[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Draft Guidance for Industry on Ingredients Declared as Evaporated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comment period for the draft guidance for industry entitled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the availability of the draft guidance was published in the Federal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published a notice announcing the availability of a draft guidance for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issued the draft guidance to seek comment on our preliminary thinking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]
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