Judge stays Annie’s ‘natural’ lawsuit, says FDA is likely to address natural claims ‘in a relatively short amount of time’

Some judges*** have opted not to stay ‘natural’ cases given the FDA’s radio silence on the issue since its 2015 call for comments on natural definitions.

However, in an October 17 order, US district judge Jeffrey White predicted that the agency would weigh into the natural debate shortly, citing a recent report from the [House] Committee on Appropriations on a bill making appropriations for agriculture, rural development, the FDA, and related agencies for fiscal year 2018.

In this report, noted White, the committee calls on the FDA to report to Congress on the status of its rule-making on 'natural' claims within a fixed timeframe: “The Committee directs FDA to provide a report within 60 days of enactment of this Act on the actions and time frame 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.”

Judge White added: “The appropriations bill remains pending in Congress and, as a result, the FDA’s 60-day deadline … has not yet commenced. Nonetheless, the court believes that the congressional interest reflected in this committee report makes it likely that the FDA will address, in a relatively short amount of time, the use of the term ‘natural’ on food labels.”

That said, if the FDA’s rule-making on ‘natural’ claims is not completed by January 15, 2018, the parties in the lawsuit must file a joint status report setting forth their respective positions on whether the stay should continue, he said.

Would reasonable consumers consider products containing xanthan gum to be ‘natural’?

In the April 2017 lawsuit - (Rosillo et al v Annie’s Homegrown Inc et al, 4:17-cv-02474, in the northern district of California), which was followed in August by a near-identical lawsuit (Campbell v. Annie's Homegrown, Inc. et al 3:17-cv-01736, in the southern district of California) – the plaintiff alleges that reasonable consumers would not expect to find xanthan gum in foods labeled as ‘natural.’

Xanthan gum – a widely used thickener and stabilizer - is produced on a commercial scale via the fermentation of sugars with the bacterium Xanthomonas campestris​, and then harvested via precipitation with isopropyl alcohol (rubbing alcohol), a process the plaintiffs argue shoppers would not consider to be ‘natural.’

How does the FDA view xanthan gum?

The FDA lists fermentation as an acceptable production method for natural flavors, but has not specifically opined on the naturalness or otherwise of other food ingredients produced via microbial fermentation.

In its oft-quoted 1991 guidance, the FDA states only that natural means “nothing artificial or synthetic . . . ​is included in, or has been added to,​​​ ​the product that would not normally be expected to be there,​” but doesn't say whether certain production methods such as microbial fermentation disqualify an ingredient from making ‘natural’ claims.

Indeed, the FDA explicitly noted in its 2015 call for comments​​ that it did not​ consider production methods when it came up with the above guidance.

"When we established our policy concerning the use of the term 'natural,'... it was not intended to address food production methods, such as the use of genetic engineering or other forms of genetic modification, the use of pesticides, or the use of specific animal husbandry practices, nor did it explicitly address food processing or manufacturing methods, such as thermal technologies, pasteurization, or irradiation."​

Is xanthan gum considered to be a ‘clean label’ ingredient?​

As to whether xanthan gum is considered to be a ‘clean label’ ingredient, that depends on who you ask (some food marketers don't like any words on their ingredients lists featuring an 'x').

However, the team behind the Go Clean Label​​ site notes that right now, at least, xanthan gum​​ is not on the ‘unacceptable ingredients’ lists of any of the key retail influencers (Whole Foods, Panera, Kroger, Trader Joe’s, H.E.B and Aldi).

It is also “one of the few hydrocolloids that actually can be found at premium, organic retail grocery stores and in kitchen cupboards of the everyday cook.”​

Attorney: Xanthan gum is ​something consumers might expect to see in natural salad dressing

General Mills has not commented on the lawsuits, but in a motion to dismiss the Rosillo complaint filed in May, its attorneys argued that reasonable consumers would not balk at seeing xanthan gum in products labeled ‘natural’ given that the ingredient is approved for use in products labeled as ‘organic.’

Asked for his take on the case, Angel Garganta, a partner in Venable’s commercial litigation practice group (which is not involved in the case) told FoodNavigator-USA:

"When plaintiffs quote the FDA 1991 guidance about 'nothing artificial or synthetic... has been added to foods, they always forget to quote the last part of the sentence: 'that would not normally be expected to be there.'

“General Mills is arguing that xanthan gum - a very widely used ingredient that's also allowed in organic products - is absolutely something consumers might expect to find in a salad dressing labeled 'natural.'"​​

*Rosillo, et al. v. Annie’s Homegrown Inc., 3:17-cv-02474, in the northern district of California, filed May 1, 2017

** The judge has put the case on ice because the FDA has explicitly said it is looking into the issue of natural claims on food labels and therefore has ‘primary jurisdiction’ over this matter.

***For example, the judge handling a lawsuit over natural claims on Hint beverages​​ refused Hint’s request to stay the case in June, arguing that, “Without any sense as to when, or even if, the FDA will follow up on its request for public comment and issue formal guidelines regarding the use of 'natural' in food labeling, it would be improper for the Court to stay the proceedings in this action.”​