As the novel coronavirus (COVID-19) crisis has continued to escalate, both the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) have taken additional action to provide industry, the public, and inspectors with guidance concerning food safety and how to respond in the event that food industry personnel test positive for COVID-19. Importantly, FDA does not anticipate that food products would need to be recalled or be withdrawn from the market when a food employee tests positive for COVID-19 because there is currently no evidence to support the transmission of COVID-19 associated with food or food packaging. Similarly, USDA says that it is not aware of any reports at this time of human illnesses that suggest COVID-19 can be transmitted by food or food packaging.

This blog summarizes key takeaways in the following agency documents and communications:

  • FDA’s website on Food Safety and the Coronavirus Disease 2019 (COVID-19);
  • FDA’s temporary policy on onsite audits under the Food Safety Modernization Act (FSMA) regulations;
  • USDA’s COVID-19 Questions & Answers (Q&As);
  • USDA communications concerning Food Safety and Inspection Service (FSIS) and Agricultural Marketing Service (AMS) inspectional issues.

While this blog is focused on the guidance from federal agencies, state and local jurisdictions also are starting to issue their own guidance documents, and there are existing reporting requirements in some jurisdictions. Food companies will need to take account of federal, state, and local requirements and guidance when addressing this quickly evolving situation.

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Photo of Martin Hahn Martin Hahn

Partner, Washington, D.C.

Martin Hahn uses his background in food technology and his comprehensive understanding of the laws governing the food industry to navigate clients through the myriad regulatory and business issues impacting the industry from farm to table. He recognizes the demands…

Partner, Washington, D.C.

Martin Hahn uses his background in food technology and his comprehensive understanding of the laws governing the food industry to navigate clients through the myriad regulatory and business issues impacting the industry from farm to table. He recognizes the demands placed on his clients and finds innovative and creative solutions, particularly when responding to observations raised by regulators  during inspections. Whether the issue involves obtaining the authorization of a new food or dietary ingredient, complying with manufacturing requirements, labeling or advertising, product recalls, or enforcement, Martin serves as an effective advisor and advocate.

Martin’s career has touched on almost every issue impacting the food industry. He has a comprehensive understanding of the laws affecting the labeling and advertising of foods, dietary supplements, infant formulas, medical foods, and foods for special dietary use. He helps clients anticipate new trends and develop the data that is needed to distinguish their products from others on the market. With his understanding of science and technology in the food industry, Martin provides assistance in obtaining regulatory authorizations to market new food ingredients, food packaging materials, and dietary ingredients. He also assists clients in responding to proposed regulations and draft guidance, as well as, tracks and keeps his clients apprised of the latest trends in class action law suits and helps clients anticipate new regulatory initiatives.

Martin grew up on a farm and worked in food processing plants before going to law school. His hands-on experience in the field and degree in food technology allow him to better understand the challenges his clients face in complying with the laws impacting food manufacturing. He understands Hazard Analysis Critical Control Point (HACCP) and the regulations under the Food Safety Modernization Act (FSMA).

Photo of Maile Hermida Maile Hermida

Partner, Washington, D.C.

Maile Gradison Hermida represents all segments of the food industry and their trade associations. She has a keen understanding of the issues affecting the industry, from product development through production, distribution, and retail sale. Her core practice involves helping companies…

Partner, Washington, D.C.

Maile Gradison Hermida represents all segments of the food industry and their trade associations. She has a keen understanding of the issues affecting the industry, from product development through production, distribution, and retail sale. Her core practice involves helping companies ensure they are in compliance with regulations from federal agencies such as the Food and Drug Administration (FDA) and U.S. Department of Agriculture. Maile also provides strategic advice on public policy issues, frequently involving agency rulemakings.

Maile has considerable experience with the FDA Food Safety Modernization Act (FSMA), having worked with numerous companies and trade associations on all aspects of the law since the day it was signed. She translates her in-depth knowledge of FSMA into practical solutions for companies working on implementation strategies. She also is a Preventive Controls Qualified Individual (PCQI), as well as a Food Safety Preventive Controls Alliance Lead Instructor for the PCQI training.

Additionally, Maile assists companies with matters involving regulatory enforcement. She helps clients navigate product recalls; government inspections; and other enforcement actions, such as Warning Letters and import detentions. Maile also advises clients on the development of label and advertising claims, as well as labeling requirements for foods and dietary supplements.

Maile is a frequent speaker and contributor to industry publications. Prior to joining Hogan Lovells, she served as a judicial clerk to the Honorable Charles F. Lettow of the U.S. Court of Federal Claims. Maile graduated with high honors from The George Washington University Law School, where she served as executive editor of The George Washington Law Review.

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.

Photo of Leigh Barcham Leigh Barcham

Senior Associate, Washington, D.C.

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…

Senior Associate, Washington, D.C.

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.