
[Federal Register Volume 80, Number 218 (Thursday, November 12, 2015)]
[Proposed Rules]
[Pages 69905-69909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28779]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2014-N-1207]


Use of the Term ``Natural'' in the Labeling of Human Food 
Products; Request for Information and Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of request for comments.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
establishment of 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. We are taking this 
action in part because we received three citizen petitions asking that 
we define the term ``natural'' for use in food labeling and one citizen 
petition asking that we prohibit the term ``natural'' on food labels. 
We also note that some Federal courts, as a result of litigation 
between private parties, have requested 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.'' We are working with the 
United States Department of Agriculture (USDA) Agricultural Marketing 
Service and Food Safety and Inspection Service to also examine the use 
of the term ``natural'' in meat, poultry, and egg products, and are 
considering areas for coordination between FDA and USDA. We invite 
public comment on the term ``natural'' in the context of food labeling 
and on specific questions contained in this document.

DATES: Comments must be received on or before February 10, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

[[Page 69906]]

     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include Docket No. FDA-
2014-N-1207 for ``Use of the Term ``Natural'' in the Labeling of Human 
Food Products; Request for Information and Comments.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Loretta Carey, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2371.

SUPPLEMENTARY INFORMATION:

I. Background

A. What has been FDA's position regarding the use of the term 
``natural?''

    Under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 343(a)(1)), a food shall be deemed to be 
misbranded if its labeling is false or misleading in any particular. 
Section 201(f) of the FD&C Act (21 U.S.C. 321(f)) defines the term 
``food'' to mean articles used for food or drink for man or other 
animals, chewing gum, and articles used for components of any such 
article. Subject to certain exceptions, dietary supplements are 
generally considered to be foods under the FD&C Act (21 U.S.C. 
321(ff)). Section 201(n) of the FD&C Act (21 U.S.C. 321(n)) provides 
that labeling is misleading if, among other things, it fails to reveal 
facts that are material in light of representations made or suggested 
in the labeling, or material with respect to consequences that may 
result from the use of the food to which the labeling relates under the 
conditions of use prescribed in the labeling, or under such conditions 
of use as are customary or usual. Section 201(m) of the FD&C Act 
defines ``labeling'' as all labels and other written, printed, or 
graphic matter upon any article or any of its containers or wrappers or 
accompanying such article.
    We have a longstanding policy for the use of the term ``natural'' 
on the labels of human food. We previously considered establishing a 
definition for the term ``natural'' when used in food labeling. In the 
preamble of a proposed rule we published in the Federal Register (56 FR 
60421, November 27, 1991), we stated that 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. We also said that we 
have not attempted to restrict use of the term ``natural'' except for 
added color, synthetic substances, and flavors under Sec.  101.22 (21 
CFR 101.22) (56 FR 60421 at 60466). Further, we said that we have 
considered ``natural'' to mean 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 FR 60421 at 60466).
    We also noted that the term ``natural'' is used on a variety of 
products to mean a variety of things. Because of its widespread use, 
and the evidence that consumers regard many uses of this term as non-
informative, we said, back in 1991, that we were considering 
establishing a definition for this term (56 FR 60421 at 60466). We said 
that we believed that defining the term ``natural'' could remove some 
ambiguity surrounding use of the term that results in misleading claims 
(56 FR 60421 at 60466).
    We invited comments on several questions, including whether we 
should establish a meaningful definition for ``natural'' so that this 
term would have a common consumer understanding, and whether it should 
prohibit ``natural'' claims entirely on the grounds that they are false 
or misleading (56 FR 60421 at 60467). In the preamble to the subsequent 
final rule, we noted that we had received many comments on the subject, 
but that ``[n]one of the comments provided FDA with a specific 
direction to follow for developing a definition regarding the use of 
the term `natural.' '' (58 FR 2302 at 2407, January 6, 1993). We stated 
that at that time we would not be engaging in rulemaking to define 
``natural,'' but that we would maintain our policy not to restrict the 
use of the term ``natural'' except for added color, synthetic 
substances, and flavors. We further stated that we would maintain our 
policy to interpret the term ``natural'' 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'' (58 FR 2302 at 2407).
    When we established our policy concerning the use of the term 
``natural,'' as described previously in this document, it was not 
intended to address food production methods, such as the use of genetic 
engineering or other forms of genetic modification, the use of 
pesticides, or the use of specific animal husbandry practices, nor did 
it explicitly address food processing or manufacturing methods, such as 
thermal technologies, pasteurization, or irradiation. Furthermore, we 
did not consider whether the term ``natural'' should describe any 
nutritional or other health benefit.

