Well Done


On November 12, 2015, the Food and Drug Administration (FDA) announced the establishment of a docket (Docket No. FDA–2014–N–1207) 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.1 In direct response to subsequent requests from the public, FDA extended the closing date for the relevant original comment period from February 10, 2016 to May 10, 2016.2

To date, FDA has not developed an official definition for the term “natural,” although it has made public statements indicating the uses of the term that it accepts. For example, in a proposed rule published in 1991, FDA stated that the word ‘‘natural’’ was often used to describe a food that is composed only of substances that are not manmade and is, therefore, somehow more wholesome. In the same proposed rule, FDA stated that their informal policy considered “natural” to mean that nothing artificial or synthetic is included in, or has been added to, a product that a consumer would not normally expect. However, as a result of unclear direction from public comments, in the final rule published in 1993, FDA stated that it would not define the term “natural” but would instead maintain its policy of interpreting the term as meaning 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.”

FDA now seeks updated information that may assist it to potentially formally define “natural” given broad-based dissatisfaction with FDA’s current policy. FDA has received three Citizen Petitions3 asking that it define the term “natural” for use in food labeling and one Citizen Petition asking that FDA prohibit the term “natural” on food labels.4 Additionally, as a result of litigation between private parties, some federal courts have requested that FDA make administrative determinations regarding whether food products that contain ingredients produced using genetic engineering or foods that contain high-fructose corn syrup may be labeled as “natural.”

As of January 19, 2016, more than 3,900 public comments were submitted to the November 2015 docket. A brief review suggests that a majority of the comments are from individual consumers who believe that the term “natural” should be more tightly restricted. Other comments also suggested that the term “natural” is noninformative and ambiguous, and as a result, sometimes misleading. Many comments highlighted disapproval of the term “natural” for genetically engineered or modified food products. Despite these general concerns, the comment record provides little tangible evidence of specific consumer deception, nor does it suggest a clear path to resolving the term’s longstanding controversy.

As mentioned in our November 19, 2015 blog post, the term “natural” has been the subject of many food labeling lawsuits and has resulted in requests from some federal courts for administrative determinations about the term. A shift to a clearer definition could conceivably suppress this trend while providing consumers with a better understanding of the food they purchase. We will continue to monitor and keep readers updated about this docket.

Please contact the FDA team if you are interested in submitting a comment, which ends on May 10, 2016.

180 Fed. Reg. 69905 (Nov. 12, 2015):
280 Fed. Reg. 80718 (Dec. 28, 2015):
3See FDA–2014–P–0312, Citizen Petition from Grocery Manufacturers Association (Mar. 28, 2014):; FDA–2007–P–0007, Citizen Petition from Sara Lee Corp. (Apr. 7, 2008):; and FDA–2006– P–0206, Citizen Petition from The Sugar Association (Feb. 28, 2006):!docketDetail;D=FDA-2006-P-0206.
4See FDA–2014–P–1650, Citizen Petition from Consumers Union (Oct. 17, 2014):