[Federal Register Volume 61, Number 225 (Wednesday, November 20, 1996)]
[Rules and Regulations]
[Pages 58991-59002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29485]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 101, 131, and 133
[Docket Nos. 95P-0125, 95P-0250, 95P-0261, and 95P-0293]
Lowfat and Skim Milk Products, Lowfat and Nonfat Yogurt Products,
Lowfat Cottage Cheese: Revocation of Standards of Identity; Food
Labeling, Nutrient Content Claims for Fat, Fatty Acids, and Cholesterol
Content of Food
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is removing the
standards of identity for various lowfat milk, sour half-and-half, and
cottage cheese products, based in part on a petition filed jointly by
the Milk Industry Foundation (MIF) and the Center for Science in the
Public Interest (CSPI), and a petition filed by the American Dairy
Products Institute (ADPI). FDA is also amending the standard of
identity for dry cream; deferring action on its proposal to revoke the
standards of identity for lowfat and nonfat yogurt; and amending the
nutrient content claims regulations for fat, fatty acids, and
cholesterol content to provide for ``skim'' as a synonym for ``nonfat''
when used in labeling milk products. This rule will provide for
consistency in the nomenclature and labeling of most nutritionally
modified milk products and other foods bearing ``lowfat'' and
``nonfat'' claims; promote honesty and fair dealing in the interest of
consumers; increase flexibility for manufacturers of lower-fat dairy
products; and increase product choices available to consumers. This
action is a part of the agency's ongoing review of existing regulations
under President Clinton's Regulatory Reinvention Initiative.
DATES: Effective January 1, 1998, except as to any provisions in
revised parts 131 and 133 (21 CFR parts 131 and 133) that may be stayed
by, or as a result of, the filing of proper objections. Compliance may
begin on November 20, 1996. If any provisions are stayed, FDA will
publish timely notification in the Federal Register. Written objections
and requests for a hearing for parts 131 and 133 by December 20, 1996.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
[[Page 58992]]
FOR FURTHER INFORMATION CONTACT: Michelle A. Smith, Center for Food
Safety and Applied Nutrition (HFS-158), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5099.
SUPPLEMENTARY INFORMATION:
I. Background
A. Regulatory History
One of the main purposes of the Nutrition Labeling and Education
Act of 1990 (the 1990 amendments) (Pub. L. 101-535), which amended the
Federal Food, Drug, and Cosmetic Act (the act), was to establish the
circumstances in which claims that describe the nutrient content of
food could be made. In response to the mandates of the 1990 amendments,
in part 101 (21 CFR part 101), FDA established definitions for specific
nutrient content claims together with principles for their use
(hereinafter referred to as the nutrient content claims final rule) (58
FR 2302, January 6, 1993). In addition, in the Federal Register of
January 6, 1993 (58 FR 2431), FDA published a final rule, entitled
``Food Standards: Requirements for Foods Named by Use of a Nutrient
Content Claim and a Standardized Term'' (hereinafter referred to as the
general standard final rule), which established the general standard in
Sec. 130.10 (21 CFR 130.10) for foods named by use of a nutrient
content claim defined in part 101, such as ``nonfat,'' ``lowfat,''
``reduced fat,'' ``light,'' or ``reduced calorie,'' in conjunction with
a standardized term, for example, ``sour cream.''
As FDA noted in that final rule, certain standards of identity for
dairy products incorporate terms such as ``nonfat,'' ``light,'' and
``lowfat'' in the names of the foods, such as the standards for lowfat
dry milk (Sec. 131.123), nonfat dry milk (Sec. 131.125), nonfat dry
milk fortified with vitamins A and D (Sec. 131.127), lowfat milk
(Sec. 131.135), acidified lowfat milk (Sec. 131.136), cultured lowfat
milk (Sec. 131.138), light cream (Sec. 131.155), lowfat yogurt
(Sec. 131.203), nonfat yogurt (Sec. 131.206), and lowfat cottage cheese
(Sec. 133.131). The agency has also established standards for skim milk
products that provide for use of the synonym ``nonfat'' in place of the
term ``skim'' in the names of these foods. The use of the terms
``nonfat,'' ``light,'' and ``lowfat'' in some of the names in these
standards are inconsistent with the definitions established for the
same terms as nutrient content claims under the 1990 amendments.
Under section 403(r)(1)(A) of the act (21 U.S.C. 343(r)(1)(A)), a
food is misbranded if it bears a claim that characterizes the level of
any nutrient unless the claim is made using terms defined by the
regulations of the Secretary of the Department of Health and Human
Services (the Secretary). Section 403(r)(5)(C) of the act provides an
exemption from this requirement, however, for nutrient content claims
that are part of the name of a food that is defined by a standard of
identity that was issued before enactment of the 1990 amendments.
However, the legislative history of the 1990 amendments affirmed that
the Secretary (and, by delegation FDA) has the authority to amend the
standards of identity to conform with the regulations issued under
section 403(r) of the act (H. Rept. 101-538, 101st Cong., 2d sess. 22
(1990)).
The agency stated in the general standard final rule that, at a
later date, it would consider amending the existing standards of
identity for foods that use nutrient content claims in their names to
make the content requirements for these foods consistent with the
claims definitions that it adopted (58 FR 2431 at 2444). The agency
stated that, alternatively, it could delete some of the standards and
allow the foods defined by these standards to be named using a nutrient
content claim with a standardized term in accordance with the general
standard (Sec. 130.10).
B. Petitions
Two petitions dated May 10, 1995 (Docket No. 95P-0125) and August
2, 1995 (Docket No. 95P-0250), respectively, were filed by MIF and
CSPI. These petitions requested that the agency revoke the standards of
identity for lowfat milk (Sec. 131.135) and skim milk (Sec. 131.143),
as well as those for certain related lower-fat dairy products in parts
131 and 133 (i.e., sweetened condensed skimmed milk (Sec. 131.122),
acidified lowfat milk (Sec. 131.136), cultured lowfat milk
(Sec. 131.138), acidified skim (nonfat) milk (Sec. 131.144), cultured
skim (nonfat) milk (Sec. 131.146), sour half-and-half (Sec. 131.185),
acidified sour half-and-half (Sec. 131.187), lowfat yogurt
(Sec. 131.203), nonfat yogurt (Sec. 131.206), and lowfat cottage cheese
(Sec. 133.131)). The petitions requested that FDA regulate these
products under the general standard in Sec. 130.10. Subsequently, ADPI
filed a petition (Docket No. 95P-0261) requesting that the agency
revoke the standards of identity for two additional products in part
131, evaporated skimmed milk (Sec. 131.132) and lowfat dry milk
(Sec. 131.123), and that it amend the standard of identity for dry
cream in Sec. 131.149 by removing the reference to Sec. 131.135 (the
lowfat milk standard). The petitioners stated that the purpose of their
request is to promote consistency in the use of nutrient content claims
concerning fat on food labels and to remove product specifications that
potentially conflict with authorized nutrient content claims applicable
to foods in general.
MIF submitted a third petition, dated August 2, 1995 (Docket No.
95P-0293), requesting that, if FDA revokes the standards for skim milk
products, it concurrently amend the nutrient content claims regulations
in Sec. 101.62 to permit the continued use of the term ``skim'' as a
synonym for the term ``nonfat.'' A similar petition, dated August 10,
1995 (Docket No. 95P-0293), was submitted by ADPI.
C. Regulatory Reinvention Initiative--Review of Regulations
This final rule is a part of a larger agency project being
undertaken in response to President Clinton's memorandum of March 4,
1995, to heads of departments and agencies, entitled ``Regulatory
Reinvention Initiative.'' This memorandum, among other things, directs
departments and agencies to do a page-by-page review of their
regulations and to eliminate or revise those that are outdated or
otherwise in need of reform. The review of the standards of identity
for dairy products revealed that a number of the products that are
defined by individual standards in parts 131 and 133 could be more
appropriately covered by the general standard in Sec. 130.10.
D. The Proposal
In the Federal Register of November 9, 1995 (60 FR 56541), FDA
proposed (hereinafter referred to as the November 9, 1995, proposal) to
remove those standards cited by the MIF, CSPI, and ADPI petitions that
are inconsistent with food labeling regulations established under the
1990 amendments and that are unnecessary in light of the general
standard in Sec. 130.10. Interested parties were given until January
23, 1996, to comment on the proposal.
