FDA Regulatory Update: What Does “Natural” Mean? Courts Divided on Whether to Seek FDA’s Input
As we previously reported here, here, and here, consumer litigation challenging “natural” and Genetically Modified Organisms (“GMOs”) advertising and labeling claims has steadily been on the rise. In recent months, a number of class action lawsuits against major food corporations have alleged that the companies misled consumers by labeling products containing GMOs as “natural.” These cases highlight the confusion regarding the definition of the term “natural,” and raise questions about whether courts, in reviewing allegations for mislabeling and deception, should defer to the FDA”s specialized knowledge or expertise.
Regulatory Background: FDA”s Description of “Natural”
For the purposes of food labeling, the term “natural” has not been formally defined by any FDA statute or regulation. The FDA has made reference to “natural” labeling but has not offered a concrete definition of when the term may be used to describe a food product. In a non-binding guidance document, the FDA described the term to mean that “nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food.” When pushed by industry and consumers for information regarding whether or not bioengineered ingredients or GMOs fit within the description above, the FDA failed to offer any useful clarification. Instead, the FDA responded by stating that it “does not require special labeling of bioengineered foods” because it is “not aware of any data or other information that would form a basis for concluding that the fact that a food or its ingredients was produced using bioengineering is a material fact that must be disclosed on food labels.” (To read the full text of the FDA”s guidance document, please click here.)
Several of the consumer class action cases pending before district courts allege that a food product”s label is false, misleading and deceptive where the product is labeled as “Natural” or “All Natural” or “100% Natural” but also contains ingredients that are GMO. In order to persuade the courts to dismiss or stay the proceedings pending a referral of the issue to the FDA, the defendant food companies have invoked the doctrine of primary jurisdiction. Generally, the primary jurisdiction doctrine permits courts to stay proceedings or to dismiss a complaint without prejudice pending the resolution of an issue within the special competence of an administrative agency. When deciding whether to invoke the primary jurisdiction doctrine, a court weighs several factors, including the need to resolve the issue, whether the issue has been delegated by Congress to an administrative body, and whether the issue requires expertise or uniformity in administration.
A recent string of decisions suggest that district courts disagree on the issue of whether courts should refer the task of defining what constitutes “natural” to the FDA. In Cox v. Gruma, the plaintiffs alleged that the labels on Gruma”s food products stating that the products are “all natural” were false and misleading because the products contain GMOs. Judge Rogers in the United States District Court for the Northern District of California issued an Order which stayed the proceedings for six months and referred to the FDA the question of whether and under what circumstances food products containing GMOs may or may not be labeled “Natural,” “All Natural,” or “100% Natural.” The Order stated that “deference to the FDA”s regulatory authority is the appropriate course” because doing otherwise would risk “usurp[ing] the FDA”s interpretive authority” and “undermining, through private litigation, the FDA”s considered judgments.” (For more coverage on the Cox v. Gruma case, please click here and here.)
One week later, Magistrate Judge Watanabe of the United States District Court for the District of Colorado issued an Order in a similar case, Van Atta v. General Mills. The Order recommended that the case be stayed pursuant to the primary jurisdiction doctrine “pending action by the FDA with respect to the referral made by Judge Rogers in Cox v. Gruma.” The Order explained that the “issues of fact in this matter are not within the conventional experience of judges” because the FDA has regulatory authority to oversee food labeling. (For more coverage on the Van Atta v. General Mills case, please click here.)
Next, in Parker v. JM Smucker Co., the plaintiffs alleged that the labeling of multiple Crisco products is false and misleading because the products are made with bioengineered corn and are highly processed. (To read additional coverage about Parking v. JM Smucker, please click here.) The presiding judge, Judge Conti, was not convinced that the court should defer to the FDA”s expertise and regulatory authority. In his Order, Judge Conti reasoned that the primary jurisdiction argument was unpersuasive because “various parties have repeatedly asked the FDA to rule on “natural” labeling, and the FDA has declined to do so because of its limited resources and preference to focus on other priorities.” Therefore, he concluded, “referring the matter to the FDA would do little more than protract matters.”
Six days later, a federal judge in New York presiding over a multi-district lawsuit against Frito-Lay North America, Inc. (“Frito-Lay”) reached the same conclusion as Judge Conti. (To read additional coverage regarding In re Frito Lay North America, Inc., please click here.) Interestingly, Judge Mauskopf”s Order frames the case as “far less about science than it is about whether a label is misleading.” In the Order, she explains that Frito-Lay”s reasons for invoking the primary jurisdiction doctrine were unpersuasive because “the reasonable-consumer inquiry upon which some of the claims in this case depends is one to which courts are eminently well suited, even well versed.” The Order acknowledged that the Cox and Gruma Courts recently agreed to stay cases involving similar labeling concerns, but ultimately concluded that the judiciary”s undertaking of this decision-making process “would not “risk usurping the FDA”s interpretive authority” or undermine its “considered judgments.”” Furthermore, Judge Mauskopf reasoned that her rejection of Frito-Lay”s arguments was proper, to the extent that “numerous district courts have declined to invoke primary jurisdiction in state-law consumer protection cases so that the FDA may pass on whether a food may properly be labeled “natural.””
In addition to the reasons for denying Frito-Lay”s primary jurisdiction argument, Judge Mauskopf was not persuaded that FDA”s defining of the term “natural” would resolve the issues presented in similar consumer protection cases. She explained that the “FDA is unlikely to respond in a timely manner to any referral from this Court,” and offered, as an example, the fact that the FDA took nine years to define the requirements for “gluten-free” labeling. For these reasons, she stated that “[t]here is no telling, if it even chose to respond with any directive to the Court”s referral, how the FDA would define the term, and whether its definition would shed any further light on whether a reasonable consumer is deceived by the “All Natural” food label when it contains bioengineered ingredients.”
The Uncertain Future of “Natural” Labeling
Even though industry and consumers continue to pressure the FDA to provide guidance regarding “natural” and GMO labeling, it remains unclear whether the FDA will actually accept the courts” invitations to clarify the term”s definition and use. However, given the FDA”s funding and staffing constraints, we doubt that FDA will offer any new, helpful information to help courts decide the issues in these consumer cases. As a result, it seems probable that consumers will continue to challenge the use of ill-defined terms, like “natural,” on food product labeling.
In light of the courts” inconsistent decisions regarding the application of the primary jurisdiction doctrine, it is difficult to speculate how these consumer lawsuits will unfold. If courts ultimately decide in favor of consumers, the issue of “natural” labeling could have a considerable impact on the future of the food industry”s marketing strategies and revenues. Therefore, in the absence of a uniform definition for the term or clear parameters regarding the term”s use, industry should be aware of the risks associated with the continued use of “natural” labeling and be prepared for the possibility of litigation.
Fuerst Ittleman David & Joseph, PL will continue to monitor any developments in the regulation of “natural” and GMO food product labeling. Our attorneys are knowledgeable and experienced in handling issues related to the regulation of foods. For additional information or any questions, please contact us by email at email@example.com or by telephone at (305) 350-5690.