[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]



=======================================================================
-----------------------------------------------------------------------

[[Page 5349]]


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.

-----------------------------------------------------------------------

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 

[[Page 5351]]
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 

[[Page 5352]]
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 

[[Page 5353]]
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