Labeling

News & Analysis as of

Appellate Court Gets It Right: Realistic Product Use Data Can Be Used by Businesses to Defend Lawsuits

California’s First District Court of Appeal issued a unanimous and potentially far-reaching and precedent-setting decision on March 17, 2015, siding with businesses in our defeat of a lawsuit that sought to require cancer and...more

Locke Lord QuickStudy: Tito’s Case to Move Forward — Court Denies Motion to Dismiss

On March 18, 2015, a federal judge in San Diego issued an eagerly anticipated ruling on the motion to dismiss filed by Fifth Generation, Inc. (the producer of Tito’s Handmade Vodka), effectively denying Tito’s motion to...more

Food for Thought: Mirabella v. Vital Pharmaceuticals, Inc.

In Mirabella v. Vital Pharmaceuticals, Inc., consumers sued the manufacturer of Redline Xtreme Energy Drink, alleging that the manufacturer concealed the dangerous side effects of the energy drink. Plaintiffs requested relief...more

The 'Palmetto Put-Down' Endangers Drug Cos. Nationwide

On Feb. 25, 2015, nearly two years after argument, the South Carolina Supreme Court directed entry of a $136 million judgment against Janssen Pharmaceuticals Inc. These civil penalties stemmed from a suit brought by the...more

A Clean Slate? California Bill Is Latest Attempt to Legislate Labeling Requirements for Cleaning Products

Another potentially meaningful development in legislation affecting consumer products companies: on February 25, a California legislator introduced a bill, AB 708, that would require manufacturers, distributors and retailers...more

Safety Labeling: Public Meeting Later This Month and Comment Period Extended – Key Dates Coming Up

On March 27, 2015, FDA plans to hold a public meeting entitled, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”. The meeting was announced in a Federal Register Notice posted...more

And the Beat Goes On: NY State Assembly to Vote on GMO Labeling Law

Coming on the heels of the reintroduction of the Genetically Engineered Food Right-to-Know Act, on March 3, 2015, the New York State Assembly Committee on Consumer Affairs and Protection voted 9 to 6, with one abstention, to...more

Is Toxic Flooring the New Chinese Drywall?

A few days ago, the popular television program “60 Minutes” aired a story about a national flooring retailer selling Chinese-manufactured laminate flooring that contains extremely high levels of the cancer-causing chemical...more

No Longer at Lager-Heads: Anheuser-Busch Settles Claim over Kirin Beer’s Origin

Early this year, Anheuser-Busch settled a class suit filed against it by two Miami residents who alleged that the company was deceptively advertising Kirin beer as imported from Japan, when in fact it is brewed in the United...more

First Circuit Finds Federal Preemption of State Tort Claims That Conflict With A Medication’s FDA-Approved Labeling & Warnings

An opinion issued by the U.S. Court of Appeals for the First Circuit on February 20, 2015 held that the Federal Food, Drug, and Cosmetic Act (“FDCA”) preempted claims that Lexapro’s U.S. Food and Drug Administration (FDA)...more

Free Speech & Pharmaceutical Promotion — U.S. ex rel. Solis v. Millennium Pharmaceuticals, Inc.

Off-label prescription drug use — using drugs to treat ailments not indicated on FDA-approved labeling — is among the thorniest legal issues facing the pharmaceutical sector. On one hand, off-label prescriptions are lawful...more

Deja Vu All Over Again: Federal GMO Labeling Legislation Re-Introduced

Last week, Sen. Barbara Boxer of California, Richard Blumenthal of Connecticut, and Rep. Peter DeFazio (D-Ore)–joined by chef-lebrity Tom Colicchio–announced the reintroduction of The , a federal bill that would mandate the...more

FDA Revisits Its Proposed Rule Regarding Generic Drug Labeling

On February 18, 2015, the FDA announced that it is reopening the comment period for its proposed rule that would allow ANDA holders to unilaterally update their generic drug product labels prior to the NDA holder doing so....more

Proposed Prop 65 Rules Won't Please Calif. Businesses

California’s Proposition 65 warning requirements (Health & Safety Code Sections 25249.6 et seq.) have long been a major concern for businesses that want their products offered for sale in the state’s large marketplace....more

Advertising Law - February 2015 #3

FCC Chair Announces New Net Neutrality Regs - The battle over net neutrality took a new turn when Federal Communications Commission Chairman Tom Wheeler announced his intention to reclassify broadband service as a...more

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

Made in the USA?: Suit Against Nordstorm Alleging Misleading Jeans Labels May Proceed

How much of a product has to be “Made in the USA” for a company to label it as such, and who gets to decide? Those questions are raised by an ongoing action lawsuit before a federal court in the Southern District of...more

Supreme Court Takes a Pass on Generic Drug Labeling Appeal

In the watershed case of PLIVA, Inc. v. Mensing, the United States Supreme Court determined that federal law preempts state law failure-to-warn claims against generic pharmaceutical manufacturers. More specifically, Mensing...more

Advertising Law - January 2015 #3

President Obama Focuses on Cybersecurity, Privacy, Data Breach Notification - Data security and privacy concerns received special attention in President Obama’s State of the Union address where the President advocated...more

State of the GMO Union

Just how hot is GMO-labeling legislation? On Jan. 6, 2015, a Republican state senator introduced just such a bill - in Indiana, the nation’s breadbasket. Still, federal legislation on both sides of the issue has stalled, the...more

Kimberly-Clark Corporation Wins Motion to Dismiss in Flushable Wipes Case

Judge Phyllis J. Hamilton of the Northern District of California recently granted Kimberly-Clark’s motion to dismiss a case challenging the truthfulness of the defendant’s claims that its wipes are flushable. Davidson v....more

Product labeling requirements aren't all black and white

Your company has created and developed a new, innovative product. You’ve tested your product, you’ve adopted a new trademark, and you’re ready to begin manufacturing. The remaining steps of preparing your product for sale,...more

FDA Regulatory and Compliance Monthly Recap - December 2014

FDA replaces pregnancy labeling system with a new standard in a bid to provide more clarity - The regulator is discarding its decades-old system to explain the risks of prescription drugs to women who are pregnant or...more

Vermont Doubles Down: Representative Testifies Before Congress Against Federal GMO Labeling Bill

As we’ve explored in past posts, Congress is currently considering a bill that aims to harmonize the patchwork of state efforts at regulating GMO labeling by placing such regulation firmly within FDA’s jurisdiction. Dubbed...more

Health Care Update - December 2014

In This Issue: - FDA Releases Menu Labeling Rule - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Upcoming Congressional Hearings - Excerpt from FDA...more

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