II. Summary of and Response to Comments to Proposal
FDA received 15 letters, each containing one or more comments, on
the November 9, 1995, proposal. The majority of comments supported the
proposal. A few comments expressed concerns about, or included
suggestions for, implementing the proposed revocations. Several
comments addressed issues outside the scope of the proposal (e.g.,
amending the milk solids content requirements in whole
[[Page 58993]]
milk) that will not be discussed here. A summary of the comments and
the agency's responses follow.
A. ``Skim'' as a Synonym for ``Nonfat''
As noted in the November 9, 1995, proposal (60 FR 56541 at 56543),
MIF and CSPI stated that most products currently labeled as ``nonfat
milk'' would be eligible to retain that name under the general standard
because these products generally contain less than 0.5 gram (g) of fat
per serving, which would comply with the definition of ``nonfat'' in
Sec. 101.62(b)(1)(i). However, the fat content claims regulations in
Sec. 101.62 do not authorize the use of the term ``skim.''
Consequently, at the request of the petitioners, and because of its
historic use in dairy product nomenclature, FDA proposed to amend the
fat content claims regulations in Sec. 101.62(b)(1)(i) to provide for
``skim'' as a synonym for ``nonfat'' when used in labeling milk
products.
1. All comments that addressed this issue supported FDA's proposal
to provide for the use of the term ``skim.'' Several comments
maintained that most consumers understand that ``skim'' and ``nonfat''
have the same meaning. Other comments noted consumers' reliance on the
term ``skim'' to readily identify nonfat milk products.
Thus, given the support expressed in comments to the November 9,
1995, proposal, and given consumer reliance on the term ``skim'' to
identify nonfat milk products, FDA is amending its claims regulations
under sections 403(r) and 701(a) of the act (21 U.S.C. 371(a)) to
provide for the use of the term ``skim'' as a synonym for ``nonfat'' in
describing milk products (Sec. 101.62(b)(1)). Because of the history of
use of the term ``skim'' to identify nonfat milk products, FDA
concludes that providing for continued use of this term to identify
nonfat milk products will minimize consumer confusion and facilitate
trade.
B. Dry Cream
As noted in the November 9, 1995, proposal (60 FR 56541 at 56542),
ADPI requested that the agency amend the standard of identity for dry
cream in Sec. 131.149 by removing the reference to Sec. 131.135 (the
lowfat milk standard, which FDA proposed to revoke). The petitioner
maintained that the requested change would bring the standard for dry
cream into conformity with the other suggested changes in the milk
product standards. FDA agreed with ADPI that, because it was proposing
to delete the standard of identity for lowfat milk (Sec. 131.135),
reference to that standard should be deleted from the standard of
identity for dry cream (60 FR 56541 at 56545). Therefore, the agency
proposed to amend the standard of identity for dried cream to remove
the reference to the standard of identity for lowfat milk. FDA did not
receive any comments on this proposed action. Consequently, FDA is
amending the standard of identity for dry cream in Sec. 131.149, in the
manner that it proposed.
C. Percent Fat Declaration
As noted in the November 9, 1995, proposal (60 FR 56541 at 56544),
MIF stated in its petition that it views the indication of the milkfat
percentage before the name of the product as an indispensable aspect of
lower-fat milk labeling because consumers have come to rely so heavily
on these numbers to differentiate among milk products. The petitioner
further stated that it would not be requesting the revocation of the
lower-fat milk standards if it believed that such an action would
affect milk processors' ability to state the milkfat percentage in the
name of the foods.
FDA responded to this concern in the November 9, 1995, proposal,
noting that while standards of identity require that the percentage of
milkfat be declared as part of the name of the food (e.g., lowfat
cottage cheese (Sec. 133.131(b)(2)), there is no provision requiring
percentage declaration of milkfat content in the name of the food under
Sec. 130.10. However, under Sec. 101.13(i), manufacturers may continue
to declare fat content as part of the name of the food for lower-fat
milk products, and on the labels of other products, when such
statements are not misleading.
2. Two comments expressed concern about percent fat labeling in
general but stated that, in the case of reduced fat and lowfat milk
products, special circumstances mitigate these concerns. These comments
noted that, under Sec. 130.10, lower-fat milks, originally exempt from
the 1990 amendments, will need to comply with the claims requirements.
Thus, percentage fat declaration would appear only on labels of milk
products that qualify to make a fat content claim (i.e., that contain
at least 25 percent less fat compared to whole milk). The comments also
noted that fat content per serving is provided in nutrition labeling,
and that products labeled as ``reduced fat'' must also bear a
comparative statement comparing the amount of fat per serving of the
food with the amount of fat in the reference food (Sec. 101.62(b)(4)).
The comments concluded that, therefore, percent fat declaration on
labels of milk products that are lower in fat than whole milk would not
be misleading.
FDA agrees with the comments that the nutrient content claims
requirements (Sec. 101.13(i)(1)) will be sufficient to ensure that,
when percent fat labeling in the names of reduced fat and lowfat milk
products characterizes the level of fat in the food, such statements
are consistent with the terms defined under the act. Furthermore, under
Sec. 101.13(i)(3), foods that do not meet the requirements for a
nutrient content claim (e.g., whole milk containing 3.25 percent
milkfat) may still bear statements about the percent milkfat in the
food provided that the statement does not in any way implicitly
characterize the level of fat in the food, and that it is not false or
misleading in any respect.
D. Light Cream
In the November 9, 1995, proposal (60 FR 56541 at 56545), the
agency noted that standards of identity for two cream products contain
the term ``light'' in the name of the foods, i.e., light cream in
Sec. 131.155 and light whipping cream in Sec. 131.157. FDA noted that
these products have a different texture than the higher fat cream
product, heavy cream, defined in Sec. 131.150. Because of the long
history of use of these names (since 1940), FDA did not propose to
change these standards. However, FDA requested comment on the
appropriateness of these names and on whether consumers find the use of
the term ``light'' in the names of these foods to be misleading. The
agency stated that if comments demonstrated that amendment of these
regulations is necessary, such action would be the subject of a later
rulemaking.
3. One comment objected to the continued use of the term ``light''
in the names ``light cream'' and ``light whipping cream.'' The comment
maintained that retaining the term ``light'' in the names of these
foods would undermine the agency's attempt to make all dairy products
subject to the same nutrient content claim definitions as other food
products. The comment did not, however, include any data or other
evidence that consumers find the use of the term ``light'' in the names
of these foods to be misleading.
As the agency noted in the nutrient content claims final rule (58
FR 2302 at 2359), the term ``light'' can be used to describe physical
or sensory characteristics of a food (e.g., to describe color or
texture). The agency also stated that, to the extent that the term
``light'' had become part of the statement of identity (i.e., it
describes characteristics of a food), use of the term would not be
considered a nutrient content claim (58 FR 2302 at 2359). FDA notes
that the
[[Page 58994]]
standards of identity for light cream (Sec. 131.155) and light whipping
cream (Sec. 131.157) describe foods that differ from heavy cream
(Sec. 131.150) in that they are less dense. The agency acknowledges
that light cream and light whipping cream also contain less milkfat
compared to heavy cream, and that it is this difference in fat content
that is largely responsible for differences in the density of these
products. However, FDA does not have any evidence, nor did the comment
provide any, that the use of the term ``light'' in the names of these
standardized foods is misleading. Therefore, FDA is not persuaded that
there is a need to amend or revoke the standards of identity for light
cream or light whipping cream. However, FDA reiterates that if it is
demonstrated that amendment of these regulations is necessary to
prevent consumers from being misled, such action will be the subject of
a future rulemaking.
E. Deviations From Traditional Products
4. A few comments expressed concern about how the composition of
traditional dairy products may change under the general standard. One
comment questioned the impact of this action on consumer acceptance of
new products, while another comment stated that FDA may need to educate
consumers about the possible changes in ingredients and characteristics
of foods to which they have become accustomed.
FDA acknowledges that this action will permit products to be
formulated in ways that were not previously allowed. For example,
Sec. 130.10 will allow a product named ``nonfat milk'' to contain
flavors, colors, and texturizers that provide defatted milk with the
sensory properties of whole milk. The standard of identity for nonfat
milk does not permit the addition of such flavors, colors, and
texturizers. Some manufacturers may continue to produce foods under
Sec. 130.10 that are identical to the traditional lower-fat dairy
products to which consumers have become accustomed, except that
nutrient content claims in the name of the food (e.g., nonfat milk or
lowfat cottage cheese) will be subject to the claims requirements.
