[Federal Register Volume 78, Number 34 (Wednesday, February 20, 2013)]
[Proposed Rules]
[Pages 11791-11793]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03835]


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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 78, No. 34 / Wednesday, February 20, 2013 / 
Proposed Rules

[[Page 11791]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 131

[Docket No. FDA-2009-P-0147]


Flavored Milk; Petition to Amend the Standard of Identity for 
Milk and 17 Additional Dairy Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments, data, and information.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
International Dairy Foods Association (IDFA) and the National Milk 
Producers Federation (NMPF) have filed a petition requesting that the 
Agency amend the standard of identity for milk and 17 other dairy 
products to provide for the use of any safe and suitable sweetener as 
an optional ingredient. FDA is issuing this notice to request comments, 
data, and information about the issues presented in the petition.

DATES: Submit either written or electronic comments by May 21, 2013.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
P-0147 by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the 
instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
    Mail/Hand delivery/Courier (for paper or CD-ROM submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and docket number for this rulemaking. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
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.

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. IDFA and NMPF Petition

    The IDFA and NMPF jointly submitted a citizen petition (Ref. 1) on 
March 16, 2009, requesting that FDA amend the standard of identity in 
part 131 (21 CFR part 131) for milk (Sec.  131.110). Specifically, the 
petition requests that FDA amend Sec.  131.110(c)(2) to allow the use 
of ``any safe and suitable'' sweetener in optional characterizing 
flavoring ingredients used in milk.\1\ The petition also requests that 
FDA similarly amend the standards of identity for 17 other milk and 
cream products. Those standards (hereinafter referred to as the 
``additional dairy standards'') are as follows: Acidified milk (Sec.  
131.111), cultured milk (Sec.  131.112), sweetened condensed milk 
(Sec.  131.120), nonfat dry milk (Sec.  131.125), nonfat dry milk 
fortified with vitamins A and D (Sec.  131.127), evaporated milk (Sec.  
131.130), dry cream (Sec.  131.149), heavy cream (Sec.  131.150), light 
cream (Sec.  131.155), light whipping cream (Sec.  131.157), sour cream 
(Sec.  131.160), acidified sour cream (Sec.  131.162), eggnog (Sec.  
131.170), half-and-half (Sec.  131.180), yogurt (Sec.  131.200), lowfat 
yogurt (Sec.  131.203), and nonfat yogurt (Sec.  131.206). The petition 
asks that the standards of identity for these products be amended to 
provide for the use of any safe and suitable sweetener in the optional 
ingredients.\2\
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    \1\ Section 131.110(c)(2) currently allows the use of 
``nutritive sweetener'' in optional characterizing flavoring 
ingredients used in milk.
    \2\ The National Yogurt Association (NYA) submitted a citizen 
petition on February 18, 2000 (Docket No. FDA-2000-P-0126) that 
requested that FDA make similar changes to the standards of identity 
for yogurt and cultured milk. Among other requested changes, the NYA 
petition asked that FDA amend the standards of identity for yogurt 
and cultured milk to permit the use of all safe and suitable 
sweeteners, while also revoking the standards of identity for lowfat 
and nonfat yogurt. In 2009, FDA proposed to grant the petition in 
part, and to deny it in part. See ``Milk and Cream Products and 
Yogurt Products; Proposal to Revoke the Standards for Lowfat and 
Nonfat Yogurt and to Amend the Standard for Yogurt'' (74 FR 2443, 
January 15, 2009). Thus, FDA has already requested comments on 
issues that are similar to the issues IDFA and NMPF raise with 
respect to yogurt, lowfat yogurt, nonfat yogurt, and cultured milk, 
and is addressing those issues through the rulemaking initiated in 
response to NYA's petition. Therefore, FDA is not currently 
requesting comments on IDFA and NMPF's suggested amendments to the 
yogurt, lowfat yogurt, nonfat yogurt, and cultured milk standards.
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    IDFA and NMPF request their proposed amendments to the milk 
standard of identity to allow optional characterizing flavoring 
ingredients used in milk (e.g., chocolate flavoring added to milk) to 
be sweetened with any safe and suitable sweetener--including non-
nutritive sweeteners such as aspartame. IDFA and NMPF state that the 
proposed amendments would promote more healthful eating practices and 
reduce childhood obesity by providing for lower-calorie flavored milk 
products. They state that lower-calorie flavored milk would 
particularly benefit school children who, according to IDFA and NMPF, 
are more inclined to drink flavored milk than unflavored milk at 
school. As further support for the petition, IDFA and NMPF state that 
the proposed amendments would assist in meeting several initiatives 
aimed at improving the nutrition and health profile of food served in 
the nation's schools. Those initiatives include state-level programs 
designed to limit the quantity of sugar served to children during the 
school day. Finally, IDFA and NMPF argue that the proposed amendments 
to the milk standard of identity would promote honesty and fair dealing 
in the marketplace and are therefore appropriate under section 401 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341).
    The petition acknowledges that the use of non-nutritive sweeteners 
in optional characterizing flavoring

