Elizabeth Fawell on Regulatory Oversight

FDA Announces Public Meeting on Modernizing Food Standards of Identity

The U.S. Food and Drug Administration (FDA) recently announced it will be holding a full-day public meeting on September 27, 2019, to address “Horizontal Approaches to Food Standards of Identity Modernization.” As explained...more

9/4/2019 / Food and Drug Administration (FDA) , Food Labeling , Food Supply , Public Meetings , Regulatory Agenda , Regulatory Oversight , Regulatory Standards

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 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

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans

On April 23, FDA issued draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C,” which aims to clarify how firms in a product distribution chain should prepare to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4/26/2019 / Biotechnology , Draft Guidance , Emergency Management Plans , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Medical Devices , Pharmaceutical Industry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 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

FDA Finalizes Guidance on Public Warning and Notification of Recalls

The U.S. Food and Drug Administration (FDA) has issued final Guidance regarding Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C. The document makes limited changes to the Draft Guidance that was...more

2/14/2019 / Dietary Supplements , Final Guidance , Food and Drug Administration (FDA) , Food Manufacturers , Food Recalls , Food Supply , Public Health , Public Notice , Regulatory Oversight , Regulatory Requirements

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 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

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 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

8/28/2018 / Farms , Food and Drug Administration (FDA) , Qualifying Facility , Registration Requirement , Regulatory Oversight , Regulatory Requirements , Restaurant Industry

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

FDA Finalizes Extension of Compliance Date for Nutrition Labeling Final Rules

The Food and Drug Administration (FDA) has issued a final rule extending the compliance date for the final rules revising the requirements for the nutrition and supplement facts labels and the declared serving sizes and...more

5/7/2018 / Final Rules , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Nutrition Facts Labels , Regulatory Oversight , Regulatory Standards

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

Elizabeth Fawell

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