Maile Gradison on FSMA

FDA Issues Laboratory Accreditation Proposed Rule Required Under FSMA

The U.S. Food and Drug Administration (“FDA”) recently issued a proposed rule entitled “Laboratory Accreditation for Analyses of Foods” (“Proposed Rule”), which was mandated by the FDA Food Safety Modernization Act (FSMA)....more

11/14/2019 / Accreditation , Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Safety , Food Supply , FSMA , FSVP , Imports , Laboratory Developed Tests , Proposed Rules , Public Health , Regulatory Oversight , Regulatory Requirements , Rulemaking Process , Test Guidelines

FDA Holds Public Meeting on “A New Era of Smarter Food Safety” to Further FSMA Implementation

On October 21, 2019, the U.S. Food and Drug Administration (FDA) held a public meeting to engage stakeholders on the agency’s initiative, “A New Era of Smarter Food Safety,” to build on the advances that have been and are...more

10/25/2019 / Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Safety , Food Supply , FSMA , Health and Safety , Innovative Technology , Public Health , Regulatory Oversight , Regulatory Requirements , Risk Management

FSMA Update: FDA Launches “FDA-TRACK: Food Safety Dashboard” to Track FSMA Progress

The U.S. Food and Drug Administration (FDA) has launched two new online dashboards that track key metrics reflecting the impacts from the FDA Food Safety Modernization Act (FSMA) regulations. The dashboards are part of...more

10/11/2019 / CGMP , Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Recalls , Food Safety , Food Supply , FSMA , FSVP , Regulatory Oversight , Regulatory Requirements

FSMA Update: FDA Publishes List of Required Foreign Supplier Verification Program Records

The U.S. Food and Drug Administration (FDA) recently published a list of the records that importers are required to develop and maintain under the Foreign Supplier Verification Program (FSVP) regulation....more

10/9/2019 / Food and Drug Administration (FDA) , Food Safety , Food Supply , Foreign Suppliers , FSMA , FSVP , Imports , Regulatory Oversight , Regulatory Standards

FSMA Implementation: FDA Launches Food Defense Plan Builder 2.0

The Food and Drug Administration (FDA) recently announced the launch of an updated version of the Food Defense Plan Builder Version 2.0 (FDPB) to help companies meet the requirements of the final rule “Mitigation Strategies...more

9/20/2019 / Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Safety , Food Supply , FSMA , Hazardous Substances , Public Health , Regulatory Agenda , Regulatory Requirements

FDA Announces Public Meeting and Docket for Comments on “A New Era of Smarter Food Safety” to Facilitate FSMA Implementation

The Food and Drug Administration (FDA) recently announced it will hold a full-day public meeting on October 21, 2019, regarding “A New Era of Smarter Food Safety.” As explained in more detail in this memorandum, as part of...more

9/19/2019 / Artificial Intelligence , Blockchain , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , FSMA , Innovative Technology , Regulatory Oversight , Regulatory Requirements

Lawsuit Seeks to Compel FDA to Implement FSMA’s Laboratory Accreditation Provisions

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

8/27/2019 / Accreditation , Clinical Laboratory Testing , Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Safety , Food Supply , Foreign Suppliers , FSMA , Regulatory Oversight , Regulatory Requirements

FDA Issues First Warning Letter for Foreign Supplier Verification Program Violations under FSMA

The U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major FDA Food Safety Modernization Act...more

8/16/2019 / Enforcement Actions , Food & Drug Regulations , Food and Drug Administration (FDA) , Food Contamination , Food Safety , Foreign Suppliers , FSMA , FSVP , Imports , Public Health , Regulatory Violations , Salmonella , Supply Chain , Verification Requirements , Warning Letters

FDA Announces Reinspection and VQIP Fees for Fiscal Year 2020

The Food and Drug Administration (FDA) recently announced its Fiscal Year (FY) 2020 fee rates, which in particular cover the fees for facility reinspections and participation in the Voluntary Qualified Importer Program...more

7/25/2019 / Fees , Food and Drug Administration (FDA) , Food Safety , FSMA , Imports , Inspections , Regulatory Oversight , Regulatory Requirements

FDA Finalizes Guidance on How to Determine Whether a Company Meets the “Small Business” Definition under the FSMA Preventive...