Alternatively, some manufacturers may choose to formulate new products,
e.g., a nonfat milk product with the sensory characteristics of whole
milk.
Further, some individuals may prefer a new food to a traditional
food, whereas others may prefer the traditional food. It is not the
function of the agency to determine the likes or dislikes of consumers.
Rather, the function of the agency is to ensure that foods are safe,
and that labeling is informative and not misleading. Section 130.10
provides for proper labeling of these foods and their ingredients.
Adequate product labeling, including defined nutrient content claims,
label statements required to accompany certain claims, nutrition
labeling, and ingredient declaration, will enable consumers to
distinguish traditional foods from modified versions of these products.
5. One comment maintained that the driving force behind the
petitioners' request to revoke the standards of identity for lower-fat
dairy products is to allow manufacturers to use ``non-dairy fillers''
in lower-fat dairy products made under the general standard, thus
cheapening the standardized products.
FDA disagrees with the comment's contention that this action would
promote the cheapening of products covered by standards of identity. As
noted in response to the preceding comment, this action will permit
products to be formulated in ways that were not previously allowed.
However, Sec. 130.10 contains a number of provisions to ensure that
modified foods named by use of a nutrient content claim and a
standardized term bear a close enough resemblance to the standardized
food to warrant use of the term. For example, ingredients required by
the standard must be present in the substitute food and may not be
replaced by a similar ingredient from another source. Ingredients
prohibited by the standard are also prohibited in modified foods made
under the general standard. Ingredients not provided for, and
ingredients used in excess of the levels provided for, by the standard
must be identified, at least in the ingredient declaration.
Furthermore, in the preamble for the general standard final rule (58 FR
2431 at 2439), FDA specifically provided examples of circumstances in
which certain ingredients, such as caseinate, would, or would not, be
appropriate for use in dairy products made under Sec. 130.10. FDA
concludes, therefore, that the provisions set out in Sec. 130.10 are
adequate in this regard.
F. Vitamin Addition--Milk Products
As noted in the November 9, 1995, proposal (60 FR 56541 at 56545),
under the existing standards of identity for lowfat and skim milk
products in part 131, vitamin A addition is mandatory, while vitamin D
addition is optional. Vitamin A is required to be added to a level of
2,000 International Units (IU) per quart (500 IU or 10 percent of the
daily value (DV) per reference amount customarily consumed (RACC)).
When vitamin D is added to lower-fat milk products, the level must be
400 IU per quart (100 IU or 25 percent of the DV per RACC). However,
under the general standard, the only requirement for lower-fat milk
products is that they not be nutritionally inferior to milk as defined
in Sec. 131.110. The standard of identity for whole milk provides for
the optional addition of vitamin A to a level of not less than 2,000 IU
per quart and vitamin D to a level of 400 IU per quart. Because the
addition of these nutrients to whole milk is optional, their addition
at these levels to lower-fat milks under Sec. 130.10 would also be
optional.
On average, whole milk, before fortification, contains
approximately 6 percent of the DV of vitamin A per RACC. Thus, lower-
fat milks made according to Sec. 130.10 may contain less vitamin A than
currently required under the standards of identity for lowfat and skim
milks.
6. Two comments urged FDA to retain current levels of vitamin A and
D in lower-fat milk products to ensure that reduced fat, lowfat, and
nonfat milk contain sufficient amounts of these vitamins. These
comments noted the importance of standardized, lower-fat milks as a
dietary source of vitamins A and D. One comment expressed concern that,
in the absence of the standards of identity, the levels of vitamins A
and D in lower-fat milk products would decline. Another comment
appeared to believe that revoking the standards of identity for lower-
fat milks would allow these products to have less vitamin A and D than
whole milk. Based on this assumption, the comment stated that some
consumers may be discouraged from drinking the lower-fat milks. One
comment acknowledged that, while the addition of vitamin D is currently
optional for all milk products, most fluid milk (up to 95 percent) is
fortified to contain 400 IU per quart. However, the comment urged FDA
to take the opportunity of this rulemaking to make the addition of
vitamin D mandatory for all fluid milk.
In contrast, another comment stated that revoking the standards of
identity for lower-fat milk products would not diminish the nutritional
benefits of these foods. This comment maintained that the current milk
fortification practices would almost certainly continue in the absence
of the specific standards of identity for lower-fat milks. In support
of its contention, the comment noted that the general standard
(Sec. 130.10(b)) requires that a food named by use of a nutrient
content claim and a standardized term be nutritionally equivalent to
its
[[Page 58995]]
standardized counterpart. The comment stated that since the process of
removing fat from milk unavoidably removes some vitamin A, processors
will have to add some amount of vitamin A to lower-fat milk products to
bring their vitamin A levels at least up to the level naturally found
in whole milk (i.e., approximately 6 percent of the DV per RACC).
However, under the applicable terms of the whole milk standard
(Sec. 131.110), processors will still have the option of fortifying
lower-fat milk products with vitamin A up to 10 percent of the DV per
RACC.
The comment maintained that, in the absence of standards of
identity, several incentives remain for fortifying lower-fat milk
products to the current level (10 percent of the DV). First, ``good
source'' nutrient content claims (Sec. 101.54(c)) require that a food
contain at least 10 percent of the DV for the subject nutrient. In
contrast, if processors choose to add vitamin A only to the level
normally found in milk before fortification, they cannot make claims
about vitamin A content (e.g., ``vitamin A added''). The comment noted
that consumers have become accustomed to seeing the presence of vitamin
A highlighted in the labeling of lowfat and skim milk. The comment
further noted that industry-wide promotional efforts focus on the high
levels of essential nutrients in lower-fat milk products. Consequently,
any change in fortification practices would disrupt marketing and
partially undermine nutrition based promotional campaigns. Finally,
according to the comment, the primary cost of vitamin A fortification
is not the vitamin itself but the equipment needed to add the vitamin,
as well as the analytical processes required to ensure quality control.
The comment argued that it is, therefore, highly unlikely that a
processor of lower-fat milks would choose to add only enough vitamin A
to achieve the percent of the DV for the required nutritional
equivalency and forego the obvious benefits of fortifying its products
to 10 percent of the DV per RACC.
This comment also noted that almost all of the fluid milk sold in
this country is vitamin D fortified, even though the addition of
vitamin D is optional under the standards of identity for whole milk,
lowfat milk, and skim milk. The comment concluded that any concerns
that processors will cease to fortify lower-fat milk products, simply
because such fortification is no longer technically required, are
unjustified.
FDA disagrees with the comment that stated that lower-fat milk
products made under the general standard may contain lower levels of
vitamins A and D when compared to unfortified whole milk. As noted in
the November 9, 1995, proposal (60 FR 56541 at 56545), and reiterated
in this preamble, lower-fat dairy products made according to the
general standard may not be nutritionally inferior to the full fat
product that they resemble and for which they substitute. Therefore,
FDA concludes that concerns that lower-fat milk products will contain
lower levels of vitamins A and D when compared to whole milk are
unfounded. The question, rather, is whether deleting the standards for
lowfat and skim milk products would likely result in a change in the
levels or frequency of addition of vitamins A and D to these foods.
FDA knows of no evidence that supports the contention that revoking
the standards of identity, as proposed, will cause manufacturers of
lower-fat milks to discontinue fortifying these products at the current
levels. On the contrary, current industry practice of fortifying nearly
all milk products with vitamin D, even though vitamin D addition is
optional, evidences that fortification at the current level is likely
to continue, even in the absence of an affirmative requirement.
Furthermore, as noted by the latter comment, there is considerable
incentive (e.g., the use of label statements and promotional programs)
to continue the practice of adding vitamin A at the current levels. The
agency concludes, therefore, that the provisions of Secs. 130.10(b) and
101.3(e) are adequate, and that special provisions (beyond the
nutritional equivalency requirements of Sec. 130.10) are not necessary,
to ensure that lower-fat milk products continue to serve as an
important dietary source of vitamins A and D. However, if this action
were to result in significant changes in the current industry practice
of adding vitamins A and D to lower-fat milk products, and changes were
to adversely affect the levels of these vitamins in the diet, FDA would
consider amending its regulations to require fortification of lowfat,
reduced fat, and nonfat milk products manufactured under Sec. 130.10.
