Referring ‘natural’ claims issue to FDA would be 'futile’ says judge in suit vs General Mills
Meanwhile, “any referral to the FDA [on the ‘natural’ issue] would likely prove futile”, observed US District Judge Phyllis J. Hamilton in a May 10th order on a deceptive marketing lawsuit against General Mills over ‘natural’ claims on its Nature Valley granola bars.
In a complaint filed last summer, plaintiff Judith Janney (represented by the Center for Science in the Public Interest) alleged that marketing the bars as ‘natural’ was deceptive because they contain highly processed ingredients including high fructose corn syrup, high maltose corn syrup and/or maltodextrin.
General Mills immediately filed a motion to dismiss the case on the grounds that the FDA has primary jurisdiction in such matters.
Federal pre-emption does not apply in this case as this is not a technical question requiring agency expertise
In an order granting in part and denying in part General Mills’ motion, Hamilton agreed that “the FDA does have a position of sorts” on natural, having issued some (vague) guidance on natural claims in 1993 and written a handful warning letters referring to its appropriate use.
However, there is no legal definition, and the FDA is unlikely to come up with one anytime soon, she said.
Meanwhile the plaintiffs in this case are not asking the court to define ‘natural’, but to determine an issue of state law - whether General Mills’ marketing of its bars as ‘natural’ could mislead reasonable consumers.
“Plaintiffs… argue that cases involving whether or not food labels are misleading do not necessarily entail technical questions or require agency expertise, and that for that reason the court in this case should not invoke the primary jurisdiction doctrine.
“The question is a close one”, she said, but "on balance", she is inclined to agree with the plaintiffs that federal preemption does not automatically apply in such cases.
The FDA has signaled a relative lack of interest in defining natural
Besides, referring the case to the FDA would not resolve the issue, she said.
“In repeatedly declining to promulgate regulations governing the use of ‘natural’ as it applies to food products, the FDA has signaled a relative lack of interest in devoting its limited resources to what it evidently considers a minor issue, or in establishing some uniformity in administration with regard to the use of ‘natural’ in food labels.
“Accordingly, any referral to the FDA would likely prove futile.”
Plaintiffs ‘too vague ‘about why Gen Mills’ online marketing is deceptive
However, she did agree with General Mills that the plaintiffs had been too vague about why its online marketing of the bars was deceptive.
She added: “[The plaintiffs] do not specify what the exact false or misleading statements are, why the statements are false or misleading, where exactly the statements are located, or which statements plaintiffs relied on.”
CSPI: 'This is a clear rejection of the oft-repeated defense tactic of trying to send something to the FDA despite all evidence showing that it won't do anything'
Commenting on the order, CSPI director of litigation Steve Gardner told FoodNavigator-USA: "We view the opinion as a clear rejection of the oft-repeated defense tactic of trying to send something to the FDA despite all evidence showing that it won't do anything."
He added: "Whether Mills' practices violated California state consumer protection law is completely outside of the FDA's expertise. That's a jury question.
"In addition, there's a very clear record that the FDA isn't going to take action to define natural any time soon, so the judge was quite right that putting our case on hold would be futile."
Justin Prochnow: It is unlikely that courts will continue trying to get some sort of definitive answer from FDA on the subject of 'natural'
Justin Prochnow, an attorney in the Denver office of law firm Greenberg Traurig, told us he was not surprised that Hamilton believed referring this issue to the FDA would be futile.
He added: "In 2010, several federal courts stayed proceedings and certified to FDA the issue of whether high fructose corn syrup qualifies as 'natural'. The FDA declined, citing limited resources and more pressing food-safety concerns.
"It is unlikely that courts will continue trying to get some sort of definitive answer from FDA on the subject of 'natural' when it has steadfastly refused to do so. Although the FDA has issued warning letters and has taken an informal position on 'natural', its lack of interest in developing a formal definition makes the argument for preemption on the issue of 'natural' a difficult one."
General Mills told us: "We stand behind our products, and the accuracy of our labels."
Any amended complaint must be filed by June 7.
