With 2025 underway, the AFS Consumer Products team highlights some of the most pressing legal issues facing the consumer products industry this year.

Welcome to the Winter 2025 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance tips. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.

In this episode of Five Questions, Five Answers, Birgit Matthiesen and Ryan Greer of the Canadian Manufacturers and Exporters (CME) discuss the current challenges facing Canadian manufacturers due to impending US tariffs and the broader implications for the bilateral trade relationship.

Across all industries, private companies, family offices, and their owners and management teams face rapidly evolving challenges, opportunities, and risks in the dynamic environment that is 2025. Here are 11 issues that family offices and the owners and leaders of privately held companies should consider and be mindful of this year.

In the US Supreme Court’s first post-Chevron decision involving the US Environmental Protection Agency (EPA) the Supreme Court found against EPA, invalidating ‘end result’ NPDES permit requirements.

Colorado made history in May 2024 when it became the first state to adopt a comprehensive artificial intelligence (AI) consumer protection law. This landmark legislation has inspired other states, including Virginia, to pursue similar laws.

Foreign nationals and employers should plan all international travel more carefully and further in advance. This is not a travel ban but has opened the path to create a travel ban in the future, as he did in his earlier Administration.

Effective February 3, the US International Trade Commission (ITC) amended its Rules of Practice and Procedure governing Section 337 investigations. While some of these amendments make technical corrections and clarifications, others substantively revise a number of rules for amending complaints, discovery limitations, and litigation funding.

The new Administration under President Trump is now over a month old, but there remains some uncertainty as to how the Administration will approach agricultural policy. The Administration’s first wave of environmental pronouncements have focused mainly on energy and climate initiatives, while some of the messaging challenging agricultural tools like pesticides have signaled a possible departure from the deregulatory approach of the prior Trump Administration.

As several dozen copyright infringement cases against artificial intelligence (AI) developers continue to proceed through the federal courts, a recent ruling in the District of Delaware suggests that the fair-use defense against claims of copyright infringement may offer less protection than some AI developers expect.

On March 1, President Trump issued an Executive Order (EO) requiring the US Department of Commerce (Commerce) to investigate the national security implications in connection with imports of timber, lumber, and their derivative products.

On March 3, the US Department of Health and Human Services (HHS) published a change in policy that could result in fewer opportunities for stakeholders and members of the public to weigh in on HHS regulatory action related to agency management or personnel, public property, loans, grants, benefits, or contracts.

In addition to navigating the Trump Administration’s ever-changing international trade policy through the use of existing (e.g., Section 301, Section 232, etc.) and novel (e.g., International Emergency Economic Powers Act, reciprocal) tariffs, US importers now must also be cognizant of the increased use of the False Claims Act (FCA) to enforce against customs fraud.

The H-1B is the most common work visa for foreign nationals in professional-level jobs in the United States. Effective January 17, there is a new H-1B “modernization” rule which introduced some significant changes and codified some existing processing practices to the H-1B visa program.

A Biden-era US Department of Labor (DOL) Rule permitting consideration of environmental, social, and governance (ESG) factors when choosing investments as a “tiebreaker” was recently upheld by Texas federal Judge Matthew Kacsmaryk. This decision applied the US Supreme Court’s 2024 ruling in Loper Bright v. Raimondo, revisiting three topics lost in 2025’s Department of Government Efficiency-era drama.

For the last several years, consumer class actions targeting “greenwashing” have become increasingly common. In 2024, Lululemon Athletica Inc. and Lululemon USA Inc. were on the receiving end of such a lawsuit, but they recently prevailed on a motion to dismiss.

On June 18, 2021, a group of ACE American Insurance Company employees filed a class action suit alleging that ACE misclassified them as exempt employees.

On February 25, the United Kingdom (UK) Intellectual Property Office (IPO) launched a survey to collect feedback on potential changes to the UK’s design protection framework. The goal is to ensure that the system remains relevant, accessible, and effective in supporting designers and businesses across various industries. This initiative follows a previous call for views in 2022, with insights from the survey informing a formal consultation later in 2025.

As the flurry of Corporate Transparency Act (CTA) developments continues, on March 2, the US Department of the Treasury (Treasury) announced the suspension of CTA enforcement against US citizens and domestic reporting companies, following on the heels of last week’s announcement by the Financial Crimes Enforcement Network (FinCEN) that it is not issuing fines or penalties in connection with beneficial ownership information (BOI) reporting for the time being. Going forward, as indicated by Treasury, the CTA will apply only to foreign reporting companies.

In the second installment of the Private Company Strategies podcast series, From Start-Up to Stand-Out, hosts Adam Diederich, Berin S. Romagnolo, and Sara Rosenberg are joined by AFS Partner Alexandra M. Romero to discuss essential employment law considerations for startups.

Earlier this month, the Acting General Counsel of the National Labor Relations Board (NLRB), William Cowen, rescinded a slew of his predecessor’s policy memoranda. While general counsel (GC) memoranda are not the official legal position of the NLRB, if adopted by the Board they could have far-reaching ramifications for covered employers.

To plead, or not to plead. That is a question trademark infringement plaintiffs will need to carefully consider with their legal counsel when deciding which parties to name as defendants in a lawsuit and which legal arguments and facts to assert in a dispute with a company that has many affiliates.

On January 8, Massachusetts Governor Maura Healy signed into law “An Act Relative To Pharmaceutical Access, Costs And Transparency.” The Act will have a profound impact on all parties involved in setting and applying drug prices, including Pharmacy Benefit Managers (PBMs), health insurance plans, pharmaceutical manufacturers, and retail pharmacies.