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Food Safety Modernization Act › Regulatory Requirements

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... more +
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 -
BCLP

Joining the Dots - Will the UK’s New Critical Third Party Rules Truly Move the Dial for Financial Institutions?

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The announcement in 2021 of the intention to implement new rules directly targeting the types of tech service provider relied on by most financial institutions may be a necessary corrective given the heavy market...more

White & Case LLP

FCA DP23/4: UK Regulation of Stablecoins

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On 6 November 2023, the UK Financial Conduct Authority ("FCA") set out proposals for its regulation of fiat-backed stablecoins ("DP 23/4"). DP 23/4 invites stakeholders to provide feedback by 6 February 2024....more

Goodwin

Doing Fintech Business in the UK: Regulatory Q&A for US and Other Non-UK Businesses

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With more fintech’s looking to expand their businesses internationally, it can be daunting to navigate varying regulations across borders. This article focuses on regulations in the United Kingdom....more

Hogan Lovells

FDA Holds Summit on E-Commerce and Food Safety

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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

Faegre Drinker Biddle & Reath LLP

FDA Announces Upcoming Webinar Series on ‘Food Safety Culture’

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The U.S. Food and Drug Administration (FDA) announced this week that it is partnering with Stop Foodborne Illness to co-host a webinar series entitled “Collaborating on Culture in the New Era of Smarter Food Safety.” The...more

Latham & Watkins LLP

HM Treasury Consults on Post-EU Financial Services Regulatory Framework

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The UK government signals a diversion from the onshored regime towards a more flexible financial services regulatory framework. HM Treasury has published a consultation paper marking the start of Phase II of its financial...more

Hogan Lovells

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

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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

Hogan Lovells

FDA Releases Blueprint for the New Era of Smarter Food Safety

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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

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l February 2020 #3

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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

Hogan Lovells

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

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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

Hogan Lovells

FDA Issues Laboratory Accreditation Proposed Rule Required Under FSMA

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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

Hogan Lovells

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

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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

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l October 2019 #2

Shook, Hardy & Bacon L.L.P. on

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

Hogan Lovells

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

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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

Hogan Lovells

FSMA Implementation: FDA Launches Food Defense Plan Builder 2.0

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The Food and Drug Administration (FDA) recently announced the launch of an updated version of the Food Defense Plan Builder Version 2.0 (FDPB) to help companies meet the requirements of the final rule “Mitigation Strategies...more

Hogan Lovells

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

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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

Hogan Lovells

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

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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

Hogan Lovells

FDA Announces Reinspection and VQIP Fees for Fiscal Year 2020

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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

Hogan Lovells

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

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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

Hogan Lovells

FDA Releases Strategy for the Safety of Imported Food

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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

Hogan Lovells

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

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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

Hogan Lovells

UK: PRA proposals to Increase the Part VII Transfer Transaction Fee

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On 13 February 2019, the PRA published Policy Statement (PS) 3/19, which sets out the PRA’s final policy on updating periodic fees and transaction fees for insurers. Notably PS3/19 implements a substantial increase in Part...more

Hogan Lovells

Intentional Adulteration Rule under FSMA Training Requirements and Course Availability

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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

Hogan Lovells

OMB Releases Fall 2018 Unified Agenda of Regulatory Actions

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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

Hogan Lovells

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

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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

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