In another chapter in the widespread litigation over when a product may be labeled “natural” (the subject of several prior blogs), a federal district court has asked the FDA to weigh in on whether and under what circumstances food products containing ingredients produced using bioengineered seed may be labeled “Natural,” “All Natural,” or “100% Natural.”
On July 11, 2013, Judge Yvonne Gonzalez Rogers, United States District Court Judge for the Northern District of California, issued an order referring this question to the FDA in Cox v. Gruma Corp., a putative class action alleging that the labels on certain of Gruma’s food products stating that the products are “all natural” are false and misleading because the products contain genetically modified organisms (GMOs) in the form of corn grown from bioengineered, genetically modified seeds. The court referred the matter to the FDA pursuant to 21 CFR § 10.25(c), which provides that the FDA “will institute a proceeding to determine whether to issue, amend, or revoke a regulation or order, or take or refrain from taking any other form of administrative action whenever any court, on its own initiative, holds in abeyance or refers any matter . . . and the Commissioner concludes that an administrative determination is feasible within agency priorities and resources.” The court concluded that a referral and stay was appropriate under the primary jurisdiction doctrine in order to avoid usurping the FDA’s regulatory and interpretative authority.
The court had previously issued a tentative ruling indicating that it was inclined to order a stay pending review by the FDA. The plaintiffs argued against the tentative ruling, contending that the US Supreme Court’s recent decision in Molecular Pathology et al. v. Myriad Genetics et al. reasoning that naturally occurring DNA sequences could not be patented meant by implication that Gruma’s chips, containing genetically modified corn that is patented, must not be naturally occurring. The plaintiffs also argued that the fact the Supreme Court analyzed the issue of which DNA was not natural without deferring to the FDA illustrated that FDA expertise is not required in all legal matters involving natural and engineered DNA. But despite plaintiffs’ arguments, the court went ahead and adopted the tentative ruling, referring the question to the FDA and staying the litigation for six months.
Whether the FDA will in fact address the referred question, however, remains to be seen. The FDA previously declined, in response to a New Jersey federal judge’s referral of the question of whether high fructose corn syrup qualifies as a “natural” ingredient, to provide guidance on the meaning of “natural.” If the FDA does in fact provide guidance, however, the FDA’s decision could have significant implications for the numerous pending lawsuits alleging products labeled “natural,” “all natural,” or “100% natural” are misleading. Moreover, the decision suggests that defendants in food and beverage litigation may have some success in arguing under the primary jurisdiction doctrine that courts should defer to the FDA on issues implicating the FDA’s regulatory authority, an argument that to date has had mixed success in the courts.