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Final Rules Food and Drug Administration (FDA) Public Health

Venable LLP

FDA Regulatory Updates for Summer 2025: Food, Supplements, and Cosmetics

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Recent actions by the Food and Drug Administration (FDA or Agency) reflect a sharpened scrutiny in areas where public health and safety may be critical, but a more relaxed approach in areas where it views innovation may be...more

Hogan Lovells

HHS Secretary Directs FDA to Explore Rulemaking to Eliminate Self-GRAS Pathway

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The Secretary of the U.S. Department of Health and Human Services (HHS), Robert F. Kennedy, Jr., recently issued a press release directing the Food and Drug Administration (FDA) to take steps to explore possible rulemaking to...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

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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"

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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

Venable LLP

Regulatory Freeze: FDA Pushes Back Effective Date of "Healthy" Nutrient Content Claim Rule

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On February 25, the Food and Drug Administration (FDA) announced a delay in the effective date for its final rule updating the criteria to use the "healthy" nutrient content claim on food labeling....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

Foley & Lardner LLP

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

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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

Cooley LLP

FDA Publishes Rule Updating ‘Healthy’ Nutrient Content Claim

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On December 27, 2024, the US Food and Drug Administration (FDA) published its final rule to update the definition for “healthy” claims on food labels. The new rule uses current nutrition science to both expand and restrict...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

Shook, Hardy & Bacon L.L.P.

FDA Publishes Front-of-Pack Regulation, Bans Red Dye No. 3

The U.S. Food and Drug Administration (FDA) has published a proposed front-of-package nutrition label, the "Nutrition Info box," that would give consumers readily visible information about the "Low," "Med" or "High" levels of...more

BakerHostetler

The FDA’s New Definition of ‘Healthy’: A Step Forward, or a Step Too Far?

BakerHostetler on

The Food and Drug Administration (FDA) recently issued a final rule updating the definition of the term “healthy” for use on food labels. This change aims to align with modern nutrition science and the latest Dietary...more

K&L Gates LLP

FDA Proposes Front-of-Package Labeling Requirements

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On 14 January 2024, the US Food and Drug Administration (FDA) issued a proposed rule to be published on 16 January, which, if finalized, will require a front-of-package (FOP) nutrition label on most packaged foods. This FOP...more

BakerHostetler

Federal Court Blocks FDA’s Graphic Cigarette Warning Rule: The Limits of Regulatory Authority

BakerHostetler on

On Monday, a federal judge from the Eastern District of Texas, Judge J. Campbell Barker, ruled that the U.S. Food and Drug Administration (FDA) exceeded its authority under the Tobacco Control Act by requiring cigarette...more

Morgan Lewis - Well Done

Navigating FDA from 2024 into 2025 Human Foods Program

FDA Restructures its Food Resources Although there were a number of significant new regulations, the most significant food industry change in 2024 was the overhaul of how FDA structures itself to regulate foods generally....more

DLA Piper

FDA Bans Red Dye No. 3 Under the Delaney Clause

DLA Piper on

The US Food and Drug Administration (FDA) has revoked its authorization for the use of FD&C Red No. 3, also known as Red Dye No. 3. Issued on January 15, 2025, the ban will go into effect for food (including dietary...more

Venable LLP

Red Dye No. 3 Ban at FDA and What's Next

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On January 15, 2025, the Food and Drug Administration (FDA or Agency) issued an order to revoke the authorization for the use of FD&C Red No. 3 (Red No. 3) in food and ingested drugs in response to a 2022 color additive...more

Husch Blackwell LLP

FDA Bans the Use of Red No. 3 in Food and Ingested Drugs

Husch Blackwell LLP on

On January 16, the U.S. Food and Drug Administration (FDA) announced that it is revoking the authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. The dye is commonly used in...more

Akin Gump Strauss Hauer & Feld LLP

In Waning Days of the Current Administration, FDA Announces Red No. 3 Ban

On January 15, 2025, FDA announced an order revoking the listings providing for the use of the color additive FD&C Red No. 3 in both foods (including dietary supplements) and ingested drugs. The order is in response to a 2022...more

DLA Piper

FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for...

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The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting requirements for a nonprescription drug product with an “additional condition for...more

Womble Bond Dickinson

FDA Sets Action Levels For Lead

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A year ago, the FDA issued draft guidance for lead levels in baby foods. In the year since the FDA issued its draft guidance for lead levels in baby food, two states, California and Maryland, have adopted laws which require...more

Hogan Lovells

FDA Issues Final “Healthy” Rule

Hogan Lovells on

On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued its long-awaited final rule updating the requirements for when the term “healthy” can be used as an implied nutrient content claim in food labeling. ...more

Morrison & Foerster LLP

FDA Issues Action Levels for Lead in Baby Food

On January 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance establishing action levels for lead in processed food intended for babies and young children. This is the first FDA guidance directly...more

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