[Federal Register Volume 68, Number 128 (Thursday, July 3, 2003)]
[Proposed Rules]
[Pages 39873-39877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16789]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 131
[Docket No. 00P-0685]
Milk and Cream Products and Yogurt Products; Petition to Revoke
Standards for Lowfat Yogurt and Nonfat Yogurt and to Amend Standards
for Yogurt and Cultured Milk
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
petition has been filed requesting that the agency revoke the standards
of identity for lowfat yogurt and nonfat yogurt; amend the standard of
identity for yogurt in numerous respects, including incorporation of
provisions for lowfat and nonfat yogurt; and amend the standard of
identity for cultured milk in numerous respects, including allowing for
the use of the alternate term ``fermented milk.'' We request comment on
whether the actions requested by the petition would promote honesty and
fair dealing in the interest of consumers.
DATES: Submit written or electronic comments by October 1, 2003.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. The petition is available for review at
the Division of Dockets Management or electronically on FDA's Web site
at http://www.fda.gov/ohrms/dockets/98fr/00p-0685-cp00001.pdf. You may
also request a copy of the petition from the Division of Dockets
Management.
FOR FURTHER INFORMATION CONTACT: Ritu Nalubola, Office of Nutritional
Products, Labeling, and Dietary Supplements, Center for Food Safety and
Applied Nutrition (HFS-820), Food and Drug
[[Page 39874]]
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-
436-2371.
SUPPLEMENTARY INFORMATION:
I. The Petition
The National Yogurt Association (NYA) submitted a citizen petition
on February 18, 2000, requesting that FDA revoke the standards of
identity in part 131 (21 CFR part 131) for lowfat yogurt (Sec.
131.203) and nonfat yogurt (Sec. 131.206), amend the current standard
of identity for yogurt (Sec. 131.200), and amend the standard of
identity for cultured milk (Sec. 131.112).
In its petition, NYA stated that its proposed standard establishes
that: (1) Yogurt is a food product containing a minimum level of
certain live and active cultures; (2) takes into account current
industry practices; (3) recognizes the need to allow for use of future
technologies; and (4) establishes a clear, consistent, modernized, and
flexible yogurt standard that would benefit both industry and
consumers. Specifically, NYA's proposed yogurt standard: (1) Requires a
minimum level of active cultures of 10\7\ colony-forming units (CFU)
per gram (/g); (2) requires an acidity of pH 4.6 or lower; (3) requires
a minimum level of total dairy ingredients of 51 percent; (4) provides
for preculture homogenization and pasteurization; (5) permits the use
of reconstituted milk and whey protein concentrate (WPC) as ``standard
dairy ingredients''; (6) provides for the use of any milk-derived
ingredients under optional dairy ingredients; (7) permits the use of
safe and suitable sweeteners, emulsifiers, and preservatives; (8)
permits the optional use of any safe and suitable ingredients added for
nutritional or functional purpose; and (9) makes provisions for lowfat
and nonfat yogurts based on total fat content of the food per reference
amount customarily consumed (RACC). In addition, NYA requested that the
current standard of identity for cultured milk be amended to
``conform'' to the proposed standard for yogurt. Specifically, NYA's
proposed amendments to the cultured milk standard: (1) Provide for the
alternate term ``fermented milk''; (2) require a minimum level of total
dairy ingredients of 51 percent; (3) permit the use of reconstituted
milk and WPC as ``standard dairy ingredients''; (4) provide for the use
of any milk-derived ingredient under optional dairy ingredients; (5)
permit the use of safe and suitable sweeteners, emulsifiers, and
preservatives; and (6) permit the use of any safe and suitable
ingredients added for a nutritional or functional purpose.
FDA is publishing this document in accordance with section
701(e)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 371(e)(1)), which directs the Secretary of Health and Human
Services to publish proposals made by petition to amend or repeal a
dairy food standard, so long as the petition includes reasonable
grounds for the action requested, and to provide interested persons
with an opportunity to present their views. FDA tentatively finds that
NYA's petition presents reasonable grounds. Therefore, FDA requests
comment on whether the actions proposed in the petition would promote
honesty and fair dealing in the interest of consumers.
