
[Federal Register Volume 81, Number 188 (Wednesday, September 28, 2016)]
[Proposed Rules]
[Pages 66562-66565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23365]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2016-D-2335]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; establishment of docket; 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 ``healthy'' in the labeling of human food products. 
This action is consistent with our recently released 2016-2025 Foods 
and Veterinary Medicine (FVM) Program's strategic plan with specific 
goals for nutrition and other planned and recent activity including the 
issuance of final rules updating certain of our nutrition labeling 
regulations. In addition, we received a citizen petition asking that we 
update, among other things, our nutrient content claim regulations to 
be consistent with current federal dietary guidance. In particular, the 
petitioners request that FDA amend the regulation defining the nutrient 
content claim ``healthy'' with respect to total fat intake and amend 
the regulation to emphasize whole foods and dietary patterns rather 
than specific nutrients. We invite public comment on the term 
``healthy'', generally, and as a nutrient content claim in the context 
of food labeling and on specific questions contained in this document.

DATES: Submit either electronic or written comments by January 26, 
2017.

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.
     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,

[[Page 66563]]

marked and identified, as confidential, if submitted as detailed in 
``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-2335 for ``Use of the Term ``Healthy'' 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: Vincent de Jesus, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-1450.

SUPPLEMENTARY INFORMATION: 

I. Background

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

    Under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 343(r)(1)(A)), a food is deemed 
misbranded if it bears claims, either express or implied, that 
characterize the level of a nutrient which is of a type required to be 
declared in nutrition labeling unless the claim is made in accordance 
with a regulatory definition established by FDA (see section 403(r)(2) 
of the FD&C Act). 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. 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.
    The definition in 21 CFR 101.65(d) establishes the parameters for 
use of the implied nutrient content claim ``healthy'' or related terms 
(such as ``health'', ``healthful'', ``healthfully'', ``healthfulness'', 
``healthier'', ``healthiest'', ``healthily'', and ``healthiness'') on 
the label or in labeling of a food to suggest that a food, because of 
its nutrient content, may be useful in creating a diet that is 
consistent with dietary recommendations, if the food meets certain 
nutrient conditions, and the claim is made with an explicit or implicit 
claim or statement about a nutrient (e.g., ``healthy, contains 3 grams 
of fat''). The conditions include specific criteria for nutrients to 
limit in the diet, such as total fat, saturated fat, cholesterol, 
sodium, as well as requirements for nutrients to encourage in the diet, 
including vitamin A, vitamin C, calcium, iron, protein, and fiber. The 
criteria are linked to elements in the Nutrition Facts label and 
serving size regulations (see 21 CFR 101.9 and 101.12). The nutrient 
criteria to use this nutrient content claim can vary for different food 
categories (e.g., fruits and vegetables, or seafood and game meat) (21 
CFR 101.65(d)(2)).
    In addition, under section 403(a)(1) of the FD&C Act, a food is 
deemed misbranded if its labeling is false or misleading in any 
particular.

B. What has prompted FDA to request information and comments?

    On July 14, 2016, we released the FVM Program's Strategic Plan for 
fiscal years 2016-2025. The strategic plan is organized under four 
goals: Food safety, nutrition, animal health, and organizational 
excellence (The strategic plan is available on our Web site at http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofFoods/UCM507379.pdf.)
    FDA's nutrition-related strategic goals include: Providing and 
supporting accurate and useful nutrition information to consumers so 
they can choose healthier diets consistent with the Dietary Guidelines 
for Americans and other evidence-based recommendations; and encouraging 
and facilitating new products and product reformulation to promote a 
healthier food supply. A key element in achieving these goals is the 
modernization of FDA's regulations for nutrition-related labeling 
claims to reflect current science, provide information in ways that are 
understandable and useful to consumers, and reduce barriers and 
encourage industry efforts to develop and introduce healthier food 
products through innovation or reformulation.
    In the Federal Register of May 27, 2016, we issued final rules 
updating the Nutrition Facts label and serving size information for 
packaged foods to reflect new scientific information, including the 
link between diet and chronic diseases such as obesity and heart 
disease (see 81 FR 33742, ``Food Labeling: Revision of the Nutrition 
and Supplement Facts Labels''; 81 FR 34000, ``Food Labeling: Serving 
Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; 
Dual-Column Labeling; Updating, Modifying, and Establishing Certain 
Reference Amounts Customarily Consumed; Serving Size for Breath Mints; 
and Technical Amendments''). Updates to the Nutrition Facts label 
include changes in the individual nutrients that are required to be 
declared and also changes to the Daily Value of other individual 
nutrients, reflecting changes in recommended intake levels, based on 
current science. Because the framework for many of FDA's nutrition 
labeling regulations is linked to elements in the Nutrition Facts label 
and serving size

