April 23, 2014

More Courts Weigh In On The Controversy Of Using “All Natural” with Genetically Modified Organisms (GMOs)

A question before district courts these days seems to be whether 100% natural molasses move any slower than the FDA.  In July, the Food Court in the Northern District of California asked FDA to opine on the proper use and application of “whether and under what circumstances food products containing ingredients produced using bioengineered seed may or may not be labeled ‘Natural’,” and stayed the case against Gruma for six months (previously discussed here). The following week, a U.S. District Court in Colorado followed that lead, staying a case against General Mills for natural labeling on its Nature Valley Granola Bars until FDA weighs in.  In August, Pepperidge Farms asked the same Colorado District Court for a stay, but none has been issued to date.

The Eastern District of New York sees things differently.  In the Frito Lay MDL, Judge Mauskopf said there was no telling how the FDA would define the term, and is “unlikely to respond in a timely manner.”  Judge Mauskopf pointed to FDA’s recent history with rulemaking — in 2010, a district court referred a similar case to FDA to determine whether high fructose corn syrup was a natural ingredient.  FDA responded that “making such a determination without adequate public participation would raise questions about the fairness of FDA’s action.  FDA’s experience with such proceedings suggests that it would take two to three years to complete.” Coyle v. Hornell Brewing Co., No. 08-CV-2797 (D.N.J. Sept. 16, 2010).  The Court also analogized to the nine year process for FDA to define “gluten-free,” even in the face of a congressional mandate to do so (more on “gluten-free” here).  The Eastern District of New York has a point.  Seemingly immune from climate change, FDA moves at a glacial pace in making determinations.  How long will the Colorado and Northern District of California courts stay their cases pending a decision by FDA?

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About the Author

Michelle Gillette, Commercial Litigation, Attorney, Mintz Levin, law firm

Michelle’s trial practice is focused on complex commercial litigation, intellectual property, and product liability. Experienced in both Federal and California state courts, Michelle has defended companies in cases regarding product liability (medical devices and pharmaceuticals), unfair business practices, false or misleading advertising, trade secrets, torts, breach of contract, and patent infringement.


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