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FDA declines to define "natural" in the context of food products

The US Food and Drug Administration (FDA) [official website] published a response letter [text; PDF] Thursday declining to define “Natural” in the context of food labeling. The letter was in response to three cases involving allegations of false advertising of food products; more specifically, whether food products containing bioengineered ingredients may be labeled as “Natural,” “All Natural” or “100% Natural.” The plaintiffs in Cox v. Gruma Corp., Barnes v. Campbell Soup Co. and In re General Mills, Inc. Kix Cereal Litigation filed suit on the grounds that the defendants' labeling was misleading because the products contained "corn grown from bioengineered, genetically modified seeds." While the agency declined to formulate a formal definition of the term "natural," existing policy [58 Fed. Reg. 2302, 2407] states that the term "natural" on food labels means that "nothing artificial 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." Defending their decision not to promulgate the definition, the FDA stated that adding policy would require a public process, rather than private litigation. The FDA also noted that food labeling involves the interests of other federal agencies,including the US Department of Agriculture (USDA) [official website] as both agencies, according to the letter, have been considering the issue of the term "natural" beyond the scope of the genetically modified foods.

The FDA has been in the legal news recently for their involvement in two ongoing controversies: lethal injection and contraceptives [JURIST backgrounder]. In July the US Court of Appeals for the District of Columbia Circuit [official website] ruled [JURIST report] that an FDA policy allowing the importation of a drug used in the execution of state prisoners was illegal. The court did not give deference to the federal agency's policy of neither approving or reviewing shipments of sodium thiopental from Dream Pharma [corporate website], a British manufacturer, because the policy was arbitrary and capricious. In June the FDA announced [JURIST report] that it has officially approved the brand-name emergency contraceptive Plan B One-step for all women of child-bearing potential without a prescription, regardless of age. This approval comes following an order [text, PDF; JURIST report] issued last week by Judge Edward Korman of the US District Court for the Eastern District of New York [official website], who has been overseeing the Plan B litigation [JURIST news archive] for more than six years.

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