Elizabeth Fawell on Food Supply

FDA Releases Revised Appendix 1 and Introduction to Hazard Analysis and Preventive Controls Draft Guidance

The U.S. Food and Drug Administration (FDA) recently released an update of its multi-chapter draft guidance, “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry” (PCHF Draft...more

3/19/2024 / Draft Guidance , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply

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

1/29/2024 / Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Safety , Food Supply , FSMA

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

12/15/2023 / Food and Drug Administration (FDA) , Food Safety , Food Safety and Inspection Service (FSIS) , Food Supply , OMB , Regulatory Agenda , USDA

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

4/5/2023 / Agribusiness , Environmental Protection Agency (EPA) , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Safety and Inspection Service (FSIS) , Food Supply , USDA

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

1/24/2023 / Cannabidiol (CBD) oil , Cannabis Products , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Safety , Food Supply , FSMA , PFAS , Sustainability

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

11/30/2022 / Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , FSMA , Supply Chain

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

11/7/2022 / Draft Guidance , FDA Warning Letters , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , FSMA , Inspections

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

7/29/2022 / Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply

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

5/6/2022 / Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Foreign Suppliers , FSVP , Importers , Imports

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

4/6/2022 / Dietary Supplements , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Safety , Food Supply , PFAS , Regulatory Oversight

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

3/16/2022 / Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , FSMA , Regulatory Oversight , Suppliers , Supply Chain , Verification Requirements

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

1/6/2022 / Biden Administration , CERCLA , Environmental Protection Agency (EPA) , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Safety and Inspection Service (FSIS) , Food Supply , PFAS , Popular , Product Packaging , Toxic Chemicals , USDA

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

12/10/2021 / Accreditation , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , FSMA , Laboratories

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

12/9/2021 / Baby Products , Children's Products , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Public Meetings , Regulatory Agenda

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

11/16/2021 / B2C , E-Commerce , Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Safety , Food Supply , FSMA , Public Comment , Regulatory Oversight , Regulatory Requirements

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

7/19/2021 / Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Foreign Suppliers , FSMA , Imports , Regulatory Oversight

Mounting pressure at both federal and state levels to expand PFAS oversight in food packaging

California and Vermont have recently joined a growing list of states that have passed legislation banning the use of per- and polyfluoroalkyl substances (PFAS) in food packaging. Relatedly, a group of environmental, consumer,...more

6/17/2021 / Food and Drug Administration (FDA) , Food Manufacturers , Food Supply , Hazardous Substances , PFAS , Product Packaging , Proposed Regulation , Public Health , Regulatory Agenda , Toxic Chemicals , Toxic Exposure

USDA to invest US$4 billion to strengthen food systems and improve supply chains

The U.S. Department of Agriculture (USDA or the department) recently announced plans to invest more than US$4 billion to strengthen critical supply chains under President Biden’s “Build Back Better” initiative....more

6/11/2021 / Agribusiness , Biden Administration , Critical Infrastructure Sectors , Federal Funding , Food & Drug Regulations , Food Supply , Regulatory Oversight , Supply Chain , USDA

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

5/18/2021 / Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , FSMA , Inspections , Regulatory Oversight

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

4/14/2021 / Agribusiness , E-Coli , Farms , Food and Drug Administration (FDA) , Food Contamination , Food Safety , Food Supply , Plant Based Products , Regulatory Agenda , Regulatory Oversight

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

3/17/2021 / EU , Food Contamination , Food Manufacturers , Food Safety , Food Supply , Public Health , Regulatory Oversight , Regulatory Reform , Regulatory Requirements , Retail Market , Rulemaking Process

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

3/9/2021 / Celiac Disease , Food Allergies , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Gluten-Free , Recordkeeping Requirements , Regulatory Reform , Regulatory Requirements

Final Guidance: Publishing Retail Consignees Lists to Effectuate Certain Human and Animal Food Recalls

The U.S. Food and Drug Administration (FDA or the agency) has issued a final Guidance on the Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls (Guidance)....more

12/2/2020 / Animal Food , Food and Drug Administration (FDA) , Food Manufacturers , Food Recalls , Food Safety , Food Supply , FSMA , New Guidance , Retail Market

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

10/30/2020 / Federal Pilot Programs , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , FSMA , FSVP , Regulatory Oversight , Regulatory Standards , Supply Chain , Third-Party Risk

FDA issues first injunction under Produce Safety Rule

For the first time, FDA entered into a consent decree against a firm or grower for violations of the Produce Safety Rule. For the first time, the U.S. Food and Drug Administration (FDA) has entered into consent decree of...more

9/18/2020 / CGMP , Farms , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Food Safety , Food Supply , Permanent Injunctions , Produce Safety Rule , Regulatory Requirements , Risk Mitigation , Supply Chain

Elizabeth Fawell

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