Regulatory Developments

FDA Seeks Comments on the Meaning of “Natural”

November 17, 2015

On November 12, 2015, the U.S. Food and Drug Administration (FDA) requested comment on the use of the term "natural" in the labeling of human food products. The notice states that it is establishing "a docket to receive information and comments on the use of the term 'natural' in the labeling of human food products, including foods that are genetically engineered or contain ingredients produced through the use of genetic engineering." FDA states that this action is a result of three petitions asking for "natural" to be defined in terms of its use in food labeling, and one petition asking FDA to prohibit the term "natural" from being used on food labels, as well as requests for administrative determinations from FDA regarding whether food products containing ingredients produced using genetic engineering or foods containing high fructose corn syrup may be labeled as "natural." The comment period is open until February 10, 2016.

FDA has been considering establishing a definition for "natural" since 1991, when it published a proposed rule on food labeling that included requests for comments on the use of the term "natural." The notice includes the following information that FDA describes as its "longstanding policy" for the use of the term "natural" on the labels of human food:

  • The word "natural" is often used to convey that a food is composed only of substances that are not manmade and is, therefore, somehow more wholesome (56 Fed. Reg. 60421 (Nov. 27, 1991));
     
  • The term "natural" should not be restricted except for added color, synthetic substances, and flavors under 21 C.F.R. § 101.22 (56 Fed. Reg. at 60466); and
     
  • "Natural" means that nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally be expected to be there (56 Fed. Reg. at 60466).

Besides inviting comments on the term "natural" in the general context of food labeling, FDA is also inviting comments on some very specific questions. Examples of some of these questions are below:

  • Should FDA define, through rulemaking, the term "natural"?
     
  • Should FDA prohibit the term "natural" in food labeling?
     
  • If FDA defines the term "natural," what types of food should be allowed to bear the term "natural"?
     
  • FDA is interested in any data or other information to suggest that consumers associate, confuse, or compare the term "natural" with "organic," and the term "natural" with "healthy."
     
  • Should manufacturing processes be considered in determining when a food can bear the term "natural"?
     
  • What can be done to ensure that consumers have a consistent and accurate understanding of the term "natural" in food labeling to ensure that it is not misleading?
     
  • What are the public health benefits, if any, of defining the term "natural" in food labeling?
     
  • How might we determine whether foods labeled "natural" comply with any criteria for bearing the claim?

 
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