Earlier this month, the US Food and Drug Administration (“FDA”) sent a letter to three federal judges refusing to determine whether foods with genetically modified ingredients can be labeled as “natural.” The letter was in response to three federal court orders staying and administratively terminating class actions involving food labeled as “natural.”
The FDA’s assistant commissioner for policy, Leslie Kux, stated in the letter that the agency would decline to determine “whether and under what circumstances food products containing ingredients produced using genetically engineered ingredients may or may not be labeled ‘natural.'” Kux described the complexities of making such a determination, which included the involvement of other federal agencies such as the United States Department of Agriculture (“USDA”). She indicated that the two agencies have discussed a potential definition and are currently considering the issue.
Kux also recognized the “competing concerns among and between stakeholders . . . .” The FDA didn’t rule out eventually creating a formal definition but stated that it would probably “engage the public on this issue,” presumably by issuing a regulation or formal guidance for public comment.
In addition to the concerns and complexities of making such a determination, Kux also noted that FDA’s limited resources were focused primarily on developing regulations to implement the Food Safety Modernization Act, issuing nutrition labeling regulations, and “other actions with direct public health impact . . . .”
Without a definition from FDA, food companies will probably see an uptick in class actions because the FDA’s letter will make it harder for defendants to win with preemption and primary jurisdiction defenses. Defendants, however, will still have other avenues of attack. Some food-company defendants have successfully defended such claims by arguing a reasonable consumer would not be misled by the “natural” label. See e.g. Pelayo v. Nestle USA, Inc., 2013 WL 5764644 (C.D. Cal. Oct. 25, 2013) (dismissing such a claim against Nestle USA, Inc.). But for the foreseeable future, it appears that consumers and food companies will be left to continue guessing—and litigating—whether and how “all natural” should be defined.
This article was authored by Brandon Lee Crisp (email@example.com / +1 512 536 2422) of Norton Rose Fulbright’s Life sciences and healthcare team.