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Administrative Procedure Act Public Health

Mintz - Health Care Viewpoints

Twenty States Sue the Trump Administration for HHS Program Eliminations and Staff Layoffs

Nineteen states plus the District of Columbia filed a federal Complaint in U.S. District Court for the District of Rhode Island on May 5, 2025 alleging that the Trump Administration’s recent activities to downsize and...more

Knobbe Martens

U.S. Supreme Court Defers to Agency Decision-Making in FDA’s Denial of Premarket Approval of Flavored E-Cigarette Products

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We previously reported a decision by the U.S. Food and Drug Administration (FDA), denying the premarketing authorization of several flavored e-cigarette product. On April 2, 2025, the Supreme Court of the United States...more

Latham & Watkins LLP

Supreme Court Upholds FDA’s Denial of Marketing Authorization for Flavored Tobacco Products

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On April 2, 2025, the Supreme Court unanimously held that the US Food and Drug Administration (FDA) lawfully denied marketing authorization for certain flavored e-liquids used in electronic nicotine delivery systems (ENDS),...more

Hogan Lovells

HHS Secretary Directs FDA to Explore Rulemaking to Eliminate Self-GRAS Pathway

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The Secretary of the U.S. Department of Health and Human Services (HHS), Robert F. Kennedy, Jr., recently issued a press release directing the Food and Drug Administration (FDA) to take steps to explore possible rulemaking to...more

Holland & Knight LLP

Holland & Knight Health Dose: March 4, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Morrison & Foerster LLP

Tenth Circuit Hears Challenge to Lower Court’s Ruling on High-Powered Magnets

Continuing the Zen Magnets saga, the Consumer Product Safety Commission (CPSC) faces a challenge to a rule banning products containing small, high-powered, separable magnets. CPSC has asserted that these kinds of small,...more

Cozen O'Connor

Democratic AGs Secure Order Blocking Cuts to NIH-Funded Research Grants

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A group of 22 Democratic AGs obtained a temporary restraining order blocking Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates (Rate Change Notice), which would reduce to 15 percent all...more

Cozen O'Connor

Republican AGs Have Beef with Nutritional Standards Report

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Twenty-three Republican AGs submitted a comment letter to HHS and Department of Agriculture officials opposing aspects of the Scientific Report of the 2025 Dietary Guidelines Advisory Committee; the Dietary Guidelines are...more

Holland & Knight LLP

Massachusetts District Court Temporarily Blocks NIH Research Funding Cut

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A Massachusetts federal judge has issued a temporary restraining order preventing the implementation and enforcement of the National Institutes of Health's (NIH) research funding cut (NOT-OD-25-086) (the Rate Change Notice)....more

Troutman Pepper Locke

Federal Appellate Court Agrees that FDA Cannot Regulate “Premium Cigars”

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Yet again, the premium cigar industry has prevailed in federal court against the U.S. Food and Drug Administration (FDA). FDA appealed a federal district court decision vacating its rule (the Deeming Rule) subjecting premium...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Temporary Pause of Agency Grant, Loan, and Other Financial Assistance Programs/White House Office of Management and Budget...

The White House Office of Management and Budget (“OMB”) issued a January 27th Memorandum for heads of executive departments and agencies addressing: Temporary Pause of Agency Grant, Loan, and Other Financial Assistance...more

BakerHostetler

Federal Court Blocks FDA’s Graphic Cigarette Warning Rule: The Limits of Regulatory Authority

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On Monday, a federal judge from the Eastern District of Texas, Judge J. Campbell Barker, ruled that the U.S. Food and Drug Administration (FDA) exceeded its authority under the Tobacco Control Act by requiring cigarette...more

Ropes & Gray LLP

2024 FDA Enforcement Review: Quality and Transparency Remain Critical Concerns

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The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more

Troutman Pepper Locke

FDA Says Agency Will Enforce the Cigarette Graphic Warning Rule in December 2025, But Pending Litigation Could Still Derail Those...

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In September, the U.S. Food and Drug Administration (FDA) told industry that it would begin enforcing the agency’s cigarette graphic warning rule in December 2025 in an enforcement policy outlined in a short guidance...more

Troutman Pepper Locke

Industry Urges SCOTUS to Consider FDA Graphic Cigarette Warnings

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In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration...more

Stoel Rives - Environmental Law Blog

The Chevron Doctrine’s Gone, but the APA Lives On

Many speculated on just how much Loper Bright Enterprises v. Raimondo (Loper Bright) would affect agency rulemaking challenges. Well, the D.C. Circuit is showing that that effect maybe milder than expected. Huntsman...more

King & Spalding

Fifth Circuit Reverses District Court’s Nationwide Injunction on ACA’s Preventive Care Coverage Mandates

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On June 21, 2024, a three-judge panel of the United States Court of Appeals for the Fifth Circuit issued an opinion in Braidwood Management Inc. et al. v. Xavier Becerra et al. reversing an injunction entered by the lower...more

Williams Mullen

Carolinas Environmental Legislative Update

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Both the North and South Carolina legislatures have recently adopted statutes affecting environmental issues in their respective states. This update highlights the most significant developments in North and South Carolina....more

ArentFox Schiff

Environmental Justice Update: Louisiana Decision Upholds Use of EPA Emergency Powers

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Louisiana has been at the center of the Biden Administration’s prioritization of environmental justice (EJ) issues. In United States v. Denka Performance Elastomer, the Eastern District of Louisiana granted a motion by the...more

Mintz

PFAS Rulings in South Carolina & Michigan shine a light on the fact we have no idea what removing PFAS from our environment is...

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This week Judge Gergel tentatively approved the $1.2 billion settlement between DuPont (and related companies) and water suppliers now dealing with the fact that EPA and many States have concluded that the most minute...more

Troutman Pepper Locke

Juul Labs, Inc. v. FDA: A FOIA Twist on the Challenge to FDA's Marketing Denial Order

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Recent Freedom of Information Act (FOIA) litigation raises an interesting question: When federal agency action requires analyses under a holistic, multi-factor statutory standard, may the agency withhold from disclosure as...more

Troutman Pepper Locke

Hidden FDA Report Raises Questions About Its Approach to Public Records and Premarket Tobacco Review

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FDA’s approach to a premarket tobacco product application (PMTA) raises new questions about whether its marketing denial order was arbitrary and capricious and whether the deliberative-process exemption justifies its...more

ArentFox Schiff

Administrative Law Takeaways from the Federal Travel Mask Mandate Decision

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The Center for Disease Control’s (CDC) “Mask Mandate” was recently vacated by a Florida district court on the grounds that it exceeded CDC’s statutory authority and violated the procedures for executive branch rulemaking set...more

Fisher Phillips

New York’s Mask Mandate Faces Uncertain Future After Court Decisions

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Although a New York State Supreme Court judge just overturned the statewide mask mandate as unconstitutional, that decision was almost immediately paused by an Appellate Judge pending the results of the state’s appeal....more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Beltway Buzz - March 2020 #2

COVID-19 Update. Set forth below is a quick roundup of policy developments and implications concerning the COVID-19 virus. ...more

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