Joseph Levitt at Hogan Lovells

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 Request for Information Regarding Sesame as an Allergen in Foods

The U.S. Food and Drug Administration (FDA) recently issued a request for information seeking data and other information on the prevalence and severity of sesame allergies in the U.S. and the prevalence of sesame-containing...more

11/7/2018 / Federal Food Drug and Cosmetic Act (FFDCA) , Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) , Food Allergies , Food and Drug Administration (FDA) , Food Safety , Food Supply , Request For Information

FDA Issues Draft Guidance on FSMA Food Safety Requirements for Produce Growers and Processors

The Food and Drug Administration (FDA) has issued two draft guidance documents intended to assist industry in complying with certain FDA Food Safety Modernization Act (FSMA) regulations regarding fresh produce.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10/26/2018 / Agribusiness , Draft Guidance , Farms , Food and Drug Administration (FDA) , Food Safety , Food Supply , FSMA , Health & Safety Standard , Regulatory Oversight , Regulatory Requirements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 Issues Request for Information Regarding Use of Names of Dairy Foods in the Labeling of Plant-Based Products

The Food and Drug Administration recently issued a request for information on the use of the names of dairy foods in the labeling of plant-based products. This action arose from the agency’s Nutrition Innovation Strategy, one...more

10/3/2018 / Beverage Manufacturers , Comment Period , Food and Drug Administration (FDA) , Food Labeling , Food Marketing , Food Supply , Request For Information , Retail Market

FDA Issues Draft Guidance on Publishing Retail Consignees Lists to Effectuate Certain Human and Animal Food Recalls

On September 26, 2018, the Food and Drug Administration issued a statement by FDA Commissioner Scott Gottlieb, M.D. on FDA’s commitment to disclose retailer information for certain food recalls to improve consumer safety....more

10/3/2018 / Animal Food , Draft Guidance , Food and Drug Administration (FDA) , Food Manufacturers , Food Recalls , Food Safety , Food Supply , Public Health , Retail Market

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 Proposes New Rule to Increase Transparency and Access to Agency Documents Under FOIA

The Food and Drug Administration (“FDA” or “the agency”) recently issued a proposed rule that will ease the Freedom of Information Act (“FOIA”) request process for certain records within FDA’s possession. The proposed rule...more

9/18/2018 / FOIA , Food and Drug Administration (FDA) , Public Records , Request For Information , Transparency

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

Joseph Levitt

Hogan Lovells

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