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From Health Law Daily, June 11, 2013

Debate over bioengineered foods put on hold for FDA ruling over the word “natural”

By Jenny M. Burke, JD, MS

Parties involved in a putative class action suit alleging that labels on certain food products marketed by Gruma Corporation, as well as the company’s advertising and marketing, are false and misleading were given the option of waiting for the FDA to review the matter before proceeding to trial (Cox v Gruma Corporation, June 7, 2013, Rogers, Y). Issuing a “tentative ruling,” the court provided the parties with the opportunity to either wait for the FDA to issue some guidance, or to proceed with trial. Noting that the parties had identified “a gaping hole in the current regulatory landscape for ‘natural’ claims and GMOs,” the court recommended that the action be stayed for a period of six months and referred to the FDA to determine whether products containing genetically modified organisms (GMOs) or bioengineered ingredients may properly be labeled “Natural” or “All Natural.”

Gruma’s products. The products in dispute each contain GMOs in the form of corn grown from bioengineered, genetically modified seeds. Gruma’s labels indicate that the products are “natural” and do not explain that the ingredients are bioengineered or genetically modified. Because of Gruma’s omission in its explanation of ingredients and its “natural” label, the class action formed to complain that the labels are false and misleading and violate state law.

FDA requirements. At this time, the court noted that the FDA has not released any rules requiring that products containing GMO or bioengineered ingredients be labeled that way, nor has it explained whether using the word “natural” is appropriate for GMOs. The FDA has issued a guidance document indicating that it “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.”

The FDA has also published non-binding guidance defining “natural” 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.” The FDA has not, however, addressed 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.”

The case number is 12-CV-6502 YGR.

Attorneys: Amelia D Winchester (Thompson & Knight LLP) for Gruma Corporation.

Companies: Gruma Corporation

MainStory: TopStory FoodStandardsNews FoodNews CaliforniaNews

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