Introduction

August T. Horvath*

Once again, it is my privilege to introduce FDLI’s Top Food and Drug Cases volume, this time covering significant lawsuits and legal issues from 2025. Our coverage includes government enforcement actions, civil and criminal cases, and significant appeals. The year 2025 was another wild one in the food and drug space. The initials “MAHA” entered our vocabulary with a new set of government agency priorities, and significant court decisions altered the landscape, resolving some long-standing legal questions and raising some new ones.

We typically lead with appellate decisions in this volume because of their great precedential value. This year, we start with a Supreme Court decision, not in the food and drug space, but Dan Logan and Justine Lenehan explain why FDA practitioners nevertheless should know about FCC v. Consumers’ Research. Mital Patel and Kathy Luo enlighten us about the Ninth Circuit’s ruling in Natural Grocers v. Rollins, in which the court reviewed the bioengineered-food disclosures of USDA’s Agriculture Marketing Service. Ralph Hall describes the Fifth Circuit’s ruling in Zyla Life Sciences v. Wells Pharma, examining the viability of private litigation based on state statutes mirroring the Federal Food, Drug, and Cosmetic Act. Late in 2025, the Eighth Circuit weighed in on the evidentiary requirements for class certification in food labeling class actions in the Folgers Marketing Litigation, reported by Rene Befurt, Sai Sindhura Gundavarapu, and Riddhima Sharma. Sara Koblitz and Anne Walsh cover the D.C. Circuit’s ruling in Novartis Pharmaceuticals v. Kennedy, a bright spot for FDA in the past year’s litigation, as the court validated its approach to so-called “chubby labels.”

The federal district courts also have been active in delineating the government’s regulatory authority in 2025. We hear from Rebecca Jones McKnight, David Bender, and Lily Barrett about Wulferic v. FDA, in which one such court in Texas found that a defendant has a right to a jury trial in an FDA action for civil penalties under the Tobacco Control Act. A court in the Eastern District of California struck the latest blow to the California government’s Proposition 65 warning regime in California Chamber of Commerce v. Bonita, described for us by Neil Fortin. Andrew Wasson explores a development in the post-Loper Bright doctrine of court deference to agencies, or lack thereof, here in the context of defining “biologics,” in Eli Lilly v. Kennedy in the Southern District of Indiana. An Eastern District of Texas judge in American Clinical Laboratory Association v. FDA overturned FDA’s new enforcement regime for laboratory-developed tests, as discussed by Tina Papagiannopoulos.

State courts don’t get into the action as often in food and drug cases, but Bill Janssen highlights a fascinating 2025 product liability decision from the New York Appellate Division, Silverstein v. CoolSculpting.

The federal government’s MAHA campaign to some extent feeds on long-standing government and activist concerns with the ill-defined category of “ultra-processed foods,” and this boiled over into litigation late in 2024, with the first decisions on motions to dismiss issued in 2025. Anand Agneshwar and Jocelyn Wiesner analyze these cases and their implications for what undoubtedly will continue to be a growth area for both government enforcement and consumer class litigation.

Finally, Helen Ryan and Laura Schwenderman round out this year’s volume with a survey of significant settlements between respondents and a number of agencies with authority in the food and drug spaces.

Several of the cases discussed in this year’s book, including Wulferic v. FDA, and Zyla v. Wells Pharma, are now on appeal, and therefore are cases to watch for the next year or two. Our diligent team of authors will keep the FDLI membership posted on the significant developments that will no doubt occur.

From veteran contributors to first-timers, all of our authors did an excellent job again this year, and I and FDLI extend our sincere appreciation to the group. Nothing is more gratifying to an editor than the enthusiasm and diligence of the contributors who give their time and share their expertise to keep the membership up to date on these important developments. On behalf of the entire crew, we wish our readers a happy and healthy remainder of 2026.

*   August T. Horvath chairs the Advertising and Marketing Practice at Foley Hoag LLP in New York. August’s litigation, counseling, government enforcement, and self-regulatory practice spans all sectors of consumer products and services, with a particular focus on food and beverage labeling.