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| Sent Via e-mail                                 |                    |
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| January 27, 2004                                |                    |
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| Division of Dockets Management                                        |
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| Food and Drug Administration                                          |
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| Rm. 1061 (HFA-305)                                                    |
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| 5630 Fishers Lane                                                     |
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| Rockville, MD 20852                                                   |
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Re: Comments to the Advanced Notice of Proposed Rulemaking for 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 (Docket No. 2000P-0685)

Dear Sir or Madam:

The National Yogurt Association ("NYA") is pleased to submit these
comments to the Advanced Notice of Proposed Rulemaking for 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[^1] (hereinafter referred to as the "ANPR").

NYA is the national nonprofit trade association representing the
producers of live and active culture yogurt products as well as
suppliers to the yogurt industry. NYA's member companies are among the
largest yogurt manufacturers in the United States. NYA sponsors
scientific research regarding the health benefits associated with the
consumption of yogurt with live and active cultures and serves as an
information resource to the American public about these attributes.

**I. Background on the Yogurt Standards of Identity**

On January 30, 1981, the Food and Drug Administration ("FDA") published
a final rule for the three yogurt standards of identity.[^2] The
standards established definitions for yogurt, lowfat yogurt, and nonfat
yogurt, and contained provisions regarding optional dairy ingredients,
other optional ingredients, methods of analysis, nomenclature, and label
declarations. However, due to objections FDA received requesting
hearings on certain provisions of the final rule, FDA amended some
provisions, and stayed other provisions pending hearings, which has
resulted in fragmented standards of identity for yogurt products. [^3]

On November 9, 1995, FDA proposed to revoke the standards of identity
for several lowfat and nonfat dairy products, including lowfat yogurt
and nonfat yogurt.[^4] By removing these standards, manufacturers would
still be able to name the products in accordance with the general
provisions of the Nutrition Labeling and Education Act ("NLEA")[^5] so
long as the product is not nutritionally inferior to the standard
form.[^6] Because lowfat and nonfat yogurts contain less Vitamin A than
full fat yogurt, under the proposed rule, lowfat and nonfat yogurts
would require Vitamin A fortification to meet the level of full fat
yogurt.

In the final rule, FDA acknowledged that yogurt differs from other dairy
products and agreed with industry that the rule would result in
significant relabeling, reformulation, and equipment costs for yogurt
manufacturers. FDA recognized that effective standards for yogurts that
are not full fat already exist. Thus, FDA deferred action on its
proposal to revoke the lowfat and nonfat yogurt standards.

As a result of this history of incomplete regulatory actions by FDA, the
yogurt standards of identity have remained fragmented and incoherent
twenty years after they were finalized. Because the yogurt standards are
an assortment of effective and stayed provisions, they provide little
guidance to industry. The administrative hearing that FDA committed to
after the yogurt standards of identity were established in 1981 has
never been conducted. The pending issues described above have yet to be
resolved and the yogurt standards have remained in a state of confusion.

Only recently has FDA taken step to resolve the numerous issues
associated with the standards of identity for yogurt. On July 3, 2003,
FDA published the ANPR announcing the Citizen Petition submitted by NYA
on February 18, 2000. NYA represents the major yogurt manufacturers in
the United States and the Citizen Petition provides meaningful
contributions from these companies to address the outstanding issues of
the existing standards of identity. In the ANPR, FDA raised additional
issues and requested comments on certain topics related to these
standards. In response to the ANPR, interested parties submitted
comments. NYA is responding to the Agency's requests as well as other
relevant issues that were raised by the submitted comments.

