On July 17, 2025, Senators Ed Markey (D-MA) and Cory Booker (D-NJ) introduced the “Ensuring Safe and Toxic-Free Foods Act of 2025.” If enacted, this bill would fundamentally reshape FDA’s generally recognized as safe (GRAS) framework by, among other things, requiring that companies submit GRAS notifications for all ingredients currently marketed under “self-GRAS” determinations, amending the Federal Food, Drug, and Cosmetic Act’s (FDCA’s) “GRAS” definition to exclude certain new/novel ingredients, and, within 2 years of enactment, potentially sunsetting the GRAS pathway altogether. This alert summarizes these and other key provisions of the rule.

Click here to read the full alert on cov.com.

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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…

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.

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Photo of Deepti Kulkarni Deepti Kulkarni

Drawing from over 15 years of experience working in FDA’s Office of Chief Counsel and private practice, Deepti Kulkarni provides strategic advice to clients on a wide range of matters involving FDA and USDA regulatory oversight of foods, dietary supplements, and animal health…

Drawing from over 15 years of experience working in FDA’s Office of Chief Counsel and private practice, Deepti Kulkarni provides strategic advice to clients on a wide range of matters involving FDA and USDA regulatory oversight of foods, dietary supplements, and animal health products. She works closely with clients to develop and execute strategies to satisfy regulatory requirements and mitigate enforcement and litigation risk while also meeting key commercial goals.

Deepti also counsels clients on potential crises, such as product recalls, import refusals, and responding to agency warning or noncompliance letters, adverse inspection findings and other regulatory actions.

Chambers USA reports that Deepti is “a very strategic lawyer with deep expertise and strong business acumen,” “a food law and regulation expert,” who “has an incredibly thorough grasp of the regulatory process,” finds “creative solutions to novel and complex issues,” and “is also very responsive and gives sound and practical advice.”

Deepti previously served as an Associate Chief Counsel in 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 foods, dietary supplements, cosmetics, and animal health products as well as cross-product matters involving imports and exports, advisory committees, and constitutional issues. She also played a key role in the development and implementation of regulatory frameworks for foods and other products developed using biotechnology, gene editing, and other new and emerging technologies. 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.

Deepti also serves as an Adjunct Professor of Law at Georgetown Law School where she teaches Food and Drug Law.

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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.

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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…

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. 

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Photo of Cory Trio Cory Trio

Cory Trio is an associate in the firm’s Washington, DC office where he is a member of the Food, Drug, and Device Practice Group. Cory helps food, dietary supplement, OTC drug, and consumer product clients navigate a broad range of U.S. regulatory requirements. …

Cory Trio is an associate in the firm’s Washington, DC office where he is a member of the Food, Drug, and Device Practice Group. Cory helps food, dietary supplement, OTC drug, and consumer product clients navigate a broad range of U.S. regulatory requirements. He has wide-ranging expertise on FDA and USDA food safety and manufacturing requirements, including FDA’s Food Safety Modernization Act (FSMA) regulations. He regularly advises clients on the development and implementation of food safety and quality programs and in responding to regulatory inspections, product recalls, and quality events. Cory also counsels clients on product labeling and claim substantiation issues, helping clients advance their marketing goals while mitigating regulatory and litigation risks.

Cory counsels OTC drug manufacturers on product development, labeling, and manufacturing issues, with a particular focus on helping clients navigate the CARES Act OTC monograph reforms. He also advises clients across product categories on FDA’s import and export requirements.

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