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FDA Issues Fiscal Year 2025 Priority Deliverables for the Human Foods Program

The Food and Drug Administration’s (FDA’s) newly-reorganized Human Foods Program (HFP) recently released a document explaining its Fiscal Year (FY) 2025 Priority Deliverables. The Priority Deliverables reflect what FDA plans...more

FDA Releases Revised Appendix 1 and Introduction to Hazard Analysis and Preventive Controls Draft Guidance

The U.S. Food and Drug Administration (FDA) recently released an update of its multi-chapter draft guidance, “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft...more

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

OMB releases Spring 2023 Unified Agenda of Regulatory Actions

The White House Office of Management and Budget (OMB) recently released the Spring 2023 Unified Agenda of Regulatory and Deregulatory Actions, which outlines the rulemaking actions currently under development by each federal...more

A Seat at the Table | Hogan Lovells Monthly Food Digest - March 2023

Welcome to A Seat at the Table, Hogan Lovells Monthly Food Digest, where we share our thoughts and insights about some of the past month’s more notable developments when it comes to food regulation....more

FDA proposes redesign for Human Foods Program - US

On January 31, 2023, Commissioner Califf announced a new vision for the U.S. Food and Drug Administration (FDA)’s Human Foods Program. The Proposal calls for unifying the work currently done by the Center for Food Safety and...more

U.S. Food Law Preview - Key issues affecting the food industry in 2023

We’re a few weeks into 2023, and while some new year’s resolutions may have already fallen to the wayside, there are plenty of food law issues that will take us through 2023 and beyond. Here are key issues the Hogan Lovells...more

OMB releases Fall 2022 Unified Agenda of Regulatory Actions

The Office of Management and Budget (OMB) recently released the Fall 2022 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more

FDA releases systematic review of the scientific literature on food safety culture

Last week, the U.S. Food and Drug Administration (FDA) released a systematic review of the scientific literature on food safety culture. The review was conducted as part of FDA’s New Era of Smarter Food Safety blueprint,...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

FSMA Update: FDA issues final traceability rule for certain foods

FDA published a final rule “Requirements for Additional Traceability Records for Certain Foods” designed to improve the agency's ability to rapidly track and trace food through the supply chain. The final rule maintains the...more

OMB releases Spring 2022 Unified Agenda of Regulatory Actions

The Office of Management and Budget (OMB) recently released the Spring 2022 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more

FDA releases updated priority list of food guidance documents intended for publication in 2022

The U.S. Food and Drug Administration (FDA) recently released an updated list of priority draft and final guidance documents related to foods and dietary supplements that the agency intends to publish by the end of this year....more

FDA issues final guidance on oversight of food covered by Systems Recognition Arrangements

This week, the U.S. Food and Drug Administration (FDA) issued final guidance concerning regulatory oversight of food imported from Systems Recognition Arrangement (SRA) countries. FDA employs a Systems Recognition (SR)...more

FDA Issues Draft Guidance on Evaluating Public Health Impacts from Non-Major Food Allergens

The U.S. Food and Drug Administration (FDA) recently published draft guidance that explains the approach the agency intends to take when evaluating the public health importance of food allergens that are not one of the nine...more

FSVP entries will no longer be able to list the importer as "unknown"

The US Food and Drug Administration (FDA) has changed its policy of allowing import entries to declare the identity of the Foreign Supplier Verification Program (FSVP) importer as “unknown.” Effective July 24, 2022, food...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

FDA Extends Enforcement Discretion for Several Requirements in FSMA Regulations

FDA recently issued guidance announcing its intent to exercise enforcement discretion for several specific provisions in the agency’s regulations implementing the FDA Food Safety Modernization Act (FSMA). The guidance is...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 issues Laboratory Accreditation final rule required under FSMA

The U.S. Food and Drug Administration (FDA) recently issued a final rule regarding Laboratory Accreditation for Analyses of Foods (LAAF). This memorandum summarizes the regulation. The U.S. Food and Drug Administration...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

FDA reviews New Era of Smarter Food Safety accomplishments

The U.S. Food and Drug Administration (FDA) recently issued a review of work done over the last year in advancing its New Era of Smarter Food Safety (New Era) Blueprint, which was released in July 2020. In a corresponding FDA...more

FDA issues draft guidance on oversight of food products covered by Systems Recognition Arrangements

For the past several years, the U.S. Food and Drug Administration (FDA) has used a “Systems Recognition” approach with its foreign regulatory counterparts, through which the FDA evaluates whether its foreign counterpart...more

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