**II. Live and Active Cultures are a Defining Characteristic of Yogurt**

For centuries, yogurt has been characterized by its live and active
cultures. Because of this historical significance, consumers identify
yogurt with live and active cultures and expect that when they purchase
a yogurt product, it will contain a significant amount of these
cultures. In fact, FDA recognized that "the name 'yogurt' traditionally
belongs to a food containing the characterizing microorganisms
*Lactobacillus bulgaricus* and *Streptocococcus thermophilus* and
possessing the flavor and aroma profiles, enzymes and lactic acid
created by these microorganisms."[^7] Accordingly, FDA incorporated the
requirement for these cultures into the current yogurt standards of
identity.[^8]

In the 1981 final rule that established the current yogurt standards of
identity, FDA permitted products that have been "heat-treated after
culturing" to be identified as "yogurt" and stated as its rationale that
not all consumers may be aware of the presence of the live and active
cultures. To distinguish yogurt that has been heat-treated, FDA required
auxiliary labeling (i.e., the phrase "heat-treated after culturing")
after the statement of identity.[^9] However FDA's 1981 conclusion
reflects consumers and the marketplace as it existed over 20 years ago.
In light of data compiled from several studies that have been conducted
over the last 13 years, the Agency's conclusion about consumers'
expectations of products labeled yogurt may no longer be accurate.
Consequently, revision of the yogurt standards is necessary to properly
reflect the current state of consumers' expectation of these products.
Moreover, the phrase "heat-treated after culturing" is too oblique to
inform consumers about the characteristics of the product. There is no
basis to conclude that consumers understand the phrase to mean that the
heat-treated product contains no live and active cultures.

**A. Consumers Expect Yogurt to Contain Live and Active Cultures**

In 1990, 1995-96, 1997-98 and 2004, studies were conducted that provide
evidence that consumers that regularly eat yogurt expect these products
to contain live and active cultures.[^10] The trend may correlate with
the rising interest in healthful eating and the nutrient profile of
yogurt as a beneficial and wholesome food. While yogurt consumption has
increased, scientists have increasingly researched the beneficial
properties unrelated to the nutrient profile of yogurt. These benefits
have often been associated with the presence of live and active
cultures. NYA has invested resources in funding scientific research in
the health benefits of live and active cultures. A recent review article
summarizing nearly 50 scientific articles shows that there is emerging
scientific evidence of the healthy effects of live and active
cultures.[^11]

In 1990, a study was conducted that evaluated the general public's
usage, attitudes and perceptions of frozen and regular yogurt
(hereinafter referred to as the "1990 Study").[^12] A total of 1,029
respondents that represented all parts of the United States (22% in the
Northeast, 24% in the North Central states, 34% in the South, and 20% in
the West) were interviewed by telephone. Based on this study, about half
(53%) of those interviewed ate yogurt regularly, and of those consumers
that regularly ate yogurt, about two-thirds (61%) felt that it was
important that yogurt contained live and active cultures. Consumers were
equally divided as to how they know if yogurt contains live and active
cultures. Forty-five percent (45%) of the total number interviewed and
54% of the consumers that regularly ate yogurt reported that the
information about the live and active culture content of the food
appears on the package.

In the subsequent studies conducted in 1995-96[^13] and 1997-98[^14]
(hereinafter referred to as the "1995-96 Study" and the "1997-98 Study,"
respectively), there was a significant increase in the number of
consumers that expected yogurt to contain live and active cultures.
These studies focused on mothers of a child/children between the ages of
3-13, which generally represent the household decision maker of food
purchases. The results from both the 1995-96 and 1997-98 studies
demonstrate that at least 70% of this target population agreed that it
is important for yogurt to contain live and active cultures.[^15] In
addition, of the target population, 59% of consumers reported that they
knew live and active cultures were contained in the product through the
information appearing on the packaging. The remaining 41% reported a
variety of other sources for determining whether cultures existed in the
product including a small percentage that assumed that all brands
contained the cultures.

