81_FR_66750 81 FR 66562 - Use of the Term “Healthy” in the Labeling of Human Food Products; Request for Information and Comments

81 FR 66562 - Use of the Term “Healthy” in the Labeling of Human Food Products; Request for Information and Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 188 (September 28, 2016)

Page Range66562-66565
FR Document2016-23365

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.

Federal Register, Volume 81 Issue 188 (Wednesday, September 28, 2016)
[Federal Register Volume 81, Number 188 (Wednesday, September 28, 2016)]
[Proposed Rules]
[Pages 66562-66565]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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

[[Page 66564]]

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

[[Page 66565]]

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



                                                  66562              Federal Register / Vol. 81, No. 188 / Wednesday, September 28, 2016 / Proposed Rules

                                                  cost, and assuming that all of the                       Register, the Commission provides all                issuance of final rules updating certain
                                                  affected entities qualify as small                       interested persons an opportunity to                 of our nutrition labeling regulations. In
                                                  entities, the total annual cost to the                   view and/or print the contents of this               addition, we received a citizen petition
                                                  industry as a whole is minimal                           document via the Internet through the                asking that we update, among other
                                                  ($19,577.75), and the average cost per                   Commission’s Home Page (http://                      things, our nutrient content claim
                                                  affected entity is $63.23.                               www.ferc.gov) and in the Commission’s                regulations to be consistent with current
                                                     45. According to SBA guidance, the                    Public Reference Room during normal                  federal dietary guidance. In particular,
                                                  determination of significance of impact                  business hours (8:30 a.m. to 5:00 p.m.               the petitioners request that FDA amend
                                                  ‘‘should be seen as relative to the size                 Eastern time) at 888 First Street NE.,               the regulation defining the nutrient
                                                  of the business, the size of the                         Room 2A, Washington, DC 20426.                       content claim ‘‘healthy’’ with respect to
                                                  competitor’s business, and the impact                      51. From the Commission’s Home                     total fat intake and amend the regulation
                                                  the regulation has on larger                             Page on the Internet, this information is            to emphasize whole foods and dietary
                                                  competitors.’’ 49 The Commission does                    available on eLibrary. The full text of              patterns rather than specific nutrients.
                                                  not consider the estimated burden to be                  this document is available on eLibrary               We invite public comment on the term
                                                  a significant economic impact. As a                      in PDF and Microsoft Word format for                 ‘‘healthy’’, generally, and as a nutrient
                                                  result, the Commission certifies that the                viewing, printing, and/or downloading.               content claim in the context of food
                                                  reforms proposed in this NOPR would                      To access this document in eLibrary,                 labeling and on specific questions
                                                  not have a significant economic impact                   type the docket number excluding the                 contained in this document.
                                                  on a substantial number of small                         last three digits of this document in the            DATES: Submit either electronic or
                                                  entities.                                                docket number field.                                 written comments by January 26, 2017.
                                                  VI. Comment Procedures                                     52. User assistance is available for
                                                                                                                                                                ADDRESSES: You may submit comments
                                                                                                           eLibrary and the Commission’s Web site
                                                     46. The Commission invites interested                                                                      as follows:
                                                                                                           during normal business hours from the
                                                  persons to submit comments on the                        Commission’s Online Support at (202)                 Electronic Submissions
                                                  matters and issues proposed in this                      502–6652 (toll free at 1–866–208–3676)
                                                  notice to be adopted, including any                                                                             Submit electronic comments in the
                                                                                                           or email at ferconlinesupport@ferc.gov,              following way:
                                                  related matters or alternative proposals                 or the Public Reference Room at (202)
                                                  that commenters may wish to discuss.                                                                            • Federal eRulemaking Portal: http://
                                                                                                           502–8371, TTY (202) 502–8659. Email                  www.regulations.gov. Follow the
                                                  Comments are due November 28, 2016.                      the Public Reference Room at
                                                  Comments must refer to Docket No.                                                                             instructions for submitting comments.
                                                                                                           public.referenceroom@ferc.gov.                       Comments submitted electronically,
                                                  RM16–13–000, and must include the
                                                  commenter’s name, the organization                         By direction of the Commission.                    including attachments, to http://
                                                  they represent, if applicable, and their                   Issued: September 22, 2016.                        www.regulations.gov will be posted to
                                                  address in their comments.                               Nathaniel J. Davis, Sr.,                             the docket unchanged. Because your
                                                     47. The Commission encourages                         Deputy Secretary.                                    comment will be made public, you are
                                                  comments to be filed electronically via                  [FR Doc. 2016–23442 Filed 9–27–16; 8:45 am]          solely responsible for ensuring that your
                                                  the eFiling link on the Commission’s                     BILLING CODE 6717–01–P
                                                                                                                                                                comment does not include any
                                                  Web site at http://www.ferc.gov. The                                                                          confidential information that you or a
                                                  Commission accepts most standard                                                                              third party may not wish to be posted,
                                                  word processing formats. Documents                                                                            such as medical information, your or
                                                                                                           DEPARTMENT OF HEALTH AND
                                                  created electronically using word                                                                             anyone else’s Social Security number, or
                                                                                                           HUMAN SERVICES
                                                  processing software should be filed in                                                                        confidential business information, such
                                                  native applications or print-to-PDF                      Food and Drug Administration                         as a manufacturing process. Please note
                                                  format and not in a scanned format.                                                                           that if you include your name, contact
                                                  Commenters filing electronically do not                  21 CFR Part 101                                      information, or other information that
                                                  need to make a paper filing.                                                                                  identifies you in the body of your
                                                     48. Commenters that are not able to                   [Docket No. FDA–2016–D–2335]                         comments, that information will be
                                                  file comments electronically must send                                                                        posted on http://www.regulations.gov.
                                                                                                           Use of the Term ‘‘Healthy’’ in the
                                                  an original of their comments to:                                                                               • If you want to submit a comment
                                                                                                           Labeling of Human Food Products;
                                                  Federal Energy Regulatory Commission,                                                                         with confidential information that you
                                                                                                           Request for Information and
                                                  Secretary of the Commission, 888 First                                                                        do not wish to be made available to the
                                                                                                           Comments
                                                  Street NE., Washington, DC 20426.                                                                             public, submit the comment as a
                                                     49. All comments will be placed in                    AGENCY:   Food and Drug Administration,              written/paper submission and in the
                                                  the Commission’s public files and may                    HHS.                                                 manner detailed (see ‘‘Written/Paper
                                                  be viewed, printed, or downloaded                        ACTION: Notification; establishment of               Submissions’’ and ‘‘Instructions’’).
                                                  remotely as described in the Document                    docket; request for comments.
                                                  Availability section below. Commenters                                                                        Written/Paper Submissions
                                                  on this proposal are not required to                     SUMMARY:    The Food and Drug                          Submit written/paper submissions as
                                                  serve copies of their comments on other                  Administration (FDA or we) is                        follows:
                                                  commenters.                                              announcing the establishment of a                      • Mail/Hand delivery/Courier (for
                                                                                                           docket to receive information and                    written/paper submissions): Division of
sradovich on DSK3GMQ082PROD with PROPOSALS




