Publication Details

Pass the Xantham Gum: The FDA’s New Guidance On What May Be Considered “Natural” May Be Imminent . . . Or Not

Mar 29, 2018 | Posted by Alexandra L. Preece | Topic: Class Actions

An order issued in a class action in the Northern District of California may be a hint that the long-awaited guidance from the U.S. Food and Drug Administration (“FDA”) on the use of the term “natural” in food labeling may be released in the near future.  In Rosillo v. Annie’s Homegrown, Inc., Case No. 4:17-cv-02474, the plaintiff alleges that the defendants, Annie’s Homegrown Inc. and General Mills, Inc., advertise and sell “Annie’s Naturals” products, and that despite the use of the term “natural,” the products actually include a synthetic ingredient—xantham gum.  Xantham gum, a widely used thickening agent commonly found in salad dressings, is produced via fermentation of sugars and a bacterium called Xanthomonas campestris.  The FDA currently considers fermentation an acceptable method of producing natural flavors and xantham gum is approved for use in products labeled as “organic.”

In Rosillo, the plaintiff alleges that xantham gum is not “natural,” and asserts various false advertising, unfair competition, and warranty causes of action against Annie’s Homegrown Inc. and General Mills, Inc.  The defendants moved to dismiss, or in the alternative, to stay the action because the FDA has commenced regulatory proceedings to explore whether, and to what extent, it should regulate the term “natural.”  The FDA’s regulatory proceedings began in late 2015, when the FDA asked for public comments on the use of the term “natural” in the labeling of human food products.  The request came after the FDA received Citizen Petitions asking that the agency define the term “natural” and/or prohibit the use of the term “natural” on food labels.  While the comment period ended in May 2016, the FDA has not yet issued any guidance on the matter.

In October 2017, the Rosillo court stayed the case pending the FDA’s completion of the regulatory process.  To reach this conclusion, the court relied on a bill report accompanying the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill, which directed the FDA to provide a report within 60 days of the enactment of the Act “on the actions and timeframe for defining ‘natural’ so that there is a uniform national standard for the labeling claims and consumers and food producers have certainty about the meaning of the term.”  Given this language, the Court concluded the FDA was likely to address, “in a relatively short amount of time,” the use of the term “natural” on food labels and stayed the case. 

Despite the Rosillo court’s optimistic outlook, the FDA has not yet issued its guidance on the term “natural.”  In January 2018, the Rosillo court continued the stay of the case to allow the FDA further time to complete its regulatory process.  If the FDA does not issue its ruling by July 2018, however, the court advised that it would likely lift the stay.  At which point, the court will have to address the legal issues before it, regardless of how imperfectly articulated that law regarding “natural” ingredients may be.

We will keep you apprised as this case develops, as there has been an uptick in class actions involving challenges to the use of the word “natural” for a myriad of different products.