Update on the FDA’s Request for Public Comments on the Meaning of “Natural” and Impact on Pending Litigation
Time 5 Minute Read

For the past several years, the industry and the plaintiffs’ bar have been litigating over what is “natural” and what is not when it comes to food products. This issue hit home with retailers with news of multimillion dollar settlements resolving claims concerning use of the term “natural” on food product labels. The issue certainly became blurred when it came to modern processing methods and advances in biotechnology, particularly with respect to ingredients like high fructose corn syrup or genetically modified fruits and vegetables. Late last year, however, in response to four consumer petitions, the U.S. Food and Drug Administration (“FDA”) requested public comments concerning the use of the term “natural” on food labels. Whether and how the FDA ultimately defines the term “natural” will surely impact cases in the long-run. But the FDA’s decision to request comment has more immediate effects. It arms defendants with potential means to bring pending litigation to an immediate halt.


The FDA’s decision to request public comments on the meaning of “natural” initially came as somewhat of a surprise, given that it previously resisted calls to formally define the term. It even declined requests from federal courts seeking an administrative determination on the issue. To date, the closest the FDA has come to defining the term is the issuance of non-binding guidance, which, in turn, provides that “natural” means 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.”

But the FDA apparently determined it could no longer stand on the sidelines, and, in November 2015, it requested information and public comment on questions that include:

  • Whether it is appropriate to define the term “natural.”
  • If so, how the agency should define “natural."
  • How the agency should determine appropriate use of the term on food labels.

The FDA attributed its decision to the “changing landscape of food ingredients and production,” and it noted that it was acting in direct response to requests from the public. Seemingly acknowledging the flood of litigation over the issue, the FDA specifically “note[d] that some Federal courts, as a result of litigation between private parties, have requested administrative determinations from the FDA regarding whether food products containing ingredients produced using genetic engineering or foods containing high fructose corn syrup may be labeled as ‘natural.’”

The FDA initially set a deadline of February 10, 2016, for the submission of comments. By that time, it had already received well over a thousand comments. Due to public requests for additional time to provide comments, the FDA recently extended the deadline until May 10, 2016.

How can defendants avail themselves of these developments in the interim? 

For starters, defendants should consider seeking a stay of litigation pending a determination by the FDA as to whether it will define the term “natural” and how. Defendants could do so under the primary jurisdiction doctrine, which, in turn, permits courts to dismiss or stay lawsuits when confronted with an issue over which an administrative body has regulatory authority and which requires expertise or uniformity in administration. There is ample reason to believe such motions would be successful. Indeed, similar motions were filed and granted when the FDA sought public comment in connection with use of the term “evaporated cane juice” on food product labels, and courts would likely reach the same result when it comes to the term “natural.”

At least one set of defendants has moved for a stay on primary jurisdiction grounds, although the court has yet to rule on that motion. On December 21, 2015, just days before the FDA extended the comment period, the defendants in Cruz-Acevedo v. Unilever United States, Inc., et al., U.S.D.C., D.P.R., Case No. 3:15-cv-02175-ADC, moved to stay claims concerning use of the term “all natural” on an iced tea product.

Surprisingly, there has not been a flood of such motions in pending food labeling cases. But that might be explained by other developments in those cases. For example, defendants in the Ninth Circuit, home of the “Food Court,” already have successfully stayed cases pending the Ninth Circuit’s decision in Jones v. ConAgra, which, in turn, will address a number of class certification issues that directly impact food labeling claims. Therefore, defendants in the Ninth Circuit have had alternate means to stay pending litigation. But defendants outside the Ninth Circuit might not be able to avail themselves of the Jones decision as grounds for a stay. As a result, those defendants should seriously consider moving for a stay or dismissal on primary jurisdiction grounds. At an absolute minimum, all defendants will need to assess the long-term impacts that any future FDA action will have on pending litigation concerning the term “natural.”

  • Partner

    Neil is head of the firm’s antitrust and consumer protection practice. Neil’s complex litigation practice focuses on class action and other litigation in the areas of, privacy and cybersecurity, antitrust, health care ...

  • Partner

    Jason’s practice focuses on class action defense and other complex commercial litigation in the data breach, financial services and consumer contexts. Jason has represented clients at trial and on appeal in all manner of ...


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