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Regulatory Requirements Food Safety Regulatory Oversight

Beveridge & Diamond PC

FDA Seeks Public Comment on Post-Market Chemical Review Prioritization Method

Key Takeaways - What Happened: The U.S. Food and Drug Administration (FDA) released its draft post-market chemical review prioritization method for public comment. Public comments are due July 18, 2025....more

Hogan Lovells

FDA Finalizes Guidance on Conducting Remote Regulatory Assessments

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The Food and Drug Administration (FDA) published its final guidance for industry entitled “Conducting Remote Regulatory Assessments – Questions and Answers” on June 26, 2025. Initially published in draft format in July 2022...more

Morrison & Foerster LLP

New Dietary Ingredient Notifications: FDA Addresses Common Pitfalls and Shares New Educational Tools

On June 11, 2025, the U.S. Food and Drug Administration (FDA) released educational videos and a new fact sheet to facilitate compliance with the agency’s New Dietary Ingredient Notification (NDIN) review process. Under the...more

Morgan Lewis - As Prescribed

FDA Extends Scrutiny Over Color Additives Beyond Food to Drug Products

FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug...more

Morgan Lewis - Well Done

Food for Thought Implications of FDAs New Chemical Review Program

The US Food and Drug Administration recently announced a major initiative to strengthen oversight of food additives and other food-related chemicals. The agency described this as a “stronger, more systematic review process”...more

Hogan Lovells

FDA announces expanded use of unannounced inspections at foreign manufacturing facilities

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On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. This announcement applies to facilities that produce...more

Beveridge & Diamond PC

FDA Food Chemical Regulation: Understanding Pesticide Action Levels

The U.S. Food and Drug Administration’s (FDA) March 2025 publication of its new “Chemical Contaminants Transparency Tool” spotlighted a lesser-known aspect of FDA’s regulation of pesticide residues on food: action levels....more

Bergeson & Campbell, P.C.

EUON Publishes Nanopinion on Enhancing the Regulatory Application of NAMs to Assess Nanomaterial Risks in the Food and Feed Sector

On April 8, 2025, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “A Qualification System to Accelerate Development and Regulatory Implementation of New Approach Methodologies...more

Morgan Lewis

HHS Signals GRAS Reform: How Food Manufacturers Can Prepare Now

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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

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

Husch Blackwell LLP

Say Goodbye to the Red Dye: Legal Implications Following the FDA’s Recent Ban

Husch Blackwell LLP on

On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced a significant regulatory change by revoking the authorization for use of Red Dye No. 3 in food (including dietary supplements) and ingested drugs. As...more

DLA Piper

Food and Beverage News and Trends - February 2025

DLA Piper on

New Trump Administration tariffs on Canada, Mexico, and China. On February 1, 2025, President Donald Trump signed three Executive Orders instituting sweeping new tariffs on all goods imported from Canada, Mexico, and China,...more

Jones Day

FDA's New Human Foods Program: Enhancing Post-Market Safety Assessments of Chemicals in Food

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Food chemical safety is among Food and Drug Administration ("FDA") top priorities as it rolls out a new Human Foods Program, amid a flurry of federal and state legislation addressing food additive safety, resulting in a...more

Perkins Coie

FDA Human Foods Priority Deliverables for FY 2025

Perkins Coie on

On October 30, 2024, the U.S. Food and Drug Administration’s (FDA) newly minted Human Foods Program (HFP) published a list of priority deliverables for Fiscal Year 2025.  By way of brief background, FDA designed the HFP to...more

Holland & Knight LLP

FDA Proposes Restructuring of Its Regulatory Oversight of Human Food

Holland & Knight LLP on

U.S. Food and Drug Administration (FDA) Commissioner Robert Califf on Jan. 31, 2023, announced a proposed restructuring of the agency's Human Foods Program in an effort to improve coordination among the FDA offices. These...more

McDermott Will & Emery

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Hogan Lovells

FDA Holds Summit on E-Commerce and Food Safety

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The U.S. Food and Drug Administration (FDA) recently hosted a three-day virtual summit on e-commerce, which focused on food safety for foods ordered online and delivered directly to consumers. Because of the increasing...more

Hogan Lovells

New EU regulation defines “Food Safety Culture”

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The European Union (EU) recently adopted a regulation requiring food business operators to establish and provide evidence of an appropriate food safety culture and detailing the steps they must take to satisfy this...more

Hogan Lovells

FDA issues letter to baby and toddler food manufacturers on chemical hazards

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On 5 March 2021, the U.S. Food and Drug Administration (FDA) issued a letter to baby and toddler food manufacturers and processors covered by the preventive control provisions of the Current Good Manufacturing Practice,...more

Hogan Lovells

FSIS partially grants CSPI petition on nitrate/nitrite claims

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The Food Safety and Inspection Service (FSIS) has partially granted a Center for Science in the Public Interest (CSPI) petition regarding nitrate/nitrite claims on meat and poultry products produced using substances that...more

Hogan Lovells

FSIS begins implementing new adulterated products tracking system

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The United States Department of Agriculture's Food Safety and Inspection Service (FSIS) has issued an instruction to field personnel, FSIS Notice 49-20, to begin implementing the agency’s new Adulterated Product Monitoring...more

Hogan Lovells

FDA Announces Inspections of Small Businesses under FSMA Intentional Adulteration Rule to Begin March 2021

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The U.S. Food and Drug Administration (FDA) recently announced that routine inspections of small businesses to verify compliance with the FDA Food Safety Modernization Act’s (FSMA) Intentional Adulteration (IA) rule will...more

Hogan Lovells

FDA Releases Blueprint for the New Era of Smarter Food Safety

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The U.S. Food and Drug Administration (FDA) recently released its “Blueprint for the Future” (Blueprint) as part of the New Era of Smarter Food Safety initiative. Launched in April 2019, this effort seeks to build upon FDA’s...more

Hogan Lovells

FDA Provides Update on Forthcoming New Era of Smarter Food Safety Blueprint

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The U.S. Food and Drug Administration (FDA) recently provided an update from FDA Commissioner Stephen Hahn M.D. and Deputy Commissioner for Food Policy and Response Frank Yiannas on the forthcoming New Era of Smarter Food...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | April 2020

What the FDA Requires for Food Safety During the COVID-19 Pandemic - The U.S. Food and Drug Administration’s (FDA) regulatory requirements for food companies, including manufacturers and importers, remain largely unchanged...more

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