In recent years, a rash of consumer class actions have been filed alleging false or misleading advertising where a product is marketed as “natural,” “all-natural,” “made from 100% natural ingredients,” or other similar representations when the product allegedly contains some synthetic product or was processed in some way that does not occur in nature.  These claims are thorny for defendants because the Food and Drug Administration has yet to provide a definition of what a “natural” ingredient is, thereby offering no standard governing this marketing claim that companies can look to for a safe harbor.

Identifying this ambiguity in current FDA regulation, defendants have attempted to have “natural” claims dismissed on grounds of preemption or primary jurisdiction, with mixed results.

Despite confusion surrounding what, exactly, a natural product is and how courts should respond to false advertising claims, the FDA recently stood its ground, stating in a January 6, 2014 letter that it would not bend to requests to define natural in the “context of litigation between private parties.”  The letter came in response to requests for an FDA definition of “natural” from three different courts, the first ruling in the case Cox v. Gruma Corporation.  Other entities urged the FDA to decline obliging the courts’ requests.

In its letter, the FDA stated that it had “not promulgated a formal definition of the term ‘natural’ with respect to foods,” although it has a general policy that the use of the term “natural” in a food product “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.’”  The FDA noted that in order to make a formal policy, it would “likely embark on a public process, such as issuing a regulation or formal guidance, in order to determine whether to make such a change….”

Based on these and other administrative considerations, the FDA “respectfully decline[d] to make a determination at this time regarding whether and under what circumstances food products containing ingredients produced using genetically engineered ingredients may or may not be labeled ‘natural.’”

For now, at least, the debate over what is “natural” in a food product rages on and companies would do well to proceed with caution when making any natural labeling claims.