FDA Declines To Define “Natural” for Foods Formally, Leaving Its Informal Policy in Place

FDA once again has “respectfully declined” to define the term “natural” when used in food labeling.  In a January 6, 2014, letter from Leslie Kux, Assistant Commissioner for Policy, to three federal judges handling civil litigation brought against manufacturers over “natural”-type claims made for foods containing bioengineered ingredients, FDA denied their requests essentially to define “natural” formally.  The relevant cases are:

  • Cox v. Gruma Corporation (California Northern District Court, Case Number 4:2012cv06502, filed December 21, 2012);
  • Barnes v. Campbell Soup Co. (California Northern District Court, Case Number 3:2012cv05185, filed October 5, 2012); and
  • In re General Mills, Inc. Kix Cereal Litigation (No. 12-249, administratively terminated by U.S. Dist. Ct., D.N.J., order entered November 1, 2013).

Ms. Kux’s letter offers several explanations for FDA’s reticence:

  1. First, FDA believes it would not be appropriate for the agency to define “natural” except through a public process that would allow stakeholders the opportunity to express their views: “[W]e would likely embark on a public process, such as issuing a regulation or formal guidance … we would not do so in the context of litigation between private parties.”
  2. FDA says it cannot define “natural” without coordinating with USDA: “[D]efining the term ‘natural’ on food labeling necessarily involves interests of Federal agencies other than FDA, including the United States Department of Agriculture …”
  3. Any attempt to define “natural” would have to consider far more than the narrow question posed by the courts (i.e., whether genetically engineered foods are “natural”), and FDA simply does not have the resources for such a major undertaking at this time.  FDA notes that it would need to consider the relevant science, consumer perceptions, the First Amendment, and all of the many other technologies used in food production and processing today.  “At present, priority public health and safety matters are largely occupying the limited resources that FDA has to address food matters.”

FDA’s letter says that the Grocery Manufacturers Association has announced its intention to file a Citizen Petition in early 2014 that will ask FDA to issue a regulation defining “natural.”  However, the overall tenor of Ms. Kux’s letter clearly suggests that FDA is not likely to define “natural” for foods formally anytime soon.  This leaves in place its informal policy regarding use of the term meaning: “[N]othing 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.”  58  Fed. Reg. 2302, 2407 (Jan. 6, 1993).

While FDA’s informal policy does not have the force and effect of a regulation, it nonetheless constitutes an “advisory opinion” (21 C.F.R. § 10.85(d)(1)), providing a food manufacturer a “safe harbor” from FDA enforcement activity for “natural” claims made in conformity with it:

An advisory opinion represents the formal position of FDA on a matter and … [generally] obligates the agency to follow it until it is amended or revoked. The Commissioner may not recommend legal action against a person or product with respect to an action taken in conformity with an advisory opinion which has not been amended or revoked.

21 C.F.R. § 10.85(e).  Compliance with FDA’s informal policy does not, however, provide a safe harbor from class action lawsuits alleging violations of state laws.

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