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.
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