                                                  VII. Document Availability
                                                                                                           comments on the use of the term                      Dockets Management (HFA–305), Food
                                                    50. In addition to publishing the full                 ‘‘healthy’’ in the labeling of human food            and Drug Administration, 5630 Fishers
                                                  text of this document in the Federal                     products. This action is consistent with             Lane, Rm. 1061, Rockville, MD 20852.
                                                                                                           our recently released 2016–2025 Foods                  • For written/paper comments
                                                    49 U.S. Small Business Administration, A Guide
                                                                                                           and Veterinary Medicine (FVM)                        submitted to the Division of Dockets
                                                  for Government Agencies: How to comply with the
                                                  Regulatory Flexibility Act, at 18 (May 2012), https://
                                                                                                           Program’s strategic plan with specific               Management, FDA will post your
                                                  www.sba.gov/sites/default/files/advocacy/rfaguide_       goals for nutrition and other planned                comment, as well as any attachments,
                                                  0512_0.pdf.                                              and recent activity including the                    except for information submitted,


                                             VerDate Sep<11>2014   17:27 Sep 27, 2016   Jkt 238001   PO 00000   Frm 00018   Fmt 4702   Sfmt 4702   E:\FR\FM\28SEP1.SGM   28SEP1


                                                                    Federal Register / Vol. 81, No. 188 / Wednesday, September 28, 2016 / Proposed Rules                                           66563

