Labeling

News & Analysis as of

Changes to the regulation of pharmaceutical business in Kazakhstan: implications for pharmaceutical companies

A significant number of amendments have been introduced to the Healthcare Code* of the Republic of Kazakhstan on 6 April 2015 by the adoption of the Law On Introduction of Amendments and Additions to Certain Legal Acts of the...more

Alabama Legislature Says No to Innovator Liability

On April 29, 2015, the Alabama Senate passed a bill, SB80, “to provide that a manufacturer is not liable . . . for damages resulting from a product it did not design, manufacture, sell, or lease.” Sponsored by Senator Cam...more

Retail and Fashion Law Trends: What’s ‘‘In’’ for 2015

The retail industry saw a number of significant developments in 2014, many of which were a long time in the making. As courts begin to consider new claims and legislation that arose last year, the industry needs to be aware...more

Federal Appeals Court Revives Suit Over "All Natural" Cosmetic Labeling

“A product labeled ‘all natural’... likely evokes images of ground herbs and earth extracts rather than chemicals such as ‘Polysorbate 20’ or ‘Hydroxycitronellal.’” With that opening sentence, the Ninth Circuit Court of...more

Ninth Circuit Upholds FDA’s Primary Jurisdiction Over “Natural” Labeling On Cosmetics But Orders Stay Rather Than Dismissal

Plaintiffs’ lawyers love to challenge products labeled as “natural,” with hundreds of false advertising class actions filed in just the last few years. Recently, in Astiana v. Hain Celestial (pdf), the Ninth Circuit reversed...more

Polsinelli Podcasts - The Latest on a Shift in Regulation in Dietary Supplements [Video]

The FDA provides oversight of dietary supplements. Recently, the New York Attorney General's Office sent cease and desist letters to four major national retailers accusing them of selling dietary supplements that failed to...more

PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA [Video]

The rise of social media has introduced new opportunities and new legal challenges for companies in the health care industry. Attorneys Seth Northrop and Sharon Roberg-Perez discuss the legal issues faced by care providers,...more

Product Liability Update - April 2015

In This Issue: - First Circuit Holds State Law Claims Against Drug Manufacturer for Allegedly Misleading Efficacy Representations in FDA-Approved Label Preempted by Food, Drug & Cosmetic Act Because Plaintiffs’...more

Plaintiff Gets Burned By Article III in Sunblock Class Action

Can a plaintiff sue in federal court for consumer fraud when he never purchased and never used the product? This is not a trick question, and the obvious answer is also the correct answer. No, he can’t. But the point...more

Blog: West Virginia Repeals State’s Pharmaceutical Advertising Disclosure Law

The Governor of West Virginia signed last week Senate Bill 267 to repeal the Code provisions that created the Governor’s Office of Health Enhancement and Lifestyle Planning (GOHELP)....more

FDA Holds Public Hearing On Proposed Label Change Rule

On March 27, 2015, the FDA held a public meeting regarding its proposed generic drug labeling rule, a rule that would allow ANDA holders to unilaterally update labeling prior to FDA approval. Testimony from proponents of the...more

Spirits Industry Under Fire: What You Need to Know About Class Action Litigation

In this issue: - Where did these cases come from? - What are these cases about? - Who is driving these cases? - What are the Plaintiffs suing for? - Who is a likely target? - How can...more

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

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