To confirm the results of the earlier studies, another more recent
consumer survey conducted in 2004[^16] (hereinafter referred to as the
"2004 Study"). The results for this consumer study confirmed the trend
and demonstrated that consumers expect yogurt to contain live and active
cultures. Using the same target population (i.e., women with a
child/children between the ages of 3-13) as the 1995-1996 and 1997-1998
studies, seventy-two percent (72%) of consumers agreed that it was
important for yogurt to contain live and active cultures. Fifty-two
percent (52%) of these consumers identified that the information on the
packaging was the way they determined whether the product contained
cultures.

Clearly, these consumer research results do not support FDA's previous
finding that "the word 'yogurt' also describes a particular food to a
large number of consumers who may be unaware of the presence of viable
bacteria."[^17] Perhaps, over 20 years ago when the yogurt standards of
identity were initially issued, consumers' expectation of the attributes
for yogurt was unknown. Healthful eating has become a top priority for
many Americans, and over the past decade U.S. consumers have been
increasing their yogurt consumption. In 2003, per capita, Americans
consumed approximately 5 pounds of yogurt annually.[^18]

Importantly, the purpose of the yogurt standard of identity is to
maintain the integrity of products identified as "yogurt" and ensure
honesty and fair dealing so that consumers are receiving products that
are consistent with the particular characteristics that they have
associated with the term "yogurt." It is clear from the consumer
research results described above that consumers that regularly eat
yogurt expect it to contain live and active cultures. Under the current
yogurt standards however, consumers have no assurance that the yogurt
contains this particular defining characteristic of live and active
cultures. Although NYA has attempted to address this issue through its
voluntary "Live and Active Culture" Seal Program, a regulatory
requirement is the only solution that can ensure that consumers are
receiving a product that is consistent with its generally accepted
characteristics, which is the presence of live and active cultures in
substantial amounts. The yogurt standard proposed by NYA in its Citizen
Petition recognizes this essential trait and requires products that are
labeled yogurt to contain a minimum of 10^7^ CFU/g active cultures
*Lactobacillus delbrueckii* subspecies *bulgaricus* and *Streptococcus
thermophilus* at the time of manufacture and should be incorporated as a
requirement of the yogurt standard of identity.

**III. The Proper Name for Products that are "Heat-Treated After
Culturing" is Cultured or Fermented Milk**

Within the existing yogurt standards, FDA permits products that are
manufactured with the necessary cultures but later "heat-treated after
culturing" to be referred to as "yogurt" so long as these products were
distinguished with the necessary auxiliary labeling. At the time of the
promulgation of the current standards, the FDA believed that this phrase
adequately conveyed to consumers that the product does not contain live
and active cultures. However, based on several studies performed since
the FDA's promulgation of the initial standard, it is clear that this
phrase is confusing and does not adequately convey a clear message about
the absence of cultures in the product, thus contradicting the basic
purpose of this auxiliary labeling. Moreover, products that are cultured
and then heated-treated no longer contain the defining property of live
and active cultures associated with yogurt and should not be identified
as yogurt. The more accurate and descriptive standard of identity for
these products is cultured milk, which can be moderately altered to
incorporate heat-treated products.

> **A. Consumers Do Not Understand the Phrase "Heat-Treated After
> Culturing"**

In 1995, a study was conducted that randomly evaluated 300 heads of
households (249 female, 51 male) that purchased refrigerated yogurt
within the last month.[^19] Interviews were conducted by telephone in
geographically dispersed regions across the United States. An
overwhelming majority of respondents (86%) were not familiar with the
statement "heat-treated after culturing." The stated definition by
respondents related to a cooking process or effects of the process
(e.g., the product is heated) but most respondent (48%) simply did not
know what it meant or the implications such a process might have on the
live and active cultures in yogurt.

Similar results were seen in the 1995-96 and 1997-98 Studies. Of the
target population (i.e., women with a child/children between 3-13), at
least 80% did not know the meaning of the phrase "heat-treated after
culturing,"[^20] and therefore did not know how or if it altered the
yogurt product. In a survey conducted in 2003 by Syndifrais, an
international dairy association, 1022 participants from the United
States were polled. Ninety-five percent (95%) of respondents had never
heard of "heat-treated" yogurt. Similar results were obtained in the
2004 Study, which determined that 81% of the target population (i.e.,
women with a child/children between 3-13) did not understand the meaning
of the phrase "heat-treated after culturing."