II. Grounds for the Suggested Changes to Yogurt, Lowfat Yogurt, Nonfat
Yogurt, and Cultured Milk Standards
NYA pointed out that several provisions of the standards of
identity for cultured milk, yogurt, lowfat yogurt, and nonfat yogurt
are currently stayed (47 FR 41519, September 21, 1982). The stayed
provisions are: (1) Those provisions of Sec. Sec. 131.112(d)(1),
131.200(c)(1), 131.203(c)(1), and 131.206(c)(1) that restrict the type
of milk-derived ingredients that may be used, to those so named, to
increase the nonfat solids content of cultured milk and yogurts; (2)
those provisions of Sec. Sec. 131.200(a), 131.203(a), and 131.206(a)
that exclude the use of reconstituted dairy ingredients as the basic
ingredient in the manufacture of yogurts; (3) those provisions of
Sec. Sec. 131.200(c), 131.203(c), and 131.206(c) insofar as they
exclude the addition of preservatives to yogurts; (4) those provisions
of Sec. Sec. 131.200(a), 131.203(a), and 131.206(a) that set a minimum
titratable acidity of 0.9 percent, expressed as lactic acid; and (5)
the provision in Sec. 131.200(a) that the 3.25 percent minimum milkfat
level applies to yogurt after the addition of one or more of the
optional sources of milk solids not fat listed in Sec. 131.200(c)(1).
NYA contended that these stayed provisions create multiple gaps in the
standards for which no guidelines exist and, as a result, the integrity
of the food ``yogurt'' is not maintained.
According to NYA, yogurt has been characterized for centuries by
its live and active cultures, and thus a minimum content of live and
active cultures is crucial to the yogurt standard of identity to
promote honesty and fair dealing in the interest of consumers. NYA
noted that consumers identify yogurt with live and active cultures and
expect yogurt to contain a significant amount of these cultures when
they purchase the product, but have no assurance under the current
standard that the yogurt will contain such cultures. NYA maintained
that its proposed standard recognizes the defining characteristics of
yogurt and establishes that yogurt is a product of fermentation of
certain characterizing cultures, and that the finished food contains a
significant quantity of these live and active cultures consistent with
consumer expectations.
NYA also stated that the proposed amendments to the standard for
cultured milk would further serve consumer interest. Under its proposed
actions, NYA maintained that foods otherwise satisfying the standard of
identity for yogurt that do not contain the required level of the
characterizing live and active cultures would not be named ``yogurt'';
rather they would be named ``cultured milk'' or ``fermented milk.''
Consequently, NYA stated, consumers would not be misled into believing
that these foods contain a significant amount of live and active
cultures.
NYA also maintained that its proposal would ensure that aspects of
yogurt labeling, such as the use of nutrient content claims, are
consistent with the requirements of the Nutrition Labeling and
Education Act of 1990 (NLEA) (Public Law 101-535). NYA stated that its
proposed standard maintains the three yogurt types (full fat, lowfat,
and nonfat yogurts) so manufacturers can continue to make lowfat and
nonfat yogurts without meeting the nutritional equivalence requirement
as described in Sec. 130.10 (21 CFR 130.10). In addition, NYA
maintained that its proposed standard would change the milkfat content
requirements of lowfat and nonfat yogurts to ``directly parallel'' the
nutrient content claim requirements for the terms ``lowfat'' and
``nonfat'' established under the NLEA (21 CFR 101.62(b)).
Additionally, NYA noted that food technology has advanced and
industry practices related to yogurt manufacturing have changed since
the yogurt standards have been in place. Consequently, NYA asserted
that the current yogurt standards impede the yogurt industry and do not
allow manufacturers to implement advances in food technology. NYA
stated that its proposed standard establishes a modernized, flexible
standard of identity for yogurt, taking into account current industry
practices and recognizing the need to allow for use of future
technologies.
