[Federal Register Volume 61, Number 29 (Monday, February 12, 1996)]
[Proposed Rules]
[Pages 5348-5354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2980]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket Nos. 91N-384H and 95P-0241]
RIN 0910-AA19
Food Labeling: Nutrient Content Claims, Definition of Term:
Healthy
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to revise
its food labeling regulations by amending the definition of the term
``healthy'' to permit certain processed fruits and vegetables and
enriched cereal-grain products that conform to a standard of identity
to bear this term. This action is intended to provide consumers with
information that will assist them in achieving their dietary goals and
is in response to petitions submitted to the agency by the American
Frozen Food Institute (AFFI), the National Food Processors Association
(NFPA), and the American Bakers Association (ABA).
DATES: Written comments by April 29, 1996. FDA proposes that any final
rule that may issue based on this proposal become effective on the date
of publication in the Federal Register.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Felicia B. Satchell, 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
In the Federal Register of May 10, 1994 (59 FR 24232), FDA
published a final rule entitled ``Food Labeling: Nutrient Content
Claims, Definition of Term: Healthy'' (hereinafter referred to as ``the
healthy final rule''), which established a definition for the use of
the implied nutrient content claim ``healthy'' under the Federal Food,
Drug, and Cosmetic Act, as amended by the Nutrition Labeling and
Education Act of 1990. The regulation permits the use of the term
``healthy'' and its derivatives on the labels of individual foods, main
dishes, and meal products that are particularly useful, because of
their nutrient profile, in constructing a diet that conforms to current
dietary guidelines.
The definition for ``healthy'' in Sec. 101.65(d)(21 CFR 101.65(d))
provides that an individual food, main dish, or meal product may bear
this term if: (1) It is ``low'' in fat and saturated fat, (2) its
content of sodium and cholesterol does not exceed the levels for these
nutrients established in the definition, and (3) it contributes at
least 10 percent of the Reference Daily Intake or Daily Reference Value
of one or more of the following nutrients: Vitamin A, vitamin C,
calcium, iron, protein, or fiber (that is, the food must be a ``good
source'' of one or more of the six listed nutrients). The definition
provides that a food can be fortified to meet the requirement that the
food be a ``good source'' of one or more of these nutrients if the
fortification is done in accordance with the agency's fortification
policy in Sec. 104.20 (21 CFR 104.20). -
FDA provided one narrow exception to the requirement that a food
bearing the term ``healthy'' be a ``good source'' of one or more of the
six listed nutrients. The agency stated that the claim can be used on
raw fruits and vegetables that do not meet the nutrient contribution
requirement but that meet all other aspects of the definition. As FDA
stated in the healthy final rule (59 FR 24232 at 24244), increased
consumption of raw fruits and vegetables can contribute significantly
to a healthy diet and to achieving compliance with dietary guidelines,
even if particular items, such as celery and cucumbers, do not contain
10 percent of the daily value of one of the six identified nutrients.
However, the agency also stated that it was not prepared to extend this
exemption to all fruit and vegetable products because it did not have
an adequate basis to evaluate the effects of processing (i.e., exposure
to liquid packing medium, freezing, canning, cooking, and other
procedures) on these foods. In addition, the agency sought information
on whether to propose changes in the 10 percent nutrient contribution
requirement to allow other foods to bear the term that did not meet
this aspect of the definition but may also be particularly useful in
assisting consumers to achieve dietary goals.
II. Petitions
A. Description of Petitions
Following publication of the healthy final rule, two trade
associations submitted petitions to FDA that requested that the agency
reconsider its decision regarding the nutrient contribution exemption
for raw fruits and vegetables. A third trade association submitted a
citizens petition requesting that FDA amend the ``healthy'' definition
to exempt certain enriched cereal-grain products from the 10 percent
nutrient contribution requirement.
