Food Safety Modernization Act

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 -
News & Analysis as of

Food and Beverage Alert (US) - October 2015

FSMA will have major impact on dietary ingredient suppliers, expert says. The biggest change in food regulation in the US in the past 75 years will have a major effect on the suppliers of dietary ingredients, a food-quality...more

Food Safety Does Not Exist In A Vacuum, and Neither Do the FSMA’s Rules: What the New Rules on Preventive Controls for Human and...

On September 17, 2015 the FDA published the first two of its seven rules in conjunction with the Food Safety Modernization Act’s (the “FSMA”) regulatory scheme. The rules, which focus on Current Good Manufacturing Practices...more

Long-awaited overhaul of FDA food safety rules arrives – Part I: Introducing HARPC, changes to cGMP

Since the passage of the Food Safety Modernization Act in 2011, the FDA has promulgated proposed rules that overhaul the old Good Manufacturing Practice (cGMP) rule and create new Hazard Analysis and Risk-Based Preventative...more

FDA Releases Two Final Food Safety Rules: What You Need to Know

Progress on Final Rules implementing the Food Safety Modernization Act (FSMA) took a significant step forward last week when FDA released its first two, comprising the final rules on Current Good Manufacturing Practice and...more

Finally Coming to Fruition: FDA’s Rule on the Sanitary Transportation of Food

Twenty-five years after Congress first tried to ensure that garbage trucks aren’t also used to haul fresh produce, a federal regulation establishing sanitation standards for the transportation of human and animal food by...more

Wrap-Up of Federal and State Chemical Regulatory Developments, September 2015

EPA Releases TSCA Assessment Documents For Flame Retardant Chemicals: On August 18, 2014, the U.S. Environmental Protection Agency (EPA) released for public comment three Problem Formulation and Initial Assessment documents...more

FDA Finalizes First Two Rules Under FSMA

On September 10, 2015, the U.S. Food and Drug Administration (FDA) finalized its long-anticipated preventive control rules for human and animal food under the Food Safety Modernization Act (FSMA). The Current Good...more

Long-Awaited FSMA Final Rules Published

On September 10, 2015, the U.S. Food and Drug Administration (FDA) made public two final Food Safety Modernization Act (FSMA) rules: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls...more

FSMA Rules for Preventive Controls for Human and Animal Food Manufacturing Finalized

On September 10, 2015, FDA issued a prepublication notice of its long-anticipated preventive control rules for human and animal food under the Food Safety Modernization Act (FSMA). The Current Good Manufacturing Practice,...more

Food Safety’s Shifting Paradigm

The recent news that Stewart Parnell, convicted former Peanut Corporation of America CEO, is facing a possible life sentence as a consequence of his role in the nine deaths and hundreds of illnesses caused by PCA’s salmonella...more

FDA Releases Initial FSMA Final Rules

Today the U.S. Food and Drug Administration released the first two final rules that implement the Food Safety and Modernization Act ("FSMA"). The Preventive Controls for Human Food Rule sets new safety requirements for...more

First FDA FSMA Rules Have Landed; More Likely to Follow by End of Year

Earlier today, FDA finalized the first set of major rules implementing the Food Safety Modernization Act (FSMA) – regulations addressing current good manufacturing practice (CGMP), hazard analysis, and risk-based preventive...more

Case Note: Market Abuse Proceedings in the High Court

The judgment in The Financial Conduct Authority v. Da Vinci Invest Limited [2015] EWHC 2401 (Ch) was published on 12 August 2015, following a trial in front of Mr Justice Snowden. The case concerned allegations that the...more

Joining AIM: A Field Guide for Applicants to AIM, a Market of the London Stock Exchange: Update - August 2015

In this Issue: What is the Process for Admission to Trading on AIM? Publication of either a prospectus or an admission document. A prospectus is required where a company is offering shares to the public under...more

Animal supplements still in limbo, facing increased FDA scrutiny

The thousands of food, agriculture and life sciences companies regulated by the federal government already face a barrage of complicated regulations. Add in significant regulatory uncertainty and a major reorganization of the...more

International Food Law Gazette - July 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

Alert: The AIFMD for Non-EU Fund Managers: It's Not as Bad as You Think – Part II: Small fund managers marketing to professional...

Many non-EU alternative investment fund managers (AIFMs) raising non-EU alternative investment funds (AIFs) will accept a European investor on a "reverse solicitation" basis; but they won't "market" into Europe. This is...more

High Court Holds That Liability For Series Of FOS Complaints Did Not Transfer By Way Of Part VII FSMA Business Transfer Scheme

The court considered whether liability for a series of Financial Ombudsman Service (FOS) complaints had been transferred by way of an insurance business transfer scheme under Part VII of the Financial Services and Markets Act...more

Critical Regulations and Libel Suit Raise Adverse Publicity Coverage Issues

Brand is everything! The ability and opportunities to extend a brand’s reach are vast, with the smallest companies able to brand globally. Equally important is protecting an established brand. Competitors and consumers can...more

Upper Tribunal Upholds FCA's Decision To Fine And Prohibit Financial Adviser For Poor Record Keeping And Compliance Failures

We consider here the decision of the Upper Tribunal (Tax and Chancery Chamber) in which the tribunal upheld the FCA's decision to fine and prohibit a financial adviser, Clive Rosier, for poor record keeping and compliance...more

Financial Markets Disputes and Regulatory Update - Summer 2015 Issue 1

In This Issue: - What is worth remembering from the first half of 2015? - Judgments - so far this year… ..Jurisdiction for claims in relation to bearer bonds ..Exercise of contractual rights by...more

FDA Releases Draft Guidance on Voluntary Qualified Importer Program

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

ICAP – one fine too many?

On 4 February 2015, the European Commission (Commission) fined cash broker ICAP plc (ICAP) €14.9 million for its involvement in the Japanese Yen (JPY) LIBOR cartel. Unlike the other participants in the alleged cartel, ICAP...more

FDA Finally Releases Initial Framework for Food Importation “VQIP”

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

Upper Tribunal Expresses "Wholesale Disagreement" With FCA's Assessment Of Level Of Financial Penalty To Be Imposed On...

In December 2014, the tribunal handed down a decision that partly upheld the FCA's findings in respect of Ms Burns in connection with her conduct as a non-executive director (CF2) of two mutual societies. The tribunal found...more

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