The United States Food and Drug Administration

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

A Spoonful of Sugar? Better Put It on the Label - FDA Issues Draft Guidance on Branding Honey

Addressing concerns about adulterated honey products, the FDA has issued draft guidance clarifying labeling requirements. According to the guidance, purveyors of honey products must specify on the product label and in the...more

Network Interference: A Legal Guide to the Commercial Risks and Rewards of the Social Media Phenomenon (3rd Edition)

In this edition: - Introduction - Advertising & Marketing - Brand Protection & Reputational Management - Copyright (EU) - Copyright (U.S.) - Data Privacy & Security -...more

Northern District Judge Tosses “Evaporated Cane Juice” Food Misbranding Claims Against Whole Foods

On March 31, 2014 Judge Edward J. Davila in the Northern District of California partially dismissed a lawsuit against Whole Foods Market alleging misleading labeling of its in-house “Everyday Value” products. The plaintiff...more

First Amendment And Off-Label Promotion – Prosecute What I Do, Not What I Say

On December 3, 2012, the United States Court of Appeals for the Second Circuit vacated the conviction of Alfred Caronia (“Caronia”), who had been tried and convicted of participating in an unlawful conspiracy to introduce a...more

Bipartisan Group Introduces Safe and Accurate Food Labeling Act in House

In an attempt to stop the proliferation of a patchwork of state-by-state food labeling laws, and to “reaffirm” the Food and Drug Administration (FDA) as the sole authority on food safety and labeling, a bipartisan group of...more

E-Cigarettes Reputation As Safe Alternative To Tobacco Is Just More Smoke and Mirrors

E-Cigarettes Reputation As Safe Alternative To Tobacco Is Just More Smoke and Mirrors The dangers of e-cigarettes exposed by a new study showing e-cigarettes can cause cancer and the realization that many of the “safe”...more

FDA Releases FDASIA Health IT Report

On April 3, 2014, the Food and Drug Administration (FDA) released the FDASIA Health IT Report (Report). This Report fulfills Section 618 of the Food and Drug Administration Safety and Innovation Act (FDASIA), Public Law...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. - Supporting healthy food options for students. On April 3, Senators Heidi...more

Contaminated Cheese Products Kill in California

Listeria monocytogenes returned to hospitals and media headlines as another outbreak killed a Californian and sickened seven others. ...more

Pom Wonderful and Consumer Class Actions Under State Law

The newest wave of false advertising consumer class actions asserts that consumer labeling or marketing violates state unfair competition laws by confusing (or potentially confusing) consumers. While brought under state...more

Lack of Federal Regulation in Cosmetics and Personal Care Products Leads to Litigation Risks

In recent years, consumers have become more focused on the potential for health risks associated with the use of chemicals and other ingredients in cosmetics and personal care products. Many consumers, however, may not...more

Sweet(ener) Confusion: Court Divide Over Role of Primary Jurisdiction Doctrine in “Evaporated Cane Juice” Cases Grows

In Swearingen v. Santa Cruz Natural, Inc., No. C 13-04291 (N.D. Cal. April 2, 2014), Judge Illston of the U.S. District Court for the Northern District of California granted defendant’s motion to dismiss based on the primary...more

Finally…FDASIA Health IT Regulation Report Released

The U.S. Food and Drug Administration (FDA), along with HHS’ Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC, together with FDA and ONC, the...more

The FDASIA Health IT Report

On April 7, 2014, the Food and Drug Administration (FDA) released a report entitled “FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework” (the “Report”). The Report was mandated by...more

Federal Circuit Find Fractures in Roche Boniva Patents

In Hoffman-LaRoche, Inc. v. Apotex, Inc., the Federal Circuit affirmed the district court’s summary judgment that two Roche Boniva patents are invalid as obvious. The conclusion of obviousness is not particularly remarkable...more

Part II: Fair Notice or No Notice? The Wyndham Worldwide Case and the Expanding Power of the FTC to Police Data Security

In our first blog in this series, we provided a summary of the District Court of New Jersey’s recent decision in FTC v. Wyndham Worldwide Corp., in which Judge Salas confirmed the FTC’s authority to bring enforcement actions...more

FDA Seeks Information for Implementation of Drug Supply Chain Security Act

On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States." To...more

API Manufacturers Are Not Proper Defendants In Hatch-Waxman Actions

A district court judge in New Jersey recently granted an API supplier’s motion to dismiss claims filed against the supplier in an ANDA suit, raising questions about whether an API supplier belongs as a defendant in these...more

Federal agencies propose health IT regulatory framework, seek stakeholder input and participation in new initiatives

A little more than five years after the passage of the Health Information Technology Economic and Clinical Health (HITECH) Act, the Food and Drug Administration, Federal Communications Commission and the Office of the...more

Indiana Governor Signs Biosimilar Substitution Bill

On March 25, Indiana Governor Mike Pence signed legislation (Senate Bill 262) that will allow pharmacists in Indiana to substitute an interchangeable biosimilar product for a prescribed biological product if certain...more

FDA, ONC and FCC Report Outlines Proposed Health Information Technology Regulatory Strategy and Recommendations

On April 3, 2014, the U.S. Food and Drug Administration, in conjunction with the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission, issued a draft report that...more

Chicago Extinguishes E-Cigarette Use In Enclosed Places

The city of Chicago has decided that electronic cigarettes (e-cigarettes) should be treated the same way as more conventional cigarettes. Effective April 29, 2014, e-cigarettes will be banned in enclosed public places and...more

Sixth Circuit Affirms Dismissal of Securities Class Action for Failure to Properly Plead Scienter

On March 28, the US Court of Appeals for the Sixth Circuit affirmed a lower court’s dismissal of a shareholder class action against BioMimetic Therapeutics Inc., finding that plaintiffs had failed to sufficiently allege that...more

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

FDA, ONC, and FCC Issue Report on the Regulation and Oversight of Health IT Technologies

On April 3, 2014, the Food and Drug Administration (“FDA”) released its long-awaited report on a proposed framework for the regulation and oversight of health information technology (“health IT”). The report, developed in...more

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