Legal Newsline

Friday, August 23, 2019

Warning letters from FDA cited in Ninth Circuit's decision in Dole class action

By Robert Lawson | Nov 15, 2016

SAN FRANCISCO (Legal Newsline) — A federal appeals court has allowed a class action lawsuit against Dole over the term "all natural fruit" to proceed.

In September, the U.S. Court of Appeals for the Ninth Circuit reversed a lower court's decision that dismissed the case. An attorney for Dorsey & Whitney says the court in Brazil v. Dole pointed to warning letters from the Food and Drug Administration about additives in Dole's products.

The plaintiff claimed fruit sold by Dole was labeled “all-natural fruit,” and the basis for the lawsuit asserts that preservatives contained within the packaged product disqualified the products to be considered all-natural and deceived consumers. Robert J.M. Lee, Dorsey & Whitney LLP attorney, recently wrote that the Ninth Circuit answered this question of labeling with a "definitive 'maybe.'"

The warning letters used by the plaintiff, Chad Brazil, pointed to claims about natural labels on tomatoes that contained some artificial citric acid.

"The warning letter about additives in tomatoes was an example of an important point by the Ninth Circuit: the mere presence or absence of a substance is not necessarily the FDA’s focus," Lee said

"In that example, citric acid [one of the two additives around which the lawsuit revolved] is found naturally in tomatoes but added synthetic citric acid makes the 'natural' label objectionable to the FDA in the court’s view. 

"In contrast, the district court’s summary judgment order focused only on whether a substance 'would not normally be expected to be in’ those products'."

Lee pointed out the current FDA rules about these kinds of product label issues are informal.  

"Here, 'informal' means that the FDA has not gone through official rule making to define 'natural,'" Lee said. "As cited by both the district court and the Ninth Circuit, the FDA considered officially defining the term, but ultimately declined to do so in 1993."

The Ninth Circuit reversed a decision by the district court, which noted the plaintiff needed to provide more evidence in court to satisfy the burden of proof that a significant number of consumers were impacted for summary judgement and also ruled that FDA warning letters to Dole used in court were insufficient to provide grounds for a solid argument. 

The Ninth Circuit reversed the ruling and sent it to a jury. 

Lee says some specific ways that food manufacturers and brands can protect themselves from liabilities related to ads and labels. Lee also said expenses and costs related to this vary for companies considering keeping themselves protected from such liability.  

"As with any shift in a company’s policies or strategies, it could vary substantially depending on the company’s specific products and the extent of the company’s efforts," Lee said. 

"For example, generally, once a company knows the lay of the land as to the FDA warning letters important to its specific product lines, keeping up to date on new letters of interest should not be too time-intensive or costly. 

"Something like focusing in on a consumer’s non-literal understanding of a label or advertisement, on the other hand, could represent a more substantial investment because that could require some sort of market-based research to be conducted by the company."

Lee said companies should also not simply focus on the literal wording of labels and ads alone, considering these "informal" policies by the FDA. 

Want to get notified whenever we write about U.S. District Court for the Northern District of California ?

Sign-up Next time we write about U.S. District Court for the Northern District of California, we'll email you a link to the story. You may edit your settings or unsubscribe at any time.

Organizations in this Story

U.S. District Court for the Northern District of California