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Rulemaking Process Final Rules Department of Health and Human Services (HHS)

Venable LLP

Exploring the Future of GRAS: HHS’s Recent Directive and Its Potential Impact on the Food Industry

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On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that HHS Secretary Robert F. Kennedy has directed the Food and Drug Administration (FDA or Agency) “to take steps to explore potential...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

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

Foley Hoag LLP

Department of Health and Human Services Seeks to Revise Rulemaking Policies

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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

McCarter & English, LLP

DEA Telemedicine Update

The Drug Enforcement Administration (DEA), in concert with other federal agencies, has taken various steps in the past few months to strengthen a practitioner’s ability to prescribe controlled substances via telemedicine, a...more

Ice Miller

FDA Final Rule for “Healthy” Nutrient Content Claims Effective Date Looms but Rule’s Future Is Uncertain

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After years of rulemaking with impassioned input from food producers, industry stakeholders, and consumer groups, on December 27, 2024, the Food and Drug Administration (FDA or Agency) published a final rule titled “Food...more

Mintz - Health Care Viewpoints

FDA Continues Push to Improve Food Labeling Practices in the United States

In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The...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

King & Spalding

Congressmembers Send Letter to Departments Raising Provider Concerns with No Surprises Act Implementation

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On March 18, 2024, thirty-nine (39) members of the United States House of Representatives sent a letter urging federal agencies to finalizing rulemaking regarding the implementation of the No Surprises Act. The letter,...more

Bass, Berry & Sims PLC

HHS Finalizes Rule: “Safeguarding the Rights of Conscience as Protected By Federal Statutes”

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On January 11, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published a Final Rule that seeks to provide clarity regarding OCR’s enforcement authority and processes relating to federal...more

Ballard Spahr LLP

HHS Announces Temporary Copay Accumulator Non-Enforcement Policy

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The United States Department of Health and Human Services (HHS) has filed court pleadings stating that it does not intend to initiate enforcement actions against plans that maintain copay accumulator programs....more

ArentFox Schiff

No More Surprise Medical Bills: Biden Administration Issues New Rule Governing Arbitration Fees and Takes First Step to Restarting...

ArentFox Schiff on

On September 21, 2023, the US Departments of Treasury (DOT), Labor (DOL), and Health and Human Services (HHS) (the Departments) issued new rulemaking governing the administrative fee required to access the arbitration process...more

Sheppard Mullin Richter & Hampton LLP

CMS Backs Off Price Transparency for Providers and Plans

On August 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) issued its hospital inpatient prospective payment system (“IPPS”) final rule (“Final Rule”) for fiscal year 2022. In addition to a number of other...more

Sheppard Mullin Richter & Hampton LLP

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

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

Sheppard Mullin Richter & Hampton LLP

Permanent Expansion of Medicare Telehealth Services

On December 1, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released the annual Physician Fee Schedule final rule (“Final Rule”) which, among other things, aimed to further President Trump’s October 3, 2019...more

Seyfarth Shaw LLP

CMS Announces Extension on Publishing Final Rule Governing Physician Self-Referrals in Stark Law

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Health care providers looking for long-awaited answers to new proposed rules changes governing physician self-referral arrangements may have to wait a bit longer. ...more

Ballard Spahr LLP

Health Care and Price Transparency: The Latest Summary

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Federal executive agencies recently published two rules, one final and one proposed, aimed at publicizing the various costs associated with health care. A final rule, promulgated by the Department of Health and Human Services...more

Dorsey & Whitney LLP

Court Invalidates Final Rule Requiring Advertisements to List Drug Prices Finding that CMS Exceeded Its Statutory Authority

Dorsey & Whitney LLP on

In a much anticipated decision, a federal judge ruled this week that the Trump Administration’s rule requiring drug manufacturers to list drug prices in television advertisements exceeds the agency’s authority. Back in May...more

Foley & Lardner LLP

FDA’s Response to HHS’ Revised Common Rule: Four Things to Know

Foley & Lardner LLP on

In a final rule published on January 19, 2017, HHS and several federal departments and agencies made revisions to the Common Rule, the federal policy for the protection of human subjects applicable to human subject research...more

Verrill

Tag, You’re It: FDA Issues Guidance Ahead of Revisions to its Human Subjects Protection Regulations

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Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued new guidance (“Guidance”) for sponsors, investigators, and institutional review boards (“IRBs”) regarding how recent changes to the Federal Policy for...more

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