The Department of Justice (“DOJ”) recently announced the creation of a new office in its Civil Division: the Enforcement & Affirmative Litigation Branch (the “Branch”). According to a September 2025 press release, the Branch is “dedicated to safeguarding public health and safety through proactive enforcement and high-impact affirmative litigation.”
Structure and Scope
The Branch consists of two sections: the Enforcement Section and the Affirmative Litigation Section. The Enforcement Section will take on a consumer protection role and look to enforce key consumer protection statutes, including:
- Controlled Substances Act
- Federal Food, Drug, and Cosmetic Act
- Consumer Product Safety Act
- Federal Trade Commission Act
- Children’s Online Privacy Protection Act
- Restore Online Shoppers’ Confidence Act
The Affirmative Litigation Section will file lawsuits on behalf of the United States against both public and private entities that obstruct federal policies. The Affirmative Litigation Section will also file statements of interest and amicus briefs to enforce federal laws.
Priorities
The Branch looks to broadly enforce federal law, but at this time places special emphasis on:
- Protecting women and children from false or misleading claims about gender transition care from providers, pharmaceutical manufacturers and medical associations;
- Reducing resistance to federal immigration policies;
- Holding large entities accountable for deceptive trade practices; and
- Safeguarding consumers from pharmaceutical companies’ false or misleading claims about drugs and dietary supplements.
Practical Takeaways
With the expected increases in investigations and enforcement actions from the current administration, providers in the health care sector should take proactive steps to identify areas of potential risk, especially as they relate to the identified priority areas.
- Consumer protection – Health care providers should ensure that their business policies and practices comply with existing consumer protection laws.
- Gender transition care – Those health care providers delivering gender-based or gender-affirming care should assess compliance with relevant federal, state and local laws, particularly in relation to women, children and minors.
- Stay informed – Given the recency of the DOJ’s announcement, health care providers should stay up-to-date on new developments and enforcement efforts from this new Branch.
Hall Render will continue to track and provide updates on this Working Group’s activity. If you have questions or would like more information about this topic, please contact:
- Katherine Kuchan at (414) 721-0479 or kkuchan@hallrender.com;
- Kaitlin Nucci at (248) 457-7838 or knucci@hallrender.com; or
- Your primary Hall Render contact.
Special thanks to Summer Associate Connor Reed for his assistance in the preparation of this article.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot give legal advice outside of an attorney-client relationship.
