Topic Archives: FDA

Ninth Circuit Revives Gerber Baby Food Class Action

Bruton v. Gerber, No. 15-15174.  The district court had dismissed Plaintiff’s unjust enrichment claim, denied class certification for lack of an “ascertainable class,” and granted summary judgment to Gerber because Plaintiff lacked evidence of deception.  The Ninth Circuit reversed the rulings and remanded the case. Background of the Case.  Plaintiff alleged that the labels on ...›

Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule

President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s proposed generic drug labeling rule.  The proposed rule would give generic drug manufacturers responsibility for maintaining the accuracy of their abbreviated new drug application (ANDA) labels, allowing them to make ...›

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

FDA Releases Draft Guidance For Updating Generic Drug Labels

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the goal of facilitating certain updates to abbreviated new drug application (ANDA) labels. In particular, the draft guidance addresses updates to ANDA labels where the product’s reference listed drug (RLD) was withdrawn for reasons other than safety or effectiveness, providing insight on the responsibilities of ANDA holders to update their drug labels and the processes for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

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. ...›