7. One comment expressed concern about difficulties that might be
encountered in determining whether a food complies with the
requirements of Sec. 130.10. The comment noted, for example, that,
under this provision, lower-fat milk products named by use of a
nutrient content claim and a standardized term have to be compared to
whole milk. The comment maintained that regulatory agencies would
generally need to run comparison tests using a particular
manufacturer's whole milk to determine whether the manufacturer's
lower-fat product is nutritionally equivalent to the standardized food.
The comment pointed out, however, that some manufacturers do not
produce whole milk. Therefore, the comment urged FDA to provide for the
use of an industry average as a reference food or to provide specific
nutrient content requirements for lower-fat milk products made under
Sec. 130.10. The comment suggested that the nutrient requirements
(i.e., for vitamin content) be similar to what is currently required in
the standards for lower-fat milks.
FDA agrees that it will be necessary to compare the levels of
essential nutrients in lower-fat milk products named by use of a
nutrient content claim and a standardized term to the nutrient profile
of the standardized food. However, the agency advises that it is not
necessary for a manufacturer to process whole milk for FDA to ensure
that a lower-fat milk is nutritionally equivalent to the food for which
it substitutes. FDA set out principles for determining an appropriate
reference food in Sec. 101.13(j)(1)(ii). For example, the comparison
product may be the manufacturer's regular product or that of another
manufacturer, an average value determined from the top three national
(or regional) brands, or a market basket norm. Though
Sec. 101.13(j)(1)(ii) specifically applies to reference foods used to
make a relative nutrient content claim (e.g., ``reduced fat''), the
options therein would be applicable to nutrient comparisons to
determine nutritional equivalency. Furthermore, FDA noted in the
general standard final rule (58 FR 2431 at 2435), that nutrient values
in a current valid composite data base can be used for standardized
products. In that final rule, the agency acknowledged that target
levels for nutrients necessary to determine nutritional equivalency of
a food will depend on the specific foods being compared (58 FR 2431 at
2436). However, FDA determined that it would not be appropriate, beyond
the provisions of Sec. 130.10(b), to mandate specific levels of
nutrients that must be added to substitute foods.
Much of the concern raised in the comment apparently comes from the
fact that there may be wide variations in vitamin A content of milk
because of seasonal and other factors. As noted in the November 9,
1995, proposal (60 FR 56541 at 56545), vitamin A levels in milk in
winter have been reported to range from 500 to 1,000 IU per quart,
while in summer (pasture), these levels range from 2,000 to 3,000 IU
per quart. However, FDA does not expect that processors will choose to
recalibrate equipment for vitamin fortification of
[[Page 58996]]
lower-fat milk products to accommodate daily or seasonal fluctuations
in the vitamin A content of the processor's whole milk. Rather, the
agency expects that manufacturers will choose the simplest option
available to them, such as fortifying products to be nutritionally
equivalent to the level of vitamin A listed in a composite data base.
This approach would also be the simplest option from a regulatory
standpoint.
FDA concludes that the requirement in Sec. 130.10(b) that the
modified product must not be nutritionally inferior, as defined in
Sec. 101.3(e)(4), to the standardized product is adequate, and that,
therefore, it is not necessary to specify further the required amounts
of essential nutrients that must be added to lower-fat milk products.
G. Vitamin Addition--Dairy Products Other Than Milk
8. One comment supported the proposal to make nutrient content
claims for the referenced dairy products consistent with nutrient
content claims for fat in other foods. However, the comment suggested
that, in its current form, FDA's proposal would unduly penalize
manufacturers of lower-fat yogurt products without any corresponding
benefit to either public health or consumer awareness. The comment
stated that full fat yogurt, before fortification, contains between 0.2
and 0.8 percent of the reference daily intake (RDI) for vitamin D. This
is less than a ``measurable amount,'' as defined in
Sec. 101.3(e)(4)(ii). Therefore, vitamin D fortification (currently
optional for all standardized yogurt products) would not be required
for lower-fat yogurt products made under Sec. 130.10. However, the
comment stated that full fat yogurt contains between 2 and 14 percent
of the RDI for vitamin A. In contrast, lowfat and nonfat yogurt contain
between 0.9 and 6 percent and between 0.2 and 1 percent, respectively,
of the RDI for vitamin A. Therefore, some amount of vitamin A would
need to be added to most lower-fat yogurt products for the food to be
nutritionally equivalent to full fat yogurt. The comment hypothesized
that, therefore, a processor of a lower-fat yogurt that contains 1
percent of the RDI of vitamin A may be forced to fortify its product
with 3 percent of the RDI for vitamin A to reach the 4 percent level
found in some full fat yogurt. The comment maintained that such
fortification (i.e., adding 3 percent of the RDI for vitamin A) is not
dietetically significant. The comment further argued that, although the
vitamin A fortification requirement would add little in terms of
dietary value, it would impose a significant financial burden on yogurt
manufacturers.
Another comment noted that sour half-and-half contains 2 percent of
the DV for vitamin A compared to 4 percent of the DV in full fat sour
cream. The comment maintained that requiring fortification at such low
levels would impose a significant cost on manufacturers with relatively
little benefit for consumers.
Conversely, several comments expressed concern about maintaining
requirements that will ensure that modified foods are not nutritionally
inferior to the food for which they substitute. In fact, one comment
urged FDA to make the addition of vitamin D mandatory in yogurt. The
comment stated that many consumers use yogurt as a substitute for milk
and assume that the two foods are nutritionally equivalent, when, in
fact, yogurt products generally do not contain vitamin D.
In response to the latter comment, FDA notes that vitamin D is
currently optional in all standardized yogurt products. Therefore, it
would also be optional in yogurt products made under Sec. 130.10. To
amend the standard for yogurt to make addition of vitamin D mandatory
is outside the scope of this rulemaking. However, as mentioned below in
comment 12 of this document, FDA is in the process of evaluating all of
its regulations pertaining to standards of identity. The comment's
suggestion may have relevance in a future rulemaking as a part of that
initiative.
The agency is not persuaded by the comments that maintained that
the nutritional equivalency requirements for lower-fat dairy products
made under Sec. 130.10 (e.g., lowfat yogurt or sour cream) will be of
little benefit to consumers. As noted in comments, full fat yogurt may
contain as much as 14 percent of the RDI for vitamin A, making the food
a good source of vitamin A. Furthermore, the diet is made up of a
variety of foods, not all of which are a ``good source'' (i.e., contain
10 percent or more of the DV) of a particular nutrient. Even when
nutrients are present in lesser amounts, the nutritive value of a food
may make a significant contribution to meeting dietary goals. However,
as noted in the December 28, 1995, final rule entitled ``Food Labeling;
Reference Daily Intakes'' (60 FR 67164 at 67170), adequacy of intake of
a particular nutrient or public health concerns are not criteria for
determining whether a substitute food is nutritionally inferior to the
food for which it substitutes. Rather, Sec. 101.3(e)(4)(i) defines
nutritional inferiority as any reduction in the content of an essential
nutrient that is present in a measurable amount (excluding fat or
calories). Section 101.3(e)(4)(ii) defines a measurable amount of an
essential nutrient in a food as 2 percent or more of the daily
reference value (DRV) of protein listed under Sec. 101.9(c)(7)(iii), of
potassium listed under Sec. 101.9(c)(9), and of the RDI of any vitamin
or mineral listed under Sec. 101.9(c)(8)(iv). The agency considers, per
Sec. 101.9(a)(4), a measurable amount to be a significant amount for
this purpose. Therefore, consistent with the agency's longstanding
definition of nutritional inferiority in Sec. 101.3(e)(4), FDA
concludes that a 2 percent or greater reduction in the RDI for vitamin
A in lower-fat sour cream or lower-fat yogurt products is significant,
and that such a reduction will make these foods nutritionally inferior
to the foods for which they substitute.
9. One comment maintained that application of Secs. 130.10 and
101.3(e) to lower-fat dairy products will impose, for the first time, a
requirement that well established, standardized products (e.g., lowfat
and nonfat yogurt and sour half-and-half) be nutritionally equivalent
to their full fat counterparts. The comment argued that even the final
rule revoking the standard of identity for ice milk (hereinafter
referred to as the 1994 final regulation) (59 FR 47072, September 14,
1994) did not have this overall effect. According to the comment, the
lower-fat ice cream products created by that action were not
established, standardized products bearing a new name but were
essentially ``new'' products created by the revisions.
