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 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
On 19 January 2021, the U.S. Department of Health and Human Services (the Department or HHS) published in the Federal Register Final Rule entitled “Securing Updated and Necessary Statutory Evaluations Timely (SUNSET).” The...more
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
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
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
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
The U.S. Food and Drug Administration (FDA) announced in a recent Constituent Update that it is providing additional flexibility to food manufacturers with less than $10 million in annual food sales in complying with FDA’s...more
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
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.
...more
On September 1, 2020, the Food and Drug Administration (FDA) and Occupational Safety and Health Administration (OSHA) held a joint webinar to discuss the jointly-issued Employee Health and Food Safety Checklist for Human and...more
9/4/2020
/ Animal Food ,
CGMP ,
Coronavirus/COVID-19 ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Health and Safety ,
Infectious Diseases ,
OSHA ,
Safety Inspections ,
Social Distancing ,
Workplace Safety
The National Academies of Sciences, Engineering, and Medicine have released in draft form a report providing recommendations on how to prioritize access to a COVID-19 vaccine, once one is available.The National Academies are...more
The CDC recently released updated its guidance on the criteria for determining when a worker diagnosed with COVID-19 may return to work. The interim guidance, Discontinuation of Isolation for Persons with COVID-19 Not in...more
On July 15, 2020, the Virginia Safety and Health Codes Board passed first-in-the-nation codified emergency temporary standards (the Standards) establishing requirements for employers to control, prevent, and mitigate the...more
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
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
A recent action by the National Advertising Division (NAD), a self regulatory arm of the Better Business Bureau, addresses the level of proof necessary to support “natural” and “satiety” claims involving competing experts and...more
Dr. Stephen M. Hahn, the Commissioner of Food and Drugs for the Food and Drug Administration (FDA) issued a statement on July 10, 2020, describing the agency’s intentions and approach to resuming domestic inspections in light...more
The Centers for Disease Control and Prevention (CDC) has issued a guidance document titled Testing Strategy for COVID-19 in High-Density Critical Infrastructure Workplaces after a COVID-19 Case is Identified (the Guidance),...more
6/19/2020
/ Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Critical Infrastructure Sectors ,
Employer Liability Issues ,
Essential Workers ,
Food Service Workers ,
Occupational Exposure ,
Restaurant Industry ,
Return-to-Work Agreements ,
Virus Testing ,
Workplace Safety
The Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) recently released several guidelines for various segments of the food industry to address the COVID-19 pandemic. First, CDC issued Interim...more
6/9/2020
/ Agricultural Workers ,
Centers for Disease Control and Prevention (CDC) ,
Department of Labor (DOL) ,
Food and Drug Administration (FDA) ,
Meat Processing Plants ,
Personal Protective Equipment ,
Poultry ,
Re-Opening Guidelines ,
Return-to-Work Agreements ,
Screening Procedures ,
Workplace Safety
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
On May 27, 2020, the U.S. Food and Drug Administration (FDA) issued new guidance for human food establishments on voluntarily reporting to FDA temporary closures or significantly reduced production due to the COVID-19 public...more
5/28/2020
/ Animal Food ,
Business Closures ,
Coronavirus/COVID-19 ,
Farms ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Supply ,
Manufacturing Facilities ,
Restaurant Industry ,
Retailers ,
Self-Reporting
On May 22, 2020, the U.S. Food and Drug Administration (FDA) announced two policies to provide temporary flexibility with respect to packaged foods formulation and labeling requirements during the COVID-19 pandemic. The...more
On May 19, President Trump issued an Executive Order (EO) authorizing federal agencies to provide regulatory relief to support the economic response to the COVID-19 outbreak. Specifically, the EO allows agencies to rescind,...more
The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) recently issued a Memorandum of Understanding (MOU) regarding the potential use of the Defense Production Act (DPA) with regard to...more