Alerts
FDA Seeks Comments on the Meaning of "Natural"
As food industry stakeholders are well aware, the use of the term “natural” in food labeling and advertising is fraught with ambiguity and risk of challenge. FDA’s informal policy is that “natural” means 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.[1] FDA acknowledges that its policy on “natural” claims was not intended to address food production methods (e.g., genetic engineering or genetic modification, pesticides, specific animal husbandry practices, or food processing or manufacturing methods such as thermal technologies, pasteurization, or irradiation). In addition, there have been numerous class action lawsuits challenging the use of the term “natural” in food labeling.
FDA is now officially requesting information and public comment on the use of the term “natural” in food labeling.[2] In explaining the motivation for the request, FDA noted its receipt of three Citizen Petitions requesting a formal definition for the term “natural” (submitted by the Grocery Manufacturers Association, Sara Lee Corp., and the Sugar Association) and one Citizen Petition asking that FDA prohibit use of the term “natural” on food labels (submitted by Consumers Union). The Agency also noted its receipt of multiple requests from federal courts seeking FDA’s views on whether foods containing genetically modified (GM) ingredients or foods containing high fructose corn syrup may be considered “natural.”
In its request for comment, FDA poses a series of questions regarding whether/how to define the term “natural.” FDA invites comment on nuanced issues such as whether manufacturing processes should be considered in determining whether a food may be called “natural”; whether and how consumers compare/confuse “organic”, “natural,” and “healthy”; and whether the use of genetic engineering should influence the applicability of “natural” terminology.
FDA also acknowledges that the USDA Food Safety Inspection Service (FSIS) definition of “natural claims” considers the degree of processing that the food undergoes and provides examples of “minimal processing” and “severe processes.” FDA says they are considering areas for coordination with USDA.
FDA will be accepting comments on the “natural” definition until February 10, 2016. While this notification and request for comments alone does not obligate FDA to further define the term “natural” we believe it is in the food industry’s best interests to submit comments regarding the meaning of “natural,” especially on questions such as how much of a role, if any, processing should play in that definition. We note that Agency action in this area ultimately may be dictated by federal GM labeling legislation, namely, the Safe and Accurate Food Labeling Act of 2015, which was passed by the House (H.R. 1599) in July 2015 and which would require FDA to define the term “natural” for use on food labels. Keller and Heckman will continue to monitor this issue and would be happy to assist food companies in the submission of comments on this matter.
[1] See 58 Fed. Reg. 2302 at 2407 (Jan. 6, 1993); see also http://www.fda.gov/aboutfda/transparency/basics/ucm214868.htm.
[2] See FDA Requests Comments on Use of the Term “Natural” on Food Labeling, available at, http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm471919.htm; see also 80 Fed. Reg. 69905 (Nov. 12, 2015), available at, http://www.gpo.gov/fdsys/pkg/FR-2015-11-12/pdf/2015-28779.pdf.