B. What recent events prompted FDA to request comment?

    In a citizen petition (now filed under docket number FDA-2014-P-
0312) dated March 14, 2014, the Grocery Manufacturers Association (GMA) 
requests that we ``issue a regulation

[[Page 69907]]

authorizing statements such as `natural' on foods that are or contain 
foods derived from biotechnology'' (see Citizen Petition from the 
Grocery Manufacturers Association to the Food and Drug Administration 
(``Petition'') at page 1). Specifically, GMA requests that we issue a 
regulation ``that it is neither false nor misleading to label a food as 
`natural' or similar terms solely because the food is or contains a 
food derived from biotechnology'' (Petition at page 3). GMA requests 
that FDA issue a regulation establishing that the term(s) ``natural,'' 
``all natural,'' ``100% natural,'' ``from nature,'' ``naturally 
grown,'' or ``naturally sourced'' may accompany the common or usual 
name of a food, or the name of a standardized food, or appear elsewhere 
on the label or in labeling of such foods, and that such a food shall 
not be deemed to be misbranded solely because the food contains a food 
derived from biotechnology (Petition at page 3).
    Alternatively, GMA requests that we amend Sec.  101.4 (Food; 
designation of ingredients.) by adding a new paragraph stating that: A 
food bearing a claim that its ingredient or ingredients are 
``natural,'' ``all natural,'' ``100% natural,'' ``from nature,'' 
``naturally grown,'' or ``naturally sourced'' shall not be deemed 
misbranded solely because the ingredient or ingredients are derived 
from biotechnology (Petition at page 3, footnote 2). The GMA citizen 
petition also describes, in the petitioner's view, the legal and 
factual basis for a regulation and why rulemaking is in the public 
interest (see Petition at pages 5 through 15).
    The GMA citizen petition follows earlier communications to FDA 
regarding the use of the term ``natural'' on the labels of food 
containing ingredients produced using genetic engineering. For example, 
three Federal district courts referred to us, for an administrative 
determination under 21 CFR 10.25(c), the question of whether food 
products containing ingredients produced using bioengineering may be 
labeled as ``Natural,'' ``All Natural,'' and/or ``100% Natural.'' See 
Letter from Leslie Kux, Assistant Commissioner for Policy, to the 
Honorable Yvonne Gonzales Rogers, U.S. District Court, Northern 
District of California, the Honorable Jeffrey S. White, U.S. District 
Court, Northern District of California, and the Honorable Kevin 
McNulty, U.S. District Court, District of New Jersey (January 6, 2014) 
(``Courts Letter''); see also Letter from Karin F. R. Moore, Vice 
President and General Counsel, Grocery Manufacturers Association, to 
Elizabeth H. Dickinson, Esq., Chief Counsel, FDA (December 5, 2013) 
(mentioning the district courts' referrals to FDA and stating that FDA 
has authority to issue a regulation authorizing foods containing 
ingredients derived from biotechnology to be labeled ``natural''). 
Although we declined to make a determination for the courts regarding 
whether and under what circumstances food products containing 
ingredients produced using genetic engineering may or may not be 
labeled ``natural,'' we informed the courts that, if we were inclined 
to revoke, amend, or revise our policy regarding use of the term 
``natural,'' we would likely engage in a public process and work with 
other Federal entities, such as the U.S. Department of Agriculture 
(USDA) (see Courts Letter at page 2). We issued a similar response to a 
Federal district court, in 2010, when it asked whether high fructose 
corn syrup qualified as a ``natural'' ingredient. See Letter from 
Michael M. Landa, Acting Director, Center for Food Safety and Applied 
Nutrition, to the Honorable Jerome B. Simandle, U.S. District Court 
Judge, District of New Jersey (September 16, 2010).
    On October 3, 2014, we received a citizen petition from Consumers 
Union (see FDA-2014-P-1650) requesting that we prohibit use of the term 