Both of the petitions for reconsideration requested that FDA revise
the definition of ``healthy'' to extend this exemption to processed
fruits and vegetables. The petition submitted by AFFI (Docket No. 91N-
384H/PRC1) disagreed with FDA's assertion that it did not have an
adequate basis to evaluate the effects of the freezing process on the
nutritional profile of fruits and vegetables. AFFI contended that it
had provided the agency with extensive nutrition information for frozen
fruits and vegetables, in conjunction with the development of AFFI's
nutrient data base for frozen fruits and vegetables. AFFI also stated
that the nutrient profile information for frozen products submitted in
its data base proposal shows that the nutrient profile information on
frozen vegetables does not differ significantly from the nutrient
profile information for fresh products, and that in some cases the
nutrient levels in frozen products exceed the nutrient levels in fresh
products. Consequently, AFFI argued that, contrary to FDA's assertion,
the agency already had extensive information in its possession
regarding the effects of the freezing process on the nutrient profile
of frozen fruits and vegetables, and that precluding use of the term
``healthy'' on frozen fruits and vegetables while permitting use of the
term on fresh fruits and vegetables implies a distinction in
nutritional value that does not exist.
AFFI requested that FDA reconsider its position and revise its
definition of ``healthy'' to permit frozen fruits and vegetables that
do not meet the ``good source'' requirement, but otherwise meet the
requirements of the claim, to bear the term. In addition to the
petition, AFFI also submitted supplemental comments to the
administrative record for the ``healthy'' final rule containing data
that compare the nutrient profiles of various raw and frozen fruits and
vegetables.
NFPA also petitioned (Docket No. 91N-384H/PRC2) the agency to
reconsider its position regarding the exemption for raw fruits and
vegetables. In its petition, NFPA contended that the exemption for raw
fruits and vegetables established in the final rule was not a logical
outgrowth of the proposal because FDA failed to give adequate
[[Page 5350]]
notice and opportunity for comment to the public on the different
labeling requirement for raw and processed fruits and vegetables in its
healthy proposal. Consequently, the petition argued, interested parties
were not allowed to participate in the rulemaking in a meaningful and
informed manner on the issue of establishing such an exemption.
Furthermore, NFPA asserted that FDA incorrectly drew a distinction
in the nutritional benefit between raw and processed fruits and
vegetables, and that such a distinction has no logical basis in fact or
law. It contended that the administrative record before the agency
fails to provide any justification for this distinction, and that such
a distinction is contrary to prior FDA positions and regulations. Thus,
NFPA requested that Sec. 101.65(d)(2)(iv) be revised to eliminate the
word ``raw'' so that processed fruits and vegetables, as well as raw
fruits and vegetables, will be exempt from the nutrient contribution
requirement for food labeled ``healthy.''
The third citizen petition (Docket No. 95P-0241), submitted by ABA,
requested that FDA amend the definition of ``healthy'' to permit
enriched cereal-grain products that conform to the standards of
identity in parts 136, 137, or 139 (21 CFR parts 136, 137, or 139), and
bread that conforms to the standard of identity for enriched bread in
Sec. 136.115 except that it contains whole wheat or other grain
products not permitted under that standard, to bear the term
``healthy.'' ABA contended that while some enriched breads might meet
the 10 percent nutrient contribution requirement for fiber, most
enriched grain products cannot meet the 10 percent nutrient
contribution requirement for any of the six listed nutrients because
they are precluded by the standards of identity from containing 10
percent of the six listed nutrients. In other words, under the food
standards and FDA's fortification policy, the nutrients and levels
required by the standards of identity cannot be altered. Moreover, ABA
argued that most nutritional authorities agree that grain products have
a central role in a healthy diet because they are excellent sources of
complex carbohydrates. In fact, ABA argued, most nutritional
authorities recommend that Americans increase their consumption of
grain products as alternative sources of energy to replace dietary fat.
The petitioner contended that these foods are, therefore, precisely the
kinds of foods that FDA intended to permit to bear the term
``healthy.''
