The FDA’s “Natural” Reluctance: What it Means for Class Action Lawsuits

Effect of refusal by the Food and Drug Administration (FDA) to define use of term “natural” for food on class action lawsuits and litigation.

A cottage industry of class action litigation recently grown up in the shadow of the FDA’s refusal to define the term “natural” for the purpose of food product labeling. In these class action suits, claimants allege that labeling food products as “natural,” “all natural” or “100% natural” violates state consumer protection laws if those products also contain ingredients that are artificial, synthetic, bioengineered, highly processed, or “unnatural” for other reasons.

While these class actions seek to exploit the gap that exists, they also raise challenges for federal judges. Nationwide, attorneys are supplying their own varying interpretations of “natural” and then claiming that the “natural” labels on countless products do not live up to those interpretations. These cases have also challenged the “natural” labeling of foods containing genetically modified organisms (“GMOs”), which are increasingly prevalent in our food supply but need not be labeled as such under current FDA rules.[1]

Faced with these class actions, several federal judges reached out to the FDA for an administrative determination under 21 C.F.R. § 10.25(c), asking whether manufacturers can label food products containing bioengineered ingredients as “natural” or “all natural” or “100% natural”.[2] The judges then stayed or dismissed pending class action suits while they awaited the FDA’s decision.

A Definition’s Natural Benefits

If the FDA provided a formal, regulatory definition of “natural” for food products, that definition could establish a bright line for compliance. This would then allow courts to more easily decide the truth or falsity of certain labels while also providing compliant manufacturers with more secure defenses to liability. There was also hope that such a definition would contain the current “natural” litigation flood.

The FDA recently issued a response to the judges’ requests, but refused to decide the question. In so doing,, the FDA’s response implicitly set a high bar for class certification in “natural” class actions.

The Impact of the FDA’s Refusal on Class Certification

For a court to grant class certification under Rule 23 in a suit for damages, common questions of fact and law must predominate over individual ones. As the Supreme Court instructed in Wal-Mart v. Dukes,[3] it is not merely the existence of common questions, but the availability of common proof to reach common answers that is required to certify a class. A single definition of “natural” would set the stage for common questions and answers in food labeling cases. But as it stands, the FDA’s refusal highlights the difficulties that plaintiffs should face in moving for class certification.

Currently Proposed Synonyms to “Natural” Are No Longer Valid

The FDA recognized the need for, and desirability of, engaging the public and competing stakeholders in a dialogue to fulfill its commitment to transparency and openness. As a result, the FDA implicitly confirmed that no definition of “natural” can be drawn from other proposed synonyms (such as “organic”) as some had suggested.

Competing Stakeholder Viewpoints Show Potential Inability to Reach Consensus

The FDA also noted that “defining the term ‘natural’ on food labeling necessarily involves interests of federal agencies other than FDA, including the United States Department of Agriculture (‘USDA’), as well as competing views on the part of stakeholders.” If there is no existing consensus among interested, educated agencies and stakeholders, it stands to reason the general consuming public will not reach consensus either.

Defining Commonalities Amongst the General Public Raises Complex Challenges

Additionally, the FDA identified numerous “complexities of such a definition” that would affect the reasonable consumer, including those “well beyond the narrow scope of genetically engineered food ingredients.” As the FDA put it, “if the agencies were to define the term, they would likely need to consider among other things: relevant science; consumer preferences, perceptions, and beliefs; the vast array of modern food production technologies in addition to genetic engineering (e.g., use of different types of fertilizer, growth promotion drugs, animal husbandry methods); the myriad food processing methods (e.g., nanotechnology, thermal technologies, pasteurization, irradiation); and any strictures flowing from the First Amendment.”

Given people’s close connection to and obvious interest in what they put in their mouths, it appears difficult indeed to construct a model that identified statistically significant commonality among all of these issues and among consumers. Thus, extreme difficulties arise around the ability to assess the materiality of the “natural” label in individual consumers’ purchases, or to show commonality across all class members. It will be even more difficult to show that each purchaser suffered damages. And, under the Supreme Court’s 2013 Comcast Corp. v. Behrend decision, damages must be determinable based upon a common, class-wide damage theory for class certification to pass muster.[4] Indeed, for these very reasons, federal courts have become increasingly skeptical of “natural” class actions.[5]

Showing commonality and predominance among class members is more difficult due to the greater rigor that courts apply in determining whether the class is ascertainable, another Rule 23 requirement. An emerging line of cases from the Third Circuit suggests that courts are increasingly suspicious of classes that include people based upon no more than their own say-so.[6] These cases emphasize that one cannot prove class claims “if the only proof of class membership is the say-so of putative class members or if ascertaining the class required extensive and individualized fact-finding.”[7]   

There Is Doubt As to Whether A Consensus Among the Masses Would Ever Exist

The FDA also reasoned that “even if we were to embark on a public process to define ‘natural’ in the cotext of food labeling, there is no assurance that we would revoke, amend, or add to the current policy, or develop any definition at all.” Put differently, the meaning of “natural” is so individualized and cotext-specific, it is not even clear whether the detailed administrative process required to create a regulation could amass a sufficient consensus to get out of the definitional morass. As applied to the class-action cotext, if the FDA cannot develop a consensus definition through its required administrative process, no common definition could possibly exist in the minds of the consuming public.

Getting the Food Labeling Debate Back on Track

Until now, the FDA has simply stated (and sometimes enforced) its informal policy that it does not object to the term “natural” on food when “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.”[8]  Without further definition or a common understanding of the label on the box, we will not find common answers to common questions, individualized issues will predominate, and judges should not approve class certification in the “natural” cases. The results of such consequences could hurt consumers and manufacturers alike, and leave the field of “natural” food labeling open to continued criticism and confusion. Until some stakeholders stand up and even more forcefully assert the need for a more certain definition, all will have to remain satisfied with one-off, ad hoc determinations of whether products are “natural.”

Michael Geibelson and Stephen Safranski are trial attorneys at Robins Kaplan LLP They represent Food and Beverage companies and retailers in complex business disputes and class actions involving false advertising and labeling, the protection of trade secrets, antitrust and unfair competition. MGeibelson@RobinsKaplan.com and SSafranski@RobinsKaplan.com. 

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