[[Page 39875]]
III. Matters of Particular Interest to FDA
FDA requests that interested persons submit data and information
concerning the need for, and the appropriateness of, revoking the
standards for lowfat and nonfat yogurt and amending the standards for
yogurt and cultured milk. FDA specifically requests comment on the
following provisions set forth in the petition:
1. A single standard of identity for yogurt, which includes
provisions for lowfat and nonfat yogurts;
2. A minimum of 10\7\ CFU/g of live and active characterizing
cultures at the time of manufacture of yogurt;
3. An acidity of pH 4.6 or lower, rather than the current
requirement of titratable acidity expressed as lactic acid in yogurt;
4. The use of optional milk-derived ingredients after
pasteurization and culturing of yogurt;
5. The use of reconstituted dairy ingredients and WPC as basic
dairy ingredients in yogurt, and the specifications related to WPC,
when used;
6. The optional use of any milk-derived ingredient that provides a
technical or functional purpose in yogurt;
7. The minimum dairy ingredients content requirement of 51 percent
of the total weight of yogurt;
8. The use of any safe and suitable nutritive or nonnutritive
sweeteners in yogurt;
9. The use of safe and suitable emulsifiers in yogurt;
10. The use of safe and suitable preservatives in yogurt;
11. The use of any safe and suitable ingredient added for a
nutritional or functional purpose in yogurt;
12. The use of the descriptor ``nonfat'' on a yogurt that may
contain less than 0.5 g of total fat per RACC (i.e., 225 g for yogurt
(21 CFR 101.12));
13. The use of the descriptor ``lowfat'' on a yogurt that may
contain at least 0.5 g but not more than 3.0 g total fat per RACC; and
14. The need to amend the standard for cultured milk to provide for
the alternate term ``fermented milk'' and to make it consistent with
any changes made in the standard for yogurt, and the appropriateness of
the proposed amendments to the standard for cultured milk.
After reviewing the comments received, FDA will determine the need
for, and appropriateness of, each of the amendments requested by NYA
and will decide what actions are appropriate. To facilitate comment, in
the following paragraphs FDA discusses some of the amendments requested
by NYA.
1. The standards for yogurt and cultured milk proposed by NYA
permit the use of any safe and suitable ingredient added for a
nutritional or functional purpose. NYA states that this provision is
necessary to maintain enough flexibility in the standards to permit the
use of novel ingredients as they are developed. FDA recognizes the need
for food standards to permit flexibility in food technology, so long as
that technology does not alter the basic nature or essential
characteristics of the food. The existing regulatory framework
governing standardized foods already provides for the addition of
substances for a nutritional purpose. Under the provisions of Sec.
130.10, standardized foods may be modified to contain nutrients not
specifically permitted by the relevant standard of identity and to make
an expressed nutrient content claim defined by FDA regulation. FDA also
notes that flexibility in the use of ingredients for a functional
purpose may be achieved by specifying the ingredients by functional use
category, e.g., ``emulsifiers'' or ``preservatives,'' rather than by
listing the specific ingredients. FDA seeks comment on the need for any
functional ingredient categories, in addition to the ones proposed by
the petition, in the manufacture of yogurt.
2. NYA proposed amendments to the current standard of identity for
cultured milk (Sec. 131.112) to provide for the alternate term
``fermented milk'' and to allow the use of currently prohibited
ingredients that would be permitted by NYA's proposed standard for
yogurt. NYA stated that under its proposed amendments, if the food
otherwise meets the yogurt standard of identity but does not contain
the characterizing cultures at the required levels, then the food
qualifies as cultured milk or fermented milk. The standard of identity
for cultured milk has been in place for several decades. In light of
consumer experience with the standard for cultured milk, FDA solicits
comment on the need to amend it and the appropriateness of the
amendments requested by NYA.
3. The current standards for yogurt, lowfat yogurt, and nonfat
yogurt permit heat treatment after culturing, with the requirement that
such treatment be declared in the name of the food. FDA notes that
NYA's proposed standard does not allow for heat treatment after
culturing, and seeks comment on the appropriateness of omitting this
provision.
