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
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
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
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
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
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
The U.S. Food and Drug Administration (FDA) recently provided an update regarding its plans for conducting routine surveillance inspections of domestic and foreign facilities during the COVID-19 pandemic. FDA announced in...more
On May 1, 2020, Blue Bell Creameries L.P. (Blue Bell) and the U.S. Department of Justice (DOJ) entered into two separate agreements related to the 2015 listeriosis outbreak linked to Blue Bell ice cream. This memorandum...more
This post summarizes the U.S. Food and Drug Administration (FDA) Compliance Program Guidance Manual (CPGM) for food facilities subject to preventive controls and sanitary human food operation requirements. As an overview,...more
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
2/20/2020
/ Corrective Actions ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
FSMA ,
Public Health ,
Recordkeeping Requirements ,
Regulatory Oversight ,
Regulatory Requirements ,
Rulemaking Process ,
Verification Requirements
On November 6, 2019, the Food and Drug Administration (FDA) announced in a Constituent Update that it will continue to exercise enforcement discretion with respect to certain supply-chain program requirements applicable to...more
11/18/2019
/ Enforcement Guidance ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
FSMA ,
Hazardous Substances ,
Public Health ,
Regulatory Oversight ,
Risk Management ,
Suppliers ,
Supply Chain ,
Verification Requirements
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
11/14/2019
/ Accreditation ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
FSMA ,
FSVP ,
Imports ,
Laboratory Developed Tests ,
Proposed Rules ,
Public Health ,
Regulatory Oversight ,
Regulatory Requirements ,
Rulemaking Process ,
Test Guidelines
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
10/25/2019
/ Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
FSMA ,
Health and Safety ,
Innovative Technology ,
Public Health ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management
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
10/11/2019
/ CGMP ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Recalls ,
Food Safety ,
Food Supply ,
FSMA ,
FSVP ,
Regulatory Oversight ,
Regulatory Requirements
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
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
8/27/2019
/ Accreditation ,
Clinical Laboratory Testing ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Foreign Suppliers ,
FSMA ,
Regulatory Oversight ,
Regulatory Requirements
The U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major FDA Food Safety Modernization Act...more
8/16/2019
/ Enforcement Actions ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Safety ,
Foreign Suppliers ,
FSMA ,
FSVP ,
Imports ,
Public Health ,
Regulatory Violations ,
Salmonella ,
Supply Chain ,
Verification Requirements ,
Warning Letters
The U.S. Food and Drug Administration (FDA) reached a settlement with the two consumer groups that sued FDA in October 2018 to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization...more
FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas recently issued a statement addressing new steps included in the President’s 2020 Budget proposal to advance FDA’s food safety program and expand...more
3/29/2019
/ Agribusiness ,
Biotechnology ,
Cooperative Agreements ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
FSMA ,
GMO ,
Imports ,
Public Health ,
Regulatory Standards ,
Safety Inspections ,
Safety Precautions
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
The Food and Drug Administration (FDA) recently issued final Guidance regarding its mandatory recall authority, which was granted to FDA by the FDA Food Safety Modernization Act (FSMA). Together with the release of this...more
11/12/2018
/ Agribusiness ,
Animal Food ,
Baby Products ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Recalls ,
Food Safety ,
FSMA ,
Regulatory Standards ,
Retail Market ,
Safety Precautions