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.
Footnotes
[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.
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