``natural'' on food labels altogether. The Consumers Union citizen 
petition asserts that there is a ``drastic'' difference between FDA's 
current policy for use of the term ``natural'' and ``what people think 
the `natural' label should mean'' (Citizen Petition from the Consumers 
Union to FDA (``Petition'') at page 1). More specifically, Consumers 
Union requests that FDA issue the following interpretive rule 
prohibiting use of the term ``natural'' in food labeling: ``The term 
`natural,' or any derivation of the term, such as `naturally grown,' 
`naturally sourced' or `from nature,' is vague and misleading and 
should not be used'' [emphasis in the original] (see Petition at page 
3).
    The Consumers Union citizen petition relies on Consumer Reports 
National Research Center survey data to support its position that 
consumers are misled by the term ``natural.'' \1\ According to the 
petition, the survey suggests that nearly two-thirds of U.S. consumers 
are currently misled by use of the term ``natural'' on certain food 
labels and nearly 90 percent expect it to ``mean much more than it 
does'' (see Petition at page 2 and pages 4 through 9). For example, 
according to the petition, ``Sixty-six percent of consumers think 
`natural' processed food products mean no toxic pesticides were used, 
66% think no artificial ingredients or colors were used, 65% think no 
chemicals were used during processing and 64% think no GMOs were used'' 
(see Petition at page 2). Also, according to the petition, when 
consumers were asked what they thought the term natural should mean, 
``87% believe no artificial materials or chemicals should be used 
during processing, 86% believe no artificial ingredients or colors 
should be used, 86% believe no toxic pesticides should be used, and 85% 
believe no GMOs should be used'' (see Petition at page 2).
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    \1\ Consumer Reports National Research Center Survey Research 
Report re Citizen Petition from Consumers Union, FDA-2014-P-1650-
0002. According to Consumers Union, the survey was a nationally 
representative phone survey of over 1000 adult U.S. residents.
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    Consumers Union asserts that it has observed a push from industry 
to allow the use of the term ``natural'' on food labels that do not 
represent what their survey indicates consumers believe the term 
natural should mean (see Petition at page 3). Consumers Union further 
states that ``consumers demand far more from the `natural' label, in 
line with what they expect from the `organic' label'' such that the 
term ``natural'' in food labeling ``should be banned altogether'' (see 
Petition at page 3).
    We also have received two other citizen petitions concerning the 
use of the term ``natural'' on food labels. One citizen petition, from 
the Sara Lee Corp. (see FDA-2007-P-0007), asks that we work with USDA's 
Food Safety Inspection Service (FSIS) to devise and adopt a unified 
policy, as a statement of policy, governing use of the term ``natural'' 
such that use of the term ``natural'' may be used to describe a food or 
food ingredient that does not contain any artificial flavor or 
flavoring, coloring ingredient (regardless of source), or any 
artificial or synthetic ingredient that is included within or not 
normally expected in the product (see Petition at page 2). Further, the 
Sara Lee Corp. asserts that the degree of processing necessary to 
produce the food or food ingredient should be considered in determining 
consumer expectation.
    Another citizen petition, submitted by The Sugar Association (see 
FDA-2006-P-0206), asks that we engage in rulemaking to define the term 
``natural'' with respect to food and beverages. The citizen petition 
asks for consistency across Federal Agencies with respect to such 
definition and requests that we define the term ``natural'' based on 
FSIS's definition in its Food Standards and Labeling Policy Book for 
``natural'' claims for meat products and poultry products (see Petition 
at page 1).

