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Rulemaking Process › Final Rules › Food and Drug Administration (FDA)

Ervin Cohen & Jessup LLP

FDA Webinar on the Updated Criteria for Making a “Healthy” Claim

Ervin Cohen & Jessup LLP on

On April 10, 2025, the FDA held a public webinar on the updated criteria for companies to use the “healthy” nutrient content claim. This webinar tracked the final rule issued on December 27, 2024....more

Womble Bond Dickinson

New FDA Criteria for Labeling Food as "Healthy"

Womble Bond Dickinson on

All of us have probably had the experience of browsing the aisles at the grocery store looking for healthy foods to take home for our families. A few foods we find may include the word “healthy” on the packaging. Did you know...more

Venable LLP

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

Venable LLP on

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

Skadden, Arps, Slate, Meagher & Flom LLP on

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?

Akin Gump Strauss Hauer & Feld LLP on

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

Venable LLP

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

Venable LLP on

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

Hogan Lovells

FDA Delays Effective Date for Final Healthy Rule

Hogan Lovells on

On February 25, 2025, the U.S. Food and Drug Administration (FDA) delayed the effective date for its final “Healthy” rule from February 25, 2025 to April 28, 20251. The delayed effective date is in line with President Trump’s...more

Ice Miller

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

Ice Miller on

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

Mintz - Health Care Viewpoints on

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”

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

K&L Gates LLP

FDA Proposes Front-of-Package Labeling Requirements

K&L Gates LLP on

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

Davis Wright Tremaine LLP

FDA's Definition of "Healthy" … Updated Just in Time for New Year's Resolutions

Davis Wright Tremaine LLP on

After years of talk, the U.S. Food and Drug Administration in mid-December 2024 at last finalized an updated definition of the implied nutrient content claim "healthy." The original definition of "healthy" dates back to the...more

Perkins Coie

FDA Publishes Final Rule on “Healthy”

Perkins Coie on

On December 27, 2024, the U.S. Food and Drug Administration (FDA) published a final rule updating the criteria regarding when foods may be labeled with the nutrient content claim “healthy” and derivatives thereof—“health,”...more

DLA Piper

FDA Issues Updated Final Rule for "Healthy" Labeling

DLA Piper on

The US Food and Drug Administration (FDA) released the final rule providing new criteria for when foods may be labeled with the nutrient content claim “healthy.” This rule, released on December 19, 2024, has been a priority...more

Shook, Hardy & Bacon L.L.P.

FDA Announces Final Rule Updating Definition of "Healthy" Nutrient Content Claim - Food and Beverage Litigation and Regulatory...

Shook, Hardy & Bacon L.L.P. on

The U.S. Food and Drug Administration (FDA) has announced a final rule updating the definition of the nutrient content claim “healthy.” To qualify as “healthy” under the updated definition, food products must contain a...more

Hogan Lovells

FDA Issues Final Rule on Front-of-Pack Calorie Disclosures Used for Vending Machine Labeling Compliance

Hogan Lovells on

The Food and Drug Administration (FDA) issued a final rule to revise the type size requirements for front-of-pack (FOP) calorie declarations that are used to comply with the vending machine calorie labeling requirements. The...more

Hogan Lovells

CDRH issues final rule on appeals, excluding De Novos from 517A

Hogan Lovells on

On 2 July 2019 the U.S. Food and Drug Administration (FDA) issued a final rule finalizing the category of "517A decisions," previously termed "significant decisions," as well as two accompanying guidance documents related to...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

Verrill on

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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