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CPSC Gets it Right: Unanimously Regulates High-Powered Magnet Sets Through New Safety Standard

We do not typically take positions on product specific issues pending before the U.S. Consumer Product Safety Commission (“CPSC”), but the CPSC’s new safety standard for magnet sets demonstrates both why the agency exists and...more

Lawsuit Alleges E-Cig Company Misled Smokers About Helping Them Quit

Local governments weighing electronic cigarette regulations should heed the many uncertainties surrounding the safety and risks of these devices. For example, a newly filed lawsuit that seeks class-action status in Los...more

Pharmacy Compounding Update: Regulators Search for the Right Formula

Last November, the Compounding Quality Act (‘‘Act’’) became law after a yearlong national debate about whether—and how—to regulate compounding pharmacies after a tainted injectable prepared at a Massachusetts compounding...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

Merchants Ask Supreme Court to Consider Interchange Fees

A coalition of merchants and retailers has requested that the U.S. Supreme Court weigh in on interchange fees. In March, the D.C. Circuit Court of Appeals upheld the rules promulgated by the Board of Governors of the...more

Cybersecurity Litigation Monthly Newsletter

As we discussed in July, Tiversa, a “cyber-intelligence” company, notified the FTC in 2009 that a file containing the personal information of about 9,300 LabMD patients was available on a peer-to-peer file sharing network....more

What’s Unfair is Unfair: Repeal of Reg AA May Have Little Practical Effect

The Federal Reserve Board (Board) issued a notice of proposed rulemaking on August 22, 2014 (Notice) for the repeal of Regulation AA, which is the Board’s credit practices rule prohibiting certain unfair or deceptive acts and...more

Record Actions Force Companies to Reevaluate How They Protect Consumers

Last week the FCC’s Enforcement Bureau announced that Verizon agreed to pay a record US$7.4 million to settle an investigation related to the company’s treatment of consumer personal information. Specifically, the Commission...more

FRB Issues Proposed Rules to Repeal Regulation AA, as Required by Dodd-Frank

On Wednesday, August 27, the Board of Governors of the Federal Reserve System (the “Board”) published in the Federal Register proposed rules and a request for public comment to repeal its Regulation AA (Unfair or Deceptive...more

CPSC Poised to Ban High-Powered Magnet Sets

Although the final rule currently under consideration by the CPSC sets a performance standard for magnet sets, the practical effect of the new safety standard will be a ban on the future sale or distribution of powerful rare...more

TCPA Hot Issues: Is the Scope of Consent Unlimited?

What constitutes valid consent under the Telephone Consumer Protection Act? A hot issue in TCPA litigation is the scope of consent necessary to place automated calls to consumers where the consumer has provided a cell phone...more

FDA Posts Largest-Ever Medical Device Recall

On August 29, 2014, the FDA issued 233 Class I medical device recalls for products manufactured by Customed. According to its website, Puerto Rico-based Customed is a medical supplies leader and distributes a wide range of...more

Food and Beverage News and Trends

Vermont AG defends the state’s GMO statute. On August 8, the Vermont attorney general filed a motion to dismiss a case brought by food trade groups against the state’s newly enacted statute requiring GMO foods be...more

Finally Certainty About Licensing SPVs Under the FCA Consumer Credit Regime

From 1 April 2014, responsibility for the regulation of consumer credit in the UK was transferred from the Office of Fair Trading (“OFT”) to the Financial Conduct Authority (“FCA”), drawing certain activities relating to...more

New Structure of Kazakhstan’s Government

On 6 August 2014 the President of the Republic of Kazakhstan issued Decree on reorganization of the Government (the “Decree”). The Decree envisages integration of ministries or certain authorities of theirs into one...more

CPSC Magnets Trial in December? Zen Magnets Throws Down the Gauntlet; Vows to “Fight Until the End”

Two years ago, the U.S. Consumer Product Safety Commission (CPSC) took the uncommon step of filing administrative complaints against multiple rare-earth magnet companies who refused to voluntarily recall magnetic adult desk...more

GAO issues report on CFPB civil penalty fund

The Government Accountability Office (GAO) has issued a report on the results of its review the CFPB’s Civil Penalty Fund (CPF). The review was requested by Representative Shelley Moore Capito, who chairs the House Financial...more

Drugs and the Internet: draft guidance on social media platforms and prescription drugs

The Food and Drug Administration (FDA) recently promulgated two much-anticipated draft guidance documents on the use of social media to present information about prescription drugs and medical devices. The draft guidance...more

Recent FDA Draft Guidance Addresses Social Media Challenges Faced by Drug and Device Companies

The first draft guidance discusses how drug and medical device companies may promote their products using character space limited social media (e.g., Twitter) and Internet advertisements (e.g., Google search engine...more

FDA Draft Guidance Aims to Clarify Appropriate Character-Space-Limited Social Media Use by Drug and Device Firms: Part One of Two

As technology continues to evolve, so do the ways in which patients and healthcare providers obtain information pertaining to medical products regulated by the Food and Drug Administration (FDA). Thomas Abrams, Director of...more

Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter

In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more

Labeling Laws for the Food and Beverage Industry – Unfair Competition and Mislabeled Products

In a recent unanimous U.S. Supreme Court ruling, the court opened the door for private parties, including competitors, to bring false advertising and misrepresentation claims under the Lanham Act even if the product labels...more

FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms

On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms. The first...more

"FDA Guidance Limits Flexibility in Social Media Promotional Communications"

Three recently issued draft guidance documents (Draft Guidances) from the U.S. Food and Drug Administration (FDA or Agency) are designed to assist manufacturers in product communications via social media and other interactive...more

Keeping Our Kids Healthy: Pediatric Medicine Development

Children are a precious commodity and it is important that they are cared for appropriately. Children deserve the best care so they can grow and live happy and fulfilled lives. Pediatric products development is in high demand...more

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