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FDA issues draft guidance setting action levels for lead in food intended for babies and young children

The U.S. Food and Drug Administration (FDA) issued a draft guidance for industry on Action Levels for Lead in Food Intended for Babies and Young Children (Draft Guidance).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

HHS Publishes Final SUNSET Rule With New Exemptions and Timelines

On 19 January 2021, the U.S. Department of Health and Human Services (the Department or HHS) published in the Federal Register Final Rule entitled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET).” The...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 requests information on labeling of cell-cultured seafood

The U.S. Food and Drug Administration (FDA) is requesting public comment on the labeling of seafood products made using cell culture technology. FDA’s Request for Information (RFI) entitled, “Labeling of Foods Comprised of or...more

COVID-19 Update: Agriculture Workers and Employers Guidance; Meat and Poultry Facility Assessments Toolkit; Retail Food...

The Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) recently released several guidelines for various segments of the food industry to address the COVID-19 pandemic. First, CDC issued Interim...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

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 Announces Public Meeting on Modernizing Food Standards of Identity

The U.S. Food and Drug Administration (FDA) recently announced it will be holding a full-day public meeting on September 27, 2019, to address “Horizontal Approaches to Food Standards of Identity Modernization.” As explained...more

FDA Issues Updates to Fourth Edition Seafood HACCP Guidance

The U.S. Food and Drug Administration (FDA) recently released an updated Fourth Edition of its Guidance for Industry entitled, “Fish and Fishery Products Hazards and Control Guidance, Fourth Edition – August 2019” (“the...more

National Advertising Division Issues Decision on “0 g Added Sugars” Claim for Oatmilk

Oatly, Inc. has chosen to discontinue its “no added sugars” advertising claims after the Campbell Soup Company brought a challenge before the National Advertising Division (NAD). Campbell argued that various claims found on...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

OMB Issues Memorandum Guidance on Executive Departments’ and Agencies’ Compliance with the Congressional Review Act

The Office of Management and Budget (OMB) recently issued an updated memorandum to the heads of executive departments and agencies entitled, “Guidance on Compliance with the Congressional Review Act” (2019 Memo). The 2019...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

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