FDA, 'Natural' and GMO products

Will the FDA take a stance on “natural” claims for GMO products?

A California federal court judge hopes that the Food and Drug Administration is ready to take a stance on “natural” advertising claims for genetically modified organisms. He issued an order in July to refer the issue to the agency.

The order arose from a consumer class action filed by Elizabeth Cox against Gruma Corporation. Cox alleged that the company falsely advertised its tortilla chips, among other products, as “All Natural,” even though they contained corn grown from bioengineered, genetically modified seeds.

Gruma responded with a motion to dismiss based upon primary jurisdiction, a doctrine that allows a court to stay proceedings “pending the resolution of an issue within the special competence of an administrative agency.” The doctrine normally applies to matters of first impression or in a case with a particularly complicated issue.

U.S. District Court Judge Yvonne Gonzalez Rogers agreed with the defendant that the expertise of the FDA – to which Congress granted regulatory authority over food labeling – was required under the facts of the case.

The agency has separately issued nonbinding industry guidance on bioengineered foods and the use of “natural” labels. In January 2001, the FDA wrote that it was “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.” Previously, in 1993, the agency interpreted the term “natural” on labels to mean “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.”

However, Rogers wrote, the FDA “has not addressed, even informally, the question of whether foods containing GMO or bioengineered ingredients may be labeled ‘natural’ or ‘all natural,’ or whether GMO or bioengineered ingredients would be considered ‘artificial or synthetic.’ ”

“Under these circumstances, deference to the FDA’s regulatory authority is the appropriate course,” the court concluded. “Therefore. . . this Court refers to the FDA, for an administrative determination, the question of 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 Rogers stayed the action for six months from the date of the order, a time that could be extended. LEXOLOGY