The agency disagrees with the comment's contention that this
rulemaking will, for the first time, require fortification of
traditional lower-fat dairy products to achieve nutritional equivalency
to their full fat counterparts. A number of the standards of identity
for lower-fat dairy products contain provisions to ensure that the
foods are at least nutritionally equivalent to the full fat version of
the food (e.g., lowfat and skim milk must contain not less than 2,000
IU vitamin A (Secs. 131.135 and 131.143)). Furthermore, before
establishing the general standard, FDA issued more than 150 temporary
marketing permits (TMP's) for the market testing of lower-fat dairy
products such as ``light eggnog,'' ``light sour cream,'' ``nonfat sour
cream,'' and ``nonfat cottage cheese.'' One of the criteria used in
evaluating the acceptability of these test products was that they be
nutritionally equivalent to the full fat standardized food.
[[Page 58997]]
Since the agency adopted Sec. 130.10, there has been a
proliferation of lower-fat dairy products labeled by use of a
standardized term in conjunction with a nutrient content claim (e.g.,
``light sour cream'') that are nutritionally equivalent to the full fat
foods. Therefore, FDA disagrees with the comment and notes that there
are several examples of lower-fat dairy products that resemble and
substitute for full fat standardized foods and that are fortified to be
nutritionally equivalent to the foods for which they substitute.
The nutritional equivalence requirement in Sec. 130.10 follows, in
large measure, the approach embodied in Sec. 101.3(e) with respect to
substitute foods. The authority for Sec. 101.3 is section 403(c) of the
act. When this section of the act was adopted in 1938, Congress was
seeking to protect the consumer from the uninformed purchase of an
inferior substitute product that could be mistaken for the traditional
food product (38 FR 2138, January 19, 1973). In 1973, in a proposal
pertaining to ``imitation foods,'' the agency noted that vast strides
in food technology had taken place since section 403(c) had been
enacted, and that since 1938 many new wholesome and nutritious food
products had entered the marketplace, some of which resembled and
substituted for traditional foods (38 FR 2138). The agency stated that
it was no longer the case that such products were necessarily inferior
to the traditional foods for which they substituted. However, FDA still
believed that the consumer must be protected from unwittingly
purchasing a product that is different from what he or she may
reasonably expect (38 FR 2138).
FDA continues to believe that, as substitute products proliferate,
it is important to ensure that these products contain essential
nutrients in amounts consistent with the reference food, so that
consumers can continue to have confidence that a varied diet will
supply adequate nutrition. This principle, that substitute foods must
not be nutritionally inferior to the foods for which they substitute,
was incorporated into the general standard final rule, in which FDA
stated that foods having significantly less essential nutrients than
the standardized food for which they are named are not modified
versions of the standardized food, do not comply with the requirements
of the general standard, and must be labeled as ``imitation'' (58 FR
2431 at 2435).
Finally, FDA is not convinced by the comment that revoking the
standards of identity for lower-fat dairy products in parts 131 and 133
differs from the rulemaking to revoke the standard of identity for ice
milk so that such products could be labeled as nutritionally modified
versions of ice cream under Sec. 130.10 in the 1994 final regulation.
Specifically, FDA disagrees with the comment's contention that the
final rule revoking the standard for ice milk did not affect a
standardized product because ice milk was not being sold under that
name. FDA notes that a number of companies were marketing the
standardized product ``ice milk'' before the 1994 final regulation made
it possible to market this product either as ``reduced fat'' or ``low
fat'' ice cream (Ref. 1) depending on the level of fat in the product.
The effect of the 1994 final regulation was to provide for the labeling
of lower-fat ice cream products, such that the product names are
consistent with the requirements for nutrient content claims, the food
for which the product substitutes is clearly identified, and the
substitute food is nutritionally equivalent to the standardized food
(ice cream).
10. One comment argued that, because standardized lower-fat yogurt
and sour cream products have never been nutritionally equivalent to the
full fat standardized foods, continued consumption of unfortified
versions of these products will not result in any unanticipated
diminution of vitamin A intake by consumers, nor would it deprive
consumers of nutrients that they were previously obtaining.
FDA disagrees with the comment's contention that, because
nutritional equivalency with the full fat food has not been required
heretofore in some standardized lower-fat dairy products, failure to
add this requirement now will not diminish the nutrient value of the
food or its contribution to the diet. This view would only be true if
dietary patterns were static. However, consumers' tastes, dietary
needs, and knowledge about nutritional content of foods change. There
are numerous ongoing educational programs designed to encourage
consumers to eat a healthier diet (e.g., a diet lower in fat) and to
encourage increased calcium consumption (from such sources as dairy
products) by that part of the population at risk for osteoporosis. The
nutrient intake of consumers who are now switching from full fat to
lower-fat dairy products, and of those who are increasing their
consumption of dairy products by eating lowfat or nonfat foods, may
indeed be decreased. FDA notes, for example, that the consumption of
yogurt products increased more than fivefold between 1970 and 1993
(Ref. 1). As the population ages, dietary recommendations will take on
even greater significance. Therefore, FDA cannot agree that exempting
lower-fat dairy products from the requirement that they be
nutritionally equivalent to the full fat foods for which they
substitute would not have an adverse effect on the diet of consumers.
Furthermore, FDA has promised consumers since 1973 that substitute
foods will be nutritionally equivalent to the foods for which they
substitute, or that if they are not, this fact is to be revealed on the
label. In the general standard final rule (58 FR 2431 at 2435), FDA
stated that all nutrients that are considered in determining the status
of a food under Sec. 101.9(c)(7)(iv) are important. FDA also stated
that any measurable reduction in an essential nutrient is significant,
and that if a food is nutritionally inferior to the standardized food,
it cannot be labeled as a modified version of the food but, rather, as
an ``imitation.'' The comments have not provided any reason to
establish an exemption from the agency's general approach for lower-fat
yogurt or sour cream products.
11. One comment stated that vitamin A fortification frequently has
a negative impact on the taste of dairy products. The comment
maintained that vitamin A fortification could, therefore, drive some
consumers away from the lower-fat products to which they were
accustomed in favor of higher fat products in which the naturally
occurring vitamin A does not cause a taste problem. The comment did
not, however, provide any data in support of its contention.
FDA is not persuaded by the comment that there exist sufficient
technical difficulties (e.g., taste considerations) that would warrant
exempting lower-fat dairy products made under Sec. 130.10 from the
requirement that they be nutritionally equivalent to the standardized
food. The agency notes that that requirement did not prevent
manufacturers from submitting scores of applications for TMP's.
Furthermore, the agency does not have any information that vitamin A
fortification has been a significant impediment to the manufacture or
marketing of lower-fat dairy products as part of the market tests
conducted before or after the enactment of the 1990 amendments or under
Sec. 130.10.
12. One comment that objected to requiring lower-fat dairy products
to be nutritionally equivalent to the full fat version of the foods
supported the basic proposition that foods bearing names that include a
defined nutrient content claim should conform to the requirements for
that claim as defined by FDA. However, it disagreed with the
[[Page 58998]]
agency's proposed approach of revoking standards of identity for lower-
fat dairy products and subjecting them to the general standard and with
the requirement that they not be nutritionally inferior, as defined in
Sec. 101.3(e)(4), to the standardized food in parts 131 and 133. As an
alternative, the comment suggested that FDA consider amending either
Sec. 101.3(e) or Sec. 130.10 such that fortification would not be
required at low levels. A second alternative suggested by the comment
would be to combine into one standard the existing standards of
identity for each group of dairy products, specifying the particular
fat levels applicable to reduced fat, lowfat, and nonfat versions of
the food. Finally, the comment suggested that FDA could leave the
standards of identity for lower-fat dairy products in place but amend
them by reducing the maximum milkfat percentages to levels that
correspond with the nutrient content claims requirements. For example,
the maximum milkfat content requirement for lowfat yogurt in
Sec. 131.203 could be reduced from 2 percent to 1.3 percent so that the
food would contain no more than 3 g fat per reference amount as
required for a ``low fat'' claim.
