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FDA to Revisit “Evaporated Cane Juice” Draft Guidance

Earlier this month, the FDA announced that it would reopen the comment period on its draft guidance for the industry concerning use of the term “evaporated cane juice” (ECJ). Draft Guidance for Industry on Ingredients...more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

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

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

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

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

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

The First Amendment and Off-Label Promotion: United States v. Caronia

For years, the U.S. Department of Justice has aggressively pursued and brought charges over “off-label promotions”—the promotion of drugs for uses that have not received FDA approval—by pharmaceutical manufacturers and their...more

False Press Release Leads To Exclusion From Federal Programs

Dr. Harkonen was the CEO of InterMune, Inc, a pharmaceutical company that developed, marketed and sold drugs for lung and liver diseases, including Actimmune. In 2002, the FDA had approved Actimmune to treat only two...more

FDA Will Not Appeal Second Circuit Decision in U.S. v. Caronia

After the Second Circuit’s split decision in U.S. v. Caronia, holding that truthful off-label marketing is protected under the First Amendment and thus cannot be prosecuted under the misbranding provisions of the Food Drug...more

Second Circuit Declares Off-Label Promotion Ban Unconstitutional: Implications for False Claims Act Defendants

On December 3, 2012, the United States Court of Appeals for the Second Circuit held that the First Amendment protects pharmaceutical companies who truthfully promote the lawful, off-label use of prescription drugs from...more

Second Circuit Vacates Off-Label Promotion Conviction on First Amendment Grounds in U.S. v. Caronia

On December 3, 2012, a panel of three judges on the U.S. Court of Appeals for the Second Circuit overturned the November 2009 conviction of Alfred Caronia for conspiracy to introduce a misbranded drug into interstate commerce...more

Off-Label Marketing Questioned as a Viable Criminal Theory – But Stay Tuned

On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label...more

United States v. Caronia: Second Circuit Rules Manufacturers Cannot Be Criminally Prosecuted for Off-Label Promotion of Drugs...

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued a landmark decision in United States v. Caronia, holding that “the government cannot prosecute pharmaceutical manufacturers and their...more

9th Circuit’s POM Wonderful Ruling Could Influence Food Class Actions

Originally published in Washington Legal Foundation on August 3, 2012. Class action lawyers looking for a shakedown have gone on a food binge. They have focused on the food industry and the ever-obliging federal court...more

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