                                                  marked and identified, as confidential,                 Dr., College Park, MD 20740, 240–402–                 nutrient content claim can vary for
                                                  if submitted as detailed in                             1450.                                                 different food categories (e.g., fruits and
                                                  ‘‘Instructions.’’                                       SUPPLEMENTARY INFORMATION:                            vegetables, or seafood and game meat)
                                                     Instructions: All submissions received                                                                     (21 CFR 101.65(d)(2)).
                                                  must include the Docket No. FDA–                        I. Background                                           In addition, under section 403(a)(1) of
                                                  2016–D–2335 for ‘‘Use of the Term                       A. What has been FDA’s position                       the FD&C Act, a food is deemed
                                                  ‘‘Healthy’’ in the Labeling of Human                    regarding the use of the term ‘‘healthy?’’            misbranded if its labeling is false or
                                                  Food Products; Request for Information                                                                        misleading in any particular.
                                                                                                             Under section 403(r)(1)(A) of the
                                                  and Comments.’’ Received comments                       Federal Food, Drug, and Cosmetic Act                  B. What has prompted FDA to request
                                                  will be placed in the docket and, except                (the FD&C Act) (21 U.S.C. 343(r)(1)(A)),              information and comments?
                                                  for those submitted as ‘‘Confidential                   a food is deemed misbranded if it bears
                                                  Submissions,’’ publicly viewable at                                                                              On July 14, 2016, we released the
                                                                                                          claims, either express or implied, that               FVM Program’s Strategic Plan for fiscal
                                                  http://www.regulations.gov or at the                    characterize the level of a nutrient
                                                  Division of Dockets Management                                                                                years 2016–2025. The strategic plan is
                                                                                                          which is of a type required to be                     organized under four goals: Food safety,
                                                  between 9 a.m. and 4 p.m., Monday                       declared in nutrition labeling unless the
                                                  through Friday.                                                                                               nutrition, animal health, and
                                                                                                          claim is made in accordance with a                    organizational excellence (The strategic
                                                     • Confidential Submissions—To                        regulatory definition established by
                                                  submit a comment with confidential                                                                            plan is available on our Web site at
                                                                                                          FDA (see section 403(r)(2) of the FD&C                http://www.fda.gov/downloads/
                                                  information that you do not wish to be                  Act). Section 201(f) of the FD&C Act (21
                                                  made publicly available, submit your                                                                          AboutFDA/CentersOffices/
                                                                                                          U.S.C. 321(f)) defines the term ‘‘food’’ to           OfficeofFoods/UCM507379.pdf.)
                                                  comments only as a written/paper                        mean articles used for food or drink for                 FDA’s nutrition-related strategic goals
                                                  submission. You should submit two                       man or other animals, chewing gum,                    include: Providing and supporting
                                                  copies total. One copy will include the                 and articles used for components of any               accurate and useful nutrition
                                                  information you claim to be confidential                such article. Section 201(n) of the FD&C              information to consumers so they can
                                                  with a heading or cover note that states                Act (21 U.S.C. 321(n)) provides that                  choose healthier diets consistent with
                                                  ‘‘THIS DOCUMENT CONTAINS                                labeling is misleading if, among other                the Dietary Guidelines for Americans
                                                  CONFIDENTIAL INFORMATION.’’ The                         things, it fails to reveal facts that are             and other evidence-based
                                                  Agency will review this copy, including                 material in light of representations made             recommendations; and encouraging and
                                                  the claimed confidential information, in                or suggested in the labeling, or material             facilitating new products and product
                                                  its consideration of comments. The                      with respect to consequences that may                 reformulation to promote a healthier
                                                  second copy, which will have the                        result from the use of the food to which              food supply. A key element in achieving
                                                  claimed confidential information                        the labeling relates under the conditions             these goals is the modernization of
