Department of Justice

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The U.S. Department of Justice (DOJ) and 18 state attorneys general (AG) announced a settlement with Boston-based QOL Medical, LLC (QOL) and its CEO, Frederick Cooper, to resolve allegations that the company provided unlawful kickbacks to health care providers. Under the terms of the settlement, QOL and Cooper agreed to pay $47 million to resolve allegations that QOL manipulated health care providers into prescribing a drug called Sucraid — an FDA-approved therapy for a rare genetic disorder, Congenital Sucrase-Isomaltase Deficiency (CSID). Regulators alleged that QOL and Cooper violated the Anti-Kickback Statute and federal and state False Claims Acts.

On January 16, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) issued “Antitrust Guidelines for Business Activities Affecting Workers” (2025 Guidelines). The 2025 Guidelines aim to “promote clarity and transparency” in demonstrating how the agencies identify certain business activities that may violate the antitrust laws. The 2025 Guidelines are intended to replace the 2016 “Antitrust Guidance for Human Resource Professionals,” (2016 Guidelines).

On September 23, Principal Deputy Assistant Attorney General Nicole M. Argentieri announced that the U.S. Department of Justice (DOJ) updated its guidance on the Evaluation of Corporate Compliance Programs (ECCP). The DOJ’s ECCP serves as a roadmap for federal prosecutors to use when evaluating the effectiveness of corporate compliance programs. Therefore, companies should also pay close attention to this guidance when reviewing their compliance programs. Ultimately, a company’s efforts to design, regularly evaluate, and update its compliance program in line with this guidance could inform criminal investigations, charging decisions, and case resolutions.

The proposed rescheduling of cannabis from Schedule I to Schedule III under the Controlled Substances Act (CSA) marks a pivotal moment in the evolution of U.S. cannabis policy but may bring few practical changes to state-licensed markets. On May 20, the U.S. Department of Justice (DOJ) and the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking[1] (NPRM) to initiate the change, launching a 60-day public comment period that concluded on July 22. The proposal has stirred significant interest and debate among stakeholders, including state regulators, advocacy groups, health experts, individuals, and licensed businesses, resulting in the posting of more than 43,000 comments.

In May, the U.S. Department of Justice (DOJ) issued a notice of proposed rulemaking to transfer cannabis from Schedule I to Schedule III of the Controlled Substances Act (CSA), a change that could significantly affect current state cannabis programs. In response, the Cannabis Regulators Association (CANNRA) submitted a detailed comment letter to the DOJ requesting clarity on how rescheduling will impact these existing regulatory structures. An examination of CANNRA’s public comment offers insights for state-legal businesses into what the future may hold for the joint regulation of cannabis at the state and federal levels.

Among the two most widely reported federal changes to cannabis regulation are the Department of Justice’s (DOJ) proposed regulation for the federal rescheduling of marijuana (the Proposed Rescheduling) and amendments to the 2018 Agricultural Improvement Act (the Farm Bill). The Proposed Rescheduling would result in the transfer of marijuana from Schedule I[1] of the Controlled Substances Act (CSA) to Schedule III[2] of the CSA.[3] The proposed amendments to the Farm Bill would change the definition of “hemp” to remedy a loophole currently utilized by hemp manufacturers who manufacture and sell intoxicating cannabis products.

Introduction

The medicinal and recreational use and popularity of marijuana has continuously grown throughout the U.S. since Oregon became the first state to decriminalize marijuana in 1973. To date, thirty-eight states and the District of Columbia have implemented medical marijuana programs, twenty-five of which have also expanded into adult-use.

Only one day after reports surfaced that the Drug Enforcement Administration (DEA) will proceed with rescheduling cannabis from Schedule I to Schedule III of the Controlled Substances Act (CSA), Senators Charles Schumer (D-NY), Cory Booker (D-NJ), and Ron Wyden (D-OR) reintroduced the Cannabis Administration and Opportunity Act (CAOA or the Act), a nearly 300-page bill that would create a framework for the comprehensive regulation and taxation of cannabis in the United States. Then, on May 16th, the Department of Justice issued its notice of proposed rulemaking to reschedule cannabis to Schedule III. Administrative and legislative approaches to cannabis reform each have their own strengths and weakness that must be carefully considered. In addition, these competing approaches offer an opportunity to highlight the political differences between administrative and legislative policy reform at the federal level.

Nebraska Attorney General (AG) Mike Hilgers is leading multistate coalitions in two lawsuits aimed at challenging the Biden administration and the State of California’s electric vehicle mandates on truck owners and operators nationwide. The lawsuits argue that these mandates exceed the constitutional and statutory authority of the federal government and California regulators.