Recently, US District Court Judge Yvonne Gonzalez Rogers, sitting in the Northern District of California, stayed a putative class action lawsuit against Gruma Corp. alleging that Gruma Corp.'s inclusion of genetically modified organisms ("GMOs") in food products labeled as "All Natural" constitutes false advertising. The Court stayed the case for six months pending an administrative determination from the Food and Drug Administration ("FDA") regarding "whether and under what circumstances food products containing ingredients produced using bioengineered seed may or may not be labeled 'Natural' or 'All Natural' or '100% Natural.'"
Judge Gonzalez Rogers held that the FDA maintains primary jurisdiction over the labeling dispute, as the agency has regulatory authority over food labeling, and the Food, Drug, and Cosmetics Act ("FDCA") establishes a uniform federal regulatory scheme to ensure that food is labeled in a manner that does not mislead customers.
The Order recognized that the FDA had issued nonbinding industry guidance on GMOs, indicating that "[the FDA] is not aware of any data or other information that would form a basis for concluding that the fact that food or its ingredients was produced using bioengineering is a material fact that must be disclosed . . . [the] FDA is therefore reaffirming its decision to not require special labeling of all bioengineered foods." However, the Court refused to expand this guidance to adjudicate whether GMOs could be labeled "natural" or "all natural." The Court noted, "[t]he FDA has not addressed, even informally, the question of whether foods containing GMOs . . . would be considered "artificial or synthetic." Thus, deference should be given to the FDA's authority to determine whether GMOs fall within the landscape of what it has defined as "natural."
This ruling may force the FDA's hand in defining the scope of "all-natural" ingredients, which it previously declined to do in 2010, denying a New Jersey District Court's request for an advisory opinion regarding whether high fructose corn syrup was considered a "natural" food ingredient. Given the trend of federal judges looking to the FDA for advisory opinions on these issues, it is likely that the FDA's next words on GMOs and "natural" ingredient labeling will have a significant national impact on food labeling litigation.