FDA: Courts on Their Own in GMO "All Natural" Lawsuits

FDA's decision to steer clear of three lawsuits opens the possibility that federal courts deciding whether food containing GMOs can be labeled "all natural" will reach incongruent decisions.

Josh Long, Associate editorial director, Natural Products Insider

January 8, 2014

2 Min Read
FDA: Courts on Their Own in GMO "All Natural" Lawsuits

WASHINGTONThe U.S. Food and Drug Administration (FDA) declined to decide whether food may be labeled "Natural", "All Natural" or "100% Natural" if it contains bioengineered ingredients, putting the onus on the federal district courts in litigation that has sprung up across the United States.

It would not be appropriate to decide the issue in litigation because it is complex, involves myriad interests and would be better suited for a public proceeding such as issuance of a regulation or formal guidance, FDA's Assistant Commissioner for Policy Leslie Kux stated in a Jan. 6 letter addressed to three district court judges in California and New Jersey.

With limited resources, FDA also must prioritize on such public health and safety matters as implementation of the 3-year-old Food Safety Modernization Act, issuance of nutrition labeling regulations and response to outbreaks of foodborne illness, Kux said.

In lawsuits that FDA declined to weigh in on, plaintiffs alleged the defendants including Gruma Corp. and Campbell Soup Co. used misleading labels because the food contained corn that was grown from bioengineered, genetically modified seeds, according to the letter. FDA's decision to steer clear of three lawsuits opens the possibility that federal courts deciding whether food containing GMOs (genetically modified organisms) can be labeled "all natural" will reach incongruent decisions.

FDA has not formally defined the term "natural", and its current policy does not address whether food may be labeled natural if it contains GMOs.

In Cox v. Gruma Corp. and Barnes v. Campbell Soup Co.two cases before the Northern District of Californiatwo judges over the summer stayed the litigation pending its referral to FDA for an answer. A judge in New Jersey later administratively terminated another case, In Re General Mills, Inc. Kix Cereal Litigation, pending FDA's response.

Kux's letter is unlikely to end requests for FDA to provide further direction. She said FDA was recently notified that the Grocery Manufacturers Association plans to file a petition asking the agency to "issue a regulation authorizing foods containing ingredients derived from biotechnology to be labeled natural".

Plaintiff's and defense lawyers in the three food litigation cases did not immediately respond today to requests for comment on FDA's letter.

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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