FDA Refuses to Address ‘Natural’ Definition in GMO Class Actions

On Monday, the U.S. Food & Drug Administration told federal judges that it would not determine whether foods with genetically modified ingredients can be labeled as “natural” at this time. The agency’s refusal to take a stance on the GMO issue continues to plague those involved in consumer product class action lawsuits.

In July, two California federal judges stayed separate class action lawsuits involving the use of the term “natural,” “100% Natural” or “All Natural” on products that contained genetically modified organisms (GMOs) and asked the FDA to clarify the issue. A New Jersey federal judge halted a class action lawsuit against General Mills Inc. in November to await a response from the FDA.

In a letter addressed to the three federal judges, Leslie Kux, the Assistant Commissioner for Policy at the FDA, indicated the agency’s refusal to address the definition of “natural” as it pertains to genetically modified ingredients, but left the issue open to decision at a future date.

“If FDA were inclined to revoke, amend, or add to this policy, we would likely embark on a public process, such as issuing a regulation or formal guidance, in order to determine whether to make such a change; we would not do so in the context of litigation between private parties,” Kux wrote in her letter. “Issuance of a regulation or guidance document allows an agency to obtain data, information, and views from all stakeholders wishing to engage on an issue. Here, given the complexities of the current request, including the competing concerns among and between stakeholders (e.g., various consumer organizations, diverse industry segments), it would be prudent and consistent with FDA’s commitment to the principles of openness and transparency to engage the public on this issue.”

Kux notes that any decision regarding the “natural” label involves the interests of other agencies, including the U.S. Department of Agriculture. She indicates that the agencies have been in communication about the issue. However, the letter states that the FDA’s primary concern is related to public health and safety matters. “Because, especially in the foods arena, FDA operates in a world of limited resources, we must prioritize which issues to address,” she says.

Kux concludes, “Based on the foregoing considerations, we respectfully decline to make a determination at this time regarding whether and under what circumstances food products containing ingredients produced using genetically engineered ingredients may or may not be labeled ‘natural.’”

FDA’s Stance Stymies GMO Class Actions

While the lack of FDA guidance is frustrating to the parties and judges involved in class action lawsuits, this letter could actually create a hardship for companies seeking to have the actions dismissed. Many companies have argued that the FDA has unintentionally failed to define the term and will make it more difficult for them to argue that the class action lawsuits are preempted by federal law.

In recent years, Top Class Actions has covered a number of class action lawsuits related to GMO-containing products that are labeled as “Natural,” “All Natural” or “100% Natural.” In October, Frito-Lay North America Inc. denied that the phrase “all natural” excludes products that contain GMOs, citing the lack of FDA guidance on the issue.

Other companies have not been successful in arguing that products with genetically modified ingredients can be classified as “natural.” In May 2013, a Florida federal judge rejected a bid by Campbell Soup Co. to dismiss a class action lawsuit accusing the company of labeling its products as “natural” when they allegedly contained genetically modified corn.

In May 2013, Naked Juice agreed to a $9 million class action settlement over products labeled as “all natural” and “non-GMO.”

The proliferation of GMO class action lawsuits shows that as consumers become aware of the alleged dangers of genetically modified ingredients, they want companies to be transparent in their marketing of GMO food products. Parties on both sides of the litigation are waiting for the FDA to take a stance, hopefully in their favor.