News & Analysis as of

Misbranding

UPDATE: The Revival of ECJ Lawsuits*

On June 8, 2017, Judge Carney dismissed Plaintiff’s class action Complaint because she failed to provide specifics about her own Sports Beans purchase. The court held that the Complaint was implausible because it only...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more

FDA Says Viewers Catch a Fleeting Glimpse; Can’t Hear What You’re Saying to Sponsor of Ad with Mismatched Audio and Visual Risk...

by Arnall Golden Gregory LLP on

Recently, FDA’s Office of Prescription Drug Promotion (OPDP) issued its first Untitled Letter of the year, citing a direct-to-consumer TV advertisement for a prescription weight- loss drug. According to OPDP, the ad made...more

The Revival of ECJ Lawsuits: Sweet Tooth For Plaintiffs, or Toothless Claims?

Introduction. On May 22, 2017, plaintiff Jessica Gomez filed an opposition on behalf of a putative class of consumers urging a federal district court judge not to dismiss her lawsuit against Jelly Belly Co. (“Jelly Belly”)...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 2

In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy...more

The Responsible Corporate Officer Doctrine in the Wake of DeCoster

Executive Summary: The most important Park doctrine case in over forty years may be heading to the Supreme Court – but not if the federal government has its way. The Responsible Corporate Officer doctrine (“RCO doctrine”),...more

Arizona Enacts Law Permitting Off-Label Promotion

by Arnall Golden Gregory LLP on

As we have previously covered, the Food and Drug Administration is in the midst of reevaluating its policy on off-label promotion of medical products—that is, promotion of drugs, medical devices, and biologics for uses not...more

Judge Koh Issues First Blow to “Added Sugars” Plaintiffs

The Big Picture: On Tuesday, Judge Koh granted Kellogg’s Motion to Dismiss in its entirety in Hadley v. Kellogg Sales Company, No. 5:16-cv-04955-LHK (N.D. Cal.). Hadley is one of three cases against well-known cereal makers...more

To Your Health: FDA Redefining the Term “Healthy” on Food Labels

On September 27, 2016, the U.S. Food and Drug Administration (FDA) announced that it has begun a public process to redefine the term “healthy” on food labels. As part of the public process, the FDA is soliciting input...more

Hot News, Shredded Wheat and Wool Underwear: Brandeis On Copyright And Trademark

October 9 marks the 100th anniversary of Louis Brandeis’ first session as a justice of the Supreme Court of the United States (October 9, 1916 was the second Monday in October – in 1917, the Court began meeting on the first...more

A Berry Mixed Decision: Consumer Class Action Challenging Packaging of “Himalania” Goji Berries Largely Survives Motion to...

On September 2, 2016, United States District Judge Dean P. Pregerson for the Central District of California granted in part and denied in part a motion to dismiss a class action complaint alleging violations of the UCL and...more

Food and Beverage News and Trends - October 2016

by DLA Piper on

FDA seeks public comment on possible revision of its definition of "healthy" on food labels. The FDA has begun an initiative to revisit its legal definition of "healthy" as used by manufacturers on food labels. In a September...more

Nature’s Way Can’t Slide Out of Coconut Oil Suit

On August 12, 2016, Southern District of California Judge William Q. Hayes denied most of a motion to dismiss and motion to strike in Hunter v. Nature’s Way Products, LLC, Case No. 16cv532-WQH-BLM. The putative class action...more

The Pleads Of The Many: 50 Years of Star Trek Lawsuits

This year marks the fiftieth anniversary of the premiere of the original series of Star Trek, which first aired on NBC in September 1966. On July 22, this milestone will be marked in earnest when Paramount Pictures releases...more

FDA Revisits Nutty Definition of “Healthy” Food

by McGuireWoods LLP on

On May 10, the Food and Drug Administration announced it will be reevaluating how it defines “healthy” food. The move constitutes a reversal of an FDA warning letter issued in March 2015 to Kind, LLC, accusing the snack bar...more

Just as the Comment Period for “Natural” Ends, FDA Announces Intent to Re-Examine What It Means to Be a “Healthy” Food

As any company making and selling food products knows, late last year FDA requested information and comments regarding the appropriate use of the term “natural” for food – the Agency asked what types of processing make that...more

Move over GNC: Crackdown on dietary supplement makers continues

by Thompson Coburn LLP on

In the fourth quarter of 2015, the dietary supplement industry was reminded that the Department of Justice (DOJ) and the federal Food and Drug Administration (FDA) were watching. This reminder came on the heels of the DOJ...more

Another Pom Case

No, this one isn’t about uniforms. The Supreme Court has refused to hear POM Wonderful’s appeal of FTC findings that claims in POM’s advertising were misleading. POM’s ads claimed that its juice could help prevent heart...more

No Tea Time for Class Action Plaintiffs: Class Certification Denied for Bigelow Green and Black Tea Drinkers

Northern District of California Judge William Orrick recently denied class certification in two food misbranding class actions challenging antioxidant claims for Bigelow green and black teas. Khasin v. R.C Bigelow Inc., Case...more

Bimbo Bakeries Suit On Hold Pending Ninth Circuit Class Certification Appeals

We’ve recently reported on numerous district court—and even Ninth Circuit—stays in false advertising actions. Many of these stays have been based on FDA’s consideration of food labeling issues, such as those involving...more

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs: Part Two

by Jackson Walker on

The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA...more

Cut the Fat . . . Just Not Yet: Court Rules that PHO Claims Are Preempted

Northern District of California Judge Maxine Chesney recently granted Nestlé’s motion to dismiss a challenge to partially hydrogenated oil (PHO) in Nestlé’s Coffee-mate® coffee-creamer products, finding plaintiff’s claims...more

Examining The Amarin/FDA Off-Label Promotion Settlement

by Reed Smith on

A lot of firms have already expended a lot of ink discussing the proposed memorandum of settlement filed on March 8, 2016 in Amarin Pharma’s First Amendment litigation against the FDA We’ll try not to be repetitive of what...more

Amarin Settles Off-Label Promotion Case Against the FDA

by Latham & Watkins LLP on

The Amarin settlement represents another important development in the FDA’s enforcement of off-label promotion. On March 8, 2016, US District Court Judge Paul A. Engelmayer entered a Stipulation & Order of Settlement in...more

Amarin/FDA Settlement: A Significant First Amendment Victory for Off-Label Marketing

On March 8, 2016, Amarin Pharma, Inc. and FDA entered into a formal settlement, close to a year after the U.S. District Court for the Southern District of New York granted a preliminary injunction against FDA’s threats to...more

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