ABA further argued that the 10 percent nutrient contribution
requirement was obviously not intended to apply to foods that conformed
to the standards of identity for enriched grain products because it
precludes virtually all enriched grain products from bearing a
``healthy'' claim. ABA contended that this exclusion is inconsistent
with the basis of the ``healthy'' claim because these foods are
particularly helpful in assisting consumers to construct a diet that
conforms to current dietary guidelines. The petition notes that the
Food Guide Pyramid recommends that 6 to 11 servings of grain products
be consumed per day. ABA contended that this recommendation
demonstrates the importance of including these foods in the diet. ABA
argued that the 10 percent nutrient contribution requirement has had
the unintended effect of precluding foods that FDA intended to be
labeled ``healthy'' from bearing that term. Thus, ABA requested that
the agency amend Sec. 101.65 to exempt: (1) Enriched grain products
that conform to a standard of identity in part 136, 137, or 139, and
(2) bread that conforms to the standard of identity for enriched bread
in Sec. 136.115 (except that it contains whole wheat or other grain
products not permitted under that standard) from the 10 percent
nutrient contribution requirement.
In the alternative, ABA suggested that the agency expand the list
of nutrients that must be present at 10 percent to include complex
carbohydrates, niacin, or thiamin. Such action would permit enriched
grain products to bear health claims because these products are a
significant source of such nutrients.
A second alternative suggested in the petition would be to amend
the 10 percent nutrient contribution requirement to allow it to apply
to a daily consumption of grain products rather than to the nutrient
profile of a specific food.
B. Response to Petitions
FDA has fully evaluated both petitions for reconsideration and
reviewed the administrative record to determine whether, in light of
the arguments raised in the petitions, the agency would have reached a
different decision regarding the exemption from the nutrient
contribution requirement for raw fruits and vegetables in the
definition of ``healthy.'' The agency has determined that based on the
administrative record at the time of publication of the healthy final
rule, FDA made the correct decision. While FDA acknowledges that AFFI
had submitted nutrient profile information on frozen fruits and
vegetables, this information was presented as an acceptable nutrient
data base for nutrition labeling of frozen fruits and vegetables and
did not contain information comparing nutrient profiles between raw
fruits and vegetables and frozen fruits and vegetables. Moreover, the
data base was not submitted, or referenced, as part of the
administrative record for the healthy final rule and therefore was not
before the agency in that rulemaking.
Although the information relied on in AFFI's petition may serve as
grounds for revising FDA's regulations concerning ``healthy'' (as
discussed in section III.C. of this document), because the information
was not part of the administrative record in the initial rulemaking,
AFFI has not met the standard in Sec. 10.33(d)(1) (21 CFR 10.33(d)(1))
for granting a petition for reconsideration. AFFI failed to demonstrate
that relevant information or views contained in the administrative
record were not previously or not adequately considered during that
rulemaking. Accordingly, the agency is denying AFFI's petition for
reconsideration.
In response to the arguments raised in NFPA's petition, FDA
acknowledges that the issue of nutrient content requirements
specifically for raw and processed fruits and vegetables was not
directly addressed in the proposal. However, the agency did discuss and
solicit comment on the appropriateness of requiring foods bearing the
term ``healthy'' to meet a nutrient contribution requirement in the
proposal that FDA published in the Federal Register of January 6, 1993
(58 FR 2944 at 2948). This discussion alerted interested parties to the
possibility that the agency could modify the proposal and include a
nutrient contribution requirement in the ultimate final rule.
In response to this discussion, the agency did receive several
comments that addressed the impact of imposing such a requirement on
raw fruits and vegetables. Some of these comments asserted that,
compared to other foods, all raw fruits and vegetables are inherently
healthy and should not be required to meet a nutrient contribution
requirement. The agency considered the merits of these comments and the
other comments that it received and determined that it was appropriate
to: (1) Include a nutrient contribution criterion in the ``healthy''
definition, and (2) exempt raw fruits and vegetables from this
requirement (59 FR 24232 at 24244).
Because this issue was addressed in the healthy proposal of January
6, 1993, the agency finds that its decision to
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include a nutrient contribution requirement in the ``healthy''
definition, and to define its application to various foods, was a
logical outgrowth of the proposal. Thus, FDA finds that it acted in
accordance with the provisions of the Administrative Procedure Act
(APA) (5 U.S.C. 553) and rejects the assertion by NFPA that the agency
violated the procedural requirements of the APA. Consequently, FDA is
also denying NFPA's petition for reconsideration.
III. The Proposal
Although the agency has decided under Sec. 10.33 not to grant the
petitions for reconsideration, FDA has been persuaded by the concerns
raised in the petitions and the information submitted in the
supplemental comments to consider whether some fruit or vegetable
products are being inappropriately excluded from bearing the
``healthy'' claim because the food cannot meet the nutrient
contribution requirement.