[[Page 69908]]

    The definition of ``natural claims'' in the FSIS's Food Standards 
and Labeling Policy Book, in relevant part, states that the term 
``natural'' may be used on labeling for meat products and poultry 
products if the applicant for such labeling demonstrates that: (1) The 
product does not contain any artificial flavor or flavoring, coloring 
ingredient, chemical preservative (as defined in Sec.  101.22), or any 
other artificial or synthetic ingredient and (2) the product and its 
ingredients are not more than minimally processed. The FSIS Food 
Standards and Labeling Policy Book further explains that minimal 
processing may include traditional processes used to make food edible 
or to preserve it or to make it safe for human consumption, e.g., 
smoking, roasting, freezing, drying, and fermenting or physical 
processes which do not fundamentally alter the raw product and/or which 
only separate a whole, intact food into component parts, e.g., grinding 
meat, separating eggs into albumen and yolk, and pressing fruits to 
produce juices. The FSIS Food Standards and Labeling Policy Book also 
states that relatively severe processes, such as solvent extraction, 
acid hydrolysis, and chemical bleaching, would be considered more than 
minimal processing, so the use of a natural flavor or flavoring in 
compliance with Sec.  101.22 that has undergone more than minimal 
processing would place a product in which it is used outside the scope 
of the FSIS guidelines. However, the FSIS Food Standards and Labeling 
Policy Book states that the presence of an ingredient that has been 
more than minimally processed would not necessarily preclude the 
product from being promoted as natural, and that exceptions may be 
granted on a case-by-case basis if it can be demonstrated that the use 
of such an ingredient would not significantly change the character of 
the product to the point that it could no longer be considered a 
natural product. In such cases, the natural claim is to be qualified to 
clearly and conspicuously identify the ingredient, e.g., ``all natural 
or all natural ingredients except dextrose, modified food starch, 
etc.''
    The FSIS Food Standards and Labeling Policy Book also states that 
all products claiming to be natural or a natural food should be 
accompanied by a brief statement that explains what is meant by the 
term natural, i.e., that the product is a natural food because it 
contains no artificial ingredients and is only minimally processed. The 
statement is to appear directly beneath or beside all natural claims 
or, if elsewhere on the principal display panel, an asterisk should be 
used to tie the explanation to the claim.
    Moreover, the FSIS Food Standards and Labeling Policy Book 
specifies that FSIS's decision to approve or deny use of a natural 
claim may be affected by the specific context in which the claim is 
made. The FSIS Food Standards and Labeling Policy Book contains an 
example showing that claims indicating that a product is natural food, 
e.g., ``Natural chili'' or ``chili--a natural product'' would be 
unacceptable for a product containing beet powder, which artificially 
colors the finished product, but states that a claim such as ``all 
natural ingredients'' might be an acceptable claim for such a product 
(see Food Standards and Labeling Policy Book, FSIS, at 116, August 
2005).
    Both the Sara Lee Corp. and The Sugar Association citizen petitions 
also state that defining or establishing a policy on ``natural'' would 
provide consistency for consumers and food manufacturers.

