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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

FDA issues first injunction under Produce Safety Rule

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

COVID-19 Update: FDA Issues Guidance on Voluntary Reporting of Temporary Closures or Significantly Reduced Production by a Human...

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

COVID-19 Update: FDA Issues Guidance for Food and Agriculture Sector Businesses on the Use of Masks and What to Do if a Worker is...

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

FDA Issues Temporary Policy Regarding Labeling of Shell Eggs Sold by Retail Establishments

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

COVID-19 Update: CISA Updates Critical Infrastructure Workers Guidance and FDA Issues Additional Guidance for Industry and the...

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

COVID-19 Update: Supplemental Update on Essential Critical Infrastructure Workers

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

FDA Announces Produce Safety Rule Enforcement Discretion Policy for Almonds, Pulse Crops, Wine Grapes, and Hops under FSMA

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

Produce Safety Rule Inspections Will Begin Soon

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

FDA Issues Draft Guidance on FSMA Food Safety Requirements for Produce Growers and Processors

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

FDA Issues Update to Facility Registration Guidance and New Supplemental Draft Guidance

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

FSMA Implementation Update (March 2018)

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

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