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

The Last Set of Major FSMA Regulations Are Done!

The last of FDA’s seven “foundational” rules mandated under the Food Safety Modernization Act of 2011 (FSMA) was published at the end of last month, just a few days before the May 31, 2016 deadline agreed to by the Agency...more

Major Federal Food Safety Law Depends on Individual State Enforcement

In 2011, Congress approved the FDA Food Safety Modernization Act in response to several deadly outbreaks of foodborne illnesses. These outbreaks convinced legislators and food industry groups that the then-existing food...more

The Legal Angle On General Mills Recall Of 10 Million Pounds Of Flour

What happened? On May 31, General Mills issued a voluntary recall (http://www.generalmills.com/flour/) of more than 10 million pounds of flour. Between mid-December 2015 and early May 2016, thirty-eight people have been...more

FSMA Food Defense Rule Requires Firms to Address Risk of Terrorism

In an effort to prevent wide-scale public harm through the nation’s food supply from acts of terrorism, the U.S. Food and Drug Administration (FDA) has published its final rule regarding Mitigation Strategies to Protect Food...more

FDA Issues Final Rules That Change Nutrition Facts Labels

No more sugar coating—the Rules impose new label requirements, and manufacturers will incur additional costs. The US Food and Drug Administration (FDA or the Agency) has announced the issuance of two new final rules: one...more

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

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

FDA Releases Draft Guidance on Determining What Constitutes a “Qualified Facility” under FSMA Preventive Controls Rules

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

Another Statute With Broad Whistleblower Protections - The FDA's Food Safety Modernization Act (FSMA)

In April, the U.S. Occupational Safety and Health Administration (OSHA) issued its final rule governing unlawful retaliation against workers who complain about or disclose food safety concerns to their employer or to OSHA....more

How the FDA’s new Sanitary Transport Rule affects food shipping

The FDA is continuing its implementation of the Food Safety and Modernization Act (FSMA) with the “Sanitary Transportation of Human and Animal Food” final rule (Sanitary Transport Rule or Rule) published in the Federal...more

OSHA Publishes Food Safety Whistleblower Final Rule

The U.S. Occupational Safety and Health Administration (OSHA) published its final rule April 18, 2016 setting forth the procedures for retaliation complaints arising under the Food and Drug Administration Food Safety...more

FDA Issues Final Rule on Sanitary Transportation of Food

The Rule is broad in scope and reaches nearly every party involved in the shipment of food through the United States. On April 6, the Food and Drug Administration (FDA) published its final rule governing the sanitary...more

Weekly Update Newsletter - April 2016 #2

DEPARTMENT OF LABOR - Procedures for Handling Retaliation Complaints - This rule establishes the final procedures and time frames for the handling of retaliation or whistleblower complaints under FDA Food Safety...more

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

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

FSMA Final Rule Published on Sanitary Transportation of Human and Animal Food

The Final Rule contains notable changes from what was originally proposed. The US Food and Drug Administration (FDA) published its final rule earlier this month regarding Sanitary Transportation of Human and Animal Food...more

FDA Publishes Sixth FSMA Final Rule on Sanitary Transportation of Human and Animal Food

The U.S. Food and Drug Administration ("FDA") today officially published the sixth of seven total final rules implementing the Food Safety Modernization Act ("FSMA"). The final rule on Sanitary Transportation of Human and...more

FDA awards grants to two additional regional centers to support smaller food operations' implementation of FSMA

FDA has announced two grant awards, each for $950,000, under a joint project with USDA to establish two more regional centers for food safety training, outreach, and technical assistance related to implementation of the Food...more

FDA creates new rigorous produce safety requirements

Over the last 10 years, a significant number of outbreaks of contaminated foods, including E. coli and Listeria, have caused severe adverse health events – even death – for many American consumers. In November 2015, the Food...more

International Food Law Gazette - January 2016

FDA Approves First Genetically Modified Food-Producing Animal - On November 19, 2015, the United States Food and Drug Administration (FDA) approved a new animal drug application (NADA) that authorizes the marketing of...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

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

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