News & Analysis as of September 21, 2024

Food Safety Modernization Act › Federal Food Drug and Cosmetic Act (FFDCA)

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The Food Safety Modernization Act is a United States federal statute enacted in 2011 to ensure the safety of the U.S. food supply and prevent food contamination. The main features of the FSMA include expanding... more +

The Food Safety Modernization Act is a United States federal statute enacted in 2011 to ensure the safety of the U.S. food supply and prevent food contamination. The main features of the FSMA include expanding the FDA's inspection of food processing facilities and imported food products, requiring all food processors, manufactures and handlers to register with HHS and maintain food safety records, and shifting the government's focus away from responding to food contamination and towards preventing food contamination. less -

Two recent developments regarding FDA inspection-related activities

Hogan Lovells on 11/7/2022

The United States Food and Drug Administration (FDA) recently announced two developments on inspection-related activities providing insight into FDA’s perspective on the legal obligations that apply to food facilities, and...more

FDA issues Laboratory Accreditation final rule required under FSMA

Hogan Lovells on 12/10/2021

The U.S. Food and Drug Administration (FDA) recently issued a final rule regarding Laboratory Accreditation for Analyses of Foods (LAAF). This memorandum summarizes the regulation. The U.S. Food and Drug Administration...more

FDA Signs Domestic Mutual Reliance Agreements with Four States to Protect Food Supply

Morgan Lewis - Well Done on 10/13/2021

FDA recently entered into domestic mutual reliance (DMR) agreements with the states of California, Florida, Utah, and Wisconsin to help ensure the safety of domestic food production and distribution systems. FDA’s goal is to...more

Congress introduces legislation to regulate heavy metal action levels in infant and toddler foods

Hogan Lovells on 3/30/2021

Last week, members of both chambers of Congress announced the introduction of new legislation – the Baby Food Safety Act of 2021 – that would establish limitations on the levels of certain heavy metals in infant and toddler...more

FSMA Update: FDA Issues Compliance Program Guidance Manual for Preventive Controls Inspections

Hogan Lovells on 4/17/2020

This post summarizes the U.S. Food and Drug Administration (FDA) Compliance Program Guidance Manual (CPGM) for food facilities subject to preventive controls and sanitary human food operation requirements. As an overview,...more

The Hammer Revealed: Mandatory Recall Authority Under The Food Safety Modernization Act

Dorsey & Whitney LLP on 11/9/2018

The Food Safety Modernization Act (FSMA) overhauled the nation’s food safety systems for the first time in over a generation. Among other changes, the food safety law gave the Federal Food and Drug Administration (FDA)...more

Food and Beverage Law Update: February 2018

Holland & Knight LLP on 2/20/2018

Deceptive Trade Practices - Meat Exporter Had No Duty Under FCA to Pay for Beef Inspection - In United States ex rel. Barrick v. Parker-Migliorini Int'l, LLC, 878 F. 3d 1224 (10th Cir. 2017), the court affirmed...more

FSMA: What Every Food Industry Executive Should Do & Why

Clark Hill PLC on 6/26/2017

With six of the seven rules implemented under the 2011 Food Safety Modernization Act (FSMA) currently being enforced, what should you know and do? Here are some considerations for facilities that manufacture, pack, process,...more

Regulatory and Product Liability Overview for Distributors of Food Products in California

Buchalter on 9/28/2016

Welcome to California! California is a great place to live and work, and we are fortunate to call it home. But there is no sugarcoating the fact that California presents unique and daunting challenges to product...more

Wrap-Up of Federal and State Chemical Regulatory Developments, August 2016

Bergeson & Campbell, P.C. on 8/16/2016

TSCA/FIFRA/IRIS/NTP/TRI - EPA Releases TRI Preliminary Dataset For Calendar Year 2015: On July 20, 2016, the U.S. Environmental Protection Agency (EPA) announced the availability of the Toxics Release Inventory (TRI)...more

Wrap-Up of Federal and State Chemical Regulatory Developments, June 2016

Bergeson & Campbell, P.C. on 6/16/2016

TSCA/FIFRA/IRIS/NTP/TRI - TSCA Reform Bill Is Sent To President Obama For Signature: It has been reported that on June 14, 2016, House Speaker Paul Ryan (R-WI) and Senate President Pro Tempore Orrin Hatch (R-UT) signed...more

FDA Publishes Final Rule for Protection Against Intentional Adulteration as Part of Food Safety Modernization Act

McDermott Will & Emery on 5/27/2016

FDA has published as part of the Food Safety Modernization Act (FSMA) a final rule concerning mitigation strategies to protect food against intentional adulteration. The rule will require domestic and foreign food facilities...more

New Food Safety Whistleblower Regulations: OSHA Bites Off More Than It Can Chew

Seyfarth Shaw LLP on 5/3/2016

Seyfarth Synopis: Employers may face liability for retaliation charges from employees who report food safety issues under the Food Safety Modernization Act (FSMA). Employers in the food industry have a new headache to...more

Blowing the Whistle on Food Safety: OSHA Issues a Final Rule Related to FDCA Complaints

Ogletree, Deakins, Nash, Smoak & Stewart,... on 4/21/2016

On April 18, 2016, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) announced that it has issued procedural rules for enforcement of whistleblower complaints alleging violations of the...more

Final FSMA Sanitary Transport Rule Published by FDA with Significant Changes

McGuireWoods LLP on 4/7/2016

The U.S. Food and Drug Administration (FDA) has published its final rule regarding the Sanitary Transportation of Human and Animal Food (“Sanitary Transport Rule”). Applicable to shippers, loaders, receivers, and carriers of...more

International Food Law Gazette - July 2015

King & Spalding on 8/3/2015

King & Spalding is pleased to provide this first edition of the International Food Law Gazette, a publication of our Food & Beverage Group. For decades, King & Spalding has closely advised leading food, beverage and dietary...more

FDA Finally Releases Initial Framework for Food Importation “VQIP”

Mintz - Consumer Product Safety Viewpoints on 6/10/2015

As many readers of this blog know, the start of 2011 saw the enactment of a massive bill aimed at overhauling the nation’s food safety system to become more preventive instead of reactive to safety problems and illness...more

Quirky Question #257, Food for thought – whistleblowing claims against agricultural companies

Dorsey & Whitney LLP on 3/26/2015

You are right to be concerned. Under the FDA Food Safety Modernization Act (FSMA), employees who work for entities engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or...more

For Whom the Whistle Blows

Polsinelli on 10/28/2014

In This Issue: - Applicability and Protected Activity - Procedure Governing Section 402 Claims - Five Steps to Compliance - For More Information - Excerpt from Applicability and Protected...more

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