Misbranding

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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

FDA Regulatory and Compliance Monthly Recap — September 2016

FDA issues final rule modifying regulations for drug establishment registration, listing requirements - The final rule, which comes nearly 10 years after changes were initially proposed, updates the regulations to...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

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

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

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

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

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

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

Amarin Pharma Settles First Amendment Claims Against FDA: Potential Implications

Irish drug company Amarin Pharma, Inc. (Amarin) and the U.S. Food and Drug Administration (FDA) agreed, on March 8, 2016, to settle claims that FDA regulations barring Amarin from making “truthful” and “non-misleading”...more

"One-Two Punch: Amarin Settlement Order and Vascular Solutions Acquittal Further Erode Off-Label Promotion Enforcement Regime"

In an apparent first, the U.S. Food and Drug Administration (FDA) has conceded that a pharmaceutical company may engage in truthful and nonmisleading speech promoting the off-label use of a prescription drug. This concession...more

K&S Effort Leads to Acquittal in Conspiracy and Misbranding Case Against Medical Device Company

On February 29, 2016, Minneapolis-based medical device company Vascular Solutions, Inc. (“VSI”) and its CEO Howard Root were acquitted by a jury of conspiracy and misbranding charges in a closely-followed trial in San...more

FDA Regulatory and Compliance Monthly Recap — January 2016

OPDP enforcement reaches record low in 2015 as drugmakers face uncertainty in digital marketing - Enforcement by the OPDP has fallen notably since 2010. The decline has been attributed, in part, to the agency's slow...more

Blame Flows Downhill: All the Way to Sales Clerks

What if a store clerk sells a product that, unbeknownst to him, is illegal? Can the clerk be convicted of a crime, despite not knowing the product was illegal and not intending to sell an illegal product? On January 14,...more

No Soup for You! Judge Denies Preliminary Approval of Settlement in CJ Foods’ Annie Chun Soup Case

A recent decision from the Southern District of California highlights two challenges with obtaining preliminary approval of nationwide food misbranding class action settlements. On December 16, 2015, in Peterson v. CJ...more

Federal Government Continues to Bring Actions Against Pharmaceutical and Medical Device Companies and Individuals for Alleged...

The Office of Inspector General (OIG) for the Department of Health and Human Services recently released its Semiannual Report to Congress. Through the first three quarters of 2015, OIG announced recoveries of $3.35 billion...more

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