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

Animal supplements still in limbo, facing increased FDA scrutiny

The thousands of food, agriculture and life sciences companies regulated by the federal government already face a barrage of complicated regulations. Add in significant regulatory uncertainty and a major reorganization of the...more

International Food Law Gazette - July 2015

King & Spalding is pleased to provide this first edition of the International Food Law Gazette, a publication of our Food & Beverage Group. For decades, King & Spalding has closely advised leading food, beverage and dietary...more

FDA Releases Draft Guidance on Voluntary Qualified Importer Program

The FDA announced last week the release of a draft guidance that outlines FDA’s plan to implement the Voluntary Qualified Importer Program (VQIP) mandated under the Food Safety Modernization Act (FSMA). The draft guidance...more

FDA Finally Releases Initial Framework for Food Importation “VQIP”

As many readers of this blog know, the start of 2011 saw the enactment of a massive bill aimed at overhauling the nation’s food safety system to become more preventive instead of reactive to safety problems and illness...more

Food and Beverage News and Trends

California bill to require warning labels on sugary drinks dies in committee. On April 29, a bill that would have required warning labels on sugary soft drinks failed to move forward in the California legislature. The...more

But We Did Everything Right?: Why Agreements with Shippers are Necessary for Carriers to Protect Themselves from...

As food transporters grapple with the myriad of compliance issues raised by the Food Safety Modernization Act and the FDA’s looming proposed “Food Safety Rule on the Sanitary Transportation of Human and Animal Food,” carriers...more

Quirky Question #257, Food for thought – whistleblowing claims against agricultural companies

You are right to be concerned. Under the FDA Food Safety Modernization Act (FSMA), employees who work for entities engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or...more

Food and Beverage News and Trends

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - Federal judge declines to dismiss olive oil consumer class actions. A US...more

FDA Publishes Four Key Supplemental Proposed Rules Under the Food Safety Modernization Act

The Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. This groundbreaking piece of legislation is aimed at improving FDA’s capacity to prevent, detect, and respond...more

FDA Announces More Changes to FSMA Implementation Rules

On September 19, 2014, FDA announced potential changes to four rules that the agency proposed in 2013 to implement the Food Safety and Modernization Act (“FSMA”). FSMA was signed into law in January 2011 in response to many...more

Food and Beverage Alert (US)

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - Judge refuses to dismiss “all natural” class action. On September 9, a...more

FDA Outbreak Response Is Not a Constitutional Taking

Food companies are asking whether they can gain compensation from the United States government after a product recall. While the FDA Food Safety Modernization Act (FSMA) does provide for the possibility, a recent ruling by...more

FDA Releases Revised FSMA Rules

On September 19, 2014, FDA released four supplementary notices of proposed rule-makings (SNPRMs), revised versions of four of the proposed rules it released previously as part of its implementation of the Food Safety...more

Growing Michigan - Second Quarter 2014

For decades, the Environmental Protection Agency has been charged with administering the United States Clean Water Act. One question that has bedeviled farmers, business owners and individuals – as well as judges and lawyers...more

FDA Draws Criticism With Proposed FSMA Animal Feed Rule And Breweries

FDA's chief food safety inspector, Michael Taylor, recently stated that the agency has "no intention" of preventing breweries from giving spent beer grains to farmers for cattle feed. The FDA's proposed rule would have...more

OSHA Increases its Whistleblowing Regulating Powers, Extending its Reach to Financial Institutions

While the Occupational Safety and Health Administration agency ("OSHA") may be more known for its worker safety programs, the agency also enforces the whistleblower provisions of the OSHA Act and twenty-one other statutes....more

New FDA Strategy Document for FSMA, Food Safety Modernization ACT

The USDA has issued a new “strategy” document that outlines the agency’s direction with regard to implementing the Food Safety Modernization Act (“FSMA”). The document is intended to “to guide the next phase of FSMA...more

FDA Proposes Regulations on Safe Food Transport

In early February, the U.S. Food and Drug Administration (FDA) issued its seventh and final major rule as part of the implementation of the Food Safety Modernization Act. The proposed rule seeks to prevent the contamination...more

OSHA Issues Interim Final Rule for FSMA Whistleblower Claims

The new rule contains important guidance regarding several aspects of the Food Safety Modernization Act’s whistleblower provision. The Occupational Safety and Health Administration (OSHA) has issued an interim final...more

OSHA Issues New Rule for Food Safety Whistleblowers

Effective Thursday, February 13, 2014, the U.S. Occupational Safety and Health Administration (OSHA) published a final rule governing the agency's future handling of whistleblower complaints under Section 402 of the FDA Food...more

A Preview Of Expected 2014 FDA And Legislative Actions Relating To The Food Industry

In This Issue: - Food Safety Modernization Act ..Produce Safety ..Human Food Risk Analysis ..Foreign Supplier Verification ..Accreditation of Food Safety Auditors ..Animal Food Risk...more

Polsinelli Podcast - Food Safety Modernization Act [Video]

Regulations have just been published impacting the food and animal food industries. The United States is undergoing its most comprehensive effort to reform U.S. Food Safety and Security Laws in more than 70 years. The Food...more

FDA Proposal Seeks to Prevent Food Terrorism

As FDA implements the various sections of the Food Safety Modernization Act (FSMA) through rulemaking, the agency continues to convey a pragmatic approach complicated by regulatory reality. With its latest proposal, FDA...more

Food Safety Modernization Act Hits The Animal Food Industry

On October 29, 2013 (the “Publication Date”), the Food and Drug Administration (“FDA”) published in the Federal Register its latest set of proposed regulations implementing the Food Safety Modernization Act (“FSMA”). The...more

Newest Food Safety Rules Approach Deadline

In June, a federal judge in California ordered the U.S. Food and Drug Administration (“FDA”) to issue proposed rules for the Food Safety Modernization Act (“FSMA”) by November 30, 2013. In July, the agency requested an...more

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