The results from these various studies demonstrate that the phrase
"heat-treated after culturing" provides little, if any, significance to
American consumers. The additional labeling phrase has merely confused
consumers and does not provide information about the quality of the
product.

**B. International Standard for Heat-Treated Products is Fermented
Milk**

From an international perspective, the Codex Alimentarius Commission
("Codex") addressed this issue at its twenty-fifth session held from
June 30, 2003 to July 7, 2003 in Rome, Italy. The Commission
recategorized products that are heat-treated after culturing by adopting
the proposed standard for fermented milk. Under the adopted standard,
heat-treated products are identified as fermented milk and no longer
considered yogurt where legislation does not exist to permit such a
name. Among the numerous delegations that voted in favor of the adoption
of this standard was the United States delegation including
representatives from the FDA and U.S. Department of Agriculture.

Because heated treated products do not contain the characterizing live
and active cultures and the additional labeling phrase does not clearly
inform consumers about the attributes of the product, the provision in
the existing yogurt standards that permits heat-treated products should
be removed and the existing cultured milk standard should be amended to
permit these products to be identified as either "cultured milk" or
"fermented milk.\" Such actions are consistent with the adoption of the
fermented milk standard by Codex. In addition, these changes do not
restrict or negatively affect manufacturers of heat-treated products.
The nomenclature is internationally accepted and product may be sold
under the cultured/fermented milk standard. Incorporating heat-treated
products into an amended cultured milk standard of identity protects
potentially susceptible American consumers, the majority of which do not
understand the phrase "heat-treated after culturing," from unknowingly
purchasing inaccurately identified products that do not contain the
expected live and active cultures in yogurt.

**IV. NYA's Proposed Yogurt Standard Ensures a High Quality Product and
Flexibility to Incorporate Technological Advancements**

In comments received since the publication of the ANPR, issues have been
raised regarding specific provisions in NYA's proposed yogurt standard.
This section will address the concerns raised by FDA and other
interested parties. NYA represents major yogurt manufacturers in the
United States many of which have become trusted household name brands.
These manufacturers value their role in providing wholesome, nutritious
and high quality yogurt to the American consumer. The yogurt standard
proposed by NYA reflects these high standards, while considering that
some producers of yogurt, such as small dairies and other small
businesses, also play a vital role in providing high quality nutritious
product to the consuming public.

In addition, NYA has consolidated the yogurt standards for fullfat,
lowfat and nonfat into a single standard that accurately reflects the
fat content as prescribed under NLEA. For example under NYA's proposed
standard, a yogurt labeled lowfat must contain at least 0.5 g but not
more than 3.0 g of total fat per reference amount customarily consumed,
which is not currently required under the existing standards of
identity. Finally, NYA, in its proposed yogurt standard, removed the
obsolete barriers that restrict manufacturers from utilizing modern
technological advances and continuously providing innovative products to
consumers.

**A. High Quality Yogurt Product**

**1. WPC is a High Quality Ingredient**

Yogurt manufacturers understand that in order to produce a high quality
product; it must begin with high quality ingredients. In a comment
received since the publication of the ANPR, the use of whey protein
concentrate ('WPC') in yogurt was raised and the commenter contended
that classifying WPC as a standard dairy ingredient would result in an
inferior product. There may be a misunderstanding regarding the use of
WPC and its excellent protein value.

