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We recently gathered a group of regulatory attorneys from across Reed Smith to provide a rundown of the key trends to watch for in Q4 2025. If you missed the webinar, you can access the recording on demand.
Please see a short summary of our top takeaways below and look out for an invite to the next installment of this quarterly series – we hope you can join us!
Antitrust enforcement in America’s “new golden age”
- Major policy shift in U.S. antitrust enforcement: Trump’s revocation of Biden’s 2021 Competition Executive Order signals a move away from broad, interventionist enforcement and back toward a more traditional, consumer welfare-focused framework.
- America First Antitrust is selective, not uniformly deregulatory: While U.S. companies may face a lighter touch, foreign-owned or politically sensitive industries may experience heightened scrutiny, especially in sectors affected by tariffs or viewed as adversarial.
- Tariff-driven volatility increases compliance risk: Rapid tariff changes elevate antitrust exposure – dynamic pricing, industry-wide cost shocks, and trade-association interactions can create risks that demand strong documentation, independent decision-making, and reinforced compliance controls.
FCPA enforcement resumes – what companies should expect next
- The DOJ is refocusing the FCPA on high‑impact cases with faster timelines and individual accountability by expanding incentives for voluntary self-disclosures.
- Senior sign‑off is required to open new FCPA matters, and recent actions against companies and individuals have focused on schemes involving narcotrafficking, substantial bribes, and sophisticated means that disadvantage U.S. companies.
- Companies should double down on risk‑based compliance, including third‑party oversight, strong internal controls, and periodic risk assessments.
Unveiling False Claims Act trends across critical sectors
- We are starting to see FCA enforcement reflecting policy priorities for the Trump administration, including around immigration and DEI.
- At the same time, DOJ is continuing with its traditional FCA enforcement, including customs duties and tariffs, health care fraud, and CARES Act and PPP loan violations.
- The Cybersecurity Maturity Model Certification for all Department of Defense solicitations and contracts became effective on November 10, 2025, with FCA consequences at stake.
AI in enforcement, investigations, and compliance
- AI is a tool for government enforcement and corporate compliance programs to identify risks, anomalies, irregularities, and trends.
- The DOJ appreciates the prudent use of AI when evaluating the effectiveness of corporate compliance programs.
- We have seen an increase in the number of AI-generated whistleblower complaints, and the quality of deepfakes, including videos, has improved thanks to free tools online.
Navigating DOJ health care fraud priorities
- DOJ health care fraud enforcement is refocusing on emerging risks, including wound care and durable medical equipment, cybersecurity vulnerabilities, and renewed scrutiny of speaker programs.
- Investigations are shaped by operational challenges such as DOJ staffing shortages and constitutional attacks on the FCA, which may influence case selection, timing, and litigation posture.
- Criminal enforcement is intensifying around telehealth, evolving opioid and controlled substance matters, and AI-enabled billing and data manipulation schemes.
Exploring new frontiers in procurement fraud enforcement
- The DOJ is providing incentives, engaging in interagency collaboration, and using data analytics to prioritize procurement fraud enforcement.
- Preference-based contracting faces intensified scrutiny: ensure eligibility, documentation, and teaming structures can withstand review.
- Ongoing audits incorporating generative AI technology are critical to compliance.
U.S. customs fraud and tariff evasion crackdowns – what companies need to know
Given the increased enforcement risk around tariff evasion and customs fraud, companies should:
- Ensure personnel within the business making decisions about supplier relationships and procurement have received training and awareness about potential customs compliance risk areas, “red flags,” and escalation procedures.
- Implement a strong internal reporting mechanism with appropriate follow-up and a documented resolution to ensure escalated issues are reviewed and remediated as needed.
- Engage in a proactive review of customs compliance areas presenting the greatest potential risk for the company (e.g., an advantageous classification change for a product subject to Section 232 tariffs or an advantageous country of origin determination for a Chinese-manufactured product that undergoes third-country processing).
Understanding the UK’s failure to prevent fraud offence and how it will be enforced
- Prosecutors are actively looking to charge the Failure to Prevent Fraud and Senior Manager offences now that both are in force.
- New prosecution policy outlines the factors prosecutors will consider when deciding to charge corporates, including the importance of an ineffective compliance program as a public interest factor favoring prosecution, and the presence of a proactive and effective one as a factor against prosecution.
- When evaluating a corporate compliance program, the key metric used by prosecutors will be whether it is “effective” rather than simply a paper exercise.
SEC enforcement priorities and developments
- 2025 underscored a back-to-basics enforcement approach that prioritized insider trading, accounting and disclosure fraud, market manipulation, and adviser fiduciary breaches.
- The SEC is testing the truthfulness of AI-related claims, with examination focus on data provenance, third-party integrations, consent, security, and model risk documentation.
- Expect continued emphasis on fraud and manipulation, heightened cross-border and gatekeeper oversight for foreign issuers, and sustained individual accountability.
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