The U.S. Food and Drug Administration (FDA) recently finalized its “Guidance for Industry: Determining the Number of Employees for Purposes of the ‘Small Business’ Definition in Parts 117 and 507 (CGMP and Preventive...more

7/22/2019 / Animal Food , Exemptions , Final Guidance , Food and Drug Administration (FDA) , Food Supply , FSMA , Regulatory Oversight , Regulatory Requirements , Small Business , Statistical Analysis

Settlement Reached in Lawsuit to Compel FDA to Implement FSMA Traceability Provisions

The U.S. Food and Drug Administration (FDA) reached a settlement with the two consumer groups that sued FDA in October 2018 to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization...more

6/13/2019 / Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Safety , FSMA , Regulatory Standards , Rulemaking Process

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

4/4/2019 / Agricultural Land , Commodities , Enforcement Authority , Farms , Food and Drug Administration (FDA) , Food Safety , FSMA , New Guidance , Regulatory Agenda , Rulemaking Process

FDA Commissioner Gottlieb and Deputy Commissioner Yiannas Issue Statement on New Steps to Strengthen FDA’s Food Safety Program for...

FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas recently issued a statement addressing new steps included in the President’s 2020 Budget proposal to advance FDA’s food safety program and expand...more

3/29/2019 / Agribusiness , Biotechnology , Cooperative Agreements , Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Safety , FSMA , GMO , Imports , Public Health , Regulatory Standards , Safety Inspections , Safety Precautions

FDA Releases Strategy for the Safety of Imported Food

The U.S. Food and Drug Administration (FDA) recently released the “FDA Strategy for the Safety of Imported Food” (the Strategy), which outlines the agency’s approach to ensuring the safety of the ever-rising volume of...more

3/15/2019 / Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , FSMA , Imports , Regulatory Oversight , Regulatory Requirements , Supply Chain

FDA Releases Second Installment of Draft Guidance for FSMA Intentional Adulteration Rule

The U.S. Food and Drug Administration (FDA) has released the second of three installments of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule....more

3/15/2019 / Agribusiness , Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Food Safety , Food Supply , FSMA , Health & Safety Standard , Regulatory Oversight , Regulatory Requirements , Vulnerability Assessments

Intentional Adulteration Rule under FSMA Training Requirements and Course Availability

This week, the Food Safety Preventative Controls Alliance (FSPCA) released the online course “Conducting Vulnerability Assessments Using Key Activity Types” (KAT Course). This course satisfies the training requirement in the...more

12/3/2018 / Food Safety , Food Supply , FSMA , Regulatory Oversight , Regulatory Requirements , Risk Mitigation , Training , Vulnerability Assessments

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

11/12/2018 / Agribusiness , Animal Food , Baby Products , Final Guidance , Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Recalls , Food Safety , FSMA , Regulatory Standards , Retail Market , Safety Precautions

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

10/26/2018 / Agribusiness , Draft Guidance , Farms , Food and Drug Administration (FDA) , Food Safety , Food Supply , FSMA , Health & Safety Standard , Regulatory Oversight , Regulatory Requirements

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

10/23/2018 / Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Foreign Suppliers , FSMA , Recordkeeping Requirements , Regulatory Requirements

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

10/1/2018 / Federal Pilot Programs , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , FSMA , Regulatory Oversight , Regulatory Standards , Safety Inspections , Supply Chain

FDA Releases Draft Guidance for FSMA Intentional Adulteration Rule

The U.S. Food and Drug Administration (FDA) has released the first of three installments of its long awaited Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration...more

6/26/2018 / Draft Guidance , Food and Drug Administration (FDA) , Food Safety , Food Supply , FSMA , Regulatory Oversight , Regulatory Requirements , Risk Mitigation , Vulnerability Assessments

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

6/4/2018 / Animal Food , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Foreign Suppliers , FSMA , Regulatory Oversight , Regulatory Requirements , Verification Requirements

OMB Releases Spring 2018 Unified Agenda of Regulatory Actions

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

5/23/2018 / APHIS , Bioengineering , Farm Animals , Food and Drug Administration (FDA) , Food Labeling , Food Safety , FSMA , Investigational New Drug Application (IND) , Livestock Protocol , Nutrition Facts Labels , OMB , Regulatory Agencies , Regulatory Agenda , Regulatory Oversight , Rulemaking Process , Seafood

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

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

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

3/26/2018 / Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Foreign Suppliers , FSMA , FSVP , Importers , Imports

Maile Gradison

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