4. NYA proposed a maximum pH of 4.6 for yogurt and stated that this
level reflects the lower end of titratable acidity levels found in
common industry practice. NYA also stated that measuring pH, rather
than titratable acidity expressed as lactic acid, reflects the current
industry practice and is a more accurate and convenient method of
measuring acidity. FDA seeks comment both on the acidity level proposed
by NYA and the use of pH rather than titratable acidity.
5. FDA notes NYA's assertion that consumers expect yogurt to
contain significant amounts of live and active cultures, as well as
NYA's proposed requirement to measure live and active cultures at the
time of manufacture. NYA proposed that manufacturers ``may'' test their
yogurt products to demonstrate that the products, under proper
distribution and storage conditions, would be expected to contain at
least 10\6\ CFU/g of live and active cultures through the
manufacturer's designated code life (i.e., shelf life) for the product
and at the anticipated time of consumption. However, as a legal
requirement, NYA proposed a minimum of 10\7\ CFU/g at the time of
manufacture because, NYA maintained, once the products enter the stream
of commerce, products are subject to different distribution and storage
conditions that are not within the manufacturer's control. FDA seeks
comment on: (1) Whether the presence of live and active cultures is an
essential characteristic of yogurt and, if so, in what amounts; (2) the
appropriateness of NYA's proposed provision that manufacturers ``may''
conduct tests to ensure the presence of live and active cultures
through the assigned code life for the product; and (3) whether NYA's
proposed standard of identity for yogurt would adequately ensure the
presence of appropriate amounts of live and active cultures in yogurt
throughout the shelf life of the product and at the point of purchase
or consumption. FDA also seeks comment on any alternative provisions
that may be needed to fulfill this requirement.
Finally, FDA seeks comment on vitamin A fortification. FDA
previously proposed to revoke a number of lowfat and nonfat standards
in parts 131 and 133 (21 CFR part 133) (i.e., Sec. Sec. 131.122
(Sweetened condensed skimmed milk), 131.123 (Lowfat dry milk), 131.132
(Evaporated skimmed milk), 131.135 (Lowfat milk), 131.136 (Acidified
lowfat milk), 131.138 (Cultured lowfat milk), 131.143 (Skim milk),
131.144 (Acidified skim milk), 131.146 (Cultured skim milk), 131.185
(Sour half-and-half), 131.187 (Acidified sour half-and-half), 131.203
(Lowfat yogurt), 131.206 (Nonfat yogurt), and 133.131 (Lowfat
[[Page 39876]]
cottage cheese) (60 FR 56541, November 9, 1995)) to ensure that the use
of nutrient content claims in the labeling of these products would be
consistent with the provisions of the NLEA. In the final rule (61 FR
58991, November 20, 1996), FDA revoked all of the previously mentioned
standards except for lowfat yogurt and nonfat yogurt. FDA delayed final
action on its proposal to revoke these standards for 120 days because
of the technical difficulties and economic considerations associated
with their revocation (61 FR 58991 at 58999). FDA acknowledged that if
the standards for lowfat and nonfat yogurts were revoked, modifying the
standardized food yogurt to make the nutrient content claims ``lowfat''
or ``nonfat'' under the provisions of Sec. 130.10 would require
vitamin A fortification to make the product nutritionally equivalent to
full fat yogurt. FDA also acknowledged that such a fortification
requirement could potentially result in significant relabeling,
reformulation, and equipment costs to manufacturers. The agency had
hoped that the 120-day deferral would provide an appropriate balance
between the problem the industry was facing and consumers' interest in
consistently and fairly labeled foods. Unfortunately, this issue has
not been resolved. According to the yogurt standard proposed by NYA,
manufacturers would continue to be able to make lowfat and nonfat
yogurts without having to meet the nutritional equivalence requirement.
FDA seeks comment on whether the yogurt industry is better able and
equipped to meet the nutritional equivalence requirements of Sec.
