The United States Food and Drug Administration Food Safety Modernization Act

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -
News & Analysis as of

New FSMA Compliance Deadlines Impact Written Customer Assurances

In an August 23 action, the U.S. Food and Drug Administration (FDA) extended a range of compliance dates and clarified compliance obligations for provisions within four foundational rules set forth by the Food Safety...more

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

TSCA/FIFRA/IRIS/NTP/TRI - EPA Releases TRI Preliminary Dataset For Calendar Year 2015: On July 20, 2016, the U.S. Environmental Protection Agency (EPA) announced the availability of the Toxics Release Inventory (TRI)...more

The updated face of food labels: The nutrition facts panel

Under the Food Safety Modernization Act (FSMA), the federal Food and Drug Administration has recently published two rules concerning the nutrition facts panel on foods and the supplement facts panel on dietary supplements....more

Food and Beverage Law Update: August 2016

When food and beverage companies think of their largest risks, data breaches have not historically come to mind, but this is changing because of reports in the past few months of major breaches by companies such as Noodles &...more

Food and Beverage News and Trends Series - August 2016

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. USDA publishes final rules to improve quality of food served in schools. On...more

Protecting Food Industry Whistleblowers: FDA, OSHA team up under FSMA

In 2011, when the Food Safety Modernization Act was passed, it sought to revamp food safety in the United States. Since then, the Food and Drug Administration (FDA) has been hard at work passing regulations to implement the...more

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

TSCA/FIFRA/IRIS/NTP/TRI - EPA Launches Advisory Panels: On June 15, 2016, the U.S. Environmental Protection Agency (EPA) launched two advisory panels designed to facilitate small businesses to provide feedback to EPA...more

Terrorism Regulations Finish FDA's FSMA Implementation

The U.S. Food and Drug Administration (FDA) recently released the last of its rules crafted to enforce the Food Safety Modernization Act (FSMA). These most recent rules aim to prevent the intentional adulteration of food in...more

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

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