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Regulatory Requirements › Food Manufacturers › Final Rules

Saul Ewing LLP

Marketing Risk in the Age of Wellness: When Are Food Claims Misbranding?

Saul Ewing LLP on

On October 1, 2024, the U.S. Food and Drug Administration (FDA or the Agency) implemented its unified Human Foods Program (HFP). The Agency established the HFP – which represented the single largest reorganization in FDA’s...more

Holland & Knight LLP

Out with the Old: FDA to Revoke 52 Standards of Identity – What Food Companies Need to Know

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) announced a final rule on July 16, 2025, revoking 52 standards of identity (SOIs) for food products that it deems obsolete. The FDA currently maintains more than 250 SOIs, and this...more

Schwabe, Williamson & Wyatt PC

Regulatory Changes Address Surge of Food-As-Health Initiatives and Shift “Healthy” ‎Standard; Plus New Labeling Requirements

Schwabe, Williamson & Wyatt PC on

Food and beverage products that promote health and well-being have proliferated. Demand has surged for foods and drinks that are loaded with nutrients and offer health benefits. Their growth is partly driven by an increased...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

Shook, Hardy & Bacon L.L.P.

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

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

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 Revokes Authorization for the Use of Red Dye No. 3 in Food and Ingestible Drugs

K&L Gates LLP on

On 15 January 2025, the US Food and Drug Administration (FDA) announced that it will revoke the color additive authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingestible drugs. This ban...more

Womble Bond Dickinson

FDA Sets Action Levels For Lead

Womble Bond Dickinson on

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

McDermott Will & Schulte

FDA’s Fresh Take on Use of “Healthy” in Food Labeling

McDermott Will & Schulte on

On December 19, 2024, the US Food and Drug Administration (FDA) issued a new final rule titled “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy.’” The rule revises regulations that govern when food...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

King & Spalding

USDA Publishes Long-Awaited Final Rule on the Labeling of “Bioengineered” Food

King & Spalding on

On December 21, 2018, the Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture (USDA) issued a final rule1 (BE Final Rule) to implement the National Bioengineered Food Disclosure Standard (NBFDS),2 which...more

Seyfarth Shaw LLP

Implementation Date For The USDA’s National Bioengineered Food Disclosure Standard

Seyfarth Shaw LLP on

The implementation date for the disclosure obligations triggered by the USDA’s final rule establishing a national standard for the disclosure of bioengineered ingredients in certain food products is January 1, 2020 for...more

Hogan Lovells

Nutrition Labeling Implementation Update – FDA Issues Technical Amendments to Final Rule

Hogan Lovells on

The Food and Drug Administration (FDA) recently issued technical amendments to the final rule revising the nutrition labeling requirements. These technical amendments restore provisions that were inadvertently omitted when...more

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