[Federal Register Volume 81, Number 102 (Thursday, May 26, 2016)]
[Notices]
[Pages 33538-33540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12402]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0430]
Ingredients Declared as Evaporated Cane Juice; Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a guidance entitled ``Ingredients Declared as
Evaporated Cane Juice.'' The document advises industry of FDA's view
that sweeteners derived from sugar
[[Page 33539]]
cane, including those derived from sugar cane syrup, should not be
declared on food labels as ``evaporated cane juice.'' Instead, such
ingredients should be declared as ``sugar,'' preceded by one or more
truthful, non-misleading descriptors if the manufacturer so chooses.
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 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-2009-D-0430 for ``Ingredients Declared as Evaporated Cane Juice.''
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 Food
Labeling and Standards Staff/Office of Nutrition and Food Labeling,
Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug
Administration, 5100 Paint Branch Pkwy., 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: Andrea Krause, Center for Food Safety
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 240-402-2371.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for industry
entitled ``Ingredients Declared as Evaporated Cane Juice.'' We are
issuing this guidance consistent with FDA's 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.
In the Federal Register of October 7, 2009 (74 FR 51610), we
announced the availability of a draft guidance for industry entitled
``Guidance for Industry: Ingredients Declared as Evaporated Cane
Juice'' and invited comment by December 7, 2009. The draft guidance,
which was issued in response to the use of the term ``evaporated cane
juice'' on food labels, stated FDA's view that ``evaporated cane
juice'' is not the common or usual name of any sweetener and that the
ingredient in question should instead be declared as ``dried cane
syrup.'' In the Federal Register of March 5, 2014 (79 FR 12507), we
reopened the comment period until May 5, 2014, and requested further
comments, data, and information about the basic nature and
characterizing properties of the ingredient sometimes declared as
``evaporated cane juice,'' how this ingredient is produced, and how it
compares with other sweeteners.
We received numerous comments on the draft guidance, including many
that included information about the processing and refining of
ingredients made from sugar cane. We have modified the final guidance
where appropriate. In addition, we made editorial changes to improve
clarity. Based on comments stating that the ingredient sometimes
declared as evaporated cane juice is not made from cane syrup as
defined in 21 CFR 168.130, FDA is no longer recommending that this
ingredient be labeled as ``dried cane syrup.'' Instead, the guidance
advises that ingredients currently being declared as ``evaporated cane
juice,'' as well as other ingredients that meet the description of
``sucrose'' in 21 CFR 184.1854, should be declared using the term
``sugar,'' accompanied by a truthful, non-misleading descriptor if the
manufacturer so desires. The guidance announced in this notice
[[Page 33540]]
finalizes the draft guidance dated October 2009.
FDA encourages firms that market sugar cane-derived sweeteners or
products that contain a sugar cane-derived sweetener to review the
final guidance and consider whether the name under which the sweetener
is declared in food labeling accurately describes its basic nature and
characterizing properties, as required by the common or usual name
regulation (21 CFR 102.5). As explained in the final guidance, our view
is that products currently labeled as containing ``evaporated cane
juice'' should be relabeled to use the name ``sugar,'' optionally
accompanied by a truthful, non-misleading descriptor to distinguish the
ingredient from other cane-based sweeteners. FDA would not object to
the use of stickers to make this change until the next regularly
scheduled label printing.
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 previously to find the most current
version of the guidance.
Dated: May 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12402 Filed 5-25-16; 8:45 am]
BILLING CODE 4164-01-P