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Laboratory-Developed Tests (LDTs) Do Not Qualify as ‘Devices’ Under the Food, Drug and Cosmetic Act

On March 31, 2025, in the U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration’s (FDA) final rule, in which FDA attempted to assert regulatory authority over laboratory-developed...more

The Post-Chevron World: 2024 Overtime EAP Exemption Rule Vacated

After filing to vacate the Department of Labor’s (DOL) promulgation of a new overtime rule, the State of Texas and other plaintiffs recently won their case in the U.S. District Court of the Eastern District of Texas....more

Ranchers-Cattlemen Legal Fund Challenges USDA Electronic Ear-Tag Rule

Ranchers-Cattlemen Action Legal Fund v. USDA On October 30, 2024, a group of plaintiffs headed by the Ranchers-Cattlemen Action Legal Fund (R-CALF), filed a complaint (Case No. 5:24-cv-5085 (D.S.D.)) against the U.S....more

The Limits on Post-Chevron Challenges to Regulations

As a wave of litigation tests the enforceability of various federal regulations following the Supreme Court’s June 28, 2024, Loper Bright Enterprises v. Raimondo decision, which overturned Chevron deference, one federal court...more

Post-Chevron Challenge to Overtime EAP Exemption Pending

On August 12, 2024, the Association of Christian Schools International (ACSI), a Colorado-based nonprofit that supports evangelical Christian schools, filed a complaint against the U.S. Department of Labor (DOL) challenging...more

Republican State AGs Challenge CMS Rule Redefining 'Lawfully Present' for ACA Eligibility Under Administrative Procedure Act (APA)

On August 8, 2024, thirteen Republican state attorneys general brought suit in the District of North Dakota against the Centers for Medicare & Medicaid Services (CMS) to challenge the agency’s recent rule allowing...more

Jarkesy Limits Power of the SEC to Rely on In-House Adjudicators When Pursuing Penalties for Fraud

The U.S. Supreme Court limited the power of the Securities and Exchange Commission (SEC) to enforce civil penalties via in-house tribunals in its decision in SEC v. Jarkesy, released on June 27, 2024. In its decision,...more

Loper Bright & Corner Post Review: Supreme Court’s Overturning of Chevron Doctrine Spells Uncertainty for Food Industry...

Loper Bright Review: The Death of Chevron Deference? On June 28, 2024, the U.S. Supreme Court overturned the Chevron doctrine of agency deference in its Loper Bright Enterprises v. Raimondo decision. The doctrine takes...more

Supreme Court Decides Corner Post, Inc. v. Board of Governors of the Federal Reserve System

On July 1, 2024, the Supreme Court decided Corner Post, Inc. v. Board of Governors of the Federal Reserve System, No. 22-1008, holding that a facial claim against enforcement of a regulation accrues under the Administrative...more

Supreme Court Decides Loper Bright Enterprises v. Raimondo

On June 28, 2024, the Supreme Court issued its decision in Loper Bright Enterprises v. Raimondo, No. 22-451, overruling the doctrine of Chevron deference and holding that courts “must exercise their independent judgment in...more

Supreme Court Decides SEC v. Jarkesy

On June 27, 2024, the U.S. Supreme Court decided SEC v. Jarkesy, No. No. 22-859, holding that the Seventh Amendment entitles a defendant to a jury trial when the Securities and Exchange Commission seeks civil penalties for...more

DOJ Announces Additional Steps to Combat COVID-19 Related Fraud

In a press release issued on September 14, 2022, the U.S. Department of Justice (DOJ) announced additional enhancements to its initiative to combat COVID-19 related fraud. Expanding on Attorney General Merrick Garland’s...more

DOJ Policy Changes Aimed at Increasing White Collar Prosecutions and Incentivizing Companies to Cooperate With the Government

During a speech on September 15, 2022, Deputy Attorney General Lisa Monaco announced significant policy changes to DOJ’s corporate enforcement strategy. Expanding on her October 28, 2021, speech and the memorandum that...more

FDA Announces Increased Inspections and Enforcement Actions, Additional Guidance to Reduce Toxic Elements in Food for Babies and...

On March 5, 2021, FDA issued a public statement announcing regulatory actions to reduce toxic elements — with a particular focus on arsenic, lead, cadmium and mercury — in food for babies and young children. FDA cited the...more

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