Last month, after decades of relative inaction regarding the definition of the term “natural,” the Food and Drug Administration announced that it was accepting public comments on the use of the word, including whether it can be false or misleading on food labels. Among other questions, the FDA asks:

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

The FDA’s silence on the definition of natural in the past created a surge in consumer class actions alleging false or misleading advertising of the use of the term on product labels. Although seeking public comment is only the first step in what could be a long rulemaking process, the ramifications for parties litigating “natural” labeling claims are significant.

FDA’s Prior Guidance on “Natural”  

Until now, the FDA has consistently refused to regulate the term “natural” on food labels. Back in 1993, the FDA issued non-binding guidance describing natural as:

[N]othing 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.

Since then, the FDA repeatedly spurned the opportunity to provide a binding definition. For example, in 2014 the FDA declined requests from multiple federal judges to determine the meaning of “natural.”

This lack of clarity has, at times, led individual states to take matters into their own hands. For example, Vermont passed legislation in 2014 banning the use of “natural” labeling on foods containing genetically modified organisms. Should the FDA ultimately issue a rule, it could potentially preempt state legislation and create more certainty for food manufacturers.

Primary Jurisdiction Considerations

The FDA’s call for public comment may also cause courts to stay pending litigation under the primary jurisdiction doctrine.

The primary jurisdiction doctrine allows courts to decline to hear claims pending resolution of an issue that is within “the special competence of an administrative agency.” Essentially, the primary jurisdiction doctrine gives courts the discretion to allow the FDA to decide the issue in the first instance so as to avoid later conflicts.

In light of the FDA’s continued refusal to define “natural,” some courts question the applicability of the primary jurisdiction doctrine. For example, in Dye v. Bodacious Food Co.,  the defendant sought to dismiss a “natural” food labeling claim under primary jurisdiction. The court declined to do so, concluding that the FDA’s consistent refusal to define the term left the matter within the court’s authority.

More recently, the Ninth Circuit decided in Astiana v. Hain Celestial that primary jurisdiction was appropriate even without FDA guidance because determining the meaning of natural was an area within the FDA’s expertise. However, in doing so, the Ninth Circuit made substantial reference to the FDA’s lack of action. It ordered the trial court to consider whether the circumstances, including the lack of FDA action, “affect the need for further proceedings at the FDA or demonstrate that another referral to the agency would be futile.” Although Astiana involved cosmetics, the court’s reasoning may also be applicable to food cases.

Immediate Effects

The FDA’s announcement suggests that referring to the agency for guidance on the term “natural” may not be futile after all. Companies defending “natural” labeling claims may be able to buttress primary jurisdiction claims by arguing deference to the FDA in light of its unexpected interest in potential regulation.

Although the FDA’s call for public comment does not mean that a definition is necessarily forthcoming, it certainly indicates increased agency attention.

The comment period ends on February 10, 2016 and we will continue to update on the status of any FDA action in this area.