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The U.S. Food and Drug Administration (FDA) has officially refused requests from several courts (discussed here and here) for a determination of whether and under what circumstances food products containing genetically modified organisms (GMOs) may be labeled “natural.” Citing the need for extensive public input from the various stakeholders, the complexity of the issue and the FDA’s “limited resources,” Leslie Kux, the FDA’s Assistant Commissioner for Policy, declined the courts’ invitations to intervene in private food-labeling litigation over the use of the terms “natural,” “all natural,” or “100% natural.”
Although the FDA has never formally defined the term “natural,” it has issued policy statements explaining that for purposes of food labeling, the term “natural” means “nothing artificial or synthetic . . . has been included in, or has been added to, a food that would not normally be expected to be in the food.” See 58 Fed. Reg. 2302, 2407 (1993). This policy statement has been variously interpreted and food manufacturers have recently faced with a flood of litigation challenging the use of the words “all natural” on their labels, particularly on foods containing GMOs. According to Ms. Kux, even if the FDA were inclined to undertake formal administrative proceedings, there is no guarantee that it would “revoke, amend or add to the current policy language, or develop any definition at all.”
Ms. Kux noted that the FDA is not the only federal agency with an interest in defining the term “natural,” pointing to the United States Department of Agriculture (USDA) as another interested stakeholder that has “been considering the issue.” She also stated that defining “natural” would have “implications well beyond the narrow scope of genetically engineered food ingredients about which the Court’s referral pertains,” suggesting that the interested agencies would have to consider a whole host of complex issues, including “relevant science; consumer preferences, perceptions and beliefs; the vast array of modern food production technologies. . . , the myriad of food processing methods,” as well as First Amendment issues.
In the end, the FDA declined to take on the task of developing a formal definition of “natural” in the context of private litigation, citing its “limited resources” and competing priorities, such as developing regulations to implement the Food Safety Modernization Act of 2011 and the Patient Protection and Affordable Care Act of 2010, responding to outbreaks of foodborne illness, overseeing the safety of imported foods and taking “other actions with direct public health impacts.” Ms. Kux’s letter, however, did not foreclose the possibility that the FDA may offer further guidance on the issue in the future. Indeed, Ms. Kux noted the Grocery Manufacturers Association’s intent to file a citizen petition in 2014 asking the FDA to “issue a regulation authorizing foods containing ingredients derived from biotechnology to be labeled ‘natural’, suggesting that the FDA may entertain this request to engage its formal administrative process, rather than providing a response in the context of private litigation.