                                                  redacted/blacked out, will be available                 of use prescribed in the labeling, or                 FDA’s regulations for nutrition-related
                                                  for public viewing and posted on http://                under such conditions of use as are                   labeling claims to reflect current
                                                  www.regulations.gov. Submit both                        customary or usual. Section 201(m) of                 science, provide information in ways
                                                  copies to the Division of Dockets                       the FD&C Act defines ‘‘labeling’’ as all              that are understandable and useful to
                                                  Management. If you do not wish your                     labels and other written, printed, or                 consumers, and reduce barriers and
                                                  name and contact information to be                      graphic matter upon any article or any                encourage industry efforts to develop
                                                  made publicly available, you can                        of its containers or wrappers or                      and introduce healthier food products
                                                  provide this information on the cover                   accompanying such article.                            through innovation or reformulation.
                                                  sheet and not in the body of your                          The definition in 21 CFR 101.65(d)                    In the Federal Register of May 27,
                                                  comments and you must identify this                     establishes the parameters for use of the             2016, we issued final rules updating the
                                                  information as ‘‘confidential.’’ Any                    implied nutrient content claim                        Nutrition Facts label and serving size
                                                  information marked as ‘‘confidential’’                  ‘‘healthy’’ or related terms (such as                 information for packaged foods to reflect
                                                  will not be disclosed except in                         ‘‘health’’, ‘‘healthful’’, ‘‘healthfully’’,           new scientific information, including
                                                  accordance with 21 CFR 10.20 and other                  ‘‘healthfulness’’, ‘‘healthier’’,                     the link between diet and chronic
                                                  applicable disclosure law. For more                     ‘‘healthiest’’, ‘‘healthily’’, and                    diseases such as obesity and heart
                                                  information about FDA’s posting of                      ‘‘healthiness’’) on the label or in                   disease (see 81 FR 33742, ‘‘Food
                                                  comments to public dockets, see 80 FR                   labeling of a food to suggest that a food,            Labeling: Revision of the Nutrition and
                                                  56469, September 18, 2015, or access                    because of its nutrient content, may be               Supplement Facts Labels’’; 81 FR 34000,
                                                  the information at: http://www.fda.gov/                 useful in creating a diet that is                     ‘‘Food Labeling: Serving Sizes of Foods
                                                  regulatoryinformation/dockets/                          consistent with dietary                               That Can Reasonably Be Consumed At
                                                  default.htm.                                            recommendations, if the food meets                    One Eating Occasion; Dual-Column
                                                     Docket: For access to the docket to                  certain nutrient conditions, and the                  Labeling; Updating, Modifying, and
                                                  read background documents or the                        claim is made with an explicit or                     Establishing Certain Reference Amounts
                                                  electronic and written/paper comments                   implicit claim or statement about a                   Customarily Consumed; Serving Size for
                                                  received, go to http://                                 nutrient (e.g., ‘‘healthy, contains 3                 Breath Mints; and Technical
                                                  www.regulations.gov and insert the                      grams of fat’’). The conditions include               Amendments’’). Updates to the
                                                  docket number, found in brackets in the                 specific criteria for nutrients to limit in           Nutrition Facts label include changes in
                                                  heading of this document, into the                      the diet, such as total fat, saturated fat,           the individual nutrients that are
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                                                  ‘‘Search’’ box and follow the prompts                   cholesterol, sodium, as well as                       required to be declared and also changes
                                                  and/or go to the Division of Dockets                    requirements for nutrients to encourage               to the Daily Value of other individual
                                                  Management, 5630 Fishers Lane, Rm.                      in the diet, including vitamin A,                     nutrients, reflecting changes in
                                                  1061, Rockville, MD 20852.                              vitamin C, calcium, iron, protein, and                recommended intake levels, based on
                                                  FOR FURTHER INFORMATION CONTACT:                        fiber. The criteria are linked to elements            current science. Because the framework
                                                  Vincent de Jesus, Center for Food Safety                in the Nutrition Facts label and serving              for many of FDA’s nutrition labeling
                                                  and Applied Nutrition (HFS–830), Food                   size regulations (see 21 CFR 101.9 and                regulations is linked to elements in the
                                                  and Drug Administration, 5001 Campus                    101.12). The nutrient criteria to use this            Nutrition Facts label and serving size


