
[Federal Register Volume 81, Number 188 (Wednesday, September 28, 2016)]
[Rules and Regulations]
[Pages 66527-66529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23367]


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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: Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance for industry entitled ``Use of the Term 
`Healthy' in the Labeling of Human Food Products: Guidance for 
Industry.'' The guidance advises manufacturers who wish to use the 
implied nutrient content claim ``healthy'' to label their food products 
as provided by our regulations. More specifically, the guidance advises 
food manufacturers of our intent to exercise enforcement discretion 
with respect to the implied nutrient content claim ``healthy'' on foods 
that have a fat profile of predominantly mono and polyunsaturated fats, 
but do not meet the regulatory definition of ``low fat'', or that 
contain at least 10 percent of the Daily Value (DV) per reference 
amount customarily consumed (RACC) of potassium or vitamin D.

DATES: Submit either electronic or written comments on FDA guidances at 
any time.

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

[[Page 66528]]

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, 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: Guidance for Industry.'' 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.
    Submit written requests for single copies of the guidance to the 
Office of Nutrition and Food Labeling, Center for Food Safety and 
Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740. Send two self-addressed adhesive labels to 
assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance.

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

    We are announcing the availability of a guidance for industry 
entitled ``Use of the Term `Healthy' in the Labeling of Human Food 
Products: Guidance for Industry.'' We are issuing this guidance 
consistent with our good guidance practices regulation (21 CFR 10.115). 
The guidance represents the current thinking of FDA on this topic. It 
does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.
    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 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). 
Our food labeling regulations at Sec.  101.65(d) (21 CFR 101.65(d)) 
provide the regulatory definition for use of the term ``healthy'' or 
related terms (such as ``health,'' ``healthful,'' ``healthfully,'' 
``healthfulness,'' ``healthier,'' ``healthiest,'' ``healthily,'' and 
``healthiness'') as an implied nutrient content claim on the label or 
in labeling of a food. This definition establishes the following 
nutrient conditions for bearing a ``healthy'' claim: (1) Specific 
criteria for nutrients to limit in the diet, such as total fat, 
saturated fat, cholesterol, and sodium; and (2) 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 
Sec. Sec.  101.9 and 101.12). The nutrient criteria to use the claim 
can vary for different food categories (e.g., fruits and vegetables, or 
seafood and game meat) (Sec.  101.65(d)(2)).
    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 must be declared and 
also changes to the DV of other individual nutrients, reflecting 
changes in recommended intake levels, based on current science.
    Because the science supporting public health recommendations for 
intake of various nutrients has evolved, as reflected in the updated 
Nutrition Facts Label, FDA intends to exercise enforcement discretion 
with respect to some of the criteria for bearing the implied nutrient 
content claim ``healthy.'' In particular, we intend to exercise 
enforcement discretion with respect to the current requirement that any 
food bearing the nutrient content claim ``healthy'' meet the low fat 
requirement provided that: (1) The amounts of mono- and polyunsaturated 
fats are declared on the label; and (2) the amounts declared constitute 
the majority of the fat content.
    Similarly, we intend to exercise enforcement discretion with 
respect to the current requirement that any food bearing the nutrient 
content claim ``healthy'' contain at least 10 percent of the DV per 
RACC of vitamin A, vitamin C, calcium, iron, protein, or fiber, if the 
food instead contains at least 10 percent of the DV per RACC of 
potassium or vitamin D.
    We are issuing this guidance without prior public comment under 21 
CFR 10.115(g)(2) because we have determined that prior public 
participation is not feasible or appropriate, as this guidance 
implements a temporary enforcement policy while we update our 
regulations to be consistent with the final Nutrition Facts Label rule. 
However, as with all Agency guidances, the public may comment on the 
guidance at any time.

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II. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. 
Use the FDA Web sites listed in the previous sentence to find the most 
current version of the guidance.

    Dated: September 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23367 Filed 9-27-16; 8:45 am]
 BILLING CODE 4164-01-P