In the healthy final rule, FDA stated that it was not prepared to
extend the exemption from the nutrient contribution requirement to all
fruits and vegetables because it did not have an adequate basis to
evaluate the effects of various processing techniques on the food. The
agency was concerned that precluding raw fruits and vegetables from
bearing a ``healthy'' claim could confuse consumers and undermine an
important element of current dietary guidance that emphasizes
consumption of fruits and vegetables. For processed fruits and
vegetables, however, the agency was not sure that processing did not
have a significant effect on the nutritional profile of the food. The
agency sought information on whether to propose changes in the nutrient
contribution requirement for processed fruits and vegetables, as well
as for other foods that may be useful in achieving dietary guidelines
but did not meet the nutrient contribution requirement.
A. All Fruit and Vegetable Products
The agency has carefully considered whether all fruit and vegetable
products should be exempt from the nutrient contribution requirement,
and whether simply revising the ``healthy'' definition to remove the
term ``raw'' from Sec. 101.65(d), as requested by NFPA, would assist
consumers in maintaining healthy dietary practices. As the agency
discussed in the healthy final rule (59 FR 24232 at 24239), for this
implied claim to be useful, foods that are able to bear the term should
be of a sufficient number and variety to help consumers achieve a total
diet that is consistent with current dietary recommendations. The
agency would consider it inappropriate if the requirements in the
definition of this term, specifically the nutrient contribution
requirement, precluded use of the claim for such a large number of
fruit and vegetable products that the ``healthy'' claim was no longer
useful for this category of foods, or for consumers wishing to rely on
the ``healthy'' claim to select fruit and vegetable products that are
particularly useful in constructing diets that conform with current
dietary recommendations.
A survey of fruit and vegetable products available in the local
supermarket and a review of the U.S. Department of Agriculture's
(USDA's) nutrient data base for fruit and vegetable products reveal
that out of a total of over 700 fruit and vegetable products reviewed,
65 percent are eligible to bear the ``healthy'' claim (Refs. 1 and 2).
The agency notes that these products comply with all the criteria of
the definition for the term ``healthy,'' including the nutrient
contribution requirement. Therefore, FDA tentatively concludes that a
general exemption for all fruit and vegetable products is not warranted
because a significant number and variety of products currently on the
market are eligible to bear the claim.
In fact, FDA is concerned that if it were to propose to extend this
exemption to all fruit and vegetable products, the utility of the
``healthy'' claim for this category of foods would be greatly
diminished. If the claim were permitted on virtually all fruit and
vegetable products, it could not be used to highlight those fruit and
vegetable products that meet the requirements of the definition without
an exemption. In addition, the agency points out that permitting the
claim to appear on virtually all products would mean that it would
appear on some formulated, multi-ingredient products that include
fruits or vegetables but that have added ingredients that raise the
level of certain nutrients, i.e., fat, saturated fat, cholesterol, and
sodium, above levels found in raw or single ingredient versions of the
same fruit or vegetable. The appearance of a ``healthy'' claim on such
foods would represent them as being particularly useful in constructing
diets that conform to current dietary guidelines. Such a representation
would not necessarily be valid. While the agency recognizes that these
foods have an appropriate place in the diet, the higher fat, saturated
fat, cholesterol, or sodium levels in these products would make it
misleading to represent them as products whose nutrient profiles would
lend themselves to such use.
Furthermore, fruit and vegetable products that contain other
ingredients are not precluded from bearing the term ``healthy,''
provided that the finished food meets all the criteria for the claim.
Such foods can be formulated and fortified in accordance with the
agency's policy on rational fortification in Sec. 104.20 if they fail
to contribute 10 percent of one of the subject nutrients. Therefore,
FDA tentatively concludes that there is no reason to exempt such foods
from the 10 percent requirement. Accordingly, the agency is not
proposing to extend the exemption to all fruit and vegetable products.
