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Rulemaking Process › Enforcement Actions › Department of Health and Human Services (HHS)

Skadden, Arps, Slate, Meagher & Flom LLP

Closing the GRAS Loophole: Secretary Kennedy’s Plan To Enhance FDA Food Safety Regulations

Skadden, Arps, Slate, Meagher & Flom LLP on

On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more

McDermott+

Price Transparency: A Regulatory Priority

McDermott+ on

The Trump administration is beginning to lay out its regulatory (and deregulatory) priorities, and on February 25, 2025, the administration spotlighted one of those priorities in an executive order on price transparency....more

Troutman Pepper Locke

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

Troutman Pepper Locke on

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

Davis Wright Tremaine LLP

March 2024 UDAAP Bulletin

Davis Wright Tremaine LLP on

Editor's Note The following document provides a monthly roundup summarizing enforcement actions, guidance, rulemakings, and other public statements from the Consumer Financial Protection Bureau, the Federal Trade Commission,...more

Sheppard Mullin Richter & Hampton LLP

Federal Government Announces Enforcement Discretion, Deferral For Certain Price Disclosures And Future Rulemakings

Sheppard Mullin Richter & Hampton LLP on

Health plans and issuers racing to implement overlapping price transparency and disclosure requirements in response to the Transparency in Coverage final rule (TiC Final Rule) and the Consolidated Appropriations Act, 2021...more

K&L Gates LLP

K&L Gates Triage: The Impact of Allina — Potential Limitation on CMS’s Ability to Recoup Overpayments

K&L Gates LLP on

In this week’s episode, Adam Cooper discusses the Supreme Court’s decision in Azar v. Allina Health Services, as well as a related memorandum issued in late 2019 by the Centers for Medicare and Medicaid Services (“CMS”) that...more

McDermott Will & Emery

New Guidance on Medicare Payment Rule Enforcement

McDermott Will & Emery on

A few days before Thanksgiving, the news media published an internal memo by the Office of General Counsel (OGC) at the US Department of Health and Human Services (Department) to officials at the Centers for Medicare and...more

McDermott Will & Emery

Guidance on Guidance: DOJ Limits Use of Agency Guidance Documents in Civil Enforcement Cases

McDermott Will & Emery on

In a two-page memorandum, the US Department of Justice (DOJ) announced a broad policy statement prohibiting the use of agency guidance documents as the basis for proving legal violations in civil enforcement actions,...more

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