Topic Archives: FDA

Cheese
January 6, 2017Class Action, Consumer Products, FDA, Retail

California Court Denies Stay of Consumer Class Action Challenging “Natural Cheese”

On December 6, 2016, United States District Judge John A. Kronstadt for the Central District of California denied a motion to stay a class action alleging violations of the UCL, FAL, and CLRA against Kraft Foods Group, Inc. based on the term “natural cheese” on the packaging of its shredded cheddar cheese product, which allegedly contain artificial coloring. ...›

Branded Generic
July 21, 2016FDA, Product Liability

FDA Releases Draft Guidance For Updating Generic Drug Labels

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance addresses updates to ANDA labels where the product’s reference listed drug (RLD) was withdrawn for reasons other than safety or effectiveness, providing insight on the responsibilities of ANDA holders to update their drug labels and the processes for doing so. ...›

Branded Generic
June 15, 2016FDA

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. ...›

Bimbo Bakeries

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 hydrogenated oils (PHOs) in food products. ...›

Pharma
March 30, 2016FDA, Product Liability

Federal Preemption Claims:
Clear Evidence and an Unclear Standard

Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. The court found that the FDA’s rejection of additional warnings and consistent approval of labeling contrary to plaintiff’s demands constituted “clear evidence” of a conflict between federal and state law, and therefore served as grounds for preemption. ...›