B. Tentative Determination To Broaden Exemption
While the agency is not persuaded to extend the exemption to all
fruit and vegetable products, it is persuaded that it may well be
appropriate to broaden the exemption to include fruit and vegetable
products other than raw fruits and vegetables and to include enriched
cereal-grain products that conform to a standard of identity. In
determining whether to broaden this exemption, FDA has to consider
several questions similar to those raised when it first defined
``healthy.'' For example, does the nutrient contribution requirement,
FDA's policy on rational fortification, or other FDA regulations
preclude the use of the ``healthy'' claim on certain foods that play an
important role in the diet and that dietary guidelines recommend be
included in a healthy diet? Does the appearance of a ``healthy'' claim
on raw fruits and vegetables and the absence of the claim on processed
versions of the same fruits and vegetables, such as frozen vegetables
or canned mushrooms packed in water, confuse and mislead consumers to
believe that fruits and vegetables must be raw to be considered
healthy? Moreover, does the absence of the claim on processed fruits
and vegetables and standardized enriched cereal-grain products reduce
the opportunity for encouraging consumption of these foods at a time
when FDA and other government agencies have stated specifically that
increased consumption of fruits, vegetables, and grain products can
contribute significantly to a healthy diet?
Regarding fruits and vegetables, it is unlikely that most consumers
are aware of the narrow exemption for raw fruits and vegetables
provided in the ``healthy'' definition because, generally, most
consumers are not familiar with the specific requirements of the
nutrient content claim definitions. However, consumers are familiar
with the overall concepts governing claims, that is, that
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the claim be used consistently from food to food, that the claim be
defined by FDA, and that the food bearing the claim meet the definition
of the term being used. Foods bearing the term ``healthy'' will inform
consumers that the food, because of its nutrient profile, is
particularly useful in constructing diets that conform to current
dietary guidelines.
Because of the likelihood that most consumers are unaware of the
exemption for raw fruits and vegetables, consumers will likely not
recognize that there are alternative fruit and vegetable products that
are precluded from bearing the claim but that are just as useful as raw
fruits or vegetables in assisting consumers in meeting dietary goals.
Furthermore, it was not the intent of the agency to suggest that the
goal of increasing fruits and vegetables in the diet could only be
achieved by consuming raw products, or that raw products are
necessarily superior to all other fruit and vegetable products. FDA
acknowledges that there are processed fruit and vegetable products,
like frozen fruits and vegetables, that can be used to assist consumers
in constructing a diet that is consistent with dietary recommendations;
but those foods are currently ineligible to bear the ``healthy'' claim
because they do not meet the 10 percent nutrient contribution
requirement.
C. Single Ingredient Fruit and Vegetable Products
FDA reviewed the data presented in AFFI's supplemental comments
comparing nutrient profiles of selected raw fruits and vegetables and
frozen, single ingredient versions of the same fruits and vegetables.
While only preliminary, the data do support AFFI's argument that
blanching and freezing do not significantly change the nutrient profile
of the fruits and vegetables. These data provide examples of similar or
higher nutrient levels of one or more of the six required nutrients in
single ingredient, frozen fruit and vegetable products when compared to
the raw version of the same fruit and vegetable. The higher nutrient
levels found in the frozen version of the food are likely attributable
to the fact that unprocessed fruits and vegetables may lose some of
their nutrients over time or under certain storage conditions (Ref. 3).
Considering these data, the agency tentatively concludes that, like
raw fruits and vegetables, single ingredient frozen fruits and
vegetables can contribute significantly to a healthy diet and to
achieving compliance with dietary guidelines, even if particular
products do not meet the 10 percent nutrient contribution requirement.
Further, based on these data, the agency tentatively concludes that in
cases where the nutrient profile of a single ingredient, frozen fruit
or vegetable product is comparable to the nutrient profile of the raw
version of the same fruit or vegetable, the single ingredient, frozen
fruit or vegetable product would likely have the same effects, and
could be used interchangeably in the diet to achieve dietary goals, as
the raw version of the fruit or vegetable. Precluding such foods from
being termed ``healthy'' could undermine an important element of
current dietary guidance.
The agency tentatively concludes that such foods should not be
barred from bearing the term ``healthy,'' especially when the foods are
comparable to, and are just as useful as, raw fruits and vegetables in
assisting consumers in structuring diets that achieve dietary goals.
