Elizabeth Fawell on Food Safety

FDA Acting Commissioner Sharpless and Deputy Commissioner Yiannas Issue Statement on Steps to Usher the U.S. into a New Era of...

U.S. Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless, M.D., and Deputy Commissioner for Food Policy and Response Frank Yiannas recently issued a public statement on steps to usher the U.S. into a new era...more

5/4/2019 / Artificial Intelligence , Digital Data , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , FSMA , Imports , Public Meetings

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans

On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to facilitate timely initiation...more

4/26/2019 / Biotechnology , Draft Guidance , Emergency Management Plans , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Medical Devices , Pharmaceutical Industry , Product Recalls , Regulatory Oversight , Strategic Planning

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

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

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 3 Letters That Should Strike Fear into Every Food Executive’s Heart - And The 3 Steps You Can Take To Protect Your Company

What are the 3 letters that should strike fear into the heart of every food executive? No, the 3 letters are not F-D-A. Although the Food and Drug Administration is quite powerful, the agency can only wield that power...more

2/14/2019 / Food and Drug Administration (FDA) , Food Manufacturers , Food Recalls , Food Safety , Genome Project , Public Health , Regulatory Oversight

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

Elizabeth Fawell

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