Elizabeth Fawell on Regulatory Agenda

Trump Administration Issues Two Executive Orders Affecting Agency Regulations and Workforce

President Donald Trump recently issued two executive orders furthering his policy to reduce the number of federal regulations and the size of the federal workforce, both of which will affect the food and agriculture...more

2/17/2025 / Executive Orders , Food and Drug Administration (FDA) , Government Agencies , OMB , Regulatory Agenda , Regulatory Reform , Trump Administration , USDA

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

FDA issues draft guidance on remote regulatory assessments

DA recently released Draft Guidance on the Agency’s expanded use of remote regulatory assessments (RRAs) to review regulated establishments and / or their records. FDA outlines how it intends this tool to be incorporated...more

8/4/2022 / Beverage Manufacturers , Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Food Manufacturers , Regulatory Agenda , Regulatory Oversight , Regulatory Requirements

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

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

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

FDA provides additional time to submit DUNS number as part of the 2020 facility registration renewal

The U.S. Food and Drug Administration (FDA) released a guidance document on 1 December 2020 announcing an enforcement policy related to submission of a facility’s Unique Facility Identifier (UFI) as part of the 2020 biennial...more

12/3/2020 / Food and Drug Administration (FDA) , Food Manufacturers , Registration Requirement , Regulatory Agenda , Renewal Options , Unique Transaction Identifiers

HHS proposes to sunset regulations Issued by FDA, CMS, and other regulatory agencies

Our team wanted to highlight a proposed rule issued by the U.S. Department of Health and Human Services (HHS) on 4 November 2020 - with only a 30-day comment period - that would establish sunset (expiration) dates for...more

11/19/2020 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Regulatory Agenda , Regulatory Requirements , Rulemaking Process , Sunset Provisions

FDA Provides Update on Forthcoming New Era of Smarter Food Safety Blueprint

The U.S. Food and Drug Administration (FDA) recently provided an update from FDA Commissioner Stephen Hahn M.D. and Deputy Commissioner for Food Policy and Response Frank Yiannas on the forthcoming New Era of Smarter Food...more

6/4/2020 / E-Commerce , Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Safety , Food Supply , Regulatory Agenda , Regulatory Oversight , Regulatory Requirements , Supply Chain

FSMA Implementation: FDA Launches Food Defense Plan Builder 2.0

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

9/20/2019 / Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Safety , Food Supply , FSMA , Hazardous Substances , Public Health , Regulatory Agenda , Regulatory Requirements

FDA Announces Public Meeting on Modernizing Food Standards of Identity

The U.S. Food and Drug Administration (FDA) recently announced it will be holding a full-day public meeting on September 27, 2019, to address “Horizontal Approaches to Food Standards of Identity Modernization.” As explained...more

9/4/2019 / Food and Drug Administration (FDA) , Food Labeling , Food Supply , Public Meetings , Regulatory Agenda , Regulatory Oversight , Regulatory Standards

FDA Announces Produce Safety Rule Enforcement Discretion Policy for Almonds, Pulse Crops, Wine Grapes, and Hops under FSMA

The U.S. Food and Drug Administration (FDA) has issued Guidance detailing its intent to exercise enforcement discretion for the requirements of the Produce Safety rule as they apply to entities growing, harvesting, packing,...more

4/4/2019 / Agricultural Land , Commodities , Enforcement Authority , Farms , Food and Drug Administration (FDA) , Food Safety , FSMA , New Guidance , Regulatory Agenda , Rulemaking Process

Produce Safety Rule Inspections Will Begin Soon

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently issued a statement affirming that Produce Safety Rule inspections will begin this spring. Last year FDA chose to delay routine inspections to allow...more

2/14/2019 / Agribusiness , Farms , Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Safety , Inspection Rights , Produce Safety Rule , Regulatory Agenda , Regulatory Oversight , Regulatory Standards , Safety Precautions

Elizabeth Fawell

Hogan Lovells

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