In response to a court order requiring the parties to respond to the U.S. Food and Drug Administration’s (FDA’s) refusal at the court’s request to determine whether foods with genetically modified (GM) ingredients may be labeled “natural” or “all natural,” the parties to litigation involving tortilla chips have filed their pleadings. Cox v. Gruma Corp., No. 12-6502 (U.S. Dist. Ct., N.D. Cal., Oakland Div., filed January 24, 2014). Information about FDA’s January 6 letter appears in Issue 509 of this Update.

Gruma argues that the case continues to meet “all the factors for invoking primary jurisdiction. . . . The FDA’s response is simply that for its own proce- dural and budgetary reasons it does not intend to consider the referred issue at the current time in this particular posture. The FDA response, if anything, reinforces why the FDA should be the one to resolve this issue. This is particu- larly true because the same issue of whether products which include food derived from bioengineered seeds may be labeled ‘natural’ has been raised in more than 50 other cases and resolution of the issue by the courts will be subject to inconsistent determinations and disruptions of interstate commerce.”

Gruma asks the court to set a date to re-file a motion to dismiss. Among other matters, Gruma notes that the Grocery Manufacturers Association has indicated its intent to file a citizen petition in early 2014, which would give FDA the oppor- tunity to address the issue through its preferred process—notice-and-comment rulemaking.

The plaintiff, on the other hand, urges the court to order Gruma to answer her first amended complaint, arguing that FDA’s response letter proves that her state-law causes of action are not subject to the primary jurisdiction doctrine. Citing a number of similar lawsuits in which the courts have refused to apply the doctrine, the plaintiff asserts that her complaint “presents a garden variety consumer protection case that this Court is well-equipped to handle.”