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Regulatory Requirements Department of Health and Human Services (HHS) Public Health

Cozen O'Connor

HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice

Cozen O'Connor on

The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more

Husch Blackwell LLP

Eliminating the GRAS “Loophole”: Implications for Functional Foods and Beverages

Husch Blackwell LLP on

On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that U.S. Secretary of HHS Robert F. Kennedy Jr. directed the U.S. Food and Drug Administration (FDA) to explore closing the GRAS...more

Epstein Becker & Green

The End of the Self-Affirmed GRAS Pathway?

Epstein Becker & Green on

On March 10, 2025, Robert F. Kennedy, Jr., Secretary of the U.S. Department of Health and Human Services (“HHS”), in a seismic shift, announced that the U.S. Food and Drug Administration (“FDA”) would “explore potential...more

Morgan Lewis - Well Done

The Future of Artificial Colors in the US Food Supply Is Not So Bright

Only weeks after being confirmed, the Department of Health and Human Services (HHS) secretary has advised food companies to remove artificial colors from their food products. He recently met with several major food brand...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

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

Holland & Knight LLP

Holland & Knight Health Dose: March 19, 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

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

Beveridge & Diamond PC

GRAS Self-Affirmation for Food Ingredients – To Be or Not to Be?

Beveridge & Diamond PC on

Key Takeaways - What Happened: HHS Secretary Kennedy directed FDA to consider removing the current self-affirmation pathway for determining that a food ingredient is Generally Recognized as Safe (GRAS)....more

Ice Miller

RFK Jr. Calls to End the Self-Affirming GRAS “Loophole”

Ice Miller on

Through an Order that the Secretary of the U.S. Department of Health and Human Services (HHS) Robert F. Kennedy Jr. (RFK) called an act of “radical transparency,” the U.S. Food and Drug Administration (FDA) has been directed...more

Cozen O'Connor

Democratic AGs Block NIH Grant Cuts

Cozen O'Connor on

A coalition of 22 Democratic AGs obtained a preliminary injunction blocking the implementation of the Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates (Rate Change Notice), which would have...more

McGuireWoods Consulting

Health Care Executive Orders And Legal Actions: Part Three

Public Health - Withdrawing from the World Health Organization (WHO)...more

Faegre Drinker Biddle & Reath LLP

HHS Rescission of the Richardson Waiver and Unintended Legal Consequences for Drug and Device Manufacturers

On March 3, 2025, the U.S. Department of Health and Human Services (HHS) published a policy statement rescinding a decades-old administrative exemption for notice-and-comment rulemaking known as the Richardson Waiver. Written...more

Holland & Knight LLP

Holland & Knight Health Dose: March 4, 2025

Holland & Knight LLP on

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

Stevens & Lee

Urgent Care Centers Must Now Comply With Pennsylvania Newborn Safe Haven Law

Stevens & Lee on

Pennsylvania’s Safe Haven Law, also known as the Newborn Protection Act (the Act), allows parents to surrender their infants at hospitals, EMS providers and police stations without criminal liability, but for a few...more

Holland & Knight LLP

Holland & Knight Health Dose: February 25, 2025

Holland & Knight LLP on

Holland & Knight Health Dose 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

Alston & Bird

Health Care Week in Review | Senate Passes First Budget Resolution; DOJ Opts to Continue Defense in Braidwood SCOTUS Case

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...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

Farrell Fritz, P.C.

New York Court of Appeals Upholds Adult Home Admission Regulations

Farrell Fritz, P.C. on

New York Department of Health (DOH) regulations provide that an adult home may not admit additional residents with serious mental illness if it has a capacity of 80 or more beds and its resident population is over 25% persons...more

Cozen O'Connor

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

Cozen O'Connor on

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

Cozen O'Connor on

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

Alston & Bird

Health Care Week in Review: OMB Issues and Rescinds Memo Freezing Federal Funds; Senate Finance and HELP Committees Hold HHS...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...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

Cozen O'Connor

COVID Vaccine No Longer Required for Adjustment of Status Applicants

Cozen O'Connor on

On January 22, 2025, USCIS posted an alert pertaining to the I-693 immigration medical exam required for most individuals applying to become lawful permanent residents. USCIS indicates that they now “waive[s] any and all...more

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