News & Analysis as of September 22, 2024

Food Safety Modernization Act › Draft Guidance

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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 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FDA Issues Draft Guidance on Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting

Hogan Lovells on 7/3/2019

FDA recently released a Draft Guidance for Industry entitled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting” (“Draft Guidance”). The Draft Guidance addresses the growing, harvesting,...more

Food & Beverage Litigation Update l April 2019 #3

Shook, Hardy & Bacon L.L.P. on 4/26/2019

FSMA, Prop. 65 and Supply Chain Issues Among Subjects of Food Law Conferenc - In-house and outside counsel joined representatives from the U.S. Food and Drug Administration (FDA), Department of Agriculture (USDA) and...more

FDA Releases Second Installment of Draft Guidance for FSMA Intentional Adulteration Rule

Hogan Lovells on 3/15/2019

The U.S. Food and Drug Administration (FDA) has released the second of three installments of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule....more

FDA Issues Draft Guidance on FSMA Food Safety Requirements for Produce Growers and Processors

Hogan Lovells on 10/26/2018

The Food and Drug Administration (FDA) has issued two draft guidance documents intended to assist industry in complying with certain FDA Food Safety Modernization Act (FSMA) regulations regarding fresh produce.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

FDA Releases First in Series of Draft Guidances Regarding Mitigation Strategies to Protect Against Intentional Adulteration

Kelley Drye & Warren LLP on 7/3/2018

On June 20, 2018, the Food and Drug Administration (“FDA”) released draft guidance for companies required to comply with the FDA’s final rule, “Mitigation Strategies to Protect Food Against Intentional Adulteration” (“IA...more

FDA Releases Draft Guidance for FSMA Intentional Adulteration Rule

Hogan Lovells on 6/26/2018

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

FDA Update: Agency Seeks to Strengthen Public Warning and Notification of Recalls, Exercises FSMA Enforcement

Saul Ewing LLP on 1/22/2018

Within the past few weeks, the U.S. Food and Drug Administration (FDA or the Agency) has, among other things: Issued a Draft Guidance to strengthen public warning and notification of recalls of foods, drugs, medical...more

Belgian Financial Regulator's Tightening of Investor Protection Against Unfair Contract Terms

Jones Day on 5/24/2017

On 6 February 2017, Belgium's financial regulator (Belgian Financial Services and Markets Authority ("FSMA")) moved to fortify the protection of investors, publishing a position paper ("Position Paper") on the application of...more

Controlling L. mono in RTE Foods: FDA Publishes Draft Guidance

Davis Wright Tremaine LLP on 1/18/2017

Quick Bite: The FDA is seeking comment until July 17, 2017, on draft guidance about recommended practices to control Listeria monocytogenes in food facilities. The Details: The Food and Drug Administration (“FDA”)...more

FDA Releases Draft Guidance on Customer Disclosure Statements for Uncontrolled Hazards in Human and Animal Foods

Faegre Drinker Biddle & Reath LLP on 11/1/2016

The U.S. Food and Drug Administration (FDA) released draft guidance on October 28, 2016, offering insight into customer disclosure statements required for certain food and feed products that have not, under the Food Safety...more

FDA Releases Draft Guidance on Determining What Constitutes a “Qualified Facility” under FSMA Preventive Controls Rules

Kelley Drye & Warren LLP on 5/17/2016

On Friday, the FDA announced the availability of a draft guidance describing its current thinking on how to determine whether a business is a “qualified facility” that is subject to modified requirements under its previously...more

Food Recall Events: The Importance of Evaluating Your Insurance Coverage Before a Voluntary and Mandatory Food Recall

McCarter & English, LLP on 10/27/2015

Food recalls are on the rise as consumer protection regulations become more stringent, and they can be costly events. There can be significant expenses associated with removing impacted products from stores; reimbursing...more

FDA Releases Draft Guidance on Voluntary Qualified Importer Program

Kelley Drye & Warren LLP on 6/10/2015

The FDA announced last week the release of a draft guidance that outlines FDA’s plan to implement the Voluntary Qualified Importer Program (VQIP) mandated under the Food Safety Modernization Act (FSMA). The draft guidance...more

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Food Safety Modernization Act › Draft Guidance

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