130.10 than it was in 1996 when FDA deferred action on this issue. FDA
also seeks comment on the need and appropriateness of continuing to
exempt yogurt from the nutritional equivalence requirement, unlike
other standardized foods making lowfat and nonfat nutrient content
claims.
IV. NYA Requested Amendments
The requested amendments of the yogurt standard and the cultured
milk standard submitted by NYA are set forth in the following
paragraphs. The following language is as suggested by NYA; FDA has made
only minor nonsubstantive changes. FDA will evaluate the need and
appropriateness of these regulations proposed by NYA following the
receipt of public comments.
NYA's suggested standard of identity for yogurt is as follows:
Section 131.200 Yogurt.
(a) Description. Yogurt is the food produced by culturing one or
more of the standard dairy ingredients specified in paragraph (b) of
this section. Yogurt contains at least 10\7\ CFU/g active yogurt
cultures, at the time of manufacture, of the characterizing lactic
acid-producing bacteria, Lactobacillus delbrueckii subsp. Bulgaricus
and Streptococcus thermophilus, and the manufacturer may have
records demonstrating that, under proper conditions of distribution
and storage, the yogurt will contain at least 10\6\ CFU/g live and
active cultures through the manufacturer's assigned code life (i.e.,
shelf life) for the product. One or more of the optional ingredients
specified in paragraph (c) of this section may also be added. All
ingredients used are safe and suitable. Yogurt, before the addition
of optional ingredients specified in paragraph (c) of this section,
contains not less than 8.25 percent milk solids not fat from the
standard dairy ingredients specified in paragraph (b) of this
section, and has a pH of 4.6 or lower. Dairy ingredients comprise at
least 51 percent of the food's overall ingredients by weight. The
food may be homogenized and the ingredients specified in paragraph
(b) of this section shall be pasteurized or ultra-pasteurized prior
to the addition of the characterizing yogurt bacterial cultures.
(b) Standard dairy ingredients. Cream, milk, partially skimmed
milk, skim milk, or the reconstituted versions of these standard
dairy ingredients may be used alone or in combination. Whey protein
concentrate (WPC), minimum protein concentrate 34 percent, may be
used if the total quantity of WPC used in this paragraph and
paragraph (c) of this section does not result in a quantity of WPC
that exceeds 25 percent of the total milk solids not fat. When one
or more of the ingredients specified in this paragraph is used, it
shall be included in the culturing process.
(c) Optional dairy ingredients. (1) Dairy ingredients. Any milk-
derived ingredients used for technical or functional purposes.
(2) Optional safe and suitable cultures, in addition to the
characterizing cultures.
(3) Safe and suitable sweeteners.
(4) Flavoring ingredients.
(5) Color additives.
(6) Stabilizers and emulsifiers.
(7) Preservatives.
(8) Vitamins and minerals.
(i) If added, vitamin A shall be present in a minimum quantity
of 500 International Units (IU) per reference amount customarily
consumed (RACC).
(ii) If added, vitamin D shall be present in a minimum quantity
of 100 IU per RACC.
(9) Any safe and suitable ingredients added for nutritional or
functional purposes.
(d) Methods of analysis. (1) Enumeration of live and active
cultures--As determined by the method prescribed by the
International Dairy Federation.
(2) Milk solids not fat content--Calculated using the following
methods from the ``Official Methods of Analysis of the Association
of Official Analytical Chemists,'' 15th Ed. (Copies are available
from the Association of Official Analytical Chemists, 481 North
Frederick Ave., suite 500, Gaithersburg, MD 20877-2417, or available
for inspection at the Office of the Federal Register, 800 North
Capitol St., NW., suite 700, Washington, DC). Subtract the milkfat
content (as determined by the method prescribed in section 16.059
``Roese-Gottlieb Method (Reference method) (11)--Official Final
Action, under the heading ``Fat'') from the total milk solids
content (as determined by the method prescribed in section 16.032,
``Method I--Official Final Action,'' under the heading ``Total
Solids'').
