Food Safety Modernization Act The United States Food and Drug Administration

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

Foreign Supplier Verification Programs and Customs Compliance: Three Key Facts Companies Need To Know

On November 27, 2015, the Food and Drug Administration (FDA) published the final rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals under the FDA Food Safety Modernization Act...more

FDA dishes out major regulatory challenges for food industry in 2016

In 2015, the FDA unleashed a surge of new regulations on the food industry carrying key compliance deadlines in 2016. As the FDA continues to intensify its enforcement over its regulated industries, food companies should...more

InterConnect - Winter 2015/2016

Out Like A Lion? The waning weeks of calendar year 2015 witnessed a remarkable convergence of regulatory and legislative activity affecting the transportation industry. For instance, the Federal Motor Carrier Safety...more

Obama Administration Lays Out 2016 Regulatory Plans for Food and Agriculture

President Obama’s administration recently released its Regulatory Plan, which lays out department-specific regulatory priorities. Of interest to the food and agriculture industry are the agendas from the U.S. Department of...more

Agriculture, Food, and Health Issues to Watch for 2016

As the agriculture and food industries head into the new year, a number of important cases and regulatory issues that have the potential to dramatically affect the industry are front and center. Below, Armstrong Teasdale’s...more

Food Safety, Labeling, and Nutrition Update - December 2015

The past few weeks have seen significant action within the Food and Drug Administration (FDA) on food safety, labeling, and nutrition issues. With the release of three final rules on Food Safety, approval of the first...more

Three More FSMA Rules Finalized As the Year Comes to a Close

Although not quite meeting the deadline of October 31 established in a legal settlement last year, FDA has released a set of three more “foundational” Final Rules mandated by the Food Safety Modernization Act (FSMA or the...more

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

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 promotes safety, control by veterinarians in new Rule: Veterinary Feed Directive

The U.S. Food and Drug Administration (FDA) continues to publish new Rules as part of its implementation of the Food Safety and Modernization Act (FSMA). In addition to new animal feed and food safety rules, the FDA recently...more

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

On October 15, 2015, Bergeson & Campbell, P.C. (B&C®) and the Woodrow Wilson International Center for Scholars (Wilson Center) issued a report, "The DNA of the U.S. Regulatory System: Are We Getting It Right For Synthetic...more

Long-awaited overhaul of FDA food safety rules arrives – Part II: A roadmap for food manufacturers on FDA’s changes to cGMPs

The new FDA Rule revamping cGMPs and implementing new rules referred to as HARPC will impact the food industry greatly. In this second in a three-part series, we will discuss the FDA’s changes to cGMPs, noting the changes...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

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

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

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