Veronica Colas on Regulatory Requirements

FDA Delays Effective Date for Final Healthy Rule

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

2/26/2025 / Administrative Procedure Act , Executive Orders , Final Rules , Food and Drug Administration (FDA) , Regulatory Agenda , Regulatory Freeze , Regulatory Requirements , Rulemaking Process , Trump Administration

FDA Issues Draft Guidance on Labeling of Plant-Based Alternatives to Animal-Derived Foods

On January 6, 2025, the U.S. Food and Drug Administration (FDA) issued draft guidance on the labeling of plant-based alternatives to animal-derived foods. The draft guidance provides best practices for naming plant-based...more

1/10/2025 / Compliance , Consumer Information , Draft Guidance , Food and Drug Administration (FDA) , Food Labeling , Food Safety , Nutrition Facts Labels , Plant Based Products , Product Labels , Regulatory Requirements

Reminder: Compliance date for new FDA requirements for fermented and hydrolyzed “gluten-free” foods

The 13 August 2021 compliance date for the U.S. Food and Drug Administration’s (FDA) final rule establishing recordkeeping requirements for foods bearing “gluten-free” claims that are fermented, hydrolyzed, or contain...more

3/9/2021 / Celiac Disease , Food Allergies , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Gluten-Free , Recordkeeping Requirements , Regulatory Reform , Regulatory Requirements

FDA issues Final Guidance on use of “Potassium Salt” as an alternate name for Potassium Chloride

Last week the Food and Drug Administration (FDA) issued a Final Guidance document regarding the use of an alternate name for potassium chloride in food labeling....more

12/21/2020 / Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Safety , Nutrition Facts Labels , Regulatory Requirements

FDA Public Meeting: Horizontal Approaches to Food Standards of Identity Modernization

On September 27, 2019 the U.S. Food and Drug Administration (FDA) hosted a public meeting to gather information from stakeholders on changes the agency could make to existing standards of identity (SOIs), particularly changes...more

10/11/2019 / Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Regulatory Oversight , Regulatory Requirements

FDA Issues Final Guidance on Added Sugars Labeling for Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain...

On June 18, the Food and Drug Administration (FDA) issued its final guidance document on added sugars labeling for (1) honey, maple syrup, and other single-ingredient sugars and syrups; and (2) certain cranberry products. In...more

6/20/2019 / Final Guidance , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Supply , Regulatory Requirements , Rulemaking Process

The Use of an Alternate Name for Potassium Chloride in Food Labeling: Guidance for Industry

Last week the Food and Drug Administration (FDA) issued draft guidance announcing that the agency intends to exercise enforcement discretion to allow the use of “potassium chloride salt” as an alternative common or usual name...more

5/20/2019 / Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Safety , Food Supply , Nutrition Facts Labels , Public Health , Regulatory Agenda , Regulatory Oversight , Regulatory Requirements , Rulemaking Process

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

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

12/21/2018 / Amended Regulation , Final Rules , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Nutrition Facts Labels , Regulatory Oversight , Regulatory Requirements

FDA Issues Two Guidance Documents on New Nutrition Labeling Requirements

The U.S. Food and Drug Administration (FDA) recently issued two guidance documents – one final and one draft – related to the new nutrition labeling requirements. The final guidance is an update to the previous draft guidance...more

11/7/2018 / Draft Guidance , Food and Drug Administration (FDA) , Food Labeling , New Guidance , Nutrition Facts Labels , Regulatory Oversight , Regulatory Requirements , Retail Market

USDA Sends National Bioengineered Food Disclosure Standard to OMB While Facing Lawsuit for Failing to Meet Statutory Deadline

On August 1, 2018, two consumer groups sued the U.S. Department of Agriculture (USDA), USDA Secretary Sonny Perdue, and Agricultural Marketing Service (AMS) Administrator Bruce Summers for failing to meet the statutory...more

9/20/2018 / Bioengineering , Disclosure Requirements , Food Labeling , Food Safety , Food Supply , GMO , OMB , Preemption , Regulatory Oversight , Regulatory Requirements , Rulemaking Process , Statutory Deadlines , Summary Judgment , USDA

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

The Food and Drug Administration (FDA) is proposing 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

7/13/2018 / Comment Period , Disclosure Requirements , Food and Drug Administration (FDA) , Food Labeling , Nutrition Facts Labels , Regulatory Oversight , Regulatory Requirements , Vending Machines

Veronica Colas

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