Still Waiting—FDA Delays Rulemaking
- The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the rule in its current form. The rule, originally proposed... ›
FTC Targets “All Natural” and “100% Natural” Claims on Personal Care Products
By: Claudia M. Vetesi
As we have previously reported, FDA is currently seeking public comments on the use of the term “natural” on food labeling (see our previous post here ). The announcement came as a surprise since FDA had previously declined requests from consumers, the food industry,... ›Bimbo Bakeries Suit On Hold Pending Ninth Circuit Class Certification Appeals
We’ve recently reported on numerous district court—and even Ninth Circuit—stays in false advertising actions. Many of these stays have been based on FDA’s consideration of food labeling issues, such as those involving evaporated cane juice (ECJ), the term “natural” or the presence of partially... ›- - FDA
Cut the Fat . . . Just Not Yet: Court Rules that PHO Claims Are Preempted
Northern District of California Judge Maxine Chesney recently granted Nestlé’s motion to dismiss a challenge to partially hydrogenated oil (PHO) in Nestlé’s Coffee-mate ® coffee-creamer products, finding plaintiff’s claims were preempted by federal regulations set to be implemented three years from enactment. Backus v.... › Ninth Circuit Revives Chobani Yogurt Action, But Puts Claims on Ice and Leaves Questions Unanswered
By: Claudia M. Vetesi
There has been much recent discussion of the primary jurisdiction doctrine, as well as stay motions based on the doctrine, related to FDA’s review of its evaporated cane juice (ECJ) draft guidance. Now, in its recent memorandum disposition in Kane v. Chobani , LLC... ›Federal Preemption Claims: Clear Evidence and an Unclear Standard
By: Erin M. Bosman and Julie Y. Park
Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc. , 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The court found that the FDA’s rejection of... ›- - FDA
The (Not So) Sweet Sound of FDA’s Silence: Judge Seeks Answers from FDA on ECJ Draft Guidance
We recently reported on developments in evaporated cane juice (ECJ) stays pending the FDA’s finalized guidance on the ingredient. ( See Reviving a Forgotten Fad: Three Judges Lift Stays of Evaporated Cane Juice Claims .) In March 2014, FDA announced that it would revise its... › Testing 101: Court Dismisses Whole Foods’ Yogurt MDL over Failure to Comply With FDA Testing Requirements
By: Claudia M. Vetesi
On February 16, 2016, U.S. District Judge Sam Sparks of the Western District of Texas dismissed a multidistrict litigation involving 11 putative class action lawsuits against various Whole Foods corporate entities and Skotidakis, Inc. , a third-party manufacturer, based on an alleged misrepresentation regarding... ›HIPAA and Health Care Apps: Is Your App Covered?
By: Erin M. Bosman and Julie Y. Park
Health care apps are one of the most important and growing segments in the ecosystem known as the Internet of Things (IoT). After the recent amendments to the Health Insurance Portability and Accountability Act (HIPAA) that, among other things, broadened the definition of a... ›FDA Embraces Internet of Things: New Draft Guidance on Postmarket Cybersecurity for Medical Devices
By: Erin M. Bosman and Julie Y. Park
The FDA’s recently issued draft guidance on “ Postmarket Management of Cybersecurity in Medical Devices ” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about postmarket cybersecurity standards related to medical devices. Because the consequences of... ›