(3) pH--As determined under Sec. 114.90(a) of this chapter,
``Potentiometric method for the determination of pH.''
(e) Nomenclature. (1) If the food contains the amount of live
and active Lactobacillus delbrueckii subsp. Bulgaricus and
Streptococcus thermophilus cultures as indicated in paragraph (a) of
this section, the food is ``yogurt,'' except:
(i) If the finished food complies with the requirements of Sec.
101.62(b)(4)(i) of this chapter, and is not ``lowfat yogurt'' or
``nonfat yogurt,'' then the food must comply with Sec.
101.62(b)(4)(ii) of this chapter, and the name of the food is
``reduced fat yogurt.''
(ii) If the finished food contains at least 0.5 g, but not more
than 3.0 g, total fat per RACC, then the name of the food is
``lowfat yogurt.''
(iii) If the finished food contains less than 0.5 g total fat
per RACC, the name of the food is ``nonfat yogurt.''
(2) The name of the food shall be accompanied by a declaration
indicating the presence of any characterizing flavoring as specified
in Sec. 101.22 of this chapter.
(3) The following terms shall accompany the name of the food
wherever it appears on the principal display panel or panels of the
label in letters not less than one-half of the height of the letters
used in such name:
(i) The word ``sweetened'' if a sweetener is added without the
addition of characterizing flavor.
(ii) The phrase ``vitamin A'' or ``vitamin A added,'' or
``vitamin D'' or ``vitamin D added,'' as appropriate. The word
``vitamin'' may be abbreviated ``vit.''
(f) Declaration of ingredients. Each of the ingredients used in
the food shall be declared on the label as required by the
applicable sections of parts 101 and 130 of this chapter.
NYA's suggested standard of identity for cultured milk is as
follows:
Section 131.112 Cultured Milk/Fermented Milk.
(a) Description. Cultured milk or fermented milk is the food
produced by culturing one or more of the standard dairy ingredients
specified in paragraph (b) of this section with characterizing
microbial organisms. One or more of the optional ingredients
specified in paragraph (c) of this section may also be added. All
ingredients used are safe and suitable. Cultured milk or fermented
milk, before the addition of optional ingredients specified in
paragraph (c) of this section, contains not less than 8.25 percent
milk solids not fat from the standard dairy ingredients specified in
paragraph (b) of this section, and has a titratable acidity of not
less than 0.5 percent, expressed as lactic acid, before the addition
of bulky flavors. Dairy ingredients comprise at least 51 percent of
the food's overall ingredients by weight. The food may be
homogenized and the ingredients specified in paragraph (b) of this
[[Page 39877]]
section shall be pasteurized or ultra-pasteurized prior to the
addition of the microbial cultures.
(b) Standard dairy ingredients. Cream, milk, partially skimmed
milk, skim milk, or the reconstituted versions of any of these
standard dairy ingredients may be used. Whey protein concentrate
(WPC), minimum protein concentrate 34 percent, may be used if the
total quantity of WPC used in this paragraph and paragraph (c) of
this section does not result in a quantity of WPC that exceeds 25
percent of the total milk solids not fat. When one or more of the
ingredients specified in this paragraph is used, it shall be
included in the culturing process.
(c) Optional ingredients. (1) Dairy ingredients. Any milk-
derived ingredients used for technical or functional purposes.
(2) Aroma- and flavor-producing microbial culture.
(3) Safe and suitable sweeteners.
(4) Flavoring ingredients.
(5) Color additives that do not impart a color simulating that
of milkfat or butterfat.
(6) Stabilizers and emulsifiers.
(7) Preservatives.
(8) Vitamins and minerals.
(i) If added, vitamin A shall be present in a minimum quantity
of 500 IU per RACC.
(ii) If added, vitamin D shall be present in a minimum quantity
of 100 IU per RACC.
(9) Butterfat or milkfat, which may or may not contain color
additives, in the form of flakes or granules.
(10) Salt.
(11) Citric acid, in a maximum amount of 0.15 percent by weight
of the milk used, or an equivalent amount of sodium citrate, as a
flavor precursor.
