Food Safety Modernization Act Food Manufacturers

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

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

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

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 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

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

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

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

But We Did Everything Right?: Why Agreements with Shippers are Necessary for Carriers to Protect Themselves from...

As food transporters grapple with the myriad of compliance issues raised by the Food Safety Modernization Act and the FDA’s looming proposed “Food Safety Rule on the Sanitary Transportation of Human and Animal Food,” carriers...more

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

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

Food and Beverage News and Trends

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - Federal judge declines to dismiss olive oil consumer class actions. A US...more

For Whom the Whistle Blows

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

FDA Publishes Four Key Supplemental Proposed Rules Under the Food Safety Modernization Act

The Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. This groundbreaking piece of legislation is aimed at improving FDA’s capacity to prevent, detect, and respond...more

FDA Announces More Changes to FSMA Implementation Rules

On September 19, 2014, FDA announced potential changes to four rules that the agency proposed in 2013 to implement the Food Safety and Modernization Act (“FSMA”). FSMA was signed into law in January 2011 in response to many...more

Food and Beverage Alert (US)

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - Judge refuses to dismiss “all natural” class action. On September 9, a...more

FDA Outbreak Response Is Not a Constitutional Taking

Food companies are asking whether they can gain compensation from the United States government after a product recall. While the FDA Food Safety Modernization Act (FSMA) does provide for the possibility, a recent ruling by...more

Food Safety Whistleblower Regulations on the Way

Otto von Bismarck once said, “Laws are like sausages, it is better not to see them being made.” Fortunately, the government that makes the laws does want to see the sausage being made and, as such, has instituted new...more

FSMA Whistleblower Lawsuit Filed in Federal Court

Food industry should be aware of new risks associated with whistleblower protections for food and beverage company employees. On June 6, one of the first whistleblower lawsuits under the Food Safety Modernization Act...more

FDA Uses New Recall Power For First Time

More than two years ago, the Food Safety Modernization Act authorized, for the first time, the FDA to force a company to conduct a food recall. Prior to that, all food recalls (with the exceptions of baby formula) were...more

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