Cows milk is recognized as an excellent source of high quality protein
because it contains in varying amounts all of the essential amino acids
that our bodies cannot synthesize. Of the total protein in milk 80% is
casein and 20% is whey protein. Protein quality can be measured by any
one of several parameters. These key parameters that are used to
evaluate the protein quality are: Biological Value (BV), [^21] Protein
Digestibility (PD), [^22] Net Protein Utilization (NPU), [^23] Protein
Efficiency ratio (PER).[^24] The following table shows the average
measures of protein quality for milk and milk proteins and demonstrates
how favorably the quality of whey protein compares with the quality of
total milk protein:

  -------------- -------------- -------------- -------------- --------------
                 BV             PD             NPU            PER

  MILK           91             95             86.45          3.1

  CASEIN         77             100            76             2.9

  WHEY           104            100            92             3.6
  -------------- -------------- -------------- -------------- --------------

Source : Handbook of Dairy Foods and Nutrition. Miller, Jarvis and Mc
Bean. National Dairy Council.

WPC contributes in the formulation of yogurt both functionally as a
stabilizer and nutritionally to provide a higher quality of protein than
milk. New processing technology allows for the concentration and
isolation of whey protein components without excessive heating or
chemical addition. As a result, whey proteins are highly valued for
their nutritional value, functionality, and taste. Whey proteins are
easily digestible high-quality proteins with significant amounts of the
important amino acids leucine, isoleucine, and valine. Proteins
contained in WPC are superior in nutritional value to soy protein and
casein, providing 14% higher nutritional value. The use of WPC will not
result in a decrease in the ratio of protein to total nonfat solids of
food or of the protein efficiency ratio of all protein present.

> **2. NYA's Provision for 51% Dairy Ingredients Ensures a Wholesome
> Dairy Product**

To ensure that the resulting yogurt product is composed primarily of
dairy ingredients, the NYA proposed standard requires that yogurt
contain at least 51% dairy ingredients. This provision adds another
level of assurance that consumers are receiving a wholesome dairy
product. The existing yogurt standards do not mandate such a requirement
and producing a product with less than 51% dairy ingredients is
completely permissible under the existing standards.

The most common style of single serve yogurt sold in the United States
typically contains up to 30% fruit preparation and other non-dairy
ingredients. Under NYA's proposed standard, even if advances in
technology are such that there may be a desire for manufacturers to
increase the non-dairy part of the product, in order to maintain the
"dairy character" of yogurt the product must contain 51% of dairy
ingredients. NYA's proposed 51% dairy ingredients provision does not
allow manufacturers to produce an inferior product.

> **3. Nutritional Equivalence to Fullfat Yogurt is Unnecessary and
> Would Result in Over Fortification**

The issue of nutritional equivalence was raised. Three different
standards of identity for yogurt currently exist. These standards differ
in the milkfat content only, and allow for different qualifiers (i.e.,
lowfat or nonfat) based on this content. In 1995, FDA proposed to revoke
the lowfat and nonfat standards for dairy products (including yogurt)
and allow the nonfat and lowfat versions of the products to be labeled
using the nutritional equivalency requirement of 21 C.F.R. § 130.10,
that establishes "requirements for foods named by use of a nutrient
content claim and a standardized term." The regulation also requires
that "nutrients shall be added to the food to restore nutrient levels so
that the product is not nutritionally inferior...to the standardized
food." Due to the nutritional equivalency requirement, Vitamin A
fortification would be necessary at that time. FDA recognized that
yogurt differs from other dairy products and delayed the implementation
of this requirement for yogurt.

FDA established the nutritional equivalency policy for the purpose of
ensuring that consumers that received a standardized food that was
modified in accordance with an expressed nutrient content claim would be
guaranteed that the product was equivalent except for the nutrient
characterized in the expressed claim.[^25] However, the rationale for
nutritional equivalency does not apply to yogurt. Unlike other dairy
products, the greatest volume of yogurt has traditionally and is
currently sold as lowfat and nonfat versions. Fullfat yogurt represents
only a very small fraction of the yogurt market. To require lowfat and
nonfat yogurts to be nutritionally equivalent to fullfat yogurt would
result in an increase in the consumption of Vitamin A from the current
consumption levels without any express public health need for such
fortification.

