On January 31, 2023, FDA Commissioner Robert M. Califf announced a proposed redesign of the human foods program at FDA. The proposal follows the findings and recommendations of a Reagan-Udall Foundation expert panel that Dr. Califf had charged with evaluating the agency’s existing human foods program. Commissioner Califf called the redesign “transformative” and believes the proposed structures will have clear priorities to protect and promote a safe and nutritious food supply in the current and evolving environment.

Overall Structure

In the high-level proposal, FDA intends to unify various functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR), and Office of Regulatory Affairs (ORA) under an organization called the Human Foods Program. A Deputy Commissioner for Human Foods will lead that program and have decision-making authority over policy, strategy, and regulatory program activities, as well as resource allocation and risk-prioritization. The Deputy Commissioner will report directly to the FDA Commissioner. The Human Foods Program will have a larger executive team with clearly defined lines of authority to ensure decisive leadership. This will include a Principal Associate Commissioner reporting to the Deputy Commissioner. Based on the organizational chart provided in the proposal, the Deputy Commissioner for Human Foods appears to be on the same level as the Director of the Center for Veterinary Medicine (CVM).

In addition, a Human Foods Advisory Committee of external experts will be formed to advise FDA on issues in food safety, nutrition, and innovative food technologies.

Nutrition

FDA also plans to create a Center for Excellence in Nutrition within the Human Foods Program, that will work with industry to offer healthier, more nutritious foods. The Center is intended to elevate and empower action on nutrition science, policy, and initiatives to reduce diet-related chronic diseases and improve health equity. The Center will include an Office of Critical Foods responsible for the regulation of infant formula and medical foods, presumably also to help ensure a robust supply of such critical products.

Food Safety

FDA intends to establish an Office of Integrated Food Safety System Partnerships to prioritize and unify FDA’s work with state and local regulators. The aim is to ensure greater collaboration and support to state-level inspectional activities. The changes to ORA mentioned below will strengthen the goals in the New Era of Smarter Food Safety.

Office of Regulatory Affairs

The proposal also reimagines ORA. The new model will focus on setting the global gold standard in inspections, investigations, laboratory analysis, and import operations. ORA will support the Human Foods Program and other regulatory programs by focusing on critical activities. As a result, ORA will take a more prevention-based approach to food safety inspections. It will also will modernize and increase its specialization alongside the regulatory programs. Certain ORA functions such as state and local food safety partnership functions will be realigned into the Human Foods Program to streamline the agency’s oversight over foods.

Center for Veterinary Medicine

FDA proposes to create an Office of Animal Biotechnology Innovation within CVM, which will work on advancing FDA’s regulation of animal biotechnology. The office will collaborate with the Human Foods Program on agricultural biotechnology innovation. The CVM Director’s role will be expanded to include duties as Chief Veterinary Officer (CVO) to reinforce CVM’s One Health mission; where the Director is not a veterinarian, the duties will be held by a senior veterinarian within CVM. 

Next Steps

Commissioner Califf will next turn this high level proposal into a concrete reorganization plan. To do so, the Commissioner will engage with internal and external stakeholders on this proposal, and will provide an additional update on FDA’s progress on reorganization and timeline by the end of February.

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If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements or Animal Food and Drug practices.

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Photo of Miriam Guggenheim Miriam Guggenheim

Miriam Guggenheim, co-chair of Covington’s Food, Drug and Device Practice Group, assists a broad range of major food and dietary supplement companies in achieving their marketing goals while minimizing regulatory and litigation risks. She also helps clients successfully navigate crises such as recalls and…

Miriam Guggenheim, co-chair of Covington’s Food, Drug and Device Practice Group, assists a broad range of major food and dietary supplement companies in achieving their marketing goals while minimizing regulatory and litigation risks. She also helps clients successfully navigate crises such as recalls and unwanted Congressional or regulatory attention. In addition to her work for individual clients, Miriam serves as outside counsel to a number of key trade associations, helping them accomplish broad industry objectives by engaging with the FDA, FTC, and Congress. Chambers USA notes, Miriam is “incredibly sharp and very responsive” and a client reports, “I rely on Miriam tremendously to help me find ways forward in difficult and novel situations, and she never fails to deliver.”

As the food industry faces new challenges – including scrutiny of ingredients and food packaging materials, concerns about heavy metals and other contaminants, attention to “ultra-processed foods,” and increasing consumer fraud litigation and Prop 65 demand letters – Miriam remains at the forefront of legislative and regulatory changes and food policy and litigation trends. She draws on this deep knowledge and insight to advise clients on all aspects of food development and marketing, from product ingredient sourcing and manufacturing considerations to food labeling and marketing. Partnering with Covington colleagues in international offices, Miriam helps clients solve regulatory problems across the globe.

Photo of Jeannie Perron Jeannie Perron

Jeannie Perron is a member of the firm’s Food and Drug Practice Group, resident in the Washington, DC Office.

In addition to being an attorney, Jeannie also holds a degree in veterinary medicine and has practiced as a veterinarian.  She specializes in food and

Jeannie Perron is a member of the firm’s Food and Drug Practice Group, resident in the Washington, DC Office.

In addition to being an attorney, Jeannie also holds a degree in veterinary medicine and has practiced as a veterinarian.  She specializes in food and drug law, with a sub-specialty in animal food and drug law.  In this capacity, she represents companies that manufacture feed, feed ingredients, drugs, biologics and medical devices for animals, as well as clients in related industries.