Furthermore, consumers should be informed that these foods serve as
appropriate and useful alternatives to raw fruits and vegetables in
constructing diets consistent with current dietary recommendations.
Accordingly, FDA is proposing to amend Sec. 101.65(d)(2)(iv) to exempt
frozen, single ingredient fruit and vegetable products and mixtures of
frozen, single ingredient fruit and vegetable products from the 10
percent nutrient contribution requirement.
However, FDA does not have information comparable to that submitted
by AFFI to support extending this exemption to all single ingredient,
processed fruit and vegetable products. The agency solicits comment and
data on the effects of other types of processing, e.g., drying and
canning, and how these processes affect the nutritional profile. If
appropriate data are submitted, the agency is prepared to extend this
exemption to other single ingredient, processed fruit and vegetable
products in any final rule that issues in this proceeding.
D. Multi-Ingredient Fruit and Vegetable Products
In deciding to extend this exemption beyond raw fruits and
vegetables, the agency must ensure that the claim is permitted only on
those foods that contain nutrients in amounts that are consistent with
the basis of the claim. As discussed above, FDA tentatively concludes
that frozen, single ingredient fruit and vegetable products and
mixtures of these foods are consistent with the basis of the
``healthy'' claim and should be permitted to bear the term, even if the
food does not contain 10 percent of one of the six listed nutrients.
However, FDA has not been persuaded that multi-ingredient products that
are composed of ingredients other than fruits or vegetables and that
meet all other aspects of the claim should be exempt from the 10
percent requirement. Many of these multi-ingredient fruit and vegetable
products can have added ingredients that increase the content of fat,
saturated fat, cholesterol, or sodium beyond that for the raw version.
Considering that one reason that fruits and vegetables are helpful in
achieving a diet consistent with dietary guidelines is that they can
replace foods, such as snack foods and desserts, that contain higher
levels of fat, saturated fat, cholesterol, and sodium, FDA tentatively
concludes that providing an exemption for such multi-ingredient fruit
and vegetable products would be inconsistent with current dietary
recommendations and, consequently, inconsistent with the basis of the
``healthy'' claim.
Furthermore, consumers who rely on the appearance of the term
``healthy'' to construct a diet consistent with current dietary
recommendations could be misled to believe that these multi-ingredient
fruit and vegetable products are just as helpful as raw or frozen,
single ingredient fruits and vegetables in achieving dietary goals,
when in fact, they would increase dietary intake of less desirable
nutrients and could decrease intake of micronutrients. Consumers could
be motivated to select these multi-ingredient products rather than
products comprised solely of fruits and vegetables. In the agency's
opinion, a claim that could motivate consumers to choose fruit and
vegetable products containing added ingredients that increase the
content of fat, saturated fat, cholesterol, or sodium beyond that for
the raw version as alternatives to the raw version or to the frozen,
single ingredient version would not be beneficial for consumers and
would undermine current dietary guidelines.
Moreover, FDA tentatively concludes that fruit and vegetable
products composed of ingredients other than fruit or vegetable can be
formulated and fortified in accordance with Sec. 104.20 to meet the 10
percent contribution requirement, and, therefore, there is no reason to
exempt such foods from the 10 percent requirement. Accordingly, FDA is
not proposing to extend the exemption to multi-ingredient fruit and
vegetable products composed of ingredients other than fruit or
vegetable that do not contain 10 percent of one of the six listed
nutrients.
E. Enriched Cereal-Grain Products
FDA finds merit in the arguments raised in the ABA petition. The
agency
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acknowledges that the requirements of the standards of identity for
enriched cereal-grain products preclude reformulation and fortification
to qualify the food to meet the 10 percent nutrient contribution
requirement. As a result of the restrictions established in the
standards, manufacturers of these products are not afforded the
opportunity to reformulate and fortify the food to qualify the food to
bear a ``healthy'' claim. Consequently, any action short of exempting
such products from the 10 percent requirement or amending the standards
of identity to increase the amount of enrichment nutrients that could
be added to cereal-grain products, would mean that these foods could
not bear a ``healthy'' claim. The agency does not have information on
which to base a change in the individual standards, and the petitioner
did not provide any.