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                                                  66564             Federal Register / Vol. 81, No. 188 / Wednesday, September 28, 2016 / Proposed Rules

                                                  regulations, FDA has been planning to                   product by the following foods,                       consuming nutrient-dense foods (id. at
                                                  update these regulations to align with                  provided that such foods are used in                  pgs. 14–18). The petitioner also asserted
                                                  the updated Nutrition Facts label                       their whole form or have been processed               that dietary recommendations and
                                                  regulations. These regulations include                  in such a way that did not materially                 scientific evidence now focus on the
                                                  those for health claims and nutrient                    degrade their nutritional value: Fruits,              quality or types of dietary fat consumed
                                                  content claims (including the implied                   vegetables, nuts, seeds, legumes, whole               instead of reducing total fat
                                                  nutrient content claim ‘‘healthy’’).                    grains, and seafood; and the food meets               consumption (id. at pgs. 18–19).
                                                     The science underlying FDA’s new                     the following conditions for other                       Thus, the petitioner described its
                                                  requirements for the Nutrition Facts                    nutrients;’’                                          requested changes and actions as being
                                                  label and serving size information is                      • Amend § 101.65(d) (pertaining to                 necessary to ‘‘ensure that FDA’s
                                                  also reflected in the recently published                general nutritional claims) to ‘‘clarify              requirements are consistent with current
                                                  2015–2020 Dietary Guidelines for                        that a labeling claim that a food is useful           federal dietary recommendations and
                                                  Americans (2015–2020 Dietary                            in maintaining healthy dietary practices              with the most recent scientific evidence,
                                                  Guidelines) (Ref. 1). The Dietary                       is an implied nutrient content claim                  which is essential in providing uniform
                                                  Guidelines are designed for                             only if the claim is immediately                      federal dietary guidance to consumers’’
                                                  professionals to help all individuals                   adjacent to an implicit claim or                      (id. at page 20).
                                                  ages 2 years and older and their families               statement about a nutrient’’;
                                                  consume a healthy, nutritionally                           • Amend § 101.65(b) (pertaining to                 II. Other Issues for Consideration
                                                  adequate diet. The Dietary Guidelines                   label statements that are not implied                    We invite interested persons to
                                                  are the foundation of federal nutrition                 claims) to ‘‘clarify that a statement that            comment on the petitioner’s requests,
                                                  guidance and are fundamental in                         claims that a food is useful in                       including the use of the term ‘‘healthy’’
                                                  shaping federal policies and programs                   maintaining healthy dietary practices                 as a nutrient content claim in the
                                                  related to food, nutrition, and health.                 and that does not appear immediately                  labeling of human food products; and
                                                  Specific recommendations in the                         adjacent to an explicit or implicit claim             when, if ever, the use of the term
                                                  Dietary Guidelines have evolved over                    or statement about a nutrient is                      ‘‘healthy’’ may be false or misleading.
                                                  time, as nutrition science has advanced.                generally not an implied nutrient                     We are particularly interested in
                                                  They provide information and                            content claim, but is instead a dietary               responses to the following questions:
                                                  perspectives on consumption of foods                    guidance statement’’; and                                • Is the term ‘‘healthy’’ most
                                                  from various food groups, as well as the                   • While the rulemakings to amend                   appropriately categorized as a claim
                                                  intake of specific macronutrients such                  § 101.65 are pending, issue a guidance                based only on nutrient content? If not,
                                                  as fats and sugars, and micronutrients                  document to ‘‘clarify that a statement                what other criteria (e.g., inclusion of
                                                  such as vitamins and minerals. The                      about the usefulness of a food, or a                  foods from specific food categories)
                                                  2015–2020 Dietary Guidelines                            category of foods, in maintaining                     would be appropriate to consider in
                                                  emphasize the importance of eating                      healthy dietary practices is a dietary                defining the term ‘‘healthy’’ for use in