Her specialties also include advising clients and providing representation on matters before the United States Department of Agriculture arising under the Animal Welfare Act.  Her clients are animal research companies, pharmaceutical companies, and animal dealers and exhibitors.

Another specialized area of practice relates to the importation of animal-derived ingredients and products.  Jeannie advises clients on USDA regulations and procedures in this area and assists clients in securing the required permits and certifications.

In addition to these other practice areas, Jeannie also advises clients in the regulation of dietary supplements, over-the-counter drugs, cosmetics for humans, and import and export of products regulated by the United States Food and Drug Administration as well as those having animal or microbially-derived ingredients regulated by USDA. 

Photo of Andrew Do Andrew Do

Andrew Do is an associate in the firm’s Chambers top-ranked Food, Drug, and Device Practice Group. Andrew draws on his scientific training, years at FDA, and experience on political campaigns to provide strategic advice to clients on a broad range of regulatory compliance…

Andrew Do is an associate in the firm’s Chambers top-ranked Food, Drug, and Device Practice Group. Andrew draws on his scientific training, years at FDA, and experience on political campaigns to provide strategic advice to clients on a broad range of regulatory compliance and policy issues. He works at the intersection of law, policy, and politics to help clients navigate complex matters.

He has assisted companies, trade associations, and private equity clients on a myriad of matters, including in complying with FDA regulations, assessing regulatory and consumer litigation risks, responding to FDA enforcement actions and Congressional inquiries, analyzing proposed bills and legislative priorities on Capitol Hill, and conducting due diligences of FDA regulated companies for acquisition.

Before joining Covington, Andrew was an ORISE Research Fellow with the Center for Food Safety and Applied Nutrition (CFSAN) at FDA, where he conducted research on food allergens, gluten, and pathogens to support the agency’s regulation and enforcement concerning food products. His research and work have been published in numerous scientific peer-reviewed journals.

Photo of Jessica O'Connell Jessica O'Connell

Jessica O’Connell co-chairs Covington’s market-leading global Food, Drug, and Device Practice Group. Drawing from nearly twenty years of experience working at FDA and in private practice, Jessica provides strategic advice to a broad range of companies and trade associations in navigating regulatory frameworks…

Jessica O’Connell co-chairs Covington’s market-leading global Food, Drug, and Device Practice Group. Drawing from nearly twenty years of experience working at FDA and in private practice, Jessica provides strategic advice to a broad range of companies and trade associations in navigating regulatory frameworks and engaging with food and drug regulatory bodies and Congress. She works closely with clients to develop product strategies that are low-risk from both a regulatory and litigation perspective while also meeting marketing goals and objectives. She also regularly counsels clients regarding potential crises, such as recalls, regulator investigations, and other unanticipated regulatory attention.

Chambers USA reports that Jessica “is enthusiastic, exceptionally smart and a talented lawyer who brings tremendous insight from being a regulator” and that she “knows how best to interact with the FDA in a productive and efficient way.”

Jessica’s practice focuses on food and beverages, dietary supplements, cosmetics, and OTC drugs. She has engaged with Congress and state legislators on cosmetic and drug legislative efforts and alternative protein and other food labeling requirements, and has represented clients in both FDA and FTC investigations, including negotiating consent decrees and responding to civil investigative demands, and actively practices before the NAD. Jessica has specific expertise regarding the regulatory framework for new and emerging food technologies, including alternative protein ingredients and products and specialized nutrition products such as infant formula and medical foods, the marketing of cosmetics and OTC drugs, including sunscreens, Proposition 65, organic labeling, the federal and state legal landscapes surrounding the development and marketing of products containing CBD, and claim substantiation requirements, as well as manufacturing and supply chain requirements under FSMA and FDA’s implementation of MoCRA.

Jessica also has an active pro bono practice, with a particular focus on issues relating to reproductive rights and health care access.

Before joining Covington, Jessica served as Associate Chief Counsel in FDA’s Office of Chief Counsel. While at FDA, Jessica counseled various components of FDA and HHS on a broad range of food, cosmetic, and drug legal issues, including FDA’s implementation of FSMA, nutrition initiatives, cosmetic oversight, and FDA’s work investigating foodborne illness outbreaks and related actions, including recalls and other enforcement activities. In addition, Jessica provided legal counsel to the agency and Department regarding FDA’s import and export activities for all FDA-regulated products.

Photo of Deepti Kulkarni Deepti Kulkarni

Drawing from over a decade of experience working in both FDA’s Office of Chief Counsel and private practice, Deepti Kulkarni provides strategic advice to clients on a wide range of complex matters involving FDA and USDA regulatory oversight. She has played a key…

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Deepti advises companies developing and marketing animal products, foods, dietary supplements, and cosmetics at nearly every step of the product lifecycle. She also counsels clients on potential crises, such as product recalls, import refusals, and other regulatory actions.

Deepti previously served as an Associate Chief Counsel in the FDA’s Office of Chief Counsel. While at FDA, she counseled various components of FDA and HHS on a broad scope of issues related to animal products, foods, dietary supplements, and cosmetics, as well as cross-product matters involving imports and exports, advisory committees, and constitutional issues. Deepti received several awards during her time at the FDA, including the FDA Award of Merit (FDA’s highest award), Commissioner’s Special Recognition Award, and the CFSAN Director’s Special Citation Award.