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 -
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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

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

FDA FSMA Extension of Comment Period Announced

The Food and Drug Administration (FDA) has announced that it will soon extend for 60 days the comment period on its proposed rules for (1) Foreign Supplier Verification Programs for Importers of Food for Humans and Animals...more

FDA Releases Good Manufacturing Practices for Animal Food

Proposed requirements dictate a substantial upgrade of the current regulatory standard of care. On October 29, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule—Current Good Manufacturing...more

Agribusiness Alert: FDA Proposes Significant Regulatory Rules under FSMA related to Imported Foods, the Accreditation and Auditing...

The Food and Drug Administration (FDA) released for public comment two significant regulations promulgated under the 2011 Federal Food Safety Modernization Act (FSMA). The new regulations relate to food produced and processed...more

Food Litigation Newsletter - August 5, 2013

In This Issue: - Recent Significant Developments and Rulings ..VitaRain “Natural” Caffeine Claims Against Costco Rules Preempted ..Court Refuses To Certify Most “All Natural” Claims Against Kashi and Bear...more

New FDA Food Safety Rules Will Affect Foreign Food Suppliers, Foreign Food Producers, U.S. Food Importers

The U.S. Food and Drug Administration (FDA) has released two proposed rules, one governing foreign supplier verification and the other governing third-party audits and certification. Comments are due by November 26, 2013....more

Food Safety Regulatory Update: Court Imposes Deadlines on FDA to Promulgate and Implement FSMA Rules by 2015

On June 21, 2013, the United States District Court for the Northern District of California issued an order requiring the U.S. Food and Drug Administration (“FDA”) to publish regulations under the Food Safety Modernization Act...more

Federal Court Orders the FDA to Issue New Food Safety Rules by June 2015

Each year about 48 million people (one in six Americans) report food-borne illnesses. On January 4, 2011, the Food Safety Modernization Act (“FSMA”) was signed into law....more

Comment Period Extended For Proposed FSMA Rules

Yesterday, the Michigan Department of Agriculture and Rural Development hosted officials from the Food & Drug Administration at a "Listening Session" on the newly proposed rules under the Food Safety Modernization Act (FSMA),...more

FDA Uses New Recall Power For First Time

More than two years ago, the Food Safety Modernization Act authorized, for the first time, the FDA to force a company to conduct a food recall. Prior to that, all food recalls (with the exceptions of baby formula) were...more

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