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

Why the FDA Needs to Change Its Food Recall Policies

Add this to FDA’s growing list of things to do: improve the food recall initiation process. According to a memorandum published on June 8, 2016, the Office of Inspector General (OIG) of the Department of Health and Human...more

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

Wrap-Up of Federal and State Chemical Regulatory Developments, June 2016

TSCA/FIFRA/IRIS/NTP/TRI - TSCA Reform Bill Is Sent To President Obama For Signature: It has been reported that on June 14, 2016, House Speaker Paul Ryan (R-WI) and Senate President Pro Tempore Orrin Hatch (R-UT) signed...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

InterConnect - Summer 2016

On April 6, 2016, the Food and Drug Administration (FDA) published its Final Rule on the Sanitary Transportation of Human and Animal Food (the Final Rule). These long-awaited regulations were mandated by the Food Safety...more

Food Product Recalls – Are You Covered?

Food and beverage recalls, regardless of the reason, continue to proliferate in the news cycle. At the end of May General Mills issued a recall of 10 million pounds of flour due to a potential link to an outbreak of E. coli...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

Wrap-Up of Federal and State Chemical Regulatory Developments, May 2016

TSCA/FIFRA/IRIS/NTP/TRI - Office Of Inspector General Considers Pesticide Imports: In a memorandum dated April 22, 2016, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) informed EPA that...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

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

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

Final FSMA Sanitary Transport Rule Published by FDA with Significant Changes

The U.S. Food and Drug Administration (FDA) has published its final rule regarding the Sanitary Transportation of Human and Animal Food (“Sanitary Transport Rule”). Applicable to shippers, loaders, receivers, and carriers of...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

Wrap-Up of Federal and State Chemical Regulatory Developments, March 2016

TSCA/FIFRA/IRIS/NTP/TRI - EPA Extends Comment Period On Chlorinated Paraffins Risk Assessments: On February 22, 2016, the U.S. Environmental Protection Agency (EPA) extended the comment period on the draft risk...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

Wrap-Up of Federal and State Chemical Regulatory Developments, February 2016

NAS Hosts Workshop On Low Dose Toxicity: On February 3, 2016, the National Academies of Sciences (NAS), Engineering, and Medicine Low Dose Committee heard presentations on several chemicals and the potential effect each may...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

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

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