FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 3 – Foods – FDA Watch
In the third part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden’s FDA Regulatory Practice; Milli Hansen, Partner in Skadden’s Mass Torts, Insurance and Consumer Litigation Group; Daniel Luks, Partner in Skadden’s Mergers & Acquisitions Practice; and Douglas Stearn, Principal at Canal Row Advisors. Together, they discuss the latest developments in food regulation at FDA and at the state level; how companies may want to prepare for potential FDA and state enforcement actions and policy shifts in the coming year; how the regulatory environment impacts litigation; how regulatory uncertainty and litigation affect M&A deals; how companies can navigate the evolving food environment; and much more.
This episode and the rest of our series do not include the usual Headlines and Resources Links segments.
About Our Guests
Rachel Turow
Rachel Turow leverages nearly two decades of experience in food and drug law to guide clients through a full range of FDA regulatory issues, with a focus on product development and regulatory strategy.
A former regulatory counsel at FDA, Ms. Turow also served as in-house counsel at multinational developers and sellers of highly regulated products. She utilizes her extensive experience in advising on corporate transactions and litigation, as well as on developing regulatory risk management strategies and defending against regulatory enforcement actions.
Prior to joining Skadden, Ms. Turow oversaw regulatory strategy and compliance in various in-house counsel roles for major pharmaceutical manufacturers. Her regulatory work spans new drug development, from preclinical through post-market, and she has direct experience gaining FDA approval and launching new products. She has also worked extensively on developing and securing FDA approval of generic drugs, 505(b)(2)s and biosimilars, and has in-depth knowledge of exclusivity and other complex regulatory issues unique to those product categories. Ms. Turow also has medical device regulatory experience, with a particular focus on drug-led combination and digital health products.
Most recently, she led the regulatory legal team at one of the world’s largest retailers. During this time, she directed a team of lawyers focused on a variety of regulatory issues related to consumer products, reduced legal risks across diverse product categories, developed policies and processes to safeguard business operations, handled regulatory inquires and enforcement actions and coordinated with the government affairs and litigation teams on high-priority FDA-related issues. In this capacity, Ms. Turow leveraged her knowledge of common regulatory issues that arise regarding over-the-counter drugs, dietary supplements, cosmetics and consumer medical devices.
At FDA, Ms. Turow developed and implemented guidance and regulations, responded to citizen petitions, and advised on issues relating to the approvals of drugs and biological products as part of the Center for Drug Evaluation and Research (CDER) and medical devices at the Center for Devices and Radiological Health (CDRH).
Milli Hansen
Milli Kanani Hansen has significant experience coordinating and managing large-scale or multijurisdictional litigation, including class actions, actions coordinated in multidistrict litigation proceedings and actions pending in state courts across the country. She also represents clients in governmental enforcement actions brought by the Department of Justice and state attorney general offices.
Ms. Hansen has extensive experience overseeing pretrial discovery, including advising clients on discovery strategy, negotiating with opposing counsel, discovery motions, affirmative discovery, and factual investigation and development. She has also prepared witnesses for depositions and worked with experts to challenge plaintiffs’ scientific or economic theories.
In addition, Ms. Hansen has represented manufacturers facing purported class actions at both the trial and appellate levels. In this capacity, she has drafted motions on dispositive issues, class certification, expert admissibility and discovery disputes.
Ms. Hansen also has substantial experience representing companies—and their executives and employees—in government investigations and enforcement proceedings.
Daniel Luks
Daniel Luks is a corporate attorney who advises public and private companies, as well as private equity sponsors, on mergers, acquisitions, corporate governance, dispositions, securities offerings and other corporate matters.
Mr. Luks also advises Skadden’s investment banking clients on financial advisory work. He is actively involved in Skadden’s corporate training, recruiting and mentoring programs.
Outside of his practice, Mr. Luks was named a David Rockefeller Fellow for 2026 by the Partnership for New York City.
Douglas Stearn
Douglas Stearn, J.D., served for more than 17 years at the FDA, leading regulatory, compliance, enforcement, and policy activities across a broad range of products.
Most recently, Mr. Stearn was the Principal Deputy Associate Commissioner for Inspections and Investigations in the FDA Office of Inspections and Investigations (OII), serving as the primary advisor to and surrogate for the Associate Commissioner for OII on all organizational decisions and actions involving food, drugs, medical devices, biologics, and tobacco products. He directly oversaw emergency operations, inspectional policy, recalls, debarment, internet investigations, tobacco product inspections, and other cross-cutting functions. Mr. Stearn held similar responsibilities as Deputy Associate Commissioner in the Office of Regulatory Affairs (ORA) before the 2024 FDA reorganization.
Between 2018 and 2024, Mr. Stearn was the Deputy Director of Regulatory Affairs of the Center for Food Safety and Applied Nutrition (CFSAN), where he led regulatory and compliance activities and programs involving food safety and outbreak response. He provided executive and technical leadership on efforts to modernize food safety and the regulation of dietary supplements and cosmetics, in addition to leading precedent-setting enforcement actions.
Prior to that, Mr. Stearn was Director of ORA’s Office of Enforcement and Import Operations, overseeing major initiatives to improve import and recall processes and operational efficiency. In this position, he led a reorganization of all personnel working in import operations and FDA’s integration into a new government-wide import entry system. He also served as a Deputy Director of the Office of Compliance in the Center for Drug Evaluation and Research (CDER) and as the Director of ORA’s Division of Compliance Policy.
Mr. Stearn was a trial attorney in the U.S. Department of Justice’s Office of Consumer Litigation for more than 15 years, litigating civil and criminal cases referred by the FDA and other consumer protection agencies.
Mr. Stearn received his law degree from Cornell University and his bachelor’s degree from Brown University.
FDA Watch Podcast 