Date: Dec 20, 2012
A federal district court has dismissed a case against General Mills for alleged mislabeling of Greek yogurt, stating that the U.S. Food and Drug Administration (FDA) is the appropriate party to resolve any ambiguities involving the standard of identity for yogurt. Instead of applying the more commonly seen doctrine of Preemption, this court based its decision on the doctrine of Primary Jurisdiction. This ruling may have significant practical implications for other pending lawsuits premised on compliance with standards of identity for food. The ruling could also provide defendants with an additional argument against escalating claims of false and misleading advertising.
For years, General Mills has used milk protein concentrate (MPC) in a line of products that it labels as "Greek yogurt." FDA has created standards of identity for yogurt, lowfat yogurt, and nonfat yogurt (21 CFR 131.200, 131.203, and 131.206, respectively). These standards define yogurt generally by reference to the use of certain optional ingredients and a characterizing bacterial culture. In the General Mills lawsuit – and in other lawsuits pending around the country – class action plaintiffs have alleged that the addition of MPC is not permitted within the federal standard, thus rendering the finished yogurt product misbranded. On December 10, 2012, U.S. District Judge Susan Richard Nelson of the District of Minnesota relied on the doctrine of primary jurisdiction to dismiss a class action lawsuit filed against General Mills, stating that "the FDA is in the best position to resolve any ambiguity about the standard of identity for yogurt – a matter requiring scientific and nutritional expertise."
The confusion over what is – and isn't – allowed in yogurt dates back to FDA's creation of the yogurt standard in 1981. The standard does not expressly permit the use of MPC, reconstituted milk, or whey protein concentrate – three ingredients that have come under fire in recent years for their alleged failure to comply with the yogurt standard. When FDA first issued the standard, it also proposed to limit "other optional ingredients" that could be included in yogurt to certain milk-derived ingredients, but in response to comments and objections, this limitation was stayed. Subsequently, FDA made informal statements indicating that it viewed the addition of MPC and whey protein concentrate to yogurt as permissible. In 2009, FDA attempted to update the yogurt standard, releasing a proposed rule that would permit the use of reconstituted milk and whey protein concentrate. The Agency was required to hold a public meeting to solicit stakeholder comments, but the meeting did not take place. FDA has not considered this issue to be a high priority, particularly in light of its already strained resources and the heavy task of implementing the FDA Food Safety Modernization Act (FSMA). The confusing history of the yogurt standards has generated an unclear regulatory landscape, prompting several consumer lawsuits in which plaintiffs claim they have been misled by mislabeled products.
This ruling has acknowledged another basis on which defendants may rely to defeat the ever-increasing number of class action lawsuits, in addition to the standard preemption argument. The General Mills court relied instead on the doctrine of "primary jurisdiction," which "applies where a claim is originally cognizable in the courts, and comes into play whenever enforcement of the claim requires the resolution of issues which, under a regulatory scheme, have been placed within the special competence of an administrative body," citing Alpharma, Inc. v. Pennfield Oil Co., 411 F.3d 934, 938 (8th Cir. 2005) (internal quotation and citation omitted). The Court acknowledged that a government agency's expertise is the most common reason to apply the doctrine, and in deciding to dismiss this action, directed the parties to initiate the proper proceedings with FDA.
This ruling accords significant deference to FDA to resolve the underlying issue of what is allowed in yogurt. The ruling also recognizes that FDA action would help ensure national uniformity in labeling, and it notes the existence of several recently-filed yogurt lawsuits throughout the country involving the same or similar issues, all of which increase the potential for inconsistent judicial rulings.
It remains to be seen whether and how quickly FDA will act to address the ambiguities in the decades-old yogurt standard. But the General Mills ruling makes it far more likely for similar class action lawsuits, especially those that involve standards of identity for food that have already been regulated by FDA, to be stayed or dismissed until the Agency weighs in.The primary jurisdiction argument may even be applied to false and misleading labeling claims for terms that have not been specifically regulated by FDA, such as "natural" claims. In 1991, FDA set out to develop a regulatory definition of the term "natural," but ended up reaffirming its informal policy on "natural" claims for food: whether the food contains any added color, artificial flavor, or synthetic substance that would not normally be found in the food or dietary supplement. Regardless of lack of regulation for this term, a federal court in the Northern District of California recently found the primary jurisdiction doctrine applicable to a claim that "natural" labeling on a cosmetic was false and misleading, stating that "courts do not decide [whether conduct is false or misleading] when such a decision would ‘undermin[e], through private litigation, the FDA's considered judgments.'" Astiana v. Hain Celestial Group, Inc., No. C 11-6342 PJH, USDC NDCA Nov. 19, 2012), citing Pom Wonderful LLC v. Coca-Cola, Co., 679 F.3d 1170, 1178 (9th Cir. 2012). The court declined to apply the FDA's informal policy of natural claims for food to cosmetics, and stated that in the absence of any rules or informal statements by the FDA doing so, it would not make an independent determination of whether the term as used was false or misleading. Thus, the doctrine of primary jurisdiction should be added to a defendant's arsenal in the food, drug, cosmetics, and supplements arena.