[[Page 11792]]

ingredients in milk is allowed under the existing regulatory scheme, 
with certain additional requirements. The regulatory framework 
governing the naming of standardized foods that do not fully comply 
with the relevant standards of identity changed with the passage of the 
Nutrition Labeling and Education Act of 1990 and FDA's rulemaking 
establishing the Agency's requirements for foods named by use of a 
nutrient content claim and a standardized term (Sec.  130.10 (21 CFR 
130.10)). Section 130.10(d) allows the addition of safe and suitable 
ingredients to a food named by use of a nutrient content claim and a 
standardized term when these ingredients are used to, among other 
things, add sweetness to ensure that the modified food is not inferior 
in performance characteristic to the standardized food even if such 
ingredients are not specifically provided for by the relevant food 
standard. Therefore, while the milk standard of identity in Sec.  
131.110 only provides for the use of ``nutritive sweetener'' in an 
optional characterizing flavor, milk may contain a characterizing 
flavor that is sweetened with a non-nutritive sweetener if the food's 
label bears a nutrient content claim (e.g., ``reduced calorie'') and 
the non-nutritive sweetener is used to add sweetness to the product so 
that it is not inferior in its sweetness property compared to its 
standardized counterpart. However, IDFA and NMPF argue that nutrient 
content claims such as ``reduced calorie'' are not attractive to 
children, and maintain that consumers can more easily identify the 
overall nutritional value of milk products that are flavored with non-
nutritive sweeteners if the labels do not include such claims. Further, 
the petitioners assert that consumers do not recognize milk--including 
flavored milk--as necessarily containing sugar. Accordingly, the 
petitioners state that milk flavored with non-nutritive sweeteners 
should be labeled as milk without further claims so that consumers can 
``more easily identify its overall nutritional value.''
    As to the additional dairy standards, IDFA and NMPF state that 
administrative efficiency counsels in favor of similar changes. As long 
as FDA is dedicating resources to amending the standard of identity for 
milk, they argue, the Agency should also amend the standards for these 
products at the same time. They state that it is most efficient to 
consider all of the proposals together. According to the petition, the 
requested changes to the additional dairy standards present the same 
issues as the milk standard, and it is therefore appropriate to 
consider all of the requested changes together.