FDA notes that it published an advance notice of proposed
rulemaking (ANPRM) in the Federal Register of December 29, 1995 (60 FR
67492), announcing that it intends to review its regulations pertaining
to standards of identity, quality, and fill of container and asking for
comment on the utility of these regulations. Among the regulations on
which the agency requested comment were those pertaining to the
labeling of imitation and substitute foods in Sec. 101.3(e) (60 FR
67492 at 67502). Further, in another ANPRM that FDA published in the
Federal Register of June 12, 1996 (61 FR 29701 at 29702), the agency
requested comments on certain regulations pertaining to food labeling,
including the provisions for labeling imitation and substitute foods
set out in Sec. 101.3(e).
In the June 12, 1996, ANPRM, FDA noted that, in 1973, the agency
proposed that ``imitation'' only be applied to substitute foods that
are nutritionally inferior to the foods for which they substitute (38
FR 2143 at 2148), and that, in its final regulation (38 FR 20702,
August 2, 1973), FDA confirmed this view and defined ``nutritional
inferiority'' as the reduction in the content of an essential nutrient
that is present in a measurable amount (Sec. 101.3(e)(4)). In the June
12, 1996, ANPRM, FDA requested comment on the appropriateness of the
current definition of nutritional inferiority for the purpose of
determining whether a food is an imitation. FDA noted that it had not
reevaluated its definition of nutritional inferiority for purposes of
imitation labeling when it recently revised these regulations to
accommodate new RDI's for several nutrients (60 FR 67164), but that it
had raised the question in the December 29, 1995, ANPRM on standards of
identity. The agency further noted that it would evaluate any proposed
changes in its policy on labeling of imitation foods in light of any
changes that it ultimately decides to make in its approach to standards
of identity and common or usual name regulations.
Therefore, FDA is not proposing to amend its requirements in the
general standard (Sec. 130.10(b)) or in Sec. 101.3(e) that require
fortification of a modified food to restore nutrient levels so that the
product is not nutritionally inferior as defined in Sec. 101.3(e)(4),
as requested by the comment. However, if FDA receives comments to the
December 29, 1995, or June 12, 1996, ANPRM's suggesting changes in its
treatment of imitation and substitute foods, it will consider such
changes as part of those rulemakings.
Additionally, while modifying the existing standards as suggested
by the comment could achieve consistency between milkfat content
requirements in the standards of identity and the definitions for
nutrient content claims for fat, this change would not address fat from
sources other than milkfat (e.g., bulky flavors containing fat can
increase total fat content such that the food would not comply with the
requirements for the claim). Furthermore, the claims requirements
contain provisions in addition to nutrient content requirements (e.g.,
explanatory label statements). However, foods covered by a standard of
identity are exempt from the claims requirements (section 403(r)(5)(C)
of the act), while most other nutritionally modified foods are covered.
Thus, the comment's suggestion would neither promote uniformity in food
labeling nor minimize consumer confusion. It makes more sense to choose
an approach that will, as much as possible, provide for uniform
treatment of all nutritionally modified foods.
As noted above in comments 9 and 10 of this document, some
nutritionally modified versions of standardized dairy products are
already being made under Sec. 130.10. Many of the products that
resemble or purport to be (i.e., have similar functional, physical, and
sensory properties as) the standardized, lower-fat food, but that do
not comply with the standard of identity for the food because their fat
content falls outside of the ranges provided for in the current
standards (e.g., nonfat sour cream), would not be covered by any of the
approaches suggested by the comment. Therefore, formulation and
labeling requirements for similar foods within a product class would
continue to be different. Such a situation could lead to consumer
confusion and to inefficient enforcement of the act.
In contrast, taking the approach suggested in the petitions and
proposed by the agency, i.e., deleting the standards for lower-fat
dairy products and providing for their composition and labeling in
accordance with the general standard, will provide maximum flexibility
for manufacturers in using new ingredients and technologies and
increased product choices for consumers. Therefore, the agency
concludes that this approach most closely fulfills the goals of the
President's reinventing government initiative of simplifying
regulations and easing the burden on the regulated industry.
13. Two comments objected that the proposed rule that would require
lower-fat yogurt to be fortified with vitamin A to the level in full
fat yogurt. The comments argued that such a requirement would make
little sense because full fat yogurt is not widely marketed in this
country. (One comment maintained that full fat yogurt constitutes less
than 1 percent of the yogurt market in the United States.) These
comments argued that, because full fat yogurt is not widely marketed,
the purpose for the nutritional equivalence requirement in Sec. 130.10,
i.e., to ensure that foods that substitute for traditional products
contain essential nutrients in amounts consistent with the reference
food, does not apply. These comments argued that, because consumers are
not replacing full fat yogurt with lower-fat yogurt products but rather
are consuming lower-fat yogurt as their primary product, it is not only
inappropriate but also unnecessary to require that lower-fat yogurt
products be nutritionally equivalent to full fat yogurt. Conversely,
several comments noted that full fat yogurt is a significant source of
vitamin A, containing up to 14 percent of the RDI.
FDA disagrees with comments that argued that requiring a substitute
food to be nutritionally equivalent to a product that is rarely
marketed (i.e., full fat yogurt) is inappropriate. Market share is not
a criterion for deciding the traditional food for which the new food
named in accordance with Sec. 130.10 substitutes. Foods named in
accordance with Sec. 130.10 use the name of the
[[Page 58999]]
traditional standardized food and a nutrient content claim that
describes how the new food deviates from the traditional food. Thus, in
the case of ``lowfat'' or ``nonfat yogurt'' that is named in accordance
with Sec. 130.10, the traditional standardized food is ``yogurt'' as
defined in Sec. 131.200.
Further, as FDA noted in the general standard final rule (58 FR
2431 at 2436), a food may resemble or substitute for more than one food
(e.g., nonfat cottage cheese may substitute for cottage cheese
(Sec. 133.128) or for dry curd cottage cheese (Sec. 133.129)). However,
the food may not be nutritionally inferior to the standardized food
whose name is used in the identity statement for the substitute food.
If the agency were to revoke the standards for both lowfat and nonfat
yogurt, lower-fat yogurt products made under Sec. 130.10 would have to
be nutritionally equivalent to the standardized food (i.e., yogurt)
whose name is used in the identity statement of the foods.
FDA advises that such a result is fully consistent with the
regulatory approach that FDA has taken since 1973. As FDA stated above
in comments 9 and 10 of this document, since that time, consumers have
had the assurance that substitute foods are nutritionally equivalent to
the foods for which they substitute, or that, if they are not, this
fact is disclosed on the label, i.e., by the use of the term
``imitation.'' Furthermore, it would be inconsistent to use the fat
level of full fat yogurt for claims purposes (the name ``lowfat
yogurt'' implies that there is a yogurt that is not lowfat, or else the
food would have to be called ``yogurt, a lowfat food''), but not for
purposes of establishing a nutrient baseline (i.e., the vitamin A
level). Therefore, the agency rejects this argument.
At the same time, the agency recognizes that, for some dairy
product manufacturers, this final rule will result in relabeling,
reformulation, and equipment costs. Whether, and to what extent, a
manufacturer incurs costs as a result of this final rule will depend,
in part, on the types of products that the manufacturer produces and
whether those products are in compliance with the nutrient content
claim requirements.
FDA notes, however, that yogurt is unique among the products listed
in the proposal in that both of the following conditions apply. First,
the existing standards of identity for yogurt products do not require
vitamin addition. Secondly, these standards cover nearly the full range
of possible fat contents (i.e., full fat yogurt, lowfat yogurt, and
nonfat yogurt). In contrast, the standards of identity for cottage
cheese, for example, are limited to full fat and lowfat foods. Thus,
historically, the yogurt industry has not had the same need to produce
modified versions of the standardized food under TMP's or under the
general standard as manufacturers of other standardized dairy products
have had to do to make lowfat and nonfat products. To cite another
example, although the standards for fluid milk products in part 131
cover a wide range of fat levels, vitamin A addition is mandatory in
the lower fat foods, and the industry voluntarily adds vitamin D to
almost all milk products. Thus, although fluid milk products have
generally not been produced under TMP's or the general standard, the
milk industry has the experience and equipment necessary for adding
vitamins to lower-fat milk products to meet the nutritional equivalency
requirements of Sec. 130.10(b). In contrast, yogurt manufacturers have
significantly less experience in producing products that are fortified
with vitamin A.
