Misbranding

News & Analysis as of

FDA to Revisit “Evaporated Cane Juice” Draft Guidance

Earlier this month, the FDA announced that it would reopen the comment period on its draft guidance for the industry concerning use of the term “evaporated cane juice” (ECJ). Draft Guidance for Industry on Ingredients...more

New Reprint Guidance Maintains Bipartisan Status Quo

On February 28, 2014, the FDA issued its most recent unofficial guidance on distribution by manufacturers of research concerning off-label uses. With minor textual revisions, this new Guidance essentially restates the safe...more

FDA Issues First Compounding Pharmacy Warning Letter Under DQSA/503B

On January 17, FDA issued its opening sally in the new compounding pharmacy enforcement regime by issuing a Warning Letter to Avella of Deer Valley in Phoenix, AZ. The letter is based on a nearly year-old inspection (February...more

Health Reform + Related Health Policy News - January 2014, Issue 1

In This Issue: - Top News ..Congress Approves Budget Deal with Short-Term ‘Doc Fix' ..CMS “Two-Midnight” Rule delayed until March 31, 2014 ..Individuals with Canceled Insurance Policies May Apply for...more

Judge Koh Tosses Restitution and Disgorgement Claims in Bumble Bee Class Action

In one of the first summary judgment rulings in the onslaught of food mislabeling and misbranding class actions, Judge Lucy Koh of the Northern District of California tossed the plaintiff’s restitution and disgorgement...more

Beware of What You Wish for, You Might Get It

As this blog has reported on numerous occasions, plaintiffs have brought claims challenging labeling of food products for mislabeling. The labels challenged include the use of the term “natural”, “0g trans fat” and the...more

Food Litigation Newsletter - November 12, 2013

In This Issue: - Recent Significant Developments and Rulings ..Court Rains on Plaintiff’s Vitamin Drink Suit Parade ..Potato Chip Misbranding Claims Half-Baked, Says Court ..Court: Pasta Claims Need More...more

J&J Will Pay $2.2 Billion and Enter 5-Year CIA to Settle Off-Label and Kickback Charges

This week, the DOJ announced that J&J has agreed to pay over $2.2 billion in civil and criminal fines in one of the nation’s largest ever health care fraud settlements. As part of the resolution, J&J subsidiary Jannsen will...more

"You Want Fries With That? New North Carolina Law Restricts Obesity Related Tort Claims"

North Carolina House Bill 683, known as the Commonsense Consumption Act (“Act”), became effective on October 1, 2013. The Act contains two main provisions. First, it provides that no city or county ordinance may prohibit the...more

Misbranded Drugs: A Danger To Physicians And Patients

Mail-order businesses, including pharmacies, bombard doctors by fax, phone, and Internet offering an assortment of name-brand medications and treatments at bargain prices. These new options tempt physicians with the promise...more

Food Litigation Newsletter - September 30, 2013

In This Issue: - Recent Significant Developments and Rulings ..Court Partially Pops Plaintiffs’ Claims in Wrigley ..Lack of Standing Dooms Plaintiff’s Yogurt Claims ..Court Stands By its Partial Class...more

California, the FTC, & Made in the USA Claims

Demi Lovato’s hit song “Made in the USA” recounts how her love for her boyfriend is both amazing and patriotic. If they had fallen in love in Paris or Acapulco, however, she may be facing an enforcement action by the FTC or...more

D.A.R.E. to Market Off-Label Uses of Prescription Drugs? Make Sure You are in the Second Circuit: United States v. Caronia and the...

Truthful, non-misleading off-label promotion of prescription drugs is not illegal. At least, not in the Second Circuit. This, despite the billions of dollars in civil and criminal penalties assessed against pharmaceutical...more

Misbranding Case Against Gerber Over “Stages” Baby Food Products Trimmed but Not Kicked Entirely

A recent case in the Northern District of California against Gerber over alleged misbranding of its “stages” baby food products demonstrates the difficulty companies face in knocking out food misbranding cases at the motion...more

Food Litigation Newsletter - September 16, 2013

In This Issue: - Recent Significant Developments and Rulings ..Court Trims Frito-Lay “All Natural” MDL But Rejects Preemption and Primary Jurisdiction Defenses ..Court Trims Claims in Gerber Baby Food Labeling...more

Food Litigation Newsletter - September 3, 2013

In This Issue: - Recent Significant Developments and Rulings ..Class Certification Denied in Case About Coffee ..Court Dismisses Case Attacking Gerber’s Overall Marketing Message ..Court Denies Smucker’s...more

Food Labels: Watch for Scary Ingredients

“If you use that word [natural], you’d better be sure you can defend every ingredient,” says Stern. Consumers are eager to know more about the food they buy, and companies are eager to tell them. But the companies face a...more

Two More Courts Defer to the FDA in Food “Misbranding” Class Actions

We previously reported Judge Yvonne Gonzalez Rogers’ decision to stay proceedings in the Cox v. Gruma Corp. matter while the FDA is asked to decide whether food products containing genetically modified organisms (GMOs) may be...more

Court Dismisses Labeling Claims Against Wholesoy, Deferring to the Authority and Expertise of the FDA

Are judges in the Northern District of California losing their taste for food labeling litigation? In a recent win for Wholesoy & Co., Judge Yvonne Gonzalez Rogers dismissed plaintiff’s “misbranding” claims concerning the...more

Brandaide® does not equal Band-Aid®

Choosing a great brand name that is strong and protectable is not always easy. But then what happens when you decide to protect that brand by filing for a trademark registration, and someone tries to stop you?...more

Ocean Spray Defeats Class Certification in Food Misbranding Action

Can a named plaintiff in a class action bring suit over products she didn’t buy? This issue has been heavily litigated in the recent wave of food misbranding cases. ...more

Federal Law Allows Guilt By Association

Imagine a hospital's assistant administrator submits millions of dollars in false claims to the Medicare program. Would the administrator face criminal liability if he had no knowledge of the criminal conduct of the...more

FDCA Express Preemption Victory in Benecol Misbranding Class Action

A recent Third Circuit case brings good news for defendants making express preemption arguments under the Food, Drug and Cosmetic Act (FDCA) in misbranding class actions. Last week, the court affirmed the dismissal of a...more

Energy Drink Regulatory Update: Monster Sues City of San Francisco in Federal Court, City Fires Back in California State Court

The FDA announced that it is conducting an investigation into the use of caffeine in foods and beverages. Since the FDA’s announcement, the energy drink industry has continued to receive significant media attention. On May 6,...more

Business Litigation Report -- April 2013

In This Issue: - Firm News: DoJ Star Healthcare Fraud Prosecutor Joins Washington, D.C. Office; and Quinn Emanuel Wins Top Honors at the Inaugural U.S. Benchmark Annual Awards - Main...more

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