II. Request for Comments

    FDA requests that interested persons submit comments, data, and 
information concerning the need for, and the appropriateness of, 
amending the standard of identity for milk and the additional dairy 
standards. FDA specifically requests comment and supporting data, as 
appropriate, on the following matters:
    1. The petition states that amending the standard of identity for 
milk (Sec.  131.100) to allow the use of ``any safe and suitable'' 
sweetener in optional characterizing flavoring ingredients would 
promote honesty and fair dealing in the interest of consumers by 
creating consistency in the naming of flavored milk products because 
flavored milk could contain a non-nutritive sweetener without bearing a 
nutrient content claim (e.g., ``reduced sugar'') as part of its name. 
Would the proposed amendments promote honesty and fair dealing in the 
interest of consumers?
    2. If the standard of identity for milk is amended as requested by 
petitioners, milk manufacturers could use non-nutritive sweeteners in 
flavored milk without a nutrient content claim in its labeling. Will 
the inclusion of the non-nutritive sweeteners in the ingredient 
statement provide consumers with sufficient information to ensure that 
consumers are not misled regarding the characteristics of the milk they 
are purchasing?
    3. The petition states that flavored milk labels that bear nutrient 
content claims such as ``reduced calorie'' are unattractive to 
children. What, if any, data are available on children's purchase 
habits with regard to flavored milks labeled as ``reduced calorie 
flavored milk,'' ``no sugar added,'' ``less sugar,'' etc?
    4. The petition states that if FDA dedicates resources to amending 
the standard of identity for milk, for purposes of administrative 
efficiency the Agency should also amend the Additional Dairy Standards 
because the issues presented are the same with respect to the use of 
non-nutritive sweeteners. Would amending the Additional Dairy Standards 
as requested promote honesty and fair dealing in the interest of 
consumers? If the labels of these products do not bear nutrient content 
claims, would the inclusion of non-nutritive sweeteners in the 
ingredient statements provide consumers with sufficient information to 
distinguish between the two types of products (i.e., sweetened with 
nutritive versus non-nutritive sweeteners) so that consumers are not 
misled? \3\
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    \3\ Although FDA requests comments relevant to the IDFA and NMPF 
petition, FDA does not seek comments regarding the requested 
amendments to the standards of identity for yogurt, lowfat yogurt, 
nonfat yogurt, and cultured milk. FDA has already sought and 
collected comments regarding similar amendments to those standards 
in a proposed rulemaking. See 74 FR 2443.
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    5. The petition notes that ice cream is permitted to contain either 
a nutritive or non-nutritive sweetener without the label bearing a 
nutrient content claim or otherwise distinguishing the two types of 
products from one another. Are the considerations underlying FDA 
amendments to the standard of identity for ice cream \4\ applicable to 
the requested amendments to the standard of identity for milk or the 
Additional Dairy Standards?
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    \4\ FDA amended the standard of identity for ice cream to allow 
for ``any safe and suitable sweetener'' to be used in ice cream. See 
``Frozen Desserts: Removal of Standards of Identity for Ice Milk and 
Goat's Milk Ice Milk; Amendment of Standards of Identity for Ice 
Cream and Frozen Custard and Goat's Milk Ice Cream'' (59 FR 47072, 
September 14, 1994) (Ref 2). Before FDA's amendment, the standard 
provided only for ``nutritive carbohydrate sweeteners.''
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    6. If the standard of identity for milk and the Additional Dairy 
Standards are amended in the manner requested by the petition, what 
will be the effect on search costs \5\ for consumers who would like to 
determine whether a product contains a nutritive or non-nutritive 
sweetener?
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    \5\ Search costs include the time and energy it would take an 
average consumer to read a label and determine whether the product 
contained the nutritive sweetener or the artificial sweetener.
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    After reviewing the comments received, FDA will further evaluate 
the need for, and appropriateness of, the amendments requested by IDFA 
and NMPF and will decide what further actions are appropriate. For a 
copy of the petition filed by IDFA and NMPF please go to: http://www.regulations.gov and insert ``Docket No. FDA-2009-P-0147'' into the 
``Search'' box.

(Authority: 21 U.S.C. 321 et seq.)

III. References

    FDA has placed the following references on display. To view the 
references, go to http://www.regulations.gov and insert the docket 
number(s), found in brackets in the heading of this document, into the 
``Search'' box. The references may also be seen in the Division of 
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday.
    1. International Dairy Foods Association and the National Milk 
Producers Federation, Citizen Petition, March 16, 2009.

[[Page 11793]]

    2. ``Frozen Desserts: Removal of Standards of Identity for Ice Milk 
and Goat's Milk Ice Milk; Amendment of Standards of Identity for Ice 
Cream and Frozen Custard and Goat's Milk Ice Cream'' (59 FR 47072, 
September 14, 1994).

    Dated: February 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03835 Filed 2-19-13; 8:45 am]
BILLING CODE 4160-01-P