Elizabeth Fawell at Hogan Lovells

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11/7/2022 / Draft Guidance , FDA Warning Letters , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply ,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

Maine revises draft regulations for PFAS reporting law; triggers reporting for food packaging

The Maine Department of Environmental Protection (DEP) recently revised its proposed regulations to implement An Act to Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution (the Act) (38 Maine Revised Statutes (MRS) §...more

11/7/2022 / Comment Period , Environmental Policies , Environmental Protection Agency (EPA) , PFAS , Public Comment , Reporting Requirements , Toxic Chemicals

FDA issues draft guidance on remote regulatory assessments

DA recently released Draft Guidance on the Agency’s expanded use of remote regulatory assessments (RRAs) to review regulated establishments and / or their records.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8/4/2022 / Beverage Manufacturers , Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Food Manufacturers , Regulatory Agenda , Regulatory Oversight , Regulatory Requirements

Proposed Updates to List of Bioengineered Foods for National Bioengineered Food Disclosure Standard

The U.S. Department of Agriculture (USDA’s) Agricultural Marketing Service (AMS) has issued a proposed rule to update the List of Bioengineered Foods (List) under the National Bioengineered Food Disclosure Standard (the...more

8/3/2022 / Agricultural Marketing Act , Agricultural Sector , Bioengineering , Food Manufacturers , National Bioengineered Food Disclosure Standard (NBFDS) , Proposed Rules , USDA

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

HHS extends COVID-19 public health emergency determination

The Secretary of Health and Human Services (HHS) has renewed its determination that a public health emergency exists in light of the continued consequences of the COVID-19 pandemic. The determination has been in place since...more

4/18/2022 / Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Public Health Emergency

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

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

2/8/2022 / Final Rules , Food Labeling , Food Manufacturers , Food Safety , Public Comment , Public Schools , School Lunch Programs , USDA

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

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

7/19/2021 / Dietary Supplements , Draft Guidance , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , 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

OSHA COVID-19 Emergency Temporary Standard placed on “hold”

On April 6, 2021, the U.S. Department of Labor Secretary Marty Walsh placed a “hold” on the implementation of a potential U.S. Occupational Safety and Health (OSHA) COVID-19 Emergency Temporary Standard (ETS), which would set...more

4/8/2021 / Coronavirus/COVID-19 , Emergency Management Plans , Employer Liability Issues , Enforcement Guidance , Infectious Diseases , OSHA , Public Health , Safety Inspections , Workplace Safety

HHS postpones final SUNSET rule for one year pending judicial review

On 19 March 2021, the U.S. Department of Health and Human Services (the Department or HHS) postponed for one year the effective date of the Final Rule entitled “Securing Updated and Necessary Statutory Evaluations Timely...more

3/25/2021 / Department of Health and Human Services (HHS) , Final Rules , Healthcare Reform , Impact Assessments , Regulatory Requirements , Sunset Provisions

OSHA issues National Emphasis Program and Enforcement Response Plan targeting certain industries

As employers are revising their return to work protocols in light of increased vaccination efforts and the prospect of increased on-site work, the federal government has been busy implementing additional COVID-19 safety...more

3/19/2021 / Coronavirus/COVID-19 , Employer Liability Issues , Essential Workers , Infectious Diseases , New Guidance , Occupational Exposure , OSHA , Safety Inspections , Workplace Hazards , Workplace Safety

OSHA issues National Emphasis Program and Enforcement Response Plan, targeting certain industries for inspections