Ep. 211. Kathy Sanzo: The Implications of FDA's Synthetic Food Dye Phase-Out

Kathleen Sanzo, J.D. is Co-Chair of Morgan Lewis' life sciences industry team. She centers her practice on regulatory and compliance issues connected to U.S. Food and Drug Administration (FDA)-regulated products. She leads and counsels clients on all legal and regulatory issues concerning food, dietary supplements, and cosmetic product manufacture, approval, marketing, and distribution; food, drug, and device compliance and enforcement matters; and consumer product issues regulated by the U.S. Consumer Product Safety Commission and state enforcement agencies, among other areas. A frequent author and co-author on publications related to FDA matters, Kathleen regularly speaks on these issues at industry events. She serves as Vice Chair of the Consumer Product Regulation Committee of the American Bar Association Section of Administrative Law and Regulatory Practice, and is a member of the Food and Drug Law Institute's Medical Products Committee. In this episode of Food Safety Matters, we speak with Kathy [32:33] about: Why FDA chose a voluntary approach to phasing out synthetic food dyes, the implications of this approach, and industry's response Why state-level food additive restrictions are outpacing federal action How the emerging patchwork of state laws creates significant operational and legal challenges for food manufacturers nationwide The expected supply chain impacts of phasing out synthetic dyes               The legal risks companies face, from state enforcement to labeling, false advertising claims, and product liability How companies can prepare by monitoring legislation, securing dependable ingredient suppliers, updating labels, and planning consumer communication How state actions on additives may influence consumer expectations, spur industry innovation, and shape food policy over the next decade. News and Resources News FDA Releases Human Foods Program Priority Deliverables and Guidance Agenda for 2026 [5:48] FDA Testing Pinpoints Contaminated Ingredient in Infant Botulism Outbreak [17:44] EFSA Sets Safety Thresholds for Cereulide Toxin in Infant Formula [19:43] EFSA to Advise on Cereulide Levels in Infant Formula Following Global Recall UK Mother's Allegation that Recalled Nestlé Formula Sickened her Baby is Unconfirmed Experts Share Lessons from a Successful Listeria 'Seek and Destroy' Process [23:36] FDA to Hold Virtual Public Meeting on Food Allergen Thresholds, Releases Event Materials [29:44] Sponsored by: CINTAS We Want to Hear from You! Please send us your questions and suggestions to [email protected]