On September 25, 2025, the Department of Justice announced a new office within the Civil Division—the Enforcement & Affirmative Litigation Branch—“dedicated to safeguarding public health and safety through proactive enforcement and high-impact affirmative litigation.”
The creation of this new office restructures and consolidates affirmative litigation into a specialized branch to “hold powerful actors accountable, protect public health and safety, and enforce critical national policies.”
What DOJ Is Changing
The Enforcement & Affirmative Litigation Branch will house two sections:
- The Enforcement Section will bring suits under a variety of statutes including the Controlled Substances Act, federal Food, Drug, and Cosmetic Act (FDCA), and Federal Trade Commission Act. The stated focus includes protecting consumers from unfair and deceptive practices, defective consumer goods, and false or misleading claims about drugs and dietary supplements.
- The Affirmative Litigation Section will bring suits “against states, municipalities, and private entities that interfere with or obstruct federal policies,” with the stated aim of ensuring nationwide compliance with the U.S. Constitution and federal law.
The creation of the Enforcement & Affirmative Litigation Branch does not expand the Department’s statutory powers but reframes certain priorities that are likely to receive sustained attention under the current administration. It coincides with the winding down of the Consumer Protection Branch, with its civil affirmative work absorbed into the Enforcement Section, indicating that DOJ intends to centralize certain consumer protection matters.
Identified Priorities: Gender Transition and Immigration
The press release announcing the new Branch expressly identifies two priority areas:
- Gender Transition: DOJ notes that the Enforcement & Affirmative Litigation Branch will “[protect] women and children” by targeting “pharmaceutical companies, health care providers, and medical associations profiting off of false and misleading claims related to so-called gender transition.”
- Immigration: DOJ also highlights that the Branch will focus on ending sanctuary jurisdiction laws, policies, and practices that impede federal immigration enforcement.
These priorities track with broader administration initiatives. For example, in Executive Order 14187 (Jan. 28, 2025), the White House directed DOJ to prioritize investigations and actions addressing alleged deception and FDCA violations concerning gender affirming care for minors. Related legislation was introduced in Congress on September 18, 2025. The legislation, H.R. 5483 and S. 2907, would codify Executive Order 14187.
Enforcement Context: Focus on FDA/HHS Actions on Drug Advertising
The DOJ announcement regarding the new Branch arrives alongside a visible pivot by the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) on pharmaceutical promotion. On September 9, 2025, FDA announced a “crackdown” on deceptive drug advertising, with particular attention to disclosures, social media influencer campaigns, and direct-to-consumer telehealth marketing. The same day, the Make America Healthy Again (MAHA) Commission issued its Make Our Children Healthy Again Strategy, urging increased interagency oversight of DTC advertising—explicitly citing FDA, HHS, FTC, and DOJ.
The DOJ announcement says little about the Affirmative Litigation Section, simply that entities interfering with or obstructing federal policies, or failing to comply with the U.S. Constitution or federal laws, should expect enforcement activity. The emphasis on litigation against states and municipalities indicates that the DOJ is seeking to enforce the administration’s policies nationwide. Whether this litigation will focus on gender transition, immigration, and discrimination, or whether it could be used to compel states to conform in other areas, remains to be seen.
Practical Takeaways for Health Care and Regulated Entities
- Expect coordinated scrutiny on advertising and promotion. The creation of the Enforcement & Affirmative Litigation Branch aligns with recent FDA/HHS actions earlier this month. Companies should reassess direct-to-consumer and influencer-driven campaigns, promotional claims, and risk disclosures, including those tied to telehealth marketing.
- No expansion of statutory powers. The DOJ’s move does not expand statutory powers on its own; rather, it reorganizes how affirmative enforcement is prioritized and executed. The choice to centralize and name specific targets (g., gender transition and sanctuary policies) suggests both a legal and political through line. If pursued vigorously, expect litigation testing federalism boundaries, administrative law theories, and speech-related issues.
- False Claims Act (FCA) risk remains elevated. Although the DOJ’s announcement regarding the new Branch does not expressly mention the FCA, its 2025 initiatives make clear that recipients of federal funds (health systems, plans, universities, contractors, and grantees) should assume ongoing emphasis on FCA enforcement, particularly where alleged civil rights or consumer protection issues intersect with federal dollars. DOJ has repeatedly stated that it will deploy the FCA against “entities that receive federal funds but knowingly violate civil rights laws” (June 20 blog post). DOJ also launched the new Civil Rights Fraud Initiative in May (May 22 blog post) and, in July, established an FCA Working Group focused on six priority areas in the health care space (July 3 blog post).
- Potential state-federal collision. The Affirmative Litigation Section contemplates suits against states and municipalities that “interfere with or obstruct federal policies,” signaling potential expansion of federal challenges on topics ranging from immigration to health policy implementation.
Epstein Becker Green Staff Attorney Ann W. Parks contributed to the preparation of this post.
Blog Editors
Authors
- Board of Directors / Member of the Firm
- Member of the Firm
- Of Counsel