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Administrative Agency Products Liability

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.

Tenth Circuit Finds Citizen Petition Denial to be "Clear Evidence" of Conflict Preemption

A U.S. Court of Appeals has held that a Food and Drug Administration (FDA) denial of a citizen petition can be “clear evidence” of conflict preemption under the test set forth by the Supreme Court in Wyeth v. Levine, 555 U.S....more

Lawsuit Challenges GRAS Rule on Food Substance Safety

by Morgan Lewis on

Public interest groups challenge FDA’s “Generally Recognized as Safe” Rule as failing to ensure food ingredients are safe for consumers....more

Food, Dietary Supplement & Cosmetics Regulatory Update Vol. IV | Issue 4

by Jones Day on

On May 9, 2017, the Senate confirmed Dr. Scott Gottlieb as the next FDA commissioner. With a 57-42 vote, the Senate filled the commissioner position most recently held by Dr. Robert Califf, who resigned in January 2017 and...more

Hold That Order! FDA Freezes Menu Labeling Rules Until 2018

by Seyfarth Shaw LLP on

The Food and Drug Administration (“FDA”) has extended the compliance date for its menu labeling rules just days before the final rules were set to take effect....more

Have You Noticed the Increase in Food Recalls?

by Robins Kaplan LLP on

Almost every day, the FDA announces a new recall or safety alert for a potentially dangerous food. Earlier this month, Trader Joe’s recalled some SKUs of apple sauce due to complaints that they may contain small pieces of...more

Weathering the Freeze: The CPSC's Response to the White House's New Regulatory Restrictions

by Stinson Leonard Street on

We have heard much over the last few weeks about the new executive orders issued by the White House at the outset of the Trump Administration. One order that is not garnering as much attention as others, but could have a...more

FTC Grants Summary Judgment Against California Naturel, Inc. Falsely Advertising “All Natural” Sunscreen Products

In its opinion in In re California Naturel, Inc., the Federal Trade Commission held that the California Naturel, Inc. advertising promoting its “all natural” sunscreen on its website as containing “only the purest, most...more

Homebuilder Guaranty Fund Claims, an Informal Way for Home Purchasers to File Claims Against Homebuilders

by Pessin Katz Law, P.A. on

If someone who purchases a home believes their home was improperly constructed, they may file a claim against the Homebuilder Guarantee Fund to recover any monetary losses they suffer. In order to recover from the...more

FDA: The Powdered Gloves Come Off

by Stinson Leonard Street on

In a rare move, the Food and Drug Administration (FDA) announced on Friday that it is banning the following devices after determining that they present an unreasonable and substantial risk of illness or injury that cannot be...more

FDA Launches Website for Allegations Against Medical Device Manufacturers

The U.S. Food and Drug Administration (FDA) recently launched a website1 that will now make it easier to report allegations of medical device manufacturer misconduct to the agency.2 Misconduct reports were historically...more

FDA lets medical device-makers report safety woes in lax, secretive ways

Instead of acting as a tough federal watchdog that protects and informs patients about problems with medical devices-from heart valves to drug pumps-the federal Food and Drug Administration all too often has served as an...more

Researchers question FDA cancer experts’ ‘revolving door’ with Big Pharma

The numbers are small but the implications significant. A pair of academic researchers has tossed a conflict-of-interest grenade in the laps of the leaders of the federal Food and Drug Administration. Is there too much of a...more

Court Strikes FDA Preapproval for Tobacco Product Labeling Changes

by Morgan Lewis on

Court holds that FDA guidance cannot require preapproval for label modifications to existing tobacco products, but can require preapproval for quantity modifications....more

Responsible Corporate Officers’ Jail Sentences Upheld in Selling Contaminated Eggs

by Michael Volkov on

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

Hot CPSC Jurisdictional Issues: Does the CPSC Have Regulatory Authority Over Amusement Park Rides and Guns?

In the wake of two tragic amusement park ride accidents in Kansas and Tennessee, and the ongoing political debate in America over gun safety issues, we felt it timely to help answer a question that continues to be asked in...more

Commercial Drones Set To Take Flight

by Snell & Wilmer on

On June 21, 2016, the Federal Aviation Administration (FAA) unveiled a landmark set of new rules for the commercial operation of small Unmanned Aircraft Systems (sUAS), more popularly known as drones. The new rules will take...more

Still Waiting—FDA Delays Rulemaking

The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more

Congress Sends Chemical Safety Reform Legislation to Be Signed into Law

by Morgan Lewis on

The historic reform of the Toxic Substances Control Act overhauls the United States’ primary chemical safety law for the first time in 40 years. Following months of closed-door negotiations, the US House of...more

Senate Appropriations Bill Targets FDA Rulemaking Agenda

The Senate Appropriations Committee is looking to tinker with the Food and Drug Administration’s rulemaking agenda through its fiscal year 2017 funding bill for the Department of Agriculture and FDA (S. 2956). Passed...more

CPSC Announces Civil Penalty against Teavana; Commissioners Remain Divided on Civil Penalty Enforcement, Calculations, and...

On May 26, 2016 the U.S. Consumer Product Safety Commission (“CPSC”) announced through a Record of Commission Action (“RCA”) that Teavana Corporation (“Teavana”) has agreed to pay a $3.75 million civil penalty to resolve...more

Mark Your Calendars: BPA Prop 65 Warnings Required as of May 11, 2016; Styrene Also Added to the Prop 65 List

Earlier this month, California’s Office of Environmental Health Hazard Assessment (“OEHHA”) issued a Notice of Emergency Action to allow temporary use of a standard point-of-sale warning message for bisphenol A (“BPA”)...more

FDA Proposes Ban on Electrical Stimulation Devices for Aggressive or Self-Injurious Behavior

by Knobbe Martens on

On April 25, the U.S. Food and Drug Administration published a proposed rule banning electrical stimulation devices (ESDs) used to treat aggressive or self-injurious behavior....more

The Continuing Saga Surrounding Magnet Sets: Proof of the CPSC's Determination to Eradicate Hazards to Children

by Stinson Leonard Street on

The Consumer Product Safety Commission (CPSC) has made it very clear over the last several years that it takes hazards associated with rare earth magnet sets very seriously, primarily because the hazards affect children. Rare...more

Ninth Circuit: No Relief from Stay in General Mills’ Trans Fats Case Pending FDA Action

The Ninth Circuit will not review district court stays, the appeals court recently held, because they are not “final orders” subject to immediate appeal. On January 26, 2015, the Ninth Circuit granted General Mills’ motion to...more

FDA Classifies Transvaginal Pelvic Mesh As “High Risk” Medical Device

by Knobbe Martens on

The U.S. Food and Drug Administration issued two final orders on Monday, January 4, 2016 to strengthen the data requirements for transvaginal surgical mesh devices that repair pelvic organ prolapse (POP). First, the agency...more

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