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

Food industry sees one of first whistleblower suits under FSMA

As part of the massive overhaul of food safety regulations under the Food Safety Modernization Act, Life Sciences Decoded reported in August on new whistleblower protections for food industry employees. On Feb. 9, six months...more

Food contact goods and the FSVP: Deciphering the FDA’s stance

The last 18 months have seen a flurry of regulatory activity as the FDA has finalized and begun enforcing a number of new regulations based on the Food Safety Modernization Act (FSMA). Among these regulatory schemes is the...more

CFSAN Director Anticipates “Tweaks,” Not Rollbacks Despite Administration’s De-Regulation Emphasis

Dr. Susan Mayne, Director of FDA’s Center for Food Safety and Applied Nutrition, spoke on Thursday to the DC section of the Institute of Food Technologists. Responding to questions from the audience, Dr. Mayne was asked to...more

2017 Food And Beverage Industry Outlook: Part 1

As 2017 marks the commencement of a new presidential administration, the food and beverage industry is one of many sectors facing anticipated regulatory and legislative reforms. Specifically, the industry can expect to see...more

Controlling L. mono in RTE Foods: FDA Publishes Draft Guidance

Quick Bite: The FDA is seeking comment until July 17, 2017, on draft guidance about recommended practices to control Listeria monocytogenes in food facilities. The Details: The Food and Drug Administration (“FDA”)...more

Wrap-Up of Federal and State Chemical Regulatory Developments, January 2017

TSCA/FIFRA/IRIS/NTP/TRI - EPA Promulgates Final TSCA Reporting And Recordkeeping Rule For Nanoscale Materials: After over a decade of effort, the U.S. Environmental Protection Agency (EPA) issued on January 12, 2017, a...more

What the FDA has in store for the food industry in 2017

As Life Sciences Decoded looks forward in 2017, it is clear that FDA-regulated industries have a great deal of change confronting them. Last year, 2016, was a landmark year for the FDA and food regulations, as the agency...more

Is the FSMA a plaintiff’s lawyer’s dream and the food industry’s nightmare?

The Food Safety Modernization Act (FSMA) became law in 2011, signaling a sea change in U.S. food safety regulation and making prevention the cornerstone of safety measures. To achieve its lofty goals, while providing time for...more

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

TSCA/FIFRA/IRIS/NTP/TRI - EPA Proposes To Add Nonylphenol Ethoxylates To Section 313: On November 16, 2016, the U.S. Environmental Protection Agency (EPA) proposed to add nonylphenol ethoxylates (NPE) as a category for...more

FDA Continues FSMA Implementation, Finalizes Guidance on Voluntary Qualified Importer Program to Expedite Food Imports

The Food & Drug Administration (FDA) released last week a final version of its guidance for industry on the Voluntary Qualified Importer Program (VQIP), which will provide a mechanism for eligible food importers to expedite...more

Product Contamination: Strong Underwriting is Key

In 2011, the Food Safety Modernization Act, regarded by many as a major reform of the food safety provisions of the Federal Food, Drug and Cosmetic Act, significantly expanded the powers of the U.S. Food and Drug...more

The new look of FDA food facility registration: Human and animal food companies beware

The food industry has long been familiar with the requirement that facilities involved in the handling, packing, holding, storing, manufacturing or other processing of food must register with the Food and Drug Administration....more

FDA Releases Draft Guidance on Customer Disclosure Statements for Uncontrolled Hazards in Human and Animal Foods

The U.S. Food and Drug Administration (FDA) released draft guidance on October 28, 2016, offering insight into customer disclosure statements required for certain food and feed products that have not, under the Food Safety...more

Pondering Public Disclosure & FSMA Records

Remember last month when we said to DOCUMENT EVERYTHING under the Food Safety Modernization Act (FSMA)? Well, here’s some more context for that recommendation. For one, FSMA adds a substantial amount of documentation and...more

Setting The Table - October 2016: The Buck Starts Here - What Shippers and Brokers Must Do to Comply with FSMA’s Sanitary...

In Spring 2016, the FDA released its long-awaited Final Rule on Sanitary Transportation of Human and Animal Food (the “Rule”). The regulation, which constitutes one of seven final rules implementing the Food Safety and...more

Thompson Coburn presents a CLE on FSMA, looming deadlines and new regulations: Is the food industry ready?

The US Food and Drug Administration continues its ongoing implementation of the Food Safety Modernization Act of 2011 (FSMA). The law, which aimed to take the first hard look at the American food supply in decades, has...more

Responsibility for FSMA Preventive Controls: If Not You, Then Who?

We wrote earlier this week about the Food Safety Modernization Act (FSMA) and what it means, from a 30,000 foot perspective, for food companies. Today we are going to dig in a little deeper to one issue that we’ve seen...more

Manic Monday: FSMA Compliance Starts Today!

Today, Sept. 19, 2016, is a big day for the food industry. It is the first compliance deadline for regulations under the Food Safety Modernization Act (FSMA) – the law we’ve been talking about since 2011, the law touted as...more

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

TSCA/FIFRA/IRIS/NTP/TRI - EPA Extends Comment Period On PIPs: On August 17, 2016, the U.S. Environmental Protection Agency (EPA) extended the comment period on its White Paper describing how EPA intends to modify its...more

Summer Vacay? Not for FDA.

While you were (hopefully) lounging at the beach or hiking mountains, the FDA was hard at work in Washington D.C. churning out final rules and guidance documents that impact food companies in various, and sometimes...more

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

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