Department of Health and Human Services letter to California and New Jersey federal courts

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Department of Health and Human Services letter to California and New Jersey federal courts

Published: Monday, January 6, 2014

Editor's Note: Many companies have been sued by consumers who allege they were misled by "natural" claims on foods.  In the federal courts, it is possible for litigants to ask the court to refer questions to state courts on unique issues of state law and to federal agencies that have unique jurisdiction over a subject.  So three federal judges turned to the Food and Drug Administration (FDA) on "natural."  FDA declined to make a determination whether foods with genetically modified organism (GMO) ingredients are "natural" and the FDA's letter to the courts explains the reasons for declining. FDA did note that the Grocery Manufacturers Association (GMA) will be filing a petition on this subject with FDA this month.  

U.S. Department of Health and Human Services

Department of Health and Human Services letter to California and New Jersey federal courts 

Dear Judges Gonzalez Rogers, White and McNulty:

This letter responds to your Orders issued on July 11, July 25 and November 1, 2013 respectively, in the above-referenced cases, which referred to the question of whether food products containing ingredients produced using bioengineered ingredients may be labeled "Natural" or "All Natural" or "100% Natural" to the Food and Drug Administration ("FDA" or "agency") for an administrative determination under 21 C.F.R. § 10.25 (c). In those cases, the plaintiffs allege that the "Natural," "All Natural," and/or "100% Natural" labeling on the Defendants' products are misleading because the products contain corn grown from bioengineered, genetically modified seeds. ...

FDA has not promulgated a formal definition of the term "natural" with respect to foods. The agency has, however, stated that its policy regarding the use of the term "natural" on food labeling means 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." See 58 Fed. Reg. 2302, 2407 (1993).

If FDA were inclined to revoke, amend, or add to this policy, we would likely embark on a public process, such as issuing a regulation or formal guidance, in order to determine whether to make such a change; we would not do so in the context of litigation between private parties. ...


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