Moreover, the agency acknowledges that increased consumption of
grain products is recommended in current dietary guidelines, and that
the appearance of a ``healthy'' claim on enriched cereal-grain products
would encourage consumers to select these products as part of a healthy
diet. The agency agrees with the arguments raised in the ABA petition
that even though these foods do not contain at least 10 percent of one
of the six listed nutrients, they are recommended in dietary guidance
and can be particularly helpful in assisting consumers to achieve
dietary goals. Thus, the agency tentatively concludes that enriched
cereal-grain products that conform to a standard of identity are
consistent with the basis and intent of the ``healthy'' definition and
should not be precluded from bearing the term because they do not meet
the 10 percent nutrient contribution requirement. Further, the agency
tentatively concludes that precluding such foods from bearing the term
``healthy'' would be inconsistent with current dietary recommendations
and not beneficial for consumers. Accordingly, FDA is proposing to
amend the definition of ``healthy'' in Sec. 101.65 to exempt enriched
cereal-grain products that conform to a standard of identity in part
136, 137, or 139 from the 10 percent nutrient contribution requirement.
However, the agency is not persuaded that bread that does not
conform to the standard of identity should be exempt from the 10
percent nutrient contribution requirement. Like other nonstandardized
foods, nonstandardized bread can be formulated and fortified in
accordance with Sec. 104.20 to meet the 10 percent nutrient
contribution requirement (see Sec. 104.20(b)). Therefore, there is no
reason to exempt these foods from the 10 percent requirement.
Accordingly, FDA is not proposing to extend the exemption to bread that
conforms to the standard of identity for enriched bread in
Sec. 136.115, except that it contains whole wheat or other grain
products not permitted under that standard.
The approach that FDA is taking in this proposal is similar to the
approach that it took in establishing the definition of ``healthy'' for
seafood and game meats. In the healthy final rule (FR 59 24232 at
24249), FDA adopted different provisions for the use of the term
``healthy'' on raw, single ingredient seafood and game meat products
with regard to the amount of fat, saturated fat, and cholesterol. FDA
established different provisions for these foods, in part, because they
would not qualify for the claim if held to the criteria of being ``low
fat'' and ``low saturated fat'' because they are inherently higher in
fat and in saturated fat than many other foods, yet some are
recommended by the Surgeon General and the Food and Nutrition Board as
foods to include in a healthy diet. In addition, these provisions are
consistent with the provisions adopted by the USDA for use of the term
``healthy'' on meat and poultry products. However, FDA did not
establish different provisions for seafood and game meat products that
are composed of more than one ingredient because such foods can be
reformulated to reduce the fat, saturated fat, and cholesterol levels
inherently found in these foods. In this document, FDA is relying on
the same general concept that it based its decision on in providing
alternative criteria for raw, single ingredient seafood and game meats,
namely that the agency would consider it inappropriate if the
requirements in the definition of ``healthy'' precluded use of the
claim for foods that play an important role in the diet and that
dietary guidelines recommend be included in a healthy diet, especially
in cases where manufacturers do not have the flexibility to reformulate
the food to qualify to bear the claim.
The agency's primary goal in extending this exemption to other
fruit and vegetable products and to enriched cereal-grain products that
conform to a standard of identity is to permit the ``healthy'' claim on
products that are particularly helpful in assisting consumers to
achieve dietary goals yet are precluded from bearing the claim because
they do not contain at least 10 percent of the subject nutrients, and
they can not be reformulated to do so. The agency believes that the
action that it is proposing in this document is fully responsive to the
concerns raised by the petitioners and is appropriate because it will
permit the ``healthy'' claim on fruit and vegetable products and on
enriched cereal-grain products that are currently unfairly precluded
from bearing the claim, yet prevent other products from inappropriately
bearing the claim.
Accordingly, FDA is proposing to amend the definition of the term
``healthy'' by revising Sec. 101.65(d)(2)(iv) to allow frozen fruit and
vegetable products comprised solely of fruits and vegetables, and
enriched grain products that conform to a standard of identity in part
136, 137, or 139 that do not contain 10 percent of vitamin A, vitamin
C, calcium, iron, protein or fiber, but otherwise meet the requirement
of the ``healthy'' definition to bear the term.
