[Federal Register Volume 79, Number 43 (Wednesday, March 5, 2014)]
[Notices]
[Pages 12507-12508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-04802]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0430]


Draft Guidance for Industry on Ingredients Declared as Evaporated 
Cane Juice; Reopening of Comment Period; Request for Comments, Data, 
and Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period; request for comments, 
data, and information.

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SUMMARY: The Food and Drug Administration (FDA or we) is reopening the 
comment period for the draft guidance for industry entitled 
``Ingredients Declared as Evaporated Cane Juice.'' A notice announcing 
the availability of the draft guidance was published in the Federal 
Register of October 7, 2009, to advise industry of FDA's view that the 
common or usual name for the solid or dried form of sugar cane syrup is 
``dried cane syrup,'' and that sweeteners derived from sugar cane syrup 
should not be declared on food labels as ``evaporated cane juice'' 
because that term falsely suggests the sweeteners are juice. We have 
not reached a final decision on the common or usual name for this 
ingredient and are reopening the comment period to request 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.

DATES: Submit either electronic or written comments by May 5, 2014.

ADDRESSES: Submit electronic comments, data, and information to http://www.regulations.gov. Submit written comments, data, and information to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Daniel Y. Reese, 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

    In the Federal Register of October 7, 2009 (74 FR 51610), we 
published a notice announcing the availability of a draft guidance for 
industry entitled ``Ingredients Declared as Evaporated Cane Juice.'' We 
issued the draft guidance to seek comment on our preliminary thinking 
regarding the use of the term ``evaporated cane juice'' on food labels 
to declare the presence of sweeteners derived from sugar cane syrup 
(``cane syrup''). The draft guidance advised industry of our view that 
the term ``evaporated cane juice'' is not the common or usual name of 
any type of sweetener, including sweeteners derived from cane syrup. 
The draft guidance explained that, because cane

[[Page 12508]]

syrup has a standard of identity defined by regulation in 21 CFR 
168.130, the common or usual name for the solid or dried form of cane 
syrup is ``dried cane syrup.'' Additionally, the draft guidance stated 
that sweeteners derived from cane syrup should not be declared as 
``evaporated cane juice'' because such sweeteners are not ``juice'' as 
defined in 21 CFR 120.1(a). The draft guidance also stated that because 
sweeteners derived from cane syrup are not juice, they should not be 
included in the percentage juice declaration on the labels of beverages 
that are represented to contain fruit or vegetable juice (see 21 CFR 
101.30).
    We are reopening the comment period to obtain additional data and 
information to better understand: (1) The basic nature and 
characterizing properties of the ingredient in question; (2) the method 
of production of this ingredient; and (3) the difference between this 
ingredient and other sweeteners made from sugar cane, e.g., molasses, 
raw sugar, brown sugar, turbinado sugar, muscovado sugar, and demerara 
sugar.

II. Request for Additional Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
    FDA requests comments, including supporting data and other 
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 
derived from sugar cane. We specifically request comments and 
supporting data on the following questions:
    1. How is ``evaporated cane juice'' manufactured? Specifically, how 
is its method of manufacture different from that of other sweeteners 
made from sugar cane (such as cane sugar, cane syrup, etc.)? Is there a 
uniform industry standard for this ingredient as traded in the 
marketplace?
    2. FDA regulations provide general principles for common or usual 
names to be used in the labeling of foods. The name must describe the 
basic nature of the food or its characterizing properties or 
ingredients. Moreover, the name must be uniform among all identical or 
similar products and may not be confusingly similar to the name of any 
other food that is not encompassed within the same name (Sec.  102.5(a) 
(21 CFR 102.5(a))).
    a. We noted in the draft guidance that sweeteners derived from 
sugar cane syrup should not be declared in the ingredient list by names 
which suggest that the ingredients are juice, such as ``evaporated cane 
juice.'' Does the name ``evaporated cane juice'' adequately convey the 
basic nature of the food and its characterizing properties or 
ingredients, consistent with the principles in Sec.  102.5(a)? Why or 
why not? How does the name ``evaporated cane juice'' square with the 
principle that the name of a food may not be confusingly similar to the 
name of any other food that is not encompassed within the same name, 
given the significant differences in source and composition between 
this ingredient and beverages that are regulated as ``juice'' under 
FDA's juice labeling and juice hazard analysis and critical control 
point (HACCP) regulations (e.g., orange juice and tomato juice)?
    b. There are a number of other sweeteners that are derived from 
sugar cane (such as raw sugar, cane sugar, cane syrup, demerara sugar, 
muscovado sugar, turbinado sugar, etc.) and that use the term ``sugar'' 
or ``syrup'' as a part of their name. How is ``evaporated cane juice'' 
similar to or different from those other sugars and syrups derived from 
sugar cane in terms of basic nature and characterizing properties or 
ingredients? Considering that the ingredient sometimes declared as 
``evaporated cane juice'' is also a sweetener derived from sugar cane, 
what would be the rationale for establishing a common or usual name 
that identifies this ingredient as a ``juice'' rather than as a 
``sugar'' or ``syrup,'' and how would such an approach square with the 
principle that common or usual names should be uniform and consistent 
among similar foods? What data and other information support your views 
on these questions?
    3. The draft guidance suggested the alternative name ``dried cane 
syrup'' for the ingredient sometimes declared as ``evaporated cane 
juice.'' There was a diversity of views in the comments on the guidance 
about the suggested name, and FDA would like to better understand the 
reasoning of the comments that objected to it. Applying the principles 
for common or usual names in Sec.  102.5, in what way does ``dried cane 
syrup'' fail to identify or describe this ingredient's basic nature or 
characterizing properties or ingredients? What information and data 
support or oppose your view?
    After reviewing the comments received, we intend to revise the 
draft guidance, if appropriate, and issue it in final form, in 
accordance with FDA's good guidance practice regulations in 21 CFR 
10.115.
    For a copy of the draft guidance or to view comments submitted in 
response to the draft guidance, please go to http://www.regulations.gov 
and search for the docket number found in brackets in the heading of 
this document.

    Dated: February 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04802 Filed 3-4-14; 8:45 am]
BILLING CODE 4160-01-P