On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s 2024 Rule regulating as “devices” under the Food, Drug, and Cosmetic Act FDCA, certain laboratory-developed tests used to diagnose, monitor, or determine treatment for diseases and conditions. The decision, American Clinical Laboratory Assoc. v. FDA, No.
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California Prop 65’s Short-form Warnings Will No Longer Be Short – Summary of Amendments to Short-form Warnings under California Proposition 65 – Effective January 1, 2025 with Three-Year Grace Period
After what has amounted to a multi-year rulemaking process, the California Office of Environmental Health Hazard Assessment (OEHHA) finalized amendments to the short-form warnings under Proposition 65 on December 6, 2024. The amendments (outlined in full here) require that short-form warnings include at least one chemical name, along with other options for safe…
Trump Administration: Major Changes May Be Coming in the Federal Government’s Posture Toward Electric Vehicles (EV’s)
Automotive manufacturers, regulators and consumers face considerable uncertainty on how the incoming Trump Administration will attempt to reshape the automotive industry when President Donald Trump returns to the White House on January 20, 2025. Significant changes are on the horizon, with President Trump’s major campaign themes, including protectionist trade policies and an “all of the…
US Environmental Protection Agency (EPA) Announces Final Vessel Incidental Discharge Rule
As evidenced by the Department of Justice’s recent announcement of a US$2 million criminal fine assessed against the owners of the tanker P/S Dream as part of a guilty plea, violations of federal environmental laws governing vessel discharge can carry significant consequences.
Stakeholders should take note that the EPA recently announced the final Vessel Incidental…
ESG Due Diligence Update: First Lessons from Recent Rulings in the EU
As the EU intensifies its focus on ESG, the new Corporate Sustainability Due Diligence Directive (CS3D) is poised to enforce stricter environmental accountability across corporate operations. This directive, along with recent EU court rulings, underscores the critical need for companies to strengthen their environmental due diligence to avoid significant legal and financial penalties. For a…
U.S. Supreme Court’s Jarkesy Ruling Shifts Power for Federal Enforcement
Keith Bradly, Squire Patton Boggs (US) LLP Partner and Co-Chair of the Appellate and Supreme Court Practice, authored an article for Bloomberg Law discussing the U.S. Supreme Court’s recent decision in SEC v. Jarkesy. The Court found that when the Securities Exchange Commission (SEC) seeks civil penalties for securities fraud, the Seventh Amendment affords a…
Chevron Has Fallen: Supreme Court Seismically Shifts Regulatory Power From Agencies to Courts
On June 28, 2024, in a 6-3 decision in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the Chevron doctrine, a decades-old precedent that largely pressed federal courts to defer to federal agency interpretations of ambiguous statutes under their jurisdiction. The opportunities, the challenges, and the uncertainty will grow for a long time before the dust settles…
A Case of “Order Being Restored”
By Rob Elvin
In a judgment delivered on Wednesday 5 September, the Court of Appeal reinstated the position as to when a party can assert Legal Professional Privilege, specifically Litigation Privilege, related to an investigation into circumstances that may lead a regulator to commence criminal proceedings.
The case centred on documents produced by solicitors and forensic accountants who…
OSHA Final Rule Clarifies Employees’ Walkaround Representative; Opens Non-Union Workplaces to Union Representatives
The U.S. Department of Labor’s Occupational Safety & Health Administration (OSHA) published its controversial final “walkaround” rule on April 1, 2024. The final rule clarifies the rights of employees to authorize a representative – employee or non-employee – to accompany an OSHA compliance officer (CSHO) during an inspection of their workplace. This can include a…
FDA Announces End of PFAS Use in US Food Packaging
On February 28, 2024, the Food and Drug Administration (“FDA”) published a news release regarding the voluntary market phase-out of per and polyfluoroalkyl substances (PFAS) in grease-proofing substances used on food packaging. The FDA stated that the completion of this phase-out “eliminates the primary source of dietary exposure to PFAS from authorized food contact uses.”…