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Impact of Government Shutdown on Scope of FDA, FSIS, and CSPC Activities

On December 22, 2018, funding expired for certain agencies within the federal government, including the Food and Drug Administration (FDA), the U.S. Department of Agriculture’s (USDA’s) Food Safety Inspection Service (FSIS),...more

OMB Releases Fall 2018 Unified Agenda of Regulatory Actions

The Office of Management and Budget (OMB) recently released the Fall 2018 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more

FDA Issues Final Guidance on Mandatory Recall Authority under FSMA

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

Lawsuit Seeks to Compel FDA to Implement FSMA Traceability Provisions

Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the plaintiffs want FDA...more

Reminder: It’s Time to Renew Your FDA Food Facility Registration

As a reminder, the Food and Drug Administration (FDA) requires all registered food facilities to renew their registration biennially in each even-numbered year. The current renewal period began October 1, 2018, and runs...more

FDA Issues Draft Guidance on Publishing Retail Consignees Lists to Effectuate Certain Human and Animal Food Recalls

On September 26, 2018, the Food and Drug Administration issued a statement by FDA Commissioner Scott Gottlieb, M.D. on FDA’s commitment to disclose retailer information for certain food recalls to improve consumer safety....more

FDA Announces Pilot Program for Two-Tier Preventive Controls for Human Food Inspections under FSMA

The U.S. Food and Drug Administration (FDA) recently announced that it will engage in a pilot program to evaluate the benefits of two-tier inspections for some aspects of the Preventive Controls for Human Food (PCHF) rule...more

FSMA Implementation Update: FDA Releases New Supplier Verification Tool to Assist with FSMA Compliance and Provides Update on VQIP

The Food and Drug Administration (FDA) recently made two notable announcements regarding implementation of the FDA Food Safety Modernization Act (FSMA). First, FDA released a tool to assist companies with meeting supplier...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

FDA Publishes List of FSVP Importers Under FSMA

The Food and Drug Administration (FDA) recently posted a document on its website that lists all importers that have been identified at entry in connection with the Foreign Supplier Verification Programs (FSVP) regulation....more

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