FDA 'respectfully declines' judges' plea for it to determine if GMOs belong in all-natural products

The FDA was first asked to make such a determination by judge Yvonne Gonzalez Rogers in a July 2013 order on a deceptive marketing lawsuit filed by Elizabeth Cox vs Gruma Corp (4:12-cv-6502) over ‘all-natural’ claims on Mission tortilla chips, which Cox alleged contain ingredients from biotech corn.

Rogers put the case on ice for six months and referred “to the FDA, for an administrative determination, the question of whether and under what circumstances food products containing ingredients produced using bio-engineered seed may or may not be labeled ‘Natural’.”​

While some colleagues handling similar cases argued the courts were more than capable of determining whether reasonable consumers had been misled by natural claims without the FDA weighing in, other judges followed Rogers’ lead.

Notably, the Barnes v Campbell Soup (3:12-cv-05185) case over natural claims on selected soups was stayed for six months by judge Jeffrey S White, and the General Mills Inc Kix cereal litigation (2:12 -cv-00249) was “administratively terminated​” by judge Kevin McNulty pending FDA’s response to the referrals.

FDA: If we did attempt to define ‘natural’, we’d issue a regulation or formal guidance for public comment​

But their hopes were dashed in a January 6, 2014, letter​ from FDA assistant commissioner for policy Leslie Kux.

Were the agency inclined to change its current policy on natural (ie. “nothing artificial or synthetic - including all color additives regardless of source - has been included in or added to a food that would not normally be expected to be in the food”),​ said Kux, “We would likely embark on a public process such as issuing a regulation or formal guidance…​

“We would not do so in the context of litigation between private parties.” ​

FDA: Any definition of ‘natural’ has implications well beyond narrow scope of GMOs​

Kux also noted that: “Any definition of natural on food labeling has implications well beyond the narrow scope of genetically engineered food ingredients.”​

Meanwhile, even if the FDA were to embark on a public process to define natural in the context of food labeling, said Kux, “there is no assurance that we would revoke, amend or add to the current policy or develop any definition at all.”​

Finally Kux pointed out that “in a world with limited resources​”, the FDA currently has more pressing priorities relating to “public health and safety matters​”.

CSPI: Waiting for the FDA to act is like waiting for Godot. But it’s made the right decision here​

So what do legal experts make of the FDA's response?

Stephen Gardner, director of litigation at the Center for Science in the Public Interest (CSPI) - who has sued scores of food and beverage giants over allegedly false and misleading claims, including ‘all-natural’ claims - told FoodNavigator-USA he welcomed the agency’s response.

He said: “The FDA is correct. The only right way for FDA to define natural would be in a rulemaking context, which would take years.​

“Primary jurisdiction, which is what courts use in granting stays such as these, is not in fact about court jurisdiction, but rather about deference to a regulatory agency. But it’s only appropriate to defer when there is a chance in hell of agency action. I don’t see that as to the natural cases, at least not any time soon.”​

He added: “We’ve succeeded in three out of three cases in which CSPI was involved as counsel in convincing courts not to stay the civil lawsuits while waiting for Godot (d.b.a. FDA) to take action.​

“So it’s good to see the FDA acting, although all it’s doing is to announce its intention not to act."​

Kristen Polovoy: ​

Kristen Polovoy from the litigation department of Montgomery, McCracken, Walker & Rhoads LLP, said the FDA's polite refusal was "not altogether surprising, given the briar patch of challenges that would be involved in attempting to define “natural” – a definition that implicates many economic and logistical considerations for the food industry, not the least of which is the fact that any “natural” definition would have to account for issues far beyond GMO ingredients, such as artificial sweeteners and certain processing technologies.  ​

"Nevertheless, the FDA last year demonstrated more willingness than ever before to take positions on issues that impact the national consumer fraud food labeling class action uptick in recent years, such as the FDA’s: (1) August 2013 federal definition of “gluten free” for food manufacturers that voluntarily label FDA-regulated foods as gluten free; (2) December 2013 clarification of what the gluten-free definition means for restaurants; and (3) November 2013 announcement of a planned phase-out of partially hydrogenated oils.​

"So, I don’t think the January 6 letter is the last we’ll hear from the Agency on the “natural” definition controversy."​

Natural claims and legal confusion​

The issue of whether GMOs belong in ‘all-natural’ products - which is at the center of a growing number of proposed class action lawsuits against big food brands - has featured heavily in the debate over GMO labeling, with some state-led GMO labeling initiatives stipulating that products containing GMOs should not be dubbed ‘natural’.

While anti-GMO activists argue that GMOs are the text-book example of something that isn’t ‘natural’, other observers argue there is nothing ‘natural’ about many conventional plant breeding techniques either - while none of the food crops grown commercially today would have occurred ‘naturally’.

Meanwhile, the Grocery Manufacturers Association (GMA) recently upped the ante on this issue by telling the FDA it plans to file a petition asking the agency to issue a regulation that would authorize GM foods to be labeled ‘natural’ (click here​).

Click here​ to find out more about a Feb 13 legal webinar hosted by Perrin Conferences on 'all-natural' claims on food labels moderated by FoodNavigator-USA editor Elaine Watson.

Click here​ to read the FDA's letter.