Labeling

News & Analysis as of

USDA Issues Final Rule Amending Voluntary Labeling Program For Biobased Products

On June 15, 2015, the U.S. Department of Agriculture (USDA) issued final amendments to the regulations concerning the Voluntary Labeling Program for Biobased Products. The rule is intended to incorporate statutory amendments...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

The Label on Your "Handmade" Whiskey Is Causing More Problems Than You Think

The recent market for artisanal and handcrafted goods has spawned a spate of consumer class actions against makers of popular liquors, including Tito’s Vodka, Maker’s Mark, and Jim Beam, for using terms like “handmade,”...more

Health Canada Proposes Changes to the List of Recognized Standards for Medical Devices

Changes affecting the approval of medical devices are coming. On May 6, 2015, Health Canada released a draft List of Recognized Standards for medical devices for stakeholder consultation. The consultation period is open...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

Transatlantic Trade and Investment Partnership ('TTIP') - The main points

What is TTIP? The Transatlantic Trade and Investment Partnership ('TTIP') is an ambitious trade and investment agreement currently being negotiated between the European Commission and the United States. The European...more

Tailoring the Suit: Plaintiffs File Amended Complaint in Nordstrom Rack Price-Tag False Advertising Lawsuit

Nordstrom Rack has recently found itself at the center of an unwelcome suit over its labeling practices. Nordstrom Rack discloses the savings it offers customers by placing “compare at” labels on its price tags which show two...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

Wet Wipes Manufacturer Must Back Up Its Flushing Claims (And Not Consumers’ Plumbing)

On May 18, 2015, the FTC announced a settlement with Nice-Pak Products, Inc., concerning claims that its moist wipes are “flushable,” “break apart after being flushed,” and are “safe” for sewer and septic systems. Nice-Pak...more

A Gathering Storm in the Dietary Supplement World

This past February, the New York State Attorney General's office accused four major retailers of selling fraudulent and possibly dangerous herbal supplements and demanded that they remove the products from their shelves. The...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

U.S. OSHA HCS 2012 Deadline Less Than Two Weeks Away

On March 26, 2012, OSHA issued a final rule modifying its HCS to conform to the United Nations' Globally Harmonized System of Classification and Labeling of Chemicals (GHS), Revision 3. In the final rule, OSHA drastically...more

USDA Establishing Non-GMO Labeling Program

In a memo to U.S. Department of Agriculture (USDA) employees, Secretary Tom Vilsack revealed that the Agricultural Marketing Service (AMS) is developing a non-GMO certification program. According to the Secretary, the program...more

Maker’s Mark Defeats “Handmade” Class Action Lawsuit

Could consumers have plausibly believed that one of the country’s top-selling bourbon brands is “handmade”? Not according to one federal district court in Florida, which recently dismissed a class action alleging Maker’s...more

California District Court Refuses To Certify 33-Jurisdiction Class Due To Material Variations in State Warranty Law

The U.S. District Court for the Eastern District of California certified a California-only subclass of purchasers of allegedly mislabeled KitchenAid refrigerators but denied plaintiffs’ motion to certify a 32-state and...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

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

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