Food and Drug Enforcement, Recalls, and Litigation Attorneys

Overview

Wiley represents companies facing consequential enforcement and litigation matters before the U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), U.S. Drug Enforcement Administration (DEA), and U.S. Department of Health and Human Services Office of Inspector General (HHS OIG), ranging from routine compliance disputes to high‑stakes actions that threaten core business operations. We counsel manufacturers, distributors, retailers, and other supply‑chain participants on responding to government enforcement actions, conducting voluntary and mandated recalls, and managing product corrections, while also serving as litigation counsel in challenges to agency regulations, policies, and adverse administrative decisions.

Drawing on cross‑sector experience across human and animal food, drugs and biologics, medical devices, cosmetics, and other consumer products, our attorneys pursue coordinated regulatory and litigation strategies that can begin with citizen petitions or other formal agency engagement and, where necessary, proceed to judicial review under the Administrative Procedure Act.

We defend companies, and their directors and officers, in criminal and civil litigation arising under the Federal Food, Drug, and Cosmetic Act (FDCA); the Controlled Substances Act; and related statutes. This includes, for example, off-label marketing allegations, false claims and whistleblower actions, alleged violations of Good Manufacturing Practices (GMP), and other U.S. Department of Justice (DOJ) and HHS OIG investigations.

We assist clients with adverse administrative decisions from the USDA, including administrative hearings before USDA judicial officers and appeals through the National Appeals Division (NAD) and in federal court. Additionally, we can assist clients involved in matters brought by the USDA Office of Inspector General.

Through enforcement defense, administrative proceedings, and major court challenges requiring innovative approaches to agency interpretations of statutory authority and final agency action, we have achieved favorable outcomes for clients and, in many cases, driven new or revised interpretations of governing laws and regulations.

Our experience includes the following:

Fashioning appropriate responses to FDA and USDA regulatory controls and administrative enforcement, including:

Negotiating and responding to FDA enforcement actions, including data integrity investigations, Warning Letters, requests or demands for recall, threatened seizures, injunctions, criminal complaints, proposed consent decrees, and related product removals and corrections.
Advising on USDA Food Safety and Inspection Service (FSIS) inspection matters, food safety audits, and enforcement actions, including noncompliance records (NR), Notices of Suspension (NOS), Notices of Intended Enforcement (NOIE), withdrawal of inspection, product retention, regulatory controls, and condemnation.

Advising companies on how to respond to FDA inspections, remote regulatory assessments (RRAs), requests for information, and Form 483s (Inspectional Observations).
Counseling companies on how to manage new internal information that raises potential safety or other regulatory questions. We advise clients as they consider approaching the FDA or USDA and in negotiating solutions such as a possible recall or field correction notice, if necessary.
Advising companies and executives on enforcement risks, including conducting internal investigations; responding to FDA, USDA, Federal Trade Commission (FTC), and DOJ inquiries, subpoenas, and civil investigative demands (CIDs); and developing strategies to mitigate individual and corporate liability exposure.
Defending companies and executives through all stages of government enforcement matters, including coordinating responses to parallel regulatory and criminal investigations, engaging with enforcement authorities, and litigating enforcement actions and related civil or criminal matters when necessary.
Representing companies and individuals in FDA debarment proceedings, disqualification actions, and HHS exclusion matters, including developing strategies to contest proposed actions, negotiating favorable resolutions where possible, and advocating for reinstatement or limitation of collateral consequences affecting regulated business activities.
Handling matters subject to Consumer Product Safety Commission (CPSC) jurisdiction. Wiley has represented manufacturers, distributors, and retailers of consumer products in the full range of CPSC and other product safety regulatory activities.