Contributed by Robert Brown
When last we blogged about the ongoing battle over “natural” labeling, litigation over use of the word “natural” to describe food products containing genetically modified organisms (“GMOs”) was on the rise. Several courts requested guidance from the FDA, while others piggybacked on these requests by staying or dismissing their cases pending the FDA’s response, but the FDA maintained its neutrality on the issue. In a January 6, 2014 letter to three US District Court judges, the FDA recited its policy on the use of the “natural” label on food products as meaning “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 went on to explain, “If FDA were inclined to revoke, amend, or add to this policy, we would likely embark on a public policy process, such as issuing a regulation or formal guidance, in order to determine whether to make such a change; we would not do so in the context of litigation between private parties.” The FDA further cited its “commitment to the principles of openness and transparency to engage the public on this issue.”
Since then, the pressure on the FDA to clarify the definition of “natural” in the food label context has only grown, and litigation on the subject has not slowed down. On November 10, in direct response to consumer inquiries and partially in response to four Citizen Petitions—and in keeping its promise to engage the public on the issue—the FDA released a statement asking the public to provide information and comments on the use of the “natural” label in human food products. In doing so, the FDA admitted that the policy it quoted in its January 6, 2014 letter had fallen behind the times and did not account for all the considerations that go into a modern understanding of the term “natural” as it relates to food labels. Specifically, the FDA acknowledged that the policy “was not intended to address food production methods, such as the use of pesticides, nor did it explicitly address food processing or manufacturing methods, such as thermal technologies, pasteurization, or irradiation. The FDA also did not consider whether the term ‘natural’ should describe any nutritional or other health benefit.”
It is not entirely clear yet if the FDA’s request for public comments will lead to an FDA sanctioned definition of “natural,” especially in light of the fact that the specific questions posed for public comment include: whether the FDA should define “natural” at all; if so, how should it be defined; and how should the FDA determine the appropriate use of the term “natural” on food labels. But it is certainly a step in that direction. This change of course presents an opportunity for food manufacturers who hope to avoid becoming defendants in litigation over the use of “natural” as a label on food products. The fact that courts have previously sought the FDA’s guidance on the meaning of “natural” indicates that if the FDA ultimately does endorse a definition of the term, it will carry significant weight in US courts. The open public comment period allows for food manufacturers to have some influence on a policy shift that may impact their ability to defend their labeling practices in future litigation. Any guidance the FDA ultimately provides on the definition of “natural” would also help food manufacturers avoid litigation altogether by conforming their labeling practices to the FDA standards, knowing that courts will consider such standards authoritative.
The public comment period is now open, and directions for how to submit a comment can be found here.