[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