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
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
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
This post summarizes two recent documents the U.S. Food and Drug Administration (FDA) issued for the Food and Agriculture Sector in response to the COVID-19 outbreak. The first, “Use of Respirators, Facemasks, and Cloth Face...more
5/1/2020
/ Agribusiness ,
Agricultural Workers ,
Coronavirus/COVID-19 ,
Farms ,
Food and Drug Administration (FDA) ,
Food Safety ,
Food Supply ,
Health & Safety Standard ,
OSHA ,
Personal Protective Equipment ,
Regulatory Requirements
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
This post summarizes recent actions the federal government has taken in response to the COVID-19 outbreak. First, the Department of Homeland Security’s (DHS’s) Cybersecurity & Infrastructure Security Agency (CISA) has updated...more
In our memo of March 19, we summarized federal government policy identifying the Food and Agriculture and Transportation industries as two of the nation’s 16 Critical Infrastructure Sectors. In The President’s Coronavirus...more
3/20/2020
/ Agribusiness ,
Business Closures ,
Business Interruption ,
Coronavirus/COVID-19 ,
Critical Infrastructure Sectors ,
Cybersecurity Information Sharing Act (CISA) ,
Emergency Management Plans ,
Farms ,
Food Manufacturers ,
Food Service Workers ,
Food Supply ,
Operators of Essential Services ,
Restaurant Industry
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
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) has issued two draft guidance documents intended to assist industry in complying with certain FDA Food Safety Modernization Act (FSMA) regulations regarding fresh produce. The first...more
The U.S. Food and Drug Administration (FDA) recently issued two guidance documents to assist establishments in determining whether they have an obligation to register as a food facility. The first document is the finalized...more
There have been several recent developments regarding implementation of the FDA Food Safety Modernization Act (FSMA). The below post summarizes the following topics:
- Guidance on application of the Foreign Supplier...more
3/27/2018
/ Agricultural Sector ,
Farm Animals ,
Farms ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Foreign Suppliers ,
FSMA ,
FSVP ,
Imports ,
Regulatory Oversight ,
Regulatory Standards ,
Wine & Alcohol