WASHINGTON—The 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 California—two 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.