**B. Requirements Associated with Live and Active Cultures**

Since the opening of the comment period for the ANPR, many of the
questions regarding the live and active culture requirements of NYA's
proposed standard were raised by companies unfamiliar with the viability
of cultures in a refrigerated yogurt product. For many requirements, FDA
may defer to manufacturers within the industry because those companies
are in the best position to determine the feasibility of the technology
relevant to that field.

NYA's proposed standard establishes two appropriate levels of active
yogurt cultures; one mandatory level at the time of manufacture, and
another as a recommended level at the end of the shelf-life of the
product. Under the proposed NYA standard, at the time of manufacture,
yogurt must contain at least 10^7^ CFU/g of active yogurt cultures,
*Lactobacillus* *delbrueckii* subspecies *bulgaricus* and
*Streptococcus* *thermophilus*. Additionally, to ensure that consumers
receive a product that contains substantial levels of live and active
cultures, it was necessary to specify a minimum level of 10^6^ CFU/g to
be present through out the shelf-life of the product. However, because
storage and other conditions of the product may not be within their
control, manufacturers may not be in a position to ensure that the
product always contains the minimum 10^6^ CFU/g level. Manufacturers are
encouraged to conduct testing and maintain records to ensure that the
specific strains of yogurt cultures they select would remain at a level
of at least 10^6^ CFU/g through the designated code life of the product
assuming proper conditions of distribution and storage. These minimum
levels provide guidance to both FDA and the regulated industry regarding
the required levels of active cultures, which are not present in the
existing yogurt standards. Also, it ensures that consumers are receiving
a product with a significant amount of live and active cultures.

The purpose of the voluntary compliance of testing and record
maintenance is to limit the financial burden NYA's proposed standard may
have on smaller dairies and small manufacturers of yogurt. Because NYA's
membership consists mainly of large manufacturers, the necessary simple
assays that test for live and active cultures are performed in-house.

**C. Innovation**

The yogurt standards of identity have not been revised since 1981 when
the standards were initially issued. Since that time, the food industry
has made great strides in novel ingredients and technologies all the
while enhancing the quality of the products both in organoleptic and
nutritional qualities. In its proposed standard, NYA has incorporated
provisions that allow manufacturers enough flexibility to use these
innovations. Specifically, the proposed standard permits the use of any
safe and suitable ingredient added for nutritional or functional
purposes. This provision does not supersede the statutory mandates that
prohibit the adulteration of food and permits FDA to take the
enforcement action against the violative company. Also, NYA's 51% dairy
ingredient provision ensures that consumers are receiving a high quality
dairy product. That provision merely recognizes that advances are
constantly being made in the food industry and yogurt manufacturers
should be permitted to use novel ingredients and technology as they are
developed.

In addition, NYA's proposed standard merely restates the requirements of
the existing standards regarding homogenizing and pasteurization or
ultra-pasteurization. As with the current standard, NYA's standard
permits manufacturers to homogenize and requires pasteurization or
ultra-pasteurization before culturing. In 1981 when FDA finalized the
yogurt standards, the Agency stated that "it is the responsibility of
the manufacturers to take the precautionary measures necessary to assure
that ingredients to be added to these foods after culturing, such as
bulky flavor to yogurts, or milkfat or butterfat flakes or granules to
buttermilks, do not contaminate the food."[^26] Also, under NYA's
proposed standard, manufacturers may add optional dairy ingredients
that, depending on the previous manufacturing steps may or may not be
included in the culturing process.

For acidity level, NYA proposed in its Citizen Petition that it should
be modified to pH rather than titratable acidity expressed as lactic
acid. NYA has reevaluated its initial findings and, after discussion
with other dairy associations, determined that titratable acidity
expressed as lactic acid is an appropriate measurement for the yogurt
standard. The NYA recommends that proper minimum acidity level should be
0.6% expressed as lactic acid and as applied to the "white mass" before
the addition of "optional ingredients."

