The United States Food and Drug Administration Food Safety

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

FDA Issues Final Rule on Food Ingredients that May Be Generally Recognized as Safe (GRAS)

The US Food and Drug Administration (FDA) has issued this final rule detailing the criteria for concluding that the use of a substance in human or animal food is “generally recognized as safe” (GRAS). By way of background,...more

Responsible Corporate Officers’ Jail Sentences Upheld in Selling Contaminated Eggs

In an important decision, on July 6, 2016, the Eighth Circuit Court of Appeals affirmed the prison sentences imposed on Jack DeCoster, and his son, Peter, under the “responsible corporate officer” doctrine (aka Park doctrine)...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

Contaminated Flour – Is Nothing Sacred?

As of August 1, 2016, General Mills had voluntarily recalled some 45 million pounds of several types of raw flour products because E.coli bacteria had allegedly been found in flour produced at the General Mills plant in...more

New Industry Resources for FDA’s New Nutrition Facts Regulations

The U.S. Food and Drug Administration (FDA) published a Nutrition Facts label “Industry Resources” web page to help businesses comply with the requirements of the final rules, which became effective on July 26, 2016....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

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

Food and Beverage News and Trends Series

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. Beer trade group urges industry to adopt voluntary nutrition and calorie...more

One Step Closer to a National GMO Labeling Law

The Vermont GMO Labeling Law is currently in effect, but it may soon be preempted by federal legislation making its way through Congress. On July 7, by a vote of 63-30, the US Senate passed a measure (Senate Bill)...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

Agreement Reached on Bipartisan Federal GMO Food Labeling Bill

Provides Practical, Mandatory Disclosure and Preempts State GMO Labeling Laws - Senate Agriculture Committee leaders reached agreement June 23, 2016, on a bill that would require food containing genetic material modified...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

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

Food and Beverage News and Trends - June 2016

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. FDA draft guidance aims to cut sodium in US diet. On June 1, the FDA...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

Food and Beverage News and Trends - May 2016 #2

Report finds no danger to human health in consumption of GMOs. In a 388-page report released May 17, the National Academies of Sciences, Engineering and Medicine said it has found no evidence of adverse health effects in...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

Food and Beverage News and Trends Series - May 2016

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. FDA finalizes rule to combat antimicrobial resistance. The FDA this week...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

FDA Announces Availability of Final Guidance on Menu Labeling

On May 5, 2016, the US Food and Drug Administration (FDA) announced the availability of its final menu labeling guidance, “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II...more

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