Joseph Levitt on 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 Releases Plant and Animal Biotechnology Innovation Action Plan

The U.S. Food and Drug Administration (FDA) recently released its Plant and Animal Biotechnology Innovation Action Plan (“Action Plan”). The Action Plan provides an overview of the key priorities FDA expects to pursue through...more

11/27/2018 / Biotechnology , DNA , Food and Drug Administration (FDA) , Food Supply , Innovation , Plant Based Products , Public Health , Regulatory Agenda , Regulatory Oversight

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

11/14/2018 / APHIS , Bioengineering , Disclosure Requirements , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , FSMA , OMB , Plant Based Products , Regulatory Oversight , Regulatory Requirements , Rulemaking Process , USDA

FDA Issues Draft Guidance on FSMA Food Safety Requirements for Produce Growers and Processors

The Food and Drug Administration (FDA) has issued two draft guidance documents intended to assist industry in complying with certain FDA Food Safety Modernization Act (FSMA) regulations regarding fresh produce.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10/26/2018 / Agribusiness , Draft Guidance , Farms , Food and Drug Administration (FDA) , Food Safety , Food Supply , FSMA , Health & Safety Standard , Regulatory Oversight , Regulatory Requirements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 Issues Proposed Rule on Front-of-Pack Calorie Disclosures Used for Vending Machine Labeling Compliance

The Food and Drug Administration (FDA) is proposing to revise the type size requirements for front-of-pack (FOP) calorie declarations that are used to comply with the vending machine calorie labeling requirements. The...more

7/13/2018 / Comment Period , Disclosure Requirements , Food and Drug Administration (FDA) , Food Labeling , Nutrition Facts Labels , Regulatory Oversight , Regulatory Requirements , Vending Machines

FDA Announces Public Meeting and Request for Comments on Nutrition Innovation Strategy

The Food and Drug Administration (FDA) announced a public meeting and comment period on the agency’s comprehensive multi-year Nutrition Innovation Strategy. This public meeting and comment period follows FDA Commissioner...more

6/27/2018 / Food and Drug Administration (FDA) , Health Claims , Nutrition Facts Labels , Public Meetings , Regulatory Oversight , Regulatory Requirements

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

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

Joseph Levitt

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