News & Analysis as of

GRAS Proposed Rules

Akin Gump Strauss Hauer & Feld LLP

Food Update | GRAS‑ping the Moment: FDA GRAS Reform Steps Into the Spotlight

In case you missed it, Department of Health and Human Services Secretary Robert F. Kennedy Jr. and former Food and Drug Administration (FDA) Commissioner David Kessler appeared on 60 Minutes this past Saturday, February 15,...more

Akin Gump Strauss Hauer & Feld LLP

A New Recipe for GRAS? FDA’s Proposed Mandatory GRAS Notification Rule, BHA RFI and Congressional Reform Bills

It is no exaggeration to say that the past year has seen the most significant push to reform the U.S. Food and Drug Administration’s (FDA) generally recognized as safe (GRAS) process in more than two decades (see our prior...more

The Food Lawyers ®

FDA’s Focus on Self-Affirmed GRAS: Regulatory Recalibration and Practical Implications

The Food Lawyers ® on

The U.S. Food and Drug Administration (FDA) has signaled renewed regulatory focus on the long-standing practice of “self-affirmed” GRAS determinations....more

Morrison & Foerster LLP

FDA Releases Human Foods Program (HFP) 2026 Priority Deliverables

The U.S. Food and Drug Administration (FDA) Human Foods Program (HFP) published its 2026 Priority Deliverables, outlining a broad agenda under the Trump administration’s Make America Healthy Again (MAHA) strategy to advance...more

DLA Piper

Food and Beverage News and Trends - December 2025

DLA Piper on

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. San Francisco sues major food companies over ultra-processed foods (UPFs). The...more

Epstein Becker & Green

Eliminating the GRAS Pathway: An Update

Epstein Becker & Green on

Legislation introduced in the U.S. Senate in November, informally called the “Better FDA Act of 2025,” is perhaps a bit misleading. While it involves the Food and Drug Administration (“FDA”), the full title of S....more

Venable LLP

Prepare for FDA Proposal to Require Mandatory GRAS Notices

Venable LLP on

On December 1, the U.S. Food and Drug Administration (FDA) sent its proposed Generally Recognized as Safe (GRAS) rule, which is expected to mandate submission of GRAS notices for human and animal food substances, to the...more

Perkins Coie

FDA’s Unified Regulatory Agenda: Key Updates for Food, Dietary Supplements, and Cosmetics

Perkins Coie on

In September 2025, the U.S. Food and Drug Administration (FDA) published its Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda), which contains regulations that the FDA is currently developing. ...more

Epstein Becker & Green

A Step Closer to the Proposed End of the Self-Affirmed GRAS Pathway

Epstein Becker & Green on

As EBG previously reported, on March 10, 2025, Robert F. Kennedy, Jr., Secretary of the U.S. Department of Health and Human Services (“HHS”), announced that the U.S. Food and Drug Administration (the “FDA”) is exploring...more

Beveridge & Diamond PC

The Trump Administration’s First Unified Agenda for FDA Promises Major Changes for the GRAS Pathway, Food Ingredients, and...

Beveridge & Diamond PC on

The Make America Healthy Again (MAHA) program and implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) will keep the U.S. Food and Drug Administration (FDA) hopping for at least the next year,...more

Morrison & Foerster LLP

MAHA Strategy Report Signals Potential Changes for U.S. Food Policy and Regulation

On September 9, 2025, the Make America Healthy Again Commission published the “Make Our Children Healthy Again Strategy Report”. The Report sets out more than 120 actions to reshape U.S. food policy and regulation,...more

Venable LLP

FDA Announces Notice of Proposed Rulemaking to Eliminate Self-Affirmed GRAS and Revise GRAS Review Criteria

Venable LLP on

Last week, the Office of Information and Regulatory Affairs released the spring 2025 edition of the Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda). This semiannual publication outlines the...more

Mayer Brown

Recent Federal and State Initiatives Addressing Food Safety: MAHA Commission Driving Significant Changes in Food and Beverage...

Mayer Brown on

The food and beverage industries are seeing a fast-changing regulatory landscape at both the federal and state levels. These efforts are being driven primarily by the US Department of Health and Human Services (the “HHS”),...more

Holland & Knight LLP

Food and Chemical Update: FDA Unveils Data-Driven Assessment Tool to Rank Food Chemicals

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) is overhauling its approach to post-market oversight of food chemicals, marked by the proposed rollout of a new Post-Market Assessment Prioritization Tool. The FDA first announced...more

Holland & Knight LLP

HHS Announces Actions to Phase Out Use of Food Additives

Holland & Knight LLP on

The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) on April 22, 2025, announced their intent to phase out the use of certain food additives, including petrochemical-based dyes,...more

Baker Donelson

What Food and Beverage Manufacturers Should Be Considering With HHS Secretary Kennedy at the Reins

Baker Donelson on

Human Health and Services (HHS) Secretary Robert F. Kennedy Jr. has instructed the Food and Drug Administration (FDA) to revisit and consider rulemaking regarding its Generally Recognized as Safe (GRAS) notification and...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

Holland & Knight LLP

HHS Explores Stronger FDA Oversight for Food Ingredients

Holland & Knight LLP on

U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced on March 10, 2025, that he directed the acting commissioner of the U.S. Food and Drug Administration (FDA) to explore potential...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

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l September 2020 #2

The U.S. Food and Drug Administration (FDA) has released a proposed update to traceability recordkeeping requirements for foods considered “high risk” as sources of foodborne illness. The proposed rule would apply to entities...more

McDermott Will & Schulte

EPA Approves Use of 10 Pesticide Products on Hemp

McDermott Will & Schulte on

December 19th, 2019, the Environmental Protection Agency (EPA) announced its approval of 10 new pesticides for use on hemp products. EPA’s approval of nine biopesticides and one conventional pesticide provides greater...more

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