[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