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Medicinal Product Regulation and Product Liability in Australia: Overview

The Therapeutic Goods Act 1989 (Cth)(TG Act): - Provides a national framework for the regulation of medicinal products. - Provides a national system to control the quality, safety, efficacy and timely availability...more

Advertising Law - June 2015 #3

CARU Stresses Out Over Claims for Spa Product - The Children’s Advertising Review Unit (CARU) was stressed out over implied claims made by The Maya Group for its Orbeez Body Spa. The product consists of an...more

Advertising Law - June 2015

Fifty Years Later, Still Feeling the Impact of 1965 - In 1965, TV spots ran for 60 seconds . . . mostly in black & white. A first-class stamp cost five cents. (Remember mail?) Bonanza ruled the airwaves, while...more

FDA Increasing Scrutiny of Cosmetic Marketing Claims, New Agency Warnings Suggest

In addition to truthful and non-misleading advertising requirements, which are enforced by the FTC and certainly familiar to readers of this blog, personal care and cosmetic products are also subject to the Federal Food,...more

The Internet of Things will “rock” the retail sector

The Internet of Things will generate in the retail sector US $ 329 billion of revenues by 2018 according to a report published by SAP, but such massive growth has to deal with legal issues concerning not only privacy...more

First Circuit Finds Federal Preemption of State Tort Claims That Conflict With A Medication’s FDA-Approved Labeling & Warnings

An opinion issued by the U.S. Court of Appeals for the First Circuit on February 20, 2015 held that the Federal Food, Drug, and Cosmetic Act (“FDCA”) preempted claims that Lexapro’s U.S. Food and Drug Administration (FDA)...more

Advertising Law - February 2015 #3

FCC Chair Announces New Net Neutrality Regs - The battle over net neutrality took a new turn when Federal Communications Commission Chairman Tom Wheeler announced his intention to reclassify broadband service as a...more

Gingko, Roses, or Just Filler? The New York Attorney General's Attack on Supplements

We all know that a rose by any other name would smell as sweet. But what if the roses you give to your sweetheart are actually painted daisies or thorns without flowers? Or worse, if they do not contain flowers at all but...more

SPECIAL FOCUS: D.C. Circuit Limits FTC’s Ability to Require Two Randomized Clinical Trials to Substantiate Disease Claims in...

On January 30, 2015, the U.S. Court of Appeals for the District of Columbia Circuit issued its long-awaited opinion in the POM case. In a press release, the Federal Trade Commission (FTC or the Commission) Chairwoman Edith...more

Advertising Law - February 2015

FTC Consumer Protection Head Addresses Do’s, Don’ts for Privacy - Calling the current advertising climate “a technological revolution at the intersection of marketing and consumer data,” Director of the Federal Trade...more

Proposition 65: OEHHA Proposes Revisions to Proposition 65 Warning Regulations

On January 12, 2015, the Office of Environmental Health Hazard Assessment (OEHHA) proposed important new regulations that would repeal and replace the existing Article 6 regulations regarding the all-important "clear and...more

2014 Year in Review: OPDP Warning and Untitled Letters

In 2014, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 10 enforcement letters to pharmaceutical manufacturers. Of the 10 letters, nine were Untitled...more

There’s a Wrinkle in Your Advertising Claims: L’Oréal Settles with the FTC

L’Oreal’s Deceptive Advertising - The Federal Trade Commission (“FTC”) accused L’Oréal of making deceptive advertising claims regarding the benefits of two of its product lines. L’Oréal claimed that its Génifique...more

State of the GMO Union

Just how hot is GMO-labeling legislation? On Jan. 6, 2015, a Republican state senator introduced just such a bill - in Indiana, the nation’s breadbasket. Still, federal legislation on both sides of the issue has stalled, the...more

Advertising Law - January 2015 #2

Safeway Must Pay Customers for Higher Online Prices - A California federal court judge has ruled in a breach of contract suit that Safeway is liable to customers who paid more for items online than in the store. ...more

Advertiser Jumps the Gun With Brochure Touting Tests; Fifth Circuit Brushes Off First Amendment Challenge to Lanham Act Claims

Like claims for defamation or commercial disparagement, Lanham Act claims are viable only if they involve statements of fact, rather than opinion. But what happens if an advertising statement concerns an issue that is a...more

Preemption and Primary Jurisdiction After Pom Wonderful

After the U.S. Supreme Court decision in Pom Wonderful LLC v. The Coca-Cola Co., __ U.S. __, 134 S.Ct. 2228 (2014), fear arose among national marketers that the decision would produce a wave of class actions challenging food,...more

Post Wisely

Two FDA Guidelines Help Life Sciences Companies Solve Social Media Conundrums - Social media presents new challenges for life sciences companies. Companies that post about their products on space-constrained social...more

Enforcement Priorities and Trends in Children's and Minors' Advertising and Privacy

BakerHostetler's Alan Friel recently interviewed FTC staff lawyer Kandi Parsons and Assistant New Jersey Attorney General Elliot Sibers at the opening session of the Children's Advertising Review Unit ("CARU") of the...more

Advertising Law - November 2014

Lawmakers: Time to Discuss the Internet of Things: What are the privacy, security, and consumer protection implications of the burgeoning Internet of Things? A group of senators has called for a hearing to...more

Connected Cars – legal issues and hurdles!

Connected cars are expected to generate $ 131.9 billion by 2019 with a compound annual growth rate (CAGR) of 34.7% from 2013 to 2019. But such growth shall face legal issues that not only affect data protection matters, but...more

Court Rejects Workers Comp Insurer’s Challenge to Big Pharma

Pharmaceutical manufacturers that promote off-label uses for prescription drugs have become litigation targets for third-party payors—especially after Kaiser received a nine-figure RICO award last year against the...more

Advertising Law - September 2014 #2

Use of Flawed Study Results in $3.5M Settlement with FTC - For relying upon the results of a flawed study to make what the Federal Trade Commission characterized as “baseless” and “hopelessly flawed” weight-loss claims...more

Alabama Supreme Court Reaffirms That Plaintiffs Who Use Generic Drugs Can Recover From Brand-Name Manufacturers

On August 15, 2014, the Alabama Supreme Court held for the second time in Wyeth v. Weeks, No. 1101397 (Ala. 2014) that a plaintiff who took only the generic version of the heartburn medication Reglan could nevertheless...more

Coveting Characters: Navigating FDA's Draft Guidance on Social Media

Last week the U.S. Food and Drug Administration (FDA) issued two long-awaited draft guidances on social media: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and...more

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