II. Request for Comments and Information

    We invite interested persons to comment on the use of the term 
``natural'' in the labeling of human food products, including when, if 
ever, the use of the term is false or misleading (FDA-2014-N-1207). We 
are particularly interested in responses to the following questions:
     Should we define, through rulemaking, the term 
``natural?'' Why or why not?
     Should we prohibit the term ``natural'' in food labeling? 
Why or why not?
     If we define the term ``natural,'' what types of food 
should be allowed to bear the term ``natural?''
     Should only raw agricultural commodities be able to bear 
the term? Why or why not? Section 201(r) of the FD&C Act defines the 
term ``raw agricultural commodity'' as ``any food in its raw or natural 
state, including all fruits that are washed, colored, or otherwise 
treated in their unpeeled natural form prior to marketing.''
     Should only single ingredient foods, e.g., bottled water 
or bagged spinach, be able to bear the term? Why or why not?
     If multi-ingredient foods should be able to bear the term, 
what type(s) of ingredients would disqualify the food from bearing the 
term? Please explain why such disqualification would be warranted.
     We are interested in any data or other information to 
suggest that consumers associate, confuse, or compare the term 
``natural'' with ``organic'' (the USDA Agricultural Marketing Service 
administers the National Organic Program, which enforces laws and 
regulations regarding certified organic foods). We are interested in 
data and other information about consumers' understanding of foods 
labeled ``natural'' versus ``organic.'' Is the term ``natural'' on food 
labels perceived by consumers the same way as ``organic?'' Or is 
``natural'' perceived by consumers to be ``better'' (or not as good as) 
``organic?'' Please provide consumer research or other evidence to 
support your comment.
     If we were to revise our policy regarding the use of the 
term ``natural'' or engage in rulemaking to establish a regulatory 
definition for ``natural,'' should certain production practices used in 
agriculture, for example, genetic engineering, mutagenesis, 
hybridization, the use of pesticides, or animal husbandry practices, be 
a factor in defining ``natural?'' Why or why not?
     We are interested in any data or other information to 
suggest that consumers associate, confuse, or compare the term 
``natural'' with ``healthy.'' We have a regulation that defines the 
term ``healthy'' when used as an implied nutrient content claim with 
specific conditions related to the food's nutrient profile that must be 
met in order to use the term on the label or in labeling of a food (see 
Sec.  101.65(d)). We are interested in data and other information about 
consumers' understanding of foods labeled ``natural'' versus 
``healthy.'' Is the term ``natural'' on food labels perceived by 
consumers the same way as ``healthy?'' Or is ``natural'' perceived by 
consumers to be ``better'' (or not as good as) ``healthy?'' Do 
consumers view ``natural'' and ``healthy'' as synonymous terms? Please 
provide consumer research or other evidence to support your comment.
     Should manufacturing processes be considered in 
determining when a food can bear the term ``natural?'' For example, 
should food manufacturing processes, such as drying, salting, 
marinating, curing, freezing, canning, fermenting, pasteurizing, 
irradiating, or hydrolysis, be a factor in defining ``natural?''
     Should the term ``natural'' only apply to ``unprocessed'' 
foods? If so, how should ``unprocessed'' and ``processed'' be defined 
for purposes of bearing the claim? If the term natural should include 
some processing methods, what should those methods be? In making 
determinations related to processing, should one look at the process to 
make a single ingredient of a

[[Page 69909]]

food, or does one evaluate the process done to the formulated finished 
food product (or both)?
     The current policy regarding use of the term ``natural'' 
hinges in part on the presence or absence of synthetic ingredients. For 
example, under the current policy synthetic forms of Vitamin D would 
not be used in a food claiming to be ``natural,'' whereas naturally 
sourced Vitamin D (e.g., from salmon or egg yolks) could be. Should the 
manner in which an ingredient is produced or sourced affect whether a 
food containing that ingredient may be labeled as ``natural?'' Please 
explain your reasoning.
     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? Please provide supporting data 
and other information to support your comment.
     Should ``natural'' have some nutritional benefit 
associated with it? If so, what should be the benefit? What nutrients 
should be considered? What data are available to support the 
association between ``natural'' and a given nutritional benefit, and/or 
between ``natural'' and certain nutrients?
     How might we determine whether foods labeled ``natural'' 
comply with any criteria for bearing the claim?

    Dated: November 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28779 Filed 11-10-15; 8:45 am]
 BILLING CODE 4164-01-P