Therefore, although FDA concludes that vitamin A addition will not
result in insurmountable technical difficulties, the agency
acknowledges that it may take some time for the yogurt industry to
overcome any problems it may encounter in fortifying lower-fat yogurt
products. Furthermore, because the yogurt industry has generally not
heretofore produced vitamin fortified lower-fat yogurt products,
manufacturers who produce only yogurt may well not possess the
equipment necessary for vitamin fortification. One comment maintained
that 69 percent of the yogurt industry produces only yogurt. In the
analysis of impacts section of this preamble, using data from the same
comment, FDA estimates that the cost of vitamin metering equipment for
the yogurt industry could be as high as $52 million. In contrast, FDA
estimates that the total cost of this regulation to the rest of the
dairy industry will be approximately $2.7 million. Therefore, FDA
believes that revoking the lower-fat dairy standards as proposed would
likely impose a disproportionately larger financial burden on yogurt
manufacturers compared to the rest of the dairy industry.
Taking into consideration the technical difficulties and economic
considerations associated with the agency's proposal to revoke the
standards for lowfat and nonfat yogurt, the agency finds that fairness
suggests that it should delay final action on its proposal to revoke
these standards. Therefore, FDA is deferring action on its proposal to
revoke the standards of identity for lowfat yogurt and nonfat yogurt
for 120 days. During that period, the yogurt industry will have an
opportunity to meet with the agency and to discuss its progress in
addressing the vitamin A problems. FDA believes that a 120-day deferral
will provide an appropriate balance between the problems the industry
faces and consumers' interest in consistently and fairly labeled foods.
FDA advises that, at the end of the 120-day period, the agency
intends to move to resolve the inconsistencies between use of the terms
``lowfat'' and ``nonfat'' in the names of standardized yogurt and the
definitions for these terms established under the nutrient content
claims regulations. FDA further advises that deferring action on the
proposal to revoke the standards of identity for lowfat and nonfat
yogurt does not change the agency's conclusions with regard to deleting
the other standards of identity for lower-fat dairy products.
The agency does not believe that its decision to defer, for a
limited time, action on the standards of identity for yogurt products
will pose a serious problem for consumers because essentially all
nonfat yogurt, and the majority of lowfat yogurt, already complies with
the nutrient content claims requirements with respect to fat in that
they contain less than 0.5 and 3.0 g fat per RACC, respectively. In
contrast, approximately two-thirds of the lowfat milk products are 2
percent milk and, therefore, contain up to 60 percent more fat than is
permitted under the definition for ``lowfat'' (Ref. 1).
H. Effective Date
14. One comment objected to the proposed effective date of January
1, 1998. The comment stated that an effective date of January 1, 1998,
is overly generous. It maintained that this final rule could have a
significant impact on American's health and should be implemented as
quickly as possible. The comment urged the agency to move up the
effective date of the final rule to January 1, 1997.
FDA agrees that this final rule should be implemented as quickly as
possible. However, FDA disagrees that the proposed effective date,
January 1, 1998, would represent an unduly long compliance period. To
minimize the economic impact of required label changes, FDA
periodically announces uniform effective dates for new food labeling
requirements. On April 15, 1996, FDA published a proposed rule (61 FR
16422) to establish January 1, 1998, as its new uniform effective date
for all food labeling regulations that
[[Page 59000]]
issue before January 1, 1997. Thus, FDA has placed this change on the
same schedule as virtually all other regulatory changes made before
December 31, 1996. Given the exemption in the act for claims on
standardized foods (section 403(r)(5)(C)), FDA sees no basis for an
earlier date.
I. Other Actions--Unresolved Hearing Issue on the Lowfat Milk and Skim
Milk Standards
As noted in the November 9, 1995, proposal (60 FR 56541 at 56546),
FDA published a notice of hearing on objections in the Federal Register
of October 6, 1983 (48 FR 45545), to a final rule (45 FR 81734,
December 12, 1980) concerning the standards of identity for lowfat milk
and skim milk (Docket Nos. 81N-204F and 76N-0175). The hearing was
granted on four issues, three of which were resolved. The remaining
issue, dealing with labeling requirements of the standardized foods,
i.e, the reasonableness of the decision to prohibit use of the terms
``protein fortified'' and ``fortified with protein'' on labels of
lowfat milk and skim milk products containing not less than 10 percent
milk-derived nonfat milk solids), has been rendered moot by this final
rule which removes the standards of identity for lowfat milk and skim
milk in Secs. 131.135 and 131.143. No further rulemaking procedures
regarding the stayed provisions are necessary.
III. Conclusions Regarding Comments
After review and consideration of the comments it received in
response to the November 9, 1995, proposal, FDA concludes that no
evidence or information has been presented that would provide a basis
for altering the agency's tentative conclusion that it should remove
the standards of identity for sweetened condensed skimmed milk
(Sec. 131.122), lowfat dry milk (Sec. 131.123), evaporated skimmed milk
(Sec. 131.132), lowfat milk (Sec. 131.135), acidified lowfat milk
(Sec. 131.136), cultured lowfat milk (Sec. 131.138), skim (nonfat) milk
(Sec. 131.143), acidified skim (nonfat) milk (Sec. 131.144), cultured
skim (nonfat) milk (Sec. 131.146), sour half-and-half (Sec. 131.185),
acidified sour half-and-half (Sec. 131.187), and lowfat cottage cheese
(Sec. 133.131); that it should amend the standard of identity for dry
cream (Sec. 131.149) by removing the reference to the lowfat milk
standard; and that it should amend the nutrient content claims
regulations for fat, fatty acids, and cholesterol content (Sec. 101.62)
to provide for ``skim'' as a synonym for ``nonfat'' when used in
labeling milk products.
Therefore, in this final rule, FDA is removing these standards of
identity and amending the standard of identity for dry cream, as
proposed. In addition, FDA is amending the nutrient content claims
regulations for fat, fatty acids, and cholesterol content to provide
for ``skim'' as a synonym for ``nonfat'' when used in labeling milk
products. FDA is not revoking the standards of identity for lowfat and
nonfat yogurt at this time.
Because this rulemaking involves the removal and amendment of
standards of identity for dairy products, it is subject to the formal
rulemaking procedures of section 701(e) of the act. Section 701(e) of
the act requires that the agency provide an opportunity for objections
to the final rule. If any objections raise issues of material fact, the
agency is to hold a formal evidentiary hearing on those issues.
IV. Analysis of Impacts
Although this rule is issued in accordance with the formal
rulemaking provisions of 5 U.S.C. 556 and 557, and is, therefore,
exempted from the economic analysis requirements of Executive Order
12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), FDA has
examined the economic implications of this rulemaking.
A. Label Changes
There are approximately 1,600 lowfat milk and 770 skim (nonfat)
milk stock keeping units (SKU's) currently on the market. As a result
of this rule, all milks currently using the terms ``lowfat'' and
``nonfat'' (or ``skim'') in their names must comply with the nutrient
content claim requirements for those terms. Some of these products are
already in compliance with the claim requirements. Any milk not in
compliance with the nutrient content claim requirements for ``lowfat''
or ``nonfat'' must be relabeled. According to the petitioners, most
products currently labeled as ``nonfat milk'' would be eligible to
retain that name. However, many products currently labeled as ``lowfat
milk'' (i.e., products containing more than 1 percent milkfat) would
not be eligible to retain that name and must be relabeled.
Approximately 1,000 lowfat milk SKU's will need to be relabeled.
This regulation will also require changes in the labels of sour
half-and-half, acidified sour half-and-half, and, potentially, in
labels of lowfat cottage cheese products. There are approximately 16
sour half-and-half SKU's and approximately 420 lowfat cottage cheese
SKU's. There are no acidified sour half-and-half products in FDA's data
base. FDA estimates that approximately 192 lowfat cottage cheese
product SKU's do not comply with FDA's nutrient content claims
definitions and will, therefore, require relabeling. However, all sour
half-and-half products (16 SKU's) will need to be relabeled under the
general standard to be named using a nutrient content claim and the
name of the standardized food (e.g., ``reduced fat sour cream'').
There are approximately 570 firms manufacturing products affected
by this regulation. Of these firms, approximately 440 are small firms
with fewer than 500 employees.
The costs of the relabeling associated with this final rule include
administrative, redesign, and inventory disposal costs. The
administrative costs are estimated to be $850 per small firm and $6,300
per large firm. The total administrative costs associated with this
proposed regulation are approximately $1 million.
