Maile Gradison at Hogan Lovells

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FDA Issues Draft Guidance on Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C

The United States Food and Drug Administration (FDA) recently issued Draft Guidance for Industry entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C” (the Draft Guidance). 1/ As FDA Associate Commissioner...more

5/3/2019 / Chain of Distribution , Draft Guidance , Food and Drug Administration (FDA) , Product Recalls , Public Comment

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

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 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

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

10/23/2018 / Food and Drug Administration (FDA) , Food Manufacturers , Registration Requirement

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

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

Maile Gradison

Hogan Lovells

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