FDA Declines Courts’ Requests to Determine if GMO’s Allowed in “Natural” Products

The FDA has declined the referral requests from three U.S. District Courts seeking to have the FDA pronounce on whether “GMO ingredients may be used on food products labeled as “natural” or “all natural.”   The three cases are Cox v. Gruma Corp., 4:12-cv-6502 (N.D. Cal.), Barnes v. Campbell Soup Co. 3:12-cv-05185 (N.D. Cal.) and In Re General Mills, Inc. Kix Cereal Litigation, 2:12-cv-00249 (D. N.J.).

The FDA explained its rationale as follows in a January 6, 2014 letter to the three relevant judges signed by Leslie Kux, Assistant Commissioner for Policy:

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 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.  Issuance of a regulation or guidance document allows an agency to obtain data, information, and views from all stakeholders wishing to engage on an issue.  ….
 [In addition,] [a]ny definition of “natural” on food labeling has implications well beyond the the narrow scope of genetically engineered food ingredients about which the Court’s referral pertains.   For example, if the agencies were to define the term, they would likely need to consider among other things: relevant science; consumer preferences, perceptions, and beliefs; the vast array of modern food production technologies in addition to genetic engineering (e.g., use of different types of fertilizer, growth promotion drugs, animal husbandry methods); the myriad food processing methods (e.g., nanotechnology, thermal technologies, pasteurization, irradiation); and any strictures flowing from the First Amendment.  Thus, even if we were to embark on a public process to define “natural” in the context of food labeling, there is no assurance that we would revoke, amend, or add to the current policy, or develop any definition at all.
In other words, the FDA is keenly aware that an effort to craft a comprehensive definition of “natural” necessarily opens the door to an array of issues and interest groups that would complicate an already complex process.  Thus, the FDA concluded by observing that its current priorities are public health and safety matters, including developing regulations relating to the Food Safety and Modernization Act and the Patient Protection and Affordable Health Care Act.
The FDA’s response is not necessarily a rejection of the GMA’s recent request to have the FDA define natural (as set forth in my prior post).   Rather, the FDA is noting to these courts that the rule-making process would take years, that it is not inclined to start that process now, and that it would not engage in this process in the context of litigation.

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