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Food Law Preview - Key issues affecting the food industry in 2024

2024 is poised to be a big year for food regulation, particularly as federal agencies work to implement their regulatory agendas in preparation for a possible change in administration after the 2024 election. Here are the key...more

FSMA Update: FDA Announces Results of 3rd Party Food Safety Audit Evaluation Pilot Program

The U.S. Food and Drug Administration (FDA) recently announced the results of its pilot program evaluating whether several third-party food safety standards align with the food safety requirements in FDA’s Preventive Controls...more

FDA issues draft guidance setting action levels for lead in food intended for babies and young children

The U.S. Food and Drug Administration (FDA) issued a draft guidance for industry on Action Levels for Lead in Food Intended for Babies and Young Children (Draft Guidance). The proposed action levels would apply to processed...more

Reagan-Udall Foundation issues report with recommendations for strengthening FDA’s Human Foods Program

On December 6, 2022, the Reagan-Udall Foundation for the FDA (“RUF”) issued a highly anticipated report on FDA’s Human Foods Program (the Program) capturing the findings and recommendations of a months-long independent review...more

FDA’s FY 2023 Budget Includes Several Proposals Significant to Food and Supplement Manufacturers

The U.S. Food and Drug Administration (FDA) recently released its Congressional Justification for the fiscal year (FY) 2023 budget. The agency is requesting $1.2 billion for its Foods Program to be allocated to initiatives...more

OMB Releases Fall 2021 Unified Agenda of Regulatory Actions

The Office of Management and Budget (OMB) recently released the Fall 2021 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more

FDA Holds Public Meeting on Closer to Zero Action Plan for Baby Foods

The U.S. Food and Drug Administration (FDA) recently held a public meeting as a part of its Closer to Zero: Action Plan for Baby Foods initiative. This plan identifies steps the agency will take over the next three years...more

FDA Holds Summit on E-Commerce and Food Safety

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

OMB releases Spring 2021 Unified Agenda of Regulatory Actions

The Office of Management and Budget (OMB) recently released the Spring 2021 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This article...more

FDA extends enforcement discretion for UFI food facility registration requirement to December 2022

The U.S. Food and Drug Administration (FDA) recently issued updated guidance that extends agency enforcement discretion over compliance with the requirement that domestic and foreign food facilities provide a unique facility...more

Preliminary injunction issued against new Proposition 65 lawsuits for acrylamide in food & beverage

On 29 March 2021 the United States District Court for the Eastern District of California entered a significant ruling temporarily halting the filing of new lawsuits by the California Attorney General and anyone else related...more

FSMA update: FDA announces pilot program to evaluate third-party food safety standards

The Food and Drug Administration (FDA) recently announced a pilot program to evaluate whether third-party food safety standards align with the food safety requirements in FDA’s Preventive Controls for Human Food (PCHF) and...more

Recent FDA Warning Letters focus on inadequate allergen controls following undeclared allergen recalls

The U.S. Food and Drug Administration (FDA) recently issued a fifth Warning Letter related to allergen labeling, continuing a series of Warning letters in the past six months that cite companies for failing to “identify and...more

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

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

COVID-19 Update: FDA Issues Guidance on Temporary Flexibility Policy Regarding Certain Labeling Requirements for Foods for Humans...

On May 22, 2020, the U.S. Food and Drug Administration (FDA) announced two policies to provide temporary flexibility with respect to packaged foods formulation and labeling requirements during the COVID-19 pandemic. The...more

COVID-19 Update: FDA Issues Guidance for Food and Agriculture Sector Businesses on the Use of Masks and What to Do if a Worker is...

This post summarizes two recent documents the U.S. Food and Drug Administration (FDA) issued for the Food and Agriculture Sector in response to the COVID-19 outbreak. The first, “Use of Respirators, Facemasks, and Cloth Face...more

Chipotle Mexican Grill Enters into Deferred Prosecution Agreement to Resolve Charges Related to Foodborne Illness Outbreaks

On April 21, 2020, Chipotle Mexican Grill, Inc. (Chipotle) and the U.S. Department of Justice (DOJ) entered into a three-year deferred prosecution agreement (DPA) in connection with norovirus and Clostridium perfringens...more

FSIS Issues Revised Compliance Guidelines for Animal Raising Claims

The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has issued a revised compliance guideline for substantiating animal raising claims on labels for meat and poultry products. This updated...more

FDA Issues Laboratory Accreditation Proposed Rule Required Under FSMA

The U.S. Food and Drug Administration (“FDA”) recently issued a proposed rule entitled “Laboratory Accreditation for Analyses of Foods” (“Proposed Rule”), which was mandated by the FDA Food Safety Modernization Act (FSMA)....more

FDA Issues Draft Guidance on Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting

FDA recently released a Draft Guidance for Industry entitled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting” (“Draft Guidance”). The Draft Guidance addresses the growing, harvesting,...more

FDA Acting Commissioner Sharpless and Deputy Commissioner Yiannas Issue Statement on Steps to Usher the U.S. into a New Era of...

U.S. Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless, M.D., and Deputy Commissioner for Food Policy and Response Frank Yiannas recently issued a public statement on steps to usher the U.S. into a new era...more

CDC Publishes Updated Report on Preliminary Foodborne Illness Trends

Last week, the Centers for Disease Control and Prevention (CDC) released a report entitled, “Preliminary Incidence and Trends of Infections with Pathogens Transmitted Commonly Through Food – Foodborne Diseases Active...more

FDA Commissioner Gottlieb and Deputy Commissioner Yiannas Issue Statement on New Steps to Strengthen FDA’s Food Safety Program for...

FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas recently issued a statement addressing new steps included in the President’s 2020 Budget proposal to advance FDA’s food safety program and expand...more

FDA Releases Strategy for the Safety of Imported Food

The U.S. Food and Drug Administration (FDA) recently released the “FDA Strategy for the Safety of Imported Food” (the Strategy), which outlines the agency’s approach to ensuring the safety of the ever-rising volume of...more

USDA and FDA Announce Joint Oversight Over Cell Cultured Products

On Friday, November 16, 2018, the U.S. Department of Agriculture (USDA) Secretary Perdue and U.S. Food and Drug Administration (FDA) Commissioner Gottlieb announced a joint regulatory framework to oversee cell cultured...more

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