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
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
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
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
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
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
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 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
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
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
The California Department of Public Health (CDPH) recently issued a COVID-19 industry guidance intended for facilities that process or pack meat, dairy, or produce to support a safe and clean environment for workers. In...more
5/16/2020
/ Agribusiness ,
Coronavirus/COVID-19 ,
Employee Training ,
Farm Animals ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Meat Processing Plants ,
OSHA ,
Public Health ,
Social Distancing ,
Workplace Decontamination ,
Workplace Safety
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
Late Tuesday, U.S. Department of Agriculture (USDA) Secretary Sonny Perdue sent letters to state governors and meat and poultry processing company leaders setting forth USDA’s expectations for continued operations during the...more
5/8/2020
/ Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Department of Agriculture ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Meat Processing Plants ,
OSHA ,
Secretary of Agriculture ,
USDA ,
Workplace Safety
This week, President Donald Trump issued an Executive Order invoking the Defense Production Act (DPA) to protect the meat and poultry production supply chain. In the Executive Order, entitled, Delegating Authority Under The...more
The Centers for Disease Control and Prevention (CDC) and Occupational Safety and Health Administration (OSHA) have issued interim guidance on COVID-19 considerations for meat and poultry processing workers and employers. This...more
5/1/2020
/ Centers for Disease Control and Prevention (CDC) ,
Coronavirus/COVID-19 ,
Farm Animals ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Infectious Diseases ,
Meat Processing Plants ,
OSHA ,
Personal Protective Equipment ,
Poultry ,
Public Health ,
Workplace Safety
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
On April 7, the World Health Organization (WHO) and Food and Agriculture Organization of the United Nations (FAO) released interim guidance regarding food safety for food businesses in response to the COVID-19 pandemic. The...more
The FDA issued a new guidance document that provides retailers with some flexibility from labeling requirements for shell eggs in order to facilitate the distribution of eggs during the COVID-19 pandemic. This guidance...more
The U.S. Food and Drug Administration (FDA) announced yesterday two policies to provide flexibility with respect to nutrition labeling requirements during the COVID-19 pandemic. First, the agency committed to work...more
As the novel coronavirus (COVID-19) crisis continues to present new questions and challenges, the U.S. Food and Drug Administration (FDA) continues to update its website to provide additional information and guidance to the...more