FDA tentatively concludes that the action that it is proposing is
equitable and will provide consumers with information that will assist
them in constructing diets that conform to all aspects of current
dietary recommendations. The agency requests comment on its proposed
rule and on whether such an extension of the exemption is necessary to
ensure that consumers are not misled or confused by the current
requirement that all foods except raw fruits and vegetables provide 10
percent of one of the six listed nutrients.
IV. Analysis of Impacts
FDA has examined the economic implications of the proposed rule
under Executive Order 12866 and the Regulatory Flexibility Act (Pub. L.
96-354). Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects; distributive impacts; and equity). The Regulatory Flexibility
Act requires analyzing options for regulatory relief for small
businesses. FDA finds that this proposed rule is not an economically
significant rule as defined by Executive Order 12866. In accordance
with the Regulatory Flexibility Act, the agency certifies that the
proposed rule will not have a significant impact on a substantial
number of small businesses.
FDA is proposing to permit certain processed fruits, vegetables,
and enriched cereal-grain products that conform to a standard of
identity to bear this term. FDA has determined that these products are
particularly helpful in assisting consumers to achieve dietary goals.
The benefit of this
[[Page 5354]]
proposed rule is to provide more useful information to consumers.
The costs of this regulation will be incurred only by those
manufacturers desiring to take advantage of the opportunity to use the
term ``healthy.'' FDA cannot predict the number of manufacturers who
will take advantage of this opportunity. Therefore, the agency cannot
estimate the number of labels which will be revised as a result of this
rule. However, FDA estimates that the cost of revising a label to
include a ``healthy'' claim is approximately $3,000 per label.
V. Environmental Impact
The agency has carefully considered the potential environmental
effects of this action. FDA has determined that the action will not
have a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
VI. Paperwork Reduction Act
FDA tentatively concludes that this proposed rule contains no
reporting, recordkeeping, labeling or other third party disclosure
requirements; thus there is no ``information collection'' necessitating
clearance by the Office of Management and Budget. However, to ensure
the accuracy of this tentative conclusion, FDA is seeking comment on
whether this proposed rule to amend the definition for the implied
nutrient content claim ``healthy'' imposes any paperwork burden.
VII. Effective Date
FDA is proposing to make these regulations effective on the date of
publication in the Federal Register.
VIII. Comments
Interested persons may, on or before April 29, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above, between 9
a.m. and 4 p.m., Monday through Friday.
IX. References
The following references have been placed on display in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Satchell, F. B., Division of Programs and Enforcement Policy
(HFS-158), Center for Food Safety and Applied Nutrition, memorandum
to file, September 22, 1995, Modification of USDA's Nutrient Data
Base for National Nutrient Databank Release 9, ``Processed Fruit and
Vegetable Products that Qualify to Bear the Term 'Healthy,''' June
17, 1994, and July 17, 1995.
2. Satchell, F. B., Division of Programs and Enforcement Policy
(HFS-158), Center for Food Safety and Applied Nutrition, memorandum
to file,`` Nutrient Profiles of Marketplace Fruit and Vegetable
Products that Qualify to Bear the Term 'Healthy,''' October 10,
1995.
3. Karmas, E., and R. S. Harris, ``Nutritional Evaluation of
Food Processing, Third Edition,'' Van Nostrand Reinhold Co., Inc.,
New York, chapters 3, 4, and 11, 1988.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 101 be 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 101.65 is amended by revising paragraph (d)(2)(iv) to
read as follows:
Sec. 101.65 Implied nutrient content claims and related label -
statements.
* * * * *
(d) * * *
(2) * * *
(iv) Except for raw or frozen fruit or vegetable products comprised
solely of fruits and vegetables and for enriched grain products that
conform to a standard of identity in parts 136, 137, or 139 of this
chapter, the food contains at least 10 percent of the RDI or DRV per
reference amount customarily consumed, per labeled serving of vitamin
A, vitamin C, calcium, iron, protein, or fiber;
* * * * *
Dated: January 26, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-2980 Filed 2-9-96; 8:45 am]
BILLING CODE 4160-01-F