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FDA Releases Revised Appendix 1 and Introduction to Hazard Analysis and Preventive Controls Draft Guidance

The U.S. Food and Drug Administration (FDA) recently released an update of its multi-chapter draft guidance, “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft...more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

OMB releases Fall 2023 Unified Agenda of Regulatory Actions

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

FDA releases draft guidance on food allergen programs under the Preventive Controls rule

The U.S. Food and Drug Administration (FDA) recently issued a new food allergen-focused chapter of its Hazard Analysis and Risk-Based Preventive Controls for Human Food draft guidance. The new chapter addresses allergen...more

FDA releases Draft Compliance Policy Guide for Major Food Allergen Labeling and Cross-contact

On May 16, 2023, the U.S. Food and Drug Administration (FDA) released a draft Compliance Policy Guide (CPG) for FDA staff regarding major food allergen labeling and cross-contact. The draft CPG would replace the existing...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 to test front of pack nutrition labeling schemes through consumer research

The U.S. Food and Drug Administration (FDA) continues to explore the development of a standardized front of package (FOP) nutrition labeling scheme by conducting consumer research....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

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

Two recent developments regarding FDA inspection-related activities

The United States Food and Drug Administration (FDA) recently announced two developments on inspection-related activities providing insight into FDA’s perspective on the legal obligations that apply to food facilities, and...more

Recent developments point to renewed interest in the organizational structure of Foods Programs at FDA

The last few weeks have seen renewed interest in the organizational structure of FDA’s Foods Programs. Two recent actions are particularly notable. First, the Food Safety Administration Act is bicameral legislation introduced...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

USDA issues final rule on sodium, whole grains, and fluid milk in school meals

USDA recently issued a final rule establishing transitional nutrition standards for sodium, whole grains, and fluid milk in school meals. The new standards will take effect for the 2022-2023 and 2023-2024 school year. USDA...more

With the U.S. PFAS “Phase-out” clock ticking, what every food company should know

As regulatory bodies increase their scrutiny of per- and polyfluroalkyl substances (PFAS), food companies should work closely with their suppliers and prepare for the compliance transition....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

FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future Operations

The Food and Drug Administration (FDA or the agency) recently released a report entitled Resiliency Roadmap for FDA Inspectional Oversight (Report) recapping the inspectional activities across all parts of the agency during...more

FDA releases investigation report and plans additional steps to address safety of leafy greens

The U.S. Food and Drug Administration (FDA) has issued a report on its recent investigation into a Fall 2020 outbreak associated with leafy greens and announced its next steps to address the safety of leafy greens. ...more

New EU regulation defines “Food Safety Culture”

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

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

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