News & Analysis as of

Labeling

A Practical Approach for Resolving the Pediatric Oncology Drug Labeling Crisis

An undisputed crisis exists due to the absence of adequate labeling for pediatric oncology drug products. Almost all drugs used to treat pediatric oncology patients were approved over decades ago and knowledge of pediatric...more

State Implementation Update for Revisions to Hazardous Waste Generator Rule

by Foley & Lardner LLP on

The U.S. Environmental Protection Agency (EPA) published revisions to hazardous waste generator regulations on November 28, 2016. These revisions went into effect at a federal level and for non-delegated states on May 30,...more

What is Contributory Trademark Infringement?

by Revision Legal on

How does Amazon avoid being held liable for trademark infringement? We can find some answers by examining a case recently filed by Daimler AG, maker of Mercedes-Benz cars, against Amazon. Daimler is alleging direct trademark...more

Current Public Availability of a Drug Label Does Not Demonstrate Public Availability at an Earlier Critical Date

In inter partes review (IPR) proceedings, petitioners bear the burden of demonstrating that documents relied on as printed publications were publicly accessible before the effective filing date of a challenged patent. In...more

10 Marketing Law Takeaways From ANA/BAA 2017

We just got back from the Association of National Advertising (ANA) and Brand Activation Association (BAA) Marketing Law Conference in Chicago, held earlier this week. With hundreds in attendance, and dozens of speakers...more

Looking Beyond the Label for Inducement in Post-Launch Case

by McDermott Will & Emery on

Addressing objections to a magistrate’s report and recommendation, a Delaware district court held that a generic manufacturer’s label showing an intent to induce infringement was not enough on its own to establish induced...more

Ruling in the Asahi Beer Class Action

by McDermott Will & Emery on

Last month the US District Court for the Central District of California issued an order in the Shalikar v. Asahi Beer U.S.A., Inc. false advertising class action case. Like many similar cases, Shalikar alleges that the...more

Tito’s Taste Test Claims Leave Bad Taste for NAD

Tito’s Handmade Vodka promised to stop using claims that consumers preferred the taste of its product in a challenge brought by competitor Absolut Spirits Co. before the National Advertising Division (NAD)....more

Not So Fast: Limits of "Settlement Negotiation" Protections

by Ward and Smith, P.A. on

Think Twice Before Assuming Your "Settlement Negotiations" May Not Be Used Against You - Most people who are involved in resolving disputes or negotiating deals for their businesses have seen documents labeled...more

Full Disclosure: New Labeling for Cleaning Products

by Morrison & Foerster LLP on

On October 15, 2017, California Governor Jerry Brown signed into law Senate Bill 258, known as the Cleaning Product Right to Know Act of 2017 (the “Act”). The Act requires manufacturers of most cleaning products sold in...more

ITC Defers to FDA, Declining to Institute Section 337 Investigation

by Ropes & Gray LLP on

In what represents a departure from typical U.S. International Trade Commission (ITC) practice, the ITC on October 27, 2017 declined to institute a Section 337 investigation based on a complaint brought by Amarin Pharma, Inc....more

Criminal Enforcement/Resource Conservation and Recovery Act: United States Department of Justice Announces Guilty Plea of Metal...

The United States Department of Justice (“DOJ”) announced in an October 18th news release that Phillip Michael Huddleston pleaded guilty to violating the Resource Conservation Recovery Act (“RCRA”). DOJ states alleges that...more

TTB Issues Updated Guidance on Personalized Labels

by McDermott Will & Emery on

Recently, the Alcohol and Tobacco Tax and Trade Bureau (TTB) issued an update to its existing public guidance on personalized labels. The current update clarifies the process for obtaining an approved COLA for personalized...more

TTB Reopens Comment Period for Three Notices of Proposed Rulemaking

by McDermott Will & Emery on

On October 11, 2017, the Alcohol and Tobacco Tax and Trade Bureau (TTB) reopened the comment period for the following three notices of proposed rulemaking... ...more

Preemption, Puffery Defenses Can’t Overcome Ginger Ale Suit

A California federal court judge rejected both puffery and preemption arguments when it denied Dr. Pepper Snapple Group’s motion to dismiss a putative class action challenging the labeling for its Canada Dry Ginger Ale....more

Texas Court of Appeals Reverses T.G.I. Friday’s Label Decision

by McDermott Will & Emery on

On Friday, October 13, 2017, a Texas Court of Appeals handed down the long-awaited decision in Texas Alcoholic Beverage Commission v. Mark Anthony Brewing, Inc., No. 03-16-00039-CV. The case involves Texas’ ban on...more

FDA Scolds Company Claiming to Bake with Love

by Faegre Baker Daniels on

Where’s the love? Apparently, not at the FDA. On September 22 the FDA issued Warning Letter CMS# 532236 to Nashoba Brook Bakery, of Concord, Mass. Among several infractions cited in the letter was one for the misbranding...more

Misleading Labeling Suit Continues to Brew

A putative class action alleging that Kona Brewing Co. tricked consumers into believing its beer line is locally brewed in Hawaii will move forward after a California federal court judge denied the advertiser’s motion to...more

Working Together: FDA Releases Final Guidance on Interoperability

by Hogan Lovells on

On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices (Final...more

Hogan Lovells ITC Section 337 Monthly Highlights

by Hogan Lovells on

The latest news round-up from our Hogan Lovells ITC Section 337 practice, including a new section featuring "tips from the bench" by former ITC Judge Theodore (Ted) R. Essex. Please see full Publication below for more...more

EPA Extends Compliance Deadlines for Formaldehyde Emission Standards in Composite Wood Products

by Womble Bond Dickinson on

On September 26, 2017, EPA published a final rule in the federal register extending the compliance deadlines in its Formaldehyde Emission Standards for Composite Wood Products as follows...more

NAD Addresses “Best Selling” Claims

by Kelley Drye & Warren LLP on

Benefit Cosmetics advertised that its They’re Real Mascara was the “#1 best-selling Prestige Mascara in the U.S.” and the “#1 best-selling Prestige Mascara in the U.S. for 3 years.” A disclosure linked to the first claim...more

As Medical Food Industry Grows, So May FDA Scrutiny

by Baker Donelson on

On September 1, the United States Food and Drug Administration (FDA) issued a Warning Letter to ND Labs, Inc. of Lynbrook, New York, regarding its LPS Cherry, Liquid Fiber Flow, and Nana Flakes 'medical food' products. The...more

AD-ttorneys@law

by BakerHostetler on

Tom “Syndicate” Cassell and Trevor “TmarTn” Martin serve up high-octane reviews and commentary on games and gaming culture on YouTube. Both are wildly popular – Cassell’s YouTube channel is one of the top 100 subscribed...more

Latest Decision in Kona Beer Branding False Advertising Case

by McDermott Will & Emery on

The US District Court for the Northern District of California’s recent opinion in Broomfield v. Craft Brew Alliance, Inc., No. 17-cv-01027-BLF (Sept. 1, 2017) represents the latest decision in the now long-line of false...more

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