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regulations, FDA has been planning to update these regulations to align 
with the updated Nutrition Facts label regulations. These regulations 
include those for health claims and nutrient content claims (including 
the implied nutrient content claim ``healthy'').
    The science underlying FDA's new requirements for the Nutrition 
Facts label and serving size information is also reflected in the 
recently published 2015-2020 Dietary Guidelines for Americans (2015-
2020 Dietary Guidelines) (Ref. 1). The Dietary Guidelines are designed 
for professionals to help all individuals ages 2 years and older and 
their families consume a healthy, nutritionally adequate diet. The 
Dietary Guidelines are the foundation of federal nutrition guidance and 
are fundamental in shaping federal policies and programs related to 
food, nutrition, and health. Specific recommendations in the Dietary 
Guidelines have evolved over time, as nutrition science has advanced. 
They provide information and perspectives on consumption of foods from 
various food groups, as well as the intake of specific macronutrients 
such as fats and sugars, and micronutrients such as vitamins and 
minerals. The 2015-2020 Dietary Guidelines emphasize the importance of 
eating patterns as a whole, the combination of foods and drinks that 
people consume over time. The scientific evidence on which the Dietary 
Guidelines are based and the recommendations in the Dietary Guidelines 
will help inform additional updates to FDA's regulations on nutrition-
related claims that are permitted on the food label.
    A variety of stakeholders from academia and industry, as well as 
consumers, have also requested that FDA update additional nutrition 
labeling regulations for nutrient content and health claims, including 
the implied nutrient content claim ``healthy''. Some stakeholders have 
provided specific recommendations on how they believe we should 
approach such an update. For example, in a citizen petition dated 
December 1, 2015 (Docket Number FDA-2015-P-4564) (``Kind Citizen 
Petition''), KIND LLC requested that we make certain changes to 
existing nutrition claim regulations. A number of these changes 
specifically related to the nutrient content claim ``healthy''. With 
regards to ``healthy'', the petition requested that we:
     Amend Sec.  101.65(d)(2) so that the term ``healthy'' or 
related terms may be used if the food ``meets the following conditions 
for fat, saturated fat, and cholesterol exclusive of the fat and 
saturated fat contributed to the food product by the following foods, 
provided that such foods are used in their whole form or have been 
processed in such a way that did not materially degrade their 
nutritional value: Fruits, vegetables, nuts, seeds, legumes, whole 
grains, and seafood; and the food meets the following conditions for 
other nutrients;''
     Amend Sec.  101.65(d) (pertaining to general nutritional 
claims) to ``clarify that a labeling claim that a food is useful in 
maintaining healthy dietary practices is an implied nutrient content 
claim only if the claim is immediately adjacent to an implicit claim or 
statement about a nutrient'';
     Amend Sec.  101.65(b) (pertaining to label statements that 
are not implied claims) to ``clarify that a statement that claims that 
a food is useful in maintaining healthy dietary practices and that does 
not appear immediately adjacent to an explicit or implicit claim or 
statement about a nutrient is generally not an implied nutrient content 
claim, but is instead a dietary guidance statement''; and
     While the rulemakings to amend Sec.  101.65 are pending, 
issue a guidance document to ``clarify that a statement about the 
usefulness of a food, or a category of foods, in maintaining healthy 
dietary practices is a dietary guidance statement that is not subject 
to the requirements in FDA's nutrient content claim regulations unless 
it is an implied nutrient content claim because it is immediately 
adjacent to an explicit or implicit claim or statement about a 
nutrient''.
    See Kind Citizen Petition at pgs. 2-5. The petitioner stated that 
our existing regulatory scheme ``limits the ability of food producers 
to tell consumers that products containing certain foods--such as nuts, 
whole grains, seafood, fruits, and vegetables--are healthy, even though 
they are currently recommended as key components of a healthful diet'' 
(Kind Citizen Petition at pg. 5). The petitioner said that its request 
would ``make FDA's regulatory regime consistent with current federal 
dietary recommendations (as is required by law), consistent with 
current scientific evidence about the health benefits of certain foods, 
and would significantly benefit the public health by ensuring that 
consumers fully understand the dietary value of foods available for 
purchase'' (id.).
    The petitioner asserted that current federal dietary 
recommendations encourage dietary patterns that are rich in nuts, whole 
grains, legumes, seeds, fruits, vegetables, and seafood (id. at pgs. 
10-14) and that current science also recognizes the health benefits of 
consuming nutrient-dense foods (id. at pgs. 14-18). The petitioner also 
asserted that dietary recommendations and scientific evidence now focus 
on the quality or types of dietary fat consumed instead of reducing 
total fat consumption (id. at pgs. 18-19).
    Thus, the petitioner described its requested changes and actions as 
being necessary to ``ensure that FDA's requirements are consistent with 
current federal dietary recommendations and with the most recent 
scientific evidence, which is essential in providing uniform federal 
dietary guidance to consumers'' (id. at page 20).