**V. Conclusion**

Based on the foregoing, NYA respectfully requests that the Agency revoke
the standards of identity for lowfat and nonfat yogurt and amend the
existing standards for yogurt and cultured milk in accordance with the
Citizen Petition filed by NYA on February 18, 2000 and the comments
herein.

> Respectfully submitted,
>
> Leslie G. Sarasin
>
> President
>
> National Yogurt Association

[^1]: 68 Fed. Reg. 39873 (July 3, 2003). The comment period for this
    docket was reopened for 90 days to allow additional time for
    interested parties to submit comments. (68 Fed. Reg. 61639 (Oct. 29,
    2003).)

[^2]: 46 Fed. Reg. 9924 (January 30, 1981).

[^3]: 47 Fed. Reg. 41519 (September 21, 1982).

[^4]: 60 Fed. Reg. 56541 (November 9, 1995).

[^5]: Pub. L. 101-535, 104 Stat. 2353 (1990).

[^6]: 21 C.F.R. § 130.10(b).

[^7]: 46 Fed. Reg. at 9932.

[^8]: 21 C.F.R. § 131.200(a), 131.203(a), and 131.206(a).

[^9]: 46 Fed. Reg. at 9931.

[^10]: The consumer survey studies cited in these comments were
    conducted for various purposes other than the yogurt standard of
    identity rulemaking. Although the methodologies employed in these
    studies reflect a different purpose, the data provides helpful
    information that may assist the Agency in developing meaningful
    standards. Additionally, because the consumer survey studies contain
    commercial information that is privileged or confidential pursuant
    to 21 C.F.R. 20.61(b), the information is not included in these
    comments, but will be provided to the FDA upon request.

[^11]: Piaia, M., et al., Assessment of the Benefits of Live Yogurt:
    Methods and Markers for in vivo Studies of the Physiological Effects
    of Yogurt Cultures, *Microbial Ecology in Health and Disease*, 2003;
    15: 79-87. (Will be submitted separately, to FDA)

[^12]: The General Public's Usage, Attitudes, and Perceptions of Yogurt,
    prepared by Opinion Research Corporation, Princeton, New Jersey,
    October 1990.

[^13]: Children's Yogurt Eating Habits- Waves 1-3, prepared by Opinion
    Research Corporation, December 1995.

[^14]: National Yogurt Association Consumer Survey, prepared by Golin
    Harris Communications, February 1998.

[^15]: Specifically, 75% of the target population agreed that it was
    important for yogurt to contain live and active cultures in the
    1995-96 Study, while 70% agreed in 1997-98 Study. Due to various
    factors associated with the methodology of these studies, it may not
    be appropriate to apply a direct comparison of these results.

[^16]: Live and Active Cultures of Yogurt, Prepared for Golin Harris
    International by ORC International, Princeton, New Jersey, January
    9, 2004.

[^17]: 46 Fed. Reg. 9924 at 9931.

[^18]: "Yogurt Makers Want FDA to Demand Culture," Washington Post,
    October 21, 2003.

[^19]: Live vs. Heat-Treated Culture Study, prepared by Data Development
    Corp., July 1995.

[^20]: Specifically, in the 1995-96 Study, 80% of the target population
    did not know the meaning of the phrase "heat-treated after
    culturing, while the results of the 1997-98 study were at 83% of the
    target population.

[^21]: BV means proportion of absorbed protein that is retained in the
    body for maintenance and/or growth. BV of egg protein is defined as
    100.

[^22]: PD means proportion of food protein absorbed.

[^23]: NPU means proportion of protein intake that is retained
    (calculated by BV x PD).

[^24]: PER means gain in body weight divided by weight of protein
    consumed.

[^25]: 21 C.F.R. § 130.10.

[^26]: 46 Fed. Reg. at 9927.