News & Analysis as of August 24, 2025

Regulatory Oversight

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The Food Safety Modernization Act is a United States federal statute enacted in 2011 to ensure the safety of the U.S. food supply and prevent food contamination. The main features of the FSMA include expanding the FDA's inspection of food processing facilities and imported food products, requiring all food processors, manufactures and handlers to register with HHS and maintain food safety records, and shifting the government's focus away from responding to food contamination and towards preventing food contamination. less -

UK FCA issues updated Enforcement Information Guide

A&O Shearman on 8/18/2025

The UK Financial Conduct Authority published an updated Enforcement Information Guide, which reflects changes in the FCA Handbook to its revised Enforcement Guide (ENFG) and the Decision Procedure and Penalties manual (DEPP)....more

HMT policy statement on the Appointed Representatives Regime: addressing key gaps and proposals for

A&O Shearman on 8/15/2025

The appointed representatives regime has been around longer than many of us might realise, having been introduced in 1986, and so predating our beloved Financial Services and Markets Act 2000 (FSMA) by some years. No doubt,...more

FDA Human Foods Priority Deliverables for FY 2025

Perkins Coie on 11/5/2024

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

FDA Holds Summit on E-Commerce and Food Safety

Hogan Lovells on 11/16/2021

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

Hogan Lovells on 7/17/2020

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

FDA Releases Blueprint for the New Era of Smarter Food Safety

Hogan Lovells on 7/16/2020

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

Food & Beverage Litigation Update l February 2020 #3

Shook, Hardy & Bacon L.L.P. on 3/2/2020

LEGISLATION, REGULATIONS & STANDARDS - FDA Releases Guidance on Intentional Adulteration - The U.S. Food and Drug Administration (FDA) has released the third and final installment of its draft guidance on intentional...more

FDA Releases Third and Final Installment of Draft Guidance for FSMA Intentional Adulteration Rule

Hogan Lovells on 2/20/2020

The U.S. Food and Drug Administration (FDA) has released the third and final installment of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (“IA rule”)....more

FDA Issues Laboratory Accreditation Proposed Rule Required Under FSMA

Hogan Lovells on 11/14/2019

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 Holds Public Meeting on “A New Era of Smarter Food Safety” to Further FSMA Implementation

Hogan Lovells on 10/25/2019

On October 21, 2019, the U.S. Food and Drug Administration (FDA) held a public meeting to engage stakeholders on the agency’s initiative, “A New Era of Smarter Food Safety,” to build on the advances that have been and are...more

Food & Beverage Litigation Update l October 2019 #2

Shook, Hardy & Bacon L.L.P. on 10/14/2019

LEGISLATION, REGULATIONS & STANDARDS - FDA Warns Company Selling CBD Oil - The U.S. Food and Drug Administration has published a warning letter it sent in September 2019 to a company selling cannabidiol (CBD) oil as a...more

FSMA Update: FDA Launches “FDA-TRACK: Food Safety Dashboard” to Track FSMA Progress

Hogan Lovells on 10/11/2019

The U.S. Food and Drug Administration (FDA) has launched two new online dashboards that track key metrics reflecting the impacts from the FDA Food Safety Modernization Act (FSMA) regulations. The dashboards are part of...more

FDA Announces Public Meeting and Docket for Comments on “A New Era of Smarter Food Safety” to Facilitate FSMA Implementation

Hogan Lovells on 9/19/2019

The Food and Drug Administration (FDA) recently announced it will hold a full-day public meeting on October 21, 2019, regarding “A New Era of Smarter Food Safety.” As explained in more detail in this memorandum, as part of...more

Lawsuit Seeks to Compel FDA to Implement FSMA’s Laboratory Accreditation Provisions

Hogan Lovells on 8/27/2019

Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the laboratory accreditation provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the...more

FDA Announces Reinspection and VQIP Fees for Fiscal Year 2020

Hogan Lovells on 7/25/2019

The Food and Drug Administration (FDA) recently announced its Fiscal Year (FY) 2020 fee rates, which in particular cover the fees for facility reinspections and participation in the Voluntary Qualified Importer Program...more

FDA Finalizes Guidance on How to Determine Whether a Company Meets the “Small Business” Definition under the FSMA Preventive...

Hogan Lovells on 7/22/2019

The U.S. Food and Drug Administration (FDA) recently finalized its “Guidance for Industry: Determining the Number of Employees for Purposes of the ‘Small Business’ Definition in Parts 117 and 507 (CGMP and Preventive...more

FDA Releases Strategy for the Safety of Imported Food

Hogan Lovells on 3/15/2019

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

FDA Releases Second Installment of Draft Guidance for FSMA Intentional Adulteration Rule

Hogan Lovells on 3/15/2019

The U.S. Food and Drug Administration (FDA) has released the second of three installments of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule....more

Intentional Adulteration Rule under FSMA Training Requirements and Course Availability

Hogan Lovells on 12/3/2018

This week, the Food Safety Preventative Controls Alliance (FSPCA) released the online course “Conducting Vulnerability Assessments Using Key Activity Types” (KAT Course). This course satisfies the training requirement in the...more

OMB Releases Fall 2018 Unified Agenda of Regulatory Actions

Hogan Lovells on 11/14/2018

The Office of Management and Budget (OMB) recently released the Fall 2018 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more

FDA Issues Draft Guidance on FSMA Food Safety Requirements for Produce Growers and Processors

Hogan Lovells on 10/26/2018

The Food and Drug Administration (FDA) has issued two draft guidance documents intended to assist industry in complying with certain FDA Food Safety Modernization Act (FSMA) regulations regarding fresh produce. The first...more

FDA Releases Draft Guidance for FSMA Intentional Adulteration Rule

Hogan Lovells on 6/26/2018

The U.S. Food and Drug Administration (FDA) has released the first of three installments of its long awaited Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration...more

Corporate Insurance Newsletter – May 2018

Hogan Lovells on 6/12/2018

The Hogan Lovells’ Corporate Insurance Newsletter for May has been published. This provides a round-up of UK, EU and international regulatory developments relevant to UK based insurance market participants. In this issue,...more

FSMA Implementation Update: FDA Releases New Supplier Verification Tool to Assist with FSMA Compliance and Provides Update on VQIP

Hogan Lovells on 6/4/2018

The Food and Drug Administration (FDA) recently made two notable announcements regarding implementation of the FDA Food Safety Modernization Act (FSMA). First, FDA released a tool to assist companies with meeting supplier...more

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