(12) Any safe and suitable ingredients added for nutritional or
functional purposes.
(d) Methods of analysis. (1) Milk solids not fat content--
Calculated using the following methods from the ``Official Methods
of Analysis of the Association of Official Analytical Chemists,''
15th Ed. (Copies are available from the Association of Official
Analytical Chemists, 481 North Frederick Ave., suite 500,
Gaithersburg, MD 20877-2417, or available for inspection at the
Office of the Federal Register, 800 North Capitol St., NW., suite
700, Washington, DC). Subtract the milkfat content (as determined by
the method prescribed in section 16.059 ``Roese-Gottlieb Method
(Reference method) (11)--Official Final Action, under the heading
``Fat'') from the total milk solids content (as determined by the
method prescribed in section 16.032, ``Method I--Official Final
Action,'' under the heading ``Total Solids'').
(2) Titratable acidity--As determined by the method prescribed
in section 16.023, ``Acidity (2)--Official Final Action,'' or by an
equivalent potentiometric method.
(e) Nomenclature. (1) The name of the food is ``cultured milk''
or ``fermented milk,'' except:
(i) If the finished food complies with the requirements of Sec.
101.62(b)(4)(i) of this chapter, and is not ``lowfat fermented
milk'' or ``lowfat cultured milk'' or ``nonfat fermented milk'' or
``nonfat cultured milk,'' then the food must comply with Sec.
101.62(b)(4)(ii) of this chapter, and the name of the food is
``reduced fat fermented milk'' or ``reduced fat cultured milk.''
(ii) If the finished food contains at least 0.5 g, but not more
than 3.0 g, total fat per RACC, then name of the food is ``lowfat
fermented milk'' or ``lowfat cultured milk.''
(iii) If the finished food contains less than 0.5 g total fat
per RACC, the name of the food is ``nonfat fermented milk'' or
``nonfat cultured milk.''
(2) The name of the food shall be accompanied by a declaration
indicating the presence of any characterizing flavoring as specified
in Sec. 101.22 of this chapter.
(3) The name of the food shall be accompanied by a declaration
such as a traditional name of the food or the generic name of the
organisms used, thereby indicating the presence of the
characterizing microbial organisms or ingredients, e.g., ``kefir
cultured milk,'' ``acidophilus fermented milk,'' or when
characterizing ingredients such as those in paragraphs (c)(2),
(c)(9), (c)(10), and (c)(11) of this section and lactic acid-
producing organisms are used, the food may be named ``cultured
buttermilk.''
(4) The following terms shall accompany the name of the food
wherever it appears on the principal display panel or panels of the
label in letters not less than one-half of the height of the letters
used in such name:
(i) The word ``sweetened'' if a sweetener is added without the
addition of characterizing flavoring.
(ii) The phrase ``vitamin A'' or ``vitamin A added,'' or
``vitamin D'' or ``vitamin D added,'' or ``vitamin A and D added,''
as appropriate. The word ``vitamin'' may be abbreviated ``vit.''
(5) The parenthetical phrase ``(heat-treated after culturing)''
shall follow the name of the food if the dairy ingredients have been
heat-treated after culturing.
(f) Declaration of ingredients. Each of the ingredients used in
the food shall be declared on the label as required by the
applicable sections of parts 101 and 130 of this chapter.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. If you base your comments on
scientific evidence or data, please submit copies of the specific
information along with your comments. The petition and received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
VI. Authority
This advance notice of proposed rulemaking is issued under sections
201, 401, 403, 409, 701, and 721 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, and 379e), and under
the authority of the Commissioner of Food and Drugs, as redelegated to
the Director, Center for Food Safety and Applied Nutrition.
Dated: June 3, 2003.
L. Robert Lake,
Director, Office of Regulations and Policy, Center for Food Safety and
Applied Nutrition.
[FR Doc. 03-16789 Filed 7-2-03; 8:45 am]
BILLING CODE 4160-01-S