The agency estimates that the changes required by this final
regulation will result in a simple two-color label redesign. Also,
because firms will have a minimum of 1 year to comply, redesign costs
will be reduced by the fact that they can incorporate mandated changes
with previously planned label changes. Redesign costs of this
regulation are estimated at $1,200 per label or a total of $1.5
million.
An additional cost category is the label inventory loss associated
with the transition from old to new labels. The cost of label inventory
loss depends on average label inventory and the length of the
compliance period. FDA is establishing an effective date for this final
regulation that will provide approximately 1 year for firms to make any
necessary changes. A 1-year compliance period is sufficient to allow
producers of milk, sour half-and-half, and cottage cheese to use up
existing stocks of labels. Therefore, label inventory disposal costs
will be zero.
B. Vitamin Addition
Two comments to the November 9, 1995, proposal objected to the
absence of a discussion in the economic analysis section of the costs
of fortification for lower-fat yogurt and sour half-and-half. One
comment suggested that the cost to obtain and install vitamin metering
equipment would be $250,000 per plant. Additionally, using information
provided in the same comment, FDA estimates the cost of obtaining and
adding vitamin A to be $100 per item per year.
FDA acknowledges that it neglected to consider these costs when
analyzing the impact of the proposed rule. FDA notes
[[Page 59001]]
that the recurring cost of obtaining and adding vitamin A will apply to
nearly all lower-fat dairy products because the removal of fat also
unavoidably removes some vitamin A. However, the cost of obtaining
equipment necessary to add vitamins to lower-fat dairy products will
only be incurred by those plants that do not already possess such
equipment (i.e., those firms that do not currently manufacture other
standardized or nonstandardized products to which they routinely add
vitamins).
As previously stated in this preamble, FDA has issued over 150
TMP's for the market testing of lower-fat dairy products such as
``light eggnog,'' ``light sour cream,'' ``nonfat sour cream,'' and
``nonfat cottage cheese.'' FDA required that these test products be
nutritionally equivalent to the full fat, standardized food. The
proliferation of requests for TMP's indicates that, in spite of the
costs of fortification, many dairy product manufacturers considered the
ability to market modified foods named by use of a nutrient content
claim and a standardized term to be of benefit to them and to
consumers.
As noted earlier, most fluid milk products (approximately 95
percent) are currently fortified. FDA does not expect this rule to have
a significant impact on the fortification practices for milk products.
Therefore, this final rule will not impose significant costs of vitamin
fortification of lower-fat milk products. Furthermore, lower-fat yogurt
and sour cream products were the only products noted by comments to the
November 9, 1995, proposal for which comments claimed the fortification
requirements would be burdensome.
According to FDA data, the 16 sour half-and-half products currently
on the market represent 12 brands. Products made under the general
standard, e.g., ``light sour cream'' or ``nonfat sour cream'' are sold
under 11 of those 12 brands. Because these products are currently being
made under Sec. 130.10, the firms producing these products should
already possess the necessary equipment for vitamin fortification and
will only bear the cost of obtaining and adding vitamin A. The one firm
producing only sour half-and-half may need to purchase equipment for
vitamin addition. Therefore, the cost of requiring fortification of
sour half-and-half products may be approximately $0.25 million in the
first year and $1,600 in each subsequent year.
One comment stated that 69 percent of the yogurt industry produces
only standardized yogurt and, therefore, will have to purchase vitamin
metering equipment. Thus, it is possible that the cost to the yogurt
industry to meet the fortification requirement could be as high as $52
million (300 plants X 0.69 (percent of plants that need to purchase
equipment) X $250,000 (for equipment) plus a total of $240,000 per year
to obtain and add vitamin A). The agency notes it has not fully
evaluated these figures.
C. Conclusion of Analysis
The agency estimates that the total costs of this regulation will
be approximately $2.7 million. Because FDA is deferring action on the
standards of identity for lower-fat yogurt products, this assessment
does not include costs to the yogurt industry in the costs of this
final rule. The agency believes that consumers will benefit from this
regulation because it will provide consistency in the nomenclature of
both standardized and nonstandardized foods that bear nutrient content
claims. The agency also believes that firms will benefit from this
regulation in that it provides for greater flexibility than current
standards of identity allow.
V. Environmental Impact
The agency has determined under 21 CFR 25.24(b)(1) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VI. Objections
Any person who will be adversely affected by this regulation may at
any time on or before December 20, 1996, file with the Dockets
Management Branch (address above) written objections thereto. Each
objection shall be separately numbered, and each numbered objection
shall specify with particularity the provisions of the regulation to
which objection is made and the grounds for the objection. Each
numbered objection on which a hearing is requested shall specifically
so state. Failure to request a hearing for any particular objection
shall constitute a waiver of the right to a hearing on that objection.
Each numbered objection for which a hearing is requested shall include
a detailed description and analysis of the specific factual information
intended to be presented in support of the objection in the event that
a hearing is held. Failure to include such a description and analysis
for any particular objection shall constitute a waiver of the right to
a hearing on the objection. Three copies of all documents shall be
submitted and shall be identified with the docket number found in
brackets in the heading of this document. Any objections received in
response to the regulation may be seen in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday.
VII. References
The following reference has been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Summary of market and consumption data for lower-fat dairy
products, Laina Bush, Center for Food Safety and Applied Nutrition,
FDA, 1996.
List of Subjects
21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
21 CFR Part 131
Cream, Food grades and standards, Milk, Yogurt.
21 CFR Part 133
Cheese, Food grades and standards, Food labeling.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, parts 101,
131, and 133 are amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342,
343, 348, 371).
2. Section 101.62 is amended by revising the introductory text of
paragraph (b)(1) to read as follows:
Sec. 101.62 Nutrient content claims for fat, fatty acid, and
cholesterol content of foods.
* * * * *
(b) * * * (1) The terms ``fat free,'' ``free of fat,'' ``no fat,''
``zero fat,'' ``without fat,'' ``negligible source of fat,'' or
``dietarily insignificant source of fat'' or, in the case of milk
products, ``skim'' may be used on the label or in labeling of foods,
provided that:
* * * * *
PART 131--MILK AND CREAM
3. The authority citation for 21 CFR part 131 continues to read as
follows:
Authority: Secs. 201, 401, 403, 409, 701, 721 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371,
379e).
[[Page 59002]]
Sec. 131.122 [Removed]
4. Section 131.122 Sweetened condensed skimmed milk is removed from
subpart B.
Sec. 131.123 [Removed]
5. Section 131.123 Lowfat dry milk is removed from subpart B.
Sec. 131.132 [Removed]
6. Section 131.132 Evaporated skimmed milk is removed from subpart
B.
Sec. 131.135 [Removed]
7. Section 131.135 Lowfat milk is removed from subpart B.
Sec. 131.136 [Removed]
8. Section 131.136 Acidified lowfat milk is removed from subpart B.
Sec. 131.138 [Removed]
9. Section 131.138 Cultured lowfat milk is removed from subpart B.
Sec. 131.143 [Removed]
10. Section 131.143 Skim milk is removed from subpart B.
Sec. 131.144 [Removed]
11. Section 131.144 Acidified skim milk is removed from subpart B.
Sec. 131.146 [Removed]
12. Section 131.146 Cultured skim milk is removed from subpart B.
13. Section 131.149 is amended by revising the second sentence of
paragraph (a) to read as follows:
Sec. 131.149 Dry cream.
(a) * * * Alternatively, dry cream may be obtained by blending dry
milks as defined in Secs. 131.125(a) and 131.147(a) with dry cream as
appropriate: Provided, That the resulting product is equivalent in
composition to that obtained by the method described in the first
sentence of this paragraph. * * *
* * * * *
Sec. 131.185 [Removed]
14. Section 131.185 Sour half-and-half is removed from subpart B.
Sec. 131.187 [Removed]
15. Section 131.187 Acidified sour half-and-half is removed from
subpart B.
PART 133--CHEESE AND RELATED CHEESE PRODUCTS
16. The authority citation for 21 CFR part 133 continues to read as
follows:
Authority: Secs. 201, 401, 403, 409, 701, 721 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371,
379e).
Sec. 133.131 [Removed]
17. Section 133.131 Lowfat cottage cheese is removed from subpart
B.
Dated: November 12, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-29485 Filed 11-19-96; 8:45 am]
BILLING CODE 4160-01-F
