News & Analysis as of

Final Rules Regulatory Requirements Department of Health and Human Services (HHS)

Schwabe, Williamson & Wyatt PC

Regulatory Changes Address Surge of Food-As-Health Initiatives and Shift “Healthy” ‎Standard; Plus New Labeling Requirements

Food and beverage products that promote health and well-being have proliferated. Demand has surged for foods and drinks that are loaded with nutrients and offer health benefits. Their growth is partly driven by an increased...more

Sheppard Mullin Richter & Hampton LLP

LDT Final Rule Series: Part 4 – Rule Overturned by Federal District Court

Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug Administration’s (“FDA’s” or the...more

Husch Blackwell LLP

Litigation Looms: ERIC Seeks Stay on 2024 Mental Health Parity Rule Enforcement

Husch Blackwell LLP on

On February 20, 2025, the ERISA Industry Committee (ERIC) announced that its legal counsel submitted a letter to the U.S. Departments of Labor (DOL), Health and Human Services (HHS) and Treasury, requesting a stay of...more

Foley & Lardner LLP

DEA Buprenorphine Rule Delayed to December 31, 2025

Foley & Lardner LLP on

The U.S. Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) have postponed the effective date of the final rule regarding telemedicine prescribing of buprenorphine (the final...more

Akin Gump Strauss Hauer & Feld LLP

HHS, FDA Announce Multiple Initiatives on Food Safety, Quality and Compliance Fronts

In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more

MoFo Life Sciences

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

MoFo Life Sciences on

On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F....more

DLA Piper

Food and Beverage News and Trends - March 2025 #2

DLA Piper on

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. Secretary Kennedy takes first steps to eliminate GRAS exception. Health and...more

Jones Day

FDA Directed to Explore Elimination of Food Additive "Loophole"

Jones Day on

Secretary Kennedy seeks to enhance FDA's oversight of food additives by eliminating a pathway that allows new ingredients to be introduced into the U.S. food supply without premarket notification to or approval by FDA....more

ArentFox Schiff

RFK Jr. Takes Aim at GRAS Self-Affirmation Process

ArentFox Schiff on

On March 10, the US Department of Health and Human Services (HHS) announced that newly confirmed HHS Secretary Robert F. Kennedy Jr. has directed acting US Food and Drug Administration (FDA) Commissioner Dr. Sara Brenner to...more

McDermott+

Breaking Down the New No Surprises Act FAQs Post-TMA III

McDermott+ on

On January 14, 2025, the US Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM), jointly issued Part 69 of a series of...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

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

Akin Gump Strauss Hauer & Feld LLP

Is Self-Affirming GRAS Off the Menu?

United States Department of Health and Human Services (HHS) Secretary Kennedy recently directed the U.S. Food and Drug Administration (FDA) to consider rulemaking to revise its longstanding regulations and guidance governing...more

Proskauer - Health Care Law Brief

HHS Scraps Richardson Waiver, Clearing Way for Faster Rulemaking

On March 3, 2025, the United States Department of Health and Human Services (“HHS”) issued a policy statement rescinding the Richardson Waiver, a policy in place since 1971 that required notice-and-comment rulemaking for...more

Akerman LLP - Health Law Rx

No (Public) Comment: HHS Rescinds Policy on Public Participation in Rulemaking

The Department of Health and Human Services (HHS) recently rescinded its policy dating back to 1971 to now allow its agencies and offices to quickly alter certain rules and regulations without public notice and comment. The...more

Foley Hoag LLP

Department of Health and Human Services Seeks to Revise Rulemaking Policies

Foley Hoag LLP on

On Friday, February 28, 2025, the Department of Health and Human Services (HHS) issued a policy statement announcing changes to rulemaking processes for agencies within HHS. According to the statement, HHS is rescinding a...more

Epstein Becker & Green

A Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule

Epstein Becker & Green on

Clinical laboratories still face uncertainty and the difficult decision of whether to start the work needed to comply with the with Phase 1 expectations under FDA’s Laboratory Developed Tests Final Rule (the “LDT Final...more

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

Employer Group Sues to Block Mental Health Parity Rules

Only weeks after the principal effective date for the final 2024 federal mental health parity rules for employer-sponsored health benefit plans, those rules—and specifically some key features that are frustrating...more

Foley & Lardner LLP

Make Food “Healthy” Again: FDA’s Resolution for a Healthier 2025

Foley & Lardner LLP on

The U.S. Food and Drug Administration (FDA) began 2025 with a resolution to make food “healthy” again by announcing a trio of new final and proposed rules that are intended to make it easier for consumers to identify healthy...more

Epstein Becker & Green

Effective Dates of DEA Final Rules for Telemedicine Prescribing Delayed

Epstein Becker & Green on

On Friday, February 14, 2025, the Drug Enforcement Administration (“DEA”) and the U.S. Department of Health and Human Services (“HHS”) announced that the effective dates for two recently published final rules involving...more

McDermott Will & Emery

FDA Relaxes Critical Positions on Use of Scientific Information in Off-Label Communications

McDermott Will & Emery on

On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more

Seyfarth Shaw LLP

Federal Lawsuit and Tri-Agency Report Shake Up Mental Health Parity

Seyfarth Shaw LLP on

On January 17, 2025, the U.S. Departments of Treasury, Labor and Health and Human Services (the “Agencies”) released its annual report to Congress assessing compliance with statutory mental health parity requirements under...more

Bass, Berry & Sims PLC

Can the NIH Cap Indirect Cost Rates at 15%?

Bass, Berry & Sims PLC on

Note: This post was updated with new information on February 13, 2025. On February 7, the National Institutes of Health (NIH) issued Supplemental Guidance to its 2024 NIH Grants Policy Statement, Indirect Cost Rates,...more

McDermott Will & Emery

CMS Implements First Major Updates to Lab Personnel Requirements in 30+ Years

On December 28, 2024, a long-awaited Centers for Medicare & Medicaid Services (CMS) final rule became effective, significantly updating laboratory personnel requirements under Subpart M of the Clinical Laboratory Improvement...more

Stotler Hayes Group, LLC

CMS Cracks Down on Responsible Party Liability in LTC Admission Agreements

A nursing facility that participates in the Medicaid or Medicare programs may not require a third party to guarantee payment for a resident’s admission or continued stay. However, facilities are allowed to require a resident...more

Sheppard Mullin Richter & Hampton LLP

May the Coverage Be With You: Navigating CMS’s Changes to the Health Insurance Marketplace

The Department of Health and Human Services (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) recently issued the final “HHS Notice of Benefit and Payment Parameters for 2026” (hereinafter referred to as the “Rule”)...more

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