Labeling The United States Food and Drug Administration

News & Analysis as of

House Passes Voluntary GMO Labeling Bill

The U.S. is a step closer to enacting a consistent, national approach to certifying and labeling genetically modified (GMO) foods. On July 23, 2015, the U.S. House of Representatives passed H.R. 1599, the Safe and Accurate...more

FDA Extends Menu Labeling Regulation to December, 2016

The Food and Drug Administration (FDA) just announced plans to push the effective date for its new federal menu labeling regulations to December 1, 2016.The FDA has extended the date (most recently, December 1, 2015) in order...more

Hidden Costs of Common Beauty Treatments?

The “toxic trio” is a foreboding name some associate with common and seemingly innocuous manicures and pedicures. Salon workers suffer higher-than-average rates of birth defects, miscarriages, cancers, and skin afflictions...more

FDA Extends Menu Labeling Compliance Date

On July 9, 2015, the U.S. Food and Drug Administration (FDA) announced that it is extending the date for compliance with its menu labeling requirements by one year. Under the new timeframe, businesses covered by the menu...more

FDA Extends Menu Labeling Deadline

Responding to input from stakeholders, the FDA has decided to extend the deadline for complying with its Menu Labeling Final Rule from December 1, 2015 to December 1, 2016. In general, the Rule requires chain restaurants and...more

Food for Thought: Ninth Circuit Holds Cosmetic Labeling Claims Not Preempted by FDCA, Primary Jurisdiction Appropriately Invoked

In April 2015, the Ninth Circuit held in a cosmetic labeling class action that the Food, Drug, and Cosmetic Act (FDCA) did not expressly preempt state causes of action predicated on federal cosmetics labeling laws and that...more

Feel The Burn: Court of Appeal Strikes Down State Law Claims Regarding Mislabeled Sunscreen Products Under Finding of Federal...

In Eckler v. Neutrogena (certified for publication 7/1/15, Case No. B2536910), the California Court of Appeal, Second Appellate District, upheld the trial court’s determination that plaintiffs’ claims of mislabeling sunscreen...more

Fun Fun Fun: Cal Court Dismisses Sunscreen Cases on Preemption

During a recent Surfin’ Safari we must have told the DDL Son at least five times to slather on more sunscreen. Naturally, he engaged in the usual noncompliance-defiance and, naturally, now has a face adorned with a scarlet...more

The Name Game: AbbVie’s Citizen Petition Regarding Biosimilar Labeling

On June 2, 2015, AbbVie submitted a citizen petition to the FDA arguing against its interim labeling requirements for biosimilar products under the Biologics Price Competition and Innovation Act (“BPCIA”). As of now, the FDA...more

FDA Approach to Labeling Treats Biosimilars Like Generics

One of the FDA’s recent biosimilar guidance documents has drawn criticism for eliminating labeling information necessary for physicians to make prescribing decisions. The guidance document, titled, “Scientific Considerations...more

New Judicial Interpretations on Scope of Hatch-Waxman Safe Harbor

The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more

Product Liability Hopping & the FDA’s Generic Drug Proposal – Awful Together

A major basis for our criticism of the FDA’s still pending generic drug labeling proposal, and why we prefer industry’s EAR (“Expedited Agency Review”) system better, is that the FDA’s proposal would create festival-seating...more

Abilify®’s Saga Continues: Otsuka’s Eight-Day Streak of Generic-Free Competition Ends, For Now

On May 27, 2015, the U.S. District Court for the District of Maryland granted FDA and the Defendant-Intervenors summary judgment against Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Development and Commercialization,...more

Pharmaceutical Marketing and Unfair-Trade-Practices Claims

Lawsuits against pharmaceutical companies generally center on product-liability claims. A new trend in pharma cases, however, is to include a different kind of claim: a claim for unfair trade practices....more

“Age Defying” Make-up Case Only Partially Defies Preemption

Coco Chanel said that nature gives you your face at 20, but you earn your face at 50. Perhaps that is not so different from Mark Twain’s theory that one’s wrinkles should merely be monuments to smiles. Those platitudes do...more

Food and Beverage News and Trends

KIND LLC faces challenges from FDA on its labeling claims. KIND LLC, a New York-based natural foods company, says it is working closely with the FDA to address issues raised by the agency in a warning letter over label...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

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

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

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

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

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