Cox alleged that Gruma’s “All Natural” food labels were false and misleading because its products contain genetically modified organisms (GMOs) in the form of corn grown from bioengineered seeds. The court invoked the primary jurisdiction doctrine. The FDA has regulatory authority over food labeling, and enforcement “is a matter that Congress has indicated requires the FDA’s expertise and uniformity in administration.”
There are no FDA rules requiring GMO labeling. Nonbinding FDA guidance states that the agency “is not aware of any data or other information that would form a basis for concluding that the fact that a food or its ingredients was produced using bioengineering is a material fact that must be disclosed.... FDA is therefore reaffirming its decision to not require special labeling of all bioengineered foods.” The FDA also has nonbinding guidance on “natural” defining that term to mean 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,” but the FDA hasn’t addressed, even informally, whether foods with GMO/bioengineered ingredients can be labeled “all natural” or whether such ingredients are “artificial or synthetic.” This is a “gaping hole” in the current regulatory landscape, but nonetheless the FDA is clearly the agency charged with determining whether labels of foods containing GMO ingredients can use “all natural.” Under these circumstances, the court determined that deference to the FDA’s regulatory authority was the appropriate course, to avoid usurping the FDA’s interpretive authority.
The court referred the question to the FDA and stayed the lawsuit for six months.