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GRAS Regulatory Oversight

The Food Lawyers ®

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

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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

Wiley Rein LLP

Reforming GRAS: Digesting the Proposed “Better Food Disclosure Act” (S. 3122)

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Senator Roger Marshall (R-KS) introduced much-anticipated legislation this month that seeks to reform the process by which “generally recognized as safe” (GRAS) substances are assessed by the U.S. Food and Drug Administration...more

Baker Donelson

How Food Manufacturers Should Prepare for Impact of MAHA Strategy Report

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Last week, the Presidential Commission to Make America Healthy Again (MAHA) released its Make Our Children Healthy Again Strategy Report (the Strategy Report), a follow-up to the initial MAHA Report released earlier this...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

DLA Piper

Food and Beverage News and Trends - August 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....more

Holland & Knight LLP

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

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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

Morgan Lewis

HHS Signals GRAS Reform: How Food Manufacturers Can Prepare Now

Morgan Lewis on

Ingredient suppliers and food manufacturers face an uncertain supply chain landscape in which “generally recognized as safe” (GRAS) self-determinations may be more closely scrutinized. The US Department of Health and Human...more

Latham & Watkins LLP

HHS Directs FDA to Explore Rulemaking to Increase Oversight of Food Ingredients

Latham & Watkins LLP on

On March 10, 2025, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced in a press release that he has directed the Food and Drug Administration (FDA) to explore rulemaking to implement a...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

DLA Piper

Food and Beverage News and Trends - December 2024

DLA Piper on

On November 21, the FDA sent its proposed rule on front of package (FOP) nutrition labels to the White House Office of Management and Budget (OMB). FOP labeling has been prioritized by the agency as part of a National...more

Seyfarth Shaw LLP

FDA Stresses CBD Safety Concerns in 15 Warning Letters and Revised Consumer Update

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In its largest mass enforcement action involving cannabidiol (CBD) yet, the U.S. Food & Drug Administration (FDA) announced on November 25 the issuance of 15 warning letters to various companies for illegally selling products...more

Hogan Lovells

Developments Related to the Compliance Date for FDA’s Final Determination on the GRAS Status of Partially Hydrogenated Oils

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As the June 18, 2018 compliance date for the Food and Drug Administration’s (FDA’s) final determination that partially hydrogenated oils (PHOs) are no longer generally recognized as safe (GRAS) approaches, the food industry...more

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