Client Alert: The Department of Justice Creates New Civil Division Enforcement & Affirmative Litigation Branch

KEY TAKEAWAYS

• The Department of Justice (DOJ) recently established the Enforcement & Affirmative Litigation Branch (EALB) within its Civil Division with the stated purpose of strengthening its ability to protect public health and safety through proactive enforcement and high-impact litigation.
• This branch will be separated into two sections:
  • Enforcement Section: Enforcement actions involving consumer goods, pharmaceuticals, and deceptive trade practices.
  • Affirmative Litigation Section: Civil actions against state, municipal, and private actors that “interfere with or obstruct federal policies.”
• The restructuring signals DOJ’s increased focus on domestic enforcement priorities, particularly in the healthcare, pharmaceutical, and consumer goods sectors.

 

BACKGROUND

On September 25, 2025, DOJ announced the creation of the EALB within its Civil Division. This branch is designed to consolidate DOJ’s affirmative litigation functions and enhance coordination across enforcement areas, reflecting the administration’s broad priorities in regulatory enforcement and protection of federal policies. As a result of the creation of the EALB, DOJ dissolved the Consumer Protection Branch (CPB) on September 30, 2025. The CPB was founded in 1971 to safeguard Americans’ health and enforce laws administered by the Food and Drug Administration (FDA), Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC), and National Highway Traffic Safety Administration (NHTSA). DOJ explained that this consolidation aims to increase enforcement efficiency and align civil litigation activities with the administration’s policy directives. Assistant Attorney General Brett A. Shumate emphasized that consolidating affirmative litigation efforts into this specialized branch will allow DOJ to “hold powerful actors accountable, protect public health and safety, and enforce critical national policies.”

This structural change follows the recent DOJ memoranda announcing new enforcement initiatives and identifying current priorities. On April 22, 2025, Attorney General Pam Bondi issued a memorandum titled “Preventing the Mutilation of American Children,” which implemented Executive Order 14187, Protecting Children from Chemical and Surgical Mutilation. That memorandum provided guidance on restricting or regulating gender transition treatments and procedures. Subsequently, on June 11, 2025, the Civil Division released a memorandum outlining enforcement priorities, directing attorneys to focus on: (1) combating discriminatory practices and policies through affirmative litigation in the private sector; (2) ending antisemitism by prioritizing enforcement against federally funded entities that violate federal civil rights laws; and (3) protecting women and children through investigations of pharmaceutical companies and online drug distributors connected to gender transition medications. It is expected that the EALB will take the lead in advancing these enforcement priorities.

This new branch is designed to further DOJ’s “enforcement priorities, including protecting women and children from pharmaceutical companies, health care providers, and medical associations profiting off of false and misleading claims related to so-called gender transition, and ending sanctuary jurisdiction laws, policies, and practices that impede federal immigration enforcement and make Americans less safe in their communities.”

ENFORCEMENT & AFFIRMATIVE LITIGATION BRANCH

Organizational Structure

The EALB will be divided into two sections: 1) The Enforcement Section and 2) the Affirmative Litigation Section.

1. The Enforcement Section will focus on cases designed to guard consumers under consumer protection and public health statues such as the Controlled Substances Act (CSA), the Food, Drug, and Cosmetic Act (FDCA), and the Federal Trade Commission Act (FTC Act), the Children’s Online Privacy Protection Act (COPPA), and the Restore Online Shoppers’ Confidence Act (ROSCA). Its focus is on civil enforcement matters, including false and misleading marketing claims, product safety, and imports.
2. The Affirmative Litigation Section will pursue litigation “against states, municipal, and private actors that interfere with or obstruct federal policies.” This section is expected to play a central role in implementing the administration’s broader legal strategy.

According to DOJ, the consolidation of enforcement and affirmative litigation functions into a single branch is intended to streamline case management, align enforcement priorities, and allow for greater agility in pursuing politically and policy-sensitive matters.

Implications for Companies, Providers, and Other Organizations

The creation of the EALB carries significant implications for certain companies, providers, and organizations, particularly those operating in highly regulated industries such as healthcare, pharmaceuticals, and immigration services. These entities should anticipate increased DOJ scrutiny, with a potential rise in civil investigations and litigation. Providers of gender-affirming care, especially those treating minors, are advised to carefully review their policies, procedures, and practices and seek guidance from counsel regarding federal and state regulations. Additionally, organizations should take this opportunity to reassess and strengthen their compliance programs, given new DOJ guidance and applicable legal standards. Finally, staying informed by closely monitoring DOJ statements, enforcement actions will be essential to understanding how the branch prioritizes cases and areas of focus in the near future.

CONCLUSION

The establishment of the EALB marks a significant reorganization of DOJ’s Civil Division and reflects consolidation of enforcement authority. As DOJ centralizes affirmative litigation and civil enforcement functions, entities across multiple industries can expect expanded investigative activity consistent with the administration’s stated priorities.  Sher Tremonte LLP will continue to monitor developments related to the DOJ Civil Division’s policies.  If you have any questions about these policies or your obligations, please contact us.  Written by Brian Kidd and Taylor Fontan.