                                                  patterns as a whole, the combination of                 guidance statement that is not subject to             food labeling?
                                                  foods and drinks that people consume                    the requirements in FDA’s nutrient                       • If criteria other than nutrient
                                                  over time. The scientific evidence on                   content claim regulations unless it is an             content (e.g., amount of whole grain) are
                                                  which the Dietary Guidelines are based                  implied nutrient content claim because                to be included in the definition of the
                                                  and the recommendations in the Dietary                  it is immediately adjacent to an explicit             term ‘‘healthy,’’ how might we
                                                  Guidelines will help inform additional                  or implicit claim or statement about a                determine whether foods labeled
                                                  updates to FDA’s regulations on                         nutrient’’.                                           ‘‘healthy’’ comply with such other
                                                  nutrition-related claims that are                          See Kind Citizen Petition at pgs. 2–5.             criteria for bearing the claim?
                                                  permitted on the food label.                            The petitioner stated that our existing                  • What types of food, if any, should
                                                     A variety of stakeholders from                       regulatory scheme ‘‘limits the ability of             be allowed to bear the term ‘‘healthy?’’
                                                  academia and industry, as well as                       food producers to tell consumers that                 Should all food categories be subject to
                                                  consumers, have also requested that                     products containing certain foods—such                the same criteria? Please provide details
                                                  FDA update additional nutrition                         as nuts, whole grains, seafood, fruits,               of your reasoning.
                                                  labeling regulations for nutrient content               and vegetables—are healthy, even                         • Is ‘‘healthy’’ the best term to
                                                  and health claims, including the                        though they are currently recommended                 characterize foods that should be
                                                  implied nutrient content claim                          as key components of a healthful diet’’               encouraged to build healthy dietary
                                                  ‘‘healthy’’. Some stakeholders have                     (Kind Citizen Petition at pg. 5). The                 practices or patterns? What other words
                                                  provided specific recommendations on                    petitioner said that its request would                or terms might be more appropriate
                                                  how they believe we should approach                     ‘‘make FDA’s regulatory regime                        (e.g., ‘‘nutritious’’)? We encourage
                                                  such an update. For example, in a                       consistent with current federal dietary               submission of any studies or data
                                                  citizen petition dated December 1, 2015                 recommendations (as is required by                    related to descriptors used to
                                                  (Docket Number FDA–2015–P–4564)                         law), consistent with current scientific              communicate the overall healthfulness
                                                  (‘‘Kind Citizen Petition’’), KIND LLC                   evidence about the health benefits of                 of a food product.
                                                  requested that we make certain changes                  certain foods, and would significantly                   • What nutrient criteria should be
                                                  to existing nutrition claim regulations.                benefit the public health by ensuring                 considered for the definition of the term
                                                  A number of these changes specifically                  that consumers fully understand the                   ‘‘healthy?’’ Should nutrients for which
                                                  related to the nutrient content claim                   dietary value of foods available for                  intake is recommended to be limited be
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                                                  ‘‘healthy’’. With regards to ‘‘healthy’’,               purchase’’ (id.).                                     included? Should nutrients for which
                                                  the petition requested that we:                            The petitioner asserted that current               intake is encouraged continue to be
                                                     • Amend § 101.65(d)(2) so that the                   federal dietary recommendations                       included?
                                                  term ‘‘healthy’’ or related terms may be                encourage dietary patterns that are rich                 • If nutrients for which intake is
                                                  used if the food ‘‘meets the following                  in nuts, whole grains, legumes, seeds,                encouraged are included in the
                                                  conditions for fat, saturated fat, and                  fruits, vegetables, and seafood (id. at               definition, should these nutrients be
                                                  cholesterol exclusive of the fat and                    pgs. 10–14) and that current science also             restricted to those nutrients whose
                                                  saturated fat contributed to the food                   recognizes the health benefits of                     recommended intakes are not met by the