II. Other Issues for Consideration

    We invite interested persons to comment on the petitioner's 
requests, including the use of the term ``healthy'' as a nutrient 
content claim in the labeling of human food products; and when, if 
ever, the use of the term ``healthy'' may be false or misleading. We 
are particularly interested in responses to the following questions:
     Is the term ``healthy'' most appropriately categorized as 
a claim based only on nutrient content? If not, what other criteria 
(e.g., inclusion of foods from specific food categories) would be 
appropriate to consider in defining the term ``healthy'' for use in 
food labeling?
     If criteria other than nutrient content (e.g., amount of 
whole grain) are to be included in the definition of the term 
``healthy,'' how might we determine whether foods labeled ``healthy'' 
comply with such other criteria for bearing the claim?
     What types of food, if any, should be allowed to bear the 
term ``healthy?'' Should all food categories be subject to the same 
criteria? Please provide details of your reasoning.
     Is ``healthy'' the best term to characterize foods that 
should be encouraged to build healthy dietary practices or patterns? 
What other words or terms might be more appropriate (e.g., 
``nutritious'')? We encourage submission of any studies or data related 
to descriptors used to communicate the overall healthfulness of a food 
product.
     What nutrient criteria should be considered for the 
definition of the term ``healthy?'' Should nutrients for which intake 
is recommended to be limited be included? Should nutrients for which 
intake is encouraged continue to be included?
     If nutrients for which intake is encouraged are included 
in the definition, should these nutrients be restricted to those 
nutrients whose recommended intakes are not met by the

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general population, or should they include those nutrients that 
contribute to general overall health? Should the nutrients be intrinsic 
to the foods, or could they be provided in part--or in total--via 
fortification? Please provide details of your reasoning and provide any 
supportive data or information.
     Are there current dietary recommendations (e.g., the 
Dietary Guidelines for Americans) or nutrient intake requirements, such 
as those described in the final rule updating the Nutrition Facts label 
(see 81 FR 33742; May 27, 2016) or those provided by the Institute of 
Medicine (IOM) in the form of Dietary Reference Intakes (DRI) (http://www.nationalacademies.org/hmd/Activities/Nutrition/SummaryDRIs/DRI-Tables.aspx), that should be reflected in criteria for use of the term 
``healthy?''
     What are the public health benefits, if any, of defining 
the term ``healthy'' or other similar terms in food labeling? Please 
include any data or research related to public health benefits in your 
reasoning.
     What is consumers' understanding of the meaning of the 
term ``healthy'' as it relates to food? What are consumers' 
expectations of foods that carry a ``healthy'' claim? We are especially 
interested in any data or other information that evaluates whether or 
not consumers associate, confuse, or compare the term ``healthy'' with 
other descriptive terms and claims.
     Would this change in the term ``healthy'' cause a shift in 
consumer behavior in terms of dietary choices? For example, would it 
cause a shift away from purchasing or consuming fruits and vegetables 
that do not contain a ``healthy'' claim and towards purchasing or 
consuming processed foods that bear this new ``healthy'' claim?
     How will the food industry and consumers regard a change 
in the definition of ``healthy?''
     What would be the costs to industry of the change?

Please provide supporting data, consumer research, and other 
information to support your comments and responses to these questions.

III. References

    The following reference is on display in the Division of Dockets 
Management (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at http://www.regulations.gov. (FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over 
time.)

1. U.S. Department of Health and Human Services and U.S. Department 
of Agriculture. 2015-2020 Dietary Guidelines for Americans, 8th 
Edition, December 2015, available at http://health.gov/dietaryguidelines/2015/guidelines/.

    Dated: September 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23365 Filed 9-27-16; 8:45 am]
 BILLING CODE 4164-01-P


