU) regarding the potential use of the Defense Production Act (DPA) with regard to FDA-regulated food. Importantly, USDA retains its DPA authority for products subject to FDA jurisdiction. The MOU, however, establishes that FDA will be responsible for monitoring the continued functioning of the FDA-regulated food production sector, bringing issues to USDA’s attention should FDA believe that USDA may need to exercise its DPA authorities to address a situation. The MOU is intended to supplement preparedness efforts and directs FDA to take the lead for FDA-regulated industry and monitor the food supply, work with stakeholders to identify and assess potential supply chain disruptions, issue applicable guidance for workers, and educate stakeholders about the potential for use of DPA authority. To the extent FDA identifies disruptions to the supply or other issues, both Agencies will work together to discuss appropriate action, including potentially invoking USDA’s DPA-delegated authorities. The MOU does not actually take any action under the DPA—it does not reflect action by USDA expanding the scope of the President’s invocation of the DPA beyond the meat and poultry sectors, nor does it constitute an order under the DPA.

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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.

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Photo of Brian Eyink Brian Eyink

Counsel, Washington, D.C.

Drawing on experience throughout the supply chain — from animal production to food processing to distribution and retail sale — Brian Eyink brings vast and cross-cutting industry knowledge to help clients find practical solutions to regulatory problems. Brian is particularly…

Counsel, Washington, D.C.

Drawing on experience throughout the supply chain — from animal production to food processing to distribution and retail sale — Brian Eyink brings vast and cross-cutting industry knowledge to help clients find practical solutions to regulatory problems. Brian is particularly sensitive to risk management issues as companies adapt to a regulatory and political environment increasingly focused on inspections, enforcement, and investigations.

Brian helps food and agriculture companies navigate increasingly complex and high-stakes federal and state regulatory issues. He draws on deep experience with the USDA, FDA, and FTC, as well as state, local, and self-regulatory bodies, litigation, and acquisitions to solve clients’ regulatory and business problems. Brian advises clients on the full scope of regulatory issues facing the food and agriculture sectors, ranging from USDA and FDA enforcement actions and federal investigations to regulatory compliance, import and export issues, litigation support, comment preparation, legislative drafting, policy development, trade association governance, advertising disputes, and labeling issues.

Brian also represents food and agriculture trade associations, advising on issues including general counseling and governance, influencing policy and public perspective, and implementation of industry initiatives.

Before joining Hogan Lovells, Brian served as a judicial law clerk to the Honorable Gerald Bard Tjoflat of the United States Court of Appeals for the Eleventh Circuit. While in law school, he served as an executive editor of the Duke Law Journal.

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Photo of Christine Forgues Christine Forgues

Senior Associate, Washington, D.C.

Chris Forgues provides business-oriented legal and scientific solutions to food and agriculture companies and trade associations.
She advises clients on state and federal regulatory issues that arise throughout the entire food supply chain and production line, ranging from USDA…

Senior Associate, Washington, D.C.

Chris Forgues provides business-oriented legal and scientific solutions to food and agriculture companies and trade associations.
She advises clients on state and federal regulatory issues that arise throughout the entire food supply chain and production line, ranging from USDA and FDA enforcement actions and federal investigations to regulatory compliance, import and export issues, litigation support, comment preparation, advertising disputes, and labeling issues.

Chris’s background in life science (chemistry and pharmacology) assists her in her science-based food law practice. Chris’s unique educational background and regulatory scientist experience provides valuable context to complex scientific issues as they relate to the governing regulatory requirements.

When she joined Hogan Lovells, Chris brought with her more than nine years of regulatory consulting experience. A part-time student by night and a regulatory scientist by day, Chris worked throughout law school at a firm in Washington, D.C., focusing on product review, development, and post-marketing in the life sciences sphere, with experience handling matters under the Food and Drug Administration (FDA), the Department of Agriculture (USDA), and the Environmental Protection Agency (EPA), the Federal Trade Commission (FTC), the National Advertising Division (NAD), the Consumer Product Safety Commission (CPSC), as well as state regulatory bodies.

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  • Posted in:
    Food, Drug & Agriculture
  • Blog:
    A Seat at the Table
  • Organization:
    Hogan Lovells
  • Article: View Original Source

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