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                                                                    Federal Register / Vol. 81, No. 188 / Wednesday, September 28, 2016 / Proposed Rules                                             66565

                                                  general population, or should they                      Federal Register, but Web sites are                   DATES:  Comment due date: November
                                                  include those nutrients that contribute                 subject to change over time.)                         28, 2016.
                                                  to general overall health? Should the                   1. U.S. Department of Health and Human                ADDRESSES: Interested persons are
                                                  nutrients be intrinsic to the foods, or                     Services and U.S. Department of                   invited to submit comments regarding
                                                  could they be provided in part—or in                        Agriculture. 2015–2020 Dietary                    this proposed rule to the Regulations
                                                  total—via fortification? Please provide                     Guidelines for Americans, 8th Edition,            Division, Office of General Counsel,
                                                  details of your reasoning and provide                       December 2015, available at http://
                                                                                                                                                                Department of Housing and Urban
                                                  any supportive data or information.                         health.gov/dietaryguidelines/2015/
                                                                                                              guidelines/.                                      Development, 451 7th Street SW., Room
                                                     • Are there current dietary                                                                                10276, Washington, DC 20410–0500.
                                                  recommendations (e.g., the Dietary                        Dated: September 23, 2016.                          Communications must refer to the above
                                                  Guidelines for Americans) or nutrient                   Leslie Kux,                                           docket number and title. There are two
                                                  intake requirements, such as those                      Associate Commissioner for Policy.                    methods for submitting public
                                                  described in the final rule updating the                [FR Doc. 2016–23365 Filed 9–27–16; 8:45 am]           comments. All submissions must refer
                                                  Nutrition Facts label (see 81 FR 33742;                 BILLING CODE 4164–01–P                                to the above docket number and title.
                                                  May 27, 2016) or those provided by the
                                                                                                                                                                  1. Submission of Comments by Mail.
                                                  Institute of Medicine (IOM) in the form
                                                                                                                                                                Comments may be submitted by mail to
                                                  of Dietary Reference Intakes (DRI)
                                                                                                          DEPARTMENT OF HOUSING AND                             the Regulations Division, Office of
                                                  (http://www.nationalacademies.org/
                                                                                                          URBAN DEVELOPMENT                                     General Counsel, Department of
                                                  hmd/Activities/Nutrition/
                                                                                                                                                                Housing and Urban Development, 451
                                                  SummaryDRIs/DRI-Tables.aspx), that
                                                                                                          24 CFR Parts 203 and 234                              7th Street SW., Room 10276,
                                                  should be reflected in criteria for use of
                                                                                                                                                                Washington, DC 20410–0500.
                                                  the term ‘‘healthy?’’                                   [Docket No. FR–5715–P–01]
                                                     • What are the public health benefits,                                                                       2. Electronic Submission of
                                                  if any, of defining the term ‘‘healthy’’ or             RIN 2502–AJ30                                         Comments. Interested persons may
                                                  other similar terms in food labeling?                                                                         submit comments electronically through
                                                  Please include any data or research                     Project Approval for Single-Family                    the Federal eRulemaking Portal at
                                                  related to public health benefits in your               Condominiums                                          www.regulations.gov. HUD strongly
                                                  reasoning.                                                                                                    encourages commenters to submit
                                                                                                          AGENCY:  Office of the Assistant                      comments electronically. Electronic
                                                     • What is consumers’ understanding                   Secretary for Housing—Federal Housing
                                                  of the meaning of the term ‘‘healthy’’ as                                                                     submission of comments allows the
                                                                                                          Commissioner, HUD.                                    commenter maximum time to prepare
                                                  it relates to food? What are consumers’                 ACTION: Proposed rule.
                                                  expectations of foods that carry a                                                                            and submit a comment, ensures timely
                                                  ‘‘healthy’’ claim? We are especially                                                                          receipt by HUD, and enables HUD to
                                                                                                          SUMMARY:   This proposed rule would                   make them immediately available to the
                                                  interested in any data or other                         implement HUD’s authority under the
                                                  information that evaluates whether or                                                                         public. Comments submitted
                                                                                                          single-family mortgage insurance                      electronically through the
                                                  not consumers associate, confuse, or                    provisions of the National Housing Act
                                                  compare the term ‘‘healthy’’ with other                                                                       www.regulations.gov Web site can be
                                                                                                          to insure one-family units in a                       viewed by other commenters and
                                                  descriptive terms and claims.                           multifamily project, including a project
                                                     • Would this change in the term                                                                            interested members of the public.
                                                                                                          in which the dwelling units are                       Commenters should follow the
                                                  ‘‘healthy’’ cause a shift in consumer                   attached, or are manufactured housing
                                                  behavior in terms of dietary choices?                                                                         instructions provided on that site to
                                                                                                          units, semi-detached, or detached, and                submit comments electronically.
                                                  For example, would it cause a shift                     an undivided interest in the common
                                                  away from purchasing or consuming                       areas and facilities which serve the                    Note: To receive consideration as public
                                                  fruits and vegetables that do not contain               project. The rule would codify                        comments, comments must be submitted
                                                  a ‘‘healthy’’ claim and towards                                                                               through one of the two methods specified
                                                                                                          requirements for Direct Endorsement                   above. Again, all submissions must refer to
                                                  purchasing or consuming processed                       lenders to meet in order to be approved               the docket number and title of the rule.
                                                  foods that bear this new ‘‘healthy’’                    for the Direct Endorsement Lender
                                                  claim?                                                  Review and Approval Process (DELRAP)                     No Facsimile Comments. Facsimile
                                                     • How will the food industry and                     authority for condominiums, and basic                 (fax) comments are not acceptable.
                                                  consumers regard a change in the                        standards that projects must meet to be                  Public Inspection of Public
                                                  definition of ‘‘healthy?’’                              approved as condominiums in which                     Comments. HUD will make all properly
                                                     • What would be the costs to industry                individual units would be eligible for                submitted comments and
                                                  of the change?                                          mortgage insurance, as well as                        communications available for public
                                                  Please provide supporting data,                         particular cases such as Single-Unit                  inspection and copying between 8 a.m.
                                                  consumer research, and other                            Approvals and site condominiums. The                  and 5 p.m. weekdays at the above
                                                  information to support your comments                    rule provides a method by which certain               address. Due to security measures at the
                                                  and responses to these questions.                       approval standards could be varied                    HUD Headquarters building, you must
                                                                                                          efficiently to meet market needs while                schedule an appointment in advance to
                                                  III. References                                         providing for public comment where                    review the public comments by calling
                                                     The following reference is on display                appropriate. Currently, single-family                 the Regulations Division at 202–708–
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                                                  in the Division of Dockets Management                   condominium project approval is                       3055 (this is not a toll-free number).
                                                  (see ADDRESSES) and is available for                    provided under HUD’s Condominium                      Individuals with speech or hearing
                                                  viewing by interested persons between                   Project Approval and Processing Guide                 impairments may access this number
                                                  9 a.m. and 4 p.m., Monday through                       and related Mortgagee Letters.                        via TTY by calling the toll-free Federal
                                                  Friday; it is also available electronically                Condominiums under this rule are                   Relay Service at 800–877–8339. Copies
                                                  at http://www.regulations.gov. (FDA has                 distinct from condominiums in which                   of all comments submitted are available
                                                  verified the Web site address, as of the                the project has a blanket mortgage                    for inspection and downloading at
                                                  date this document publishes in the                     insured by HUD.                                       www.regulations.gov.


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Document Created: 2016-09-28 01:08:32
Document Modified: 2016-09-28 01:08:32
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotification; establishment of docket; request for comments.
DatesSubmit either electronic or written comments by January 26, 2017.
ContactVincent 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.
FR Citation81 FR 66562 

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