[Federal Register Volume 63, Number 57 (Wednesday, March 25, 1998)]
[Rules and Regulations]
[Pages 14349-14355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7667]


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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is revising 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 being taken to provide consumers with information 
that will assist them in achieving their dietary goals. This action 
also responds 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).

EFFECTIVE DATE:  March 25, 1998.

FOR FURTHER INFORMATION CONTACT: Loretta A. Carey, 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 NLEA). 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 assisting consumers to construct 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 (RDI) or Daily Reference 
Value (DRV) of 1 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 these six nutrients). In addition, the 
definition provides that a food can be fortified to meet the 10 percent 
nutrient contribution requirement if the fortification is done in 
accordance with the agency's fortification policy in Sec. 104.20 (21 
CFR 104.20). The definition further provides that raw fruits and 
vegetables are exempt from the 10 percent nutrient contribution 
requirement and may bear the term provided they meet the other 
requirements.
    Following publication of the healthy final rule, three trade 
associations, AFFI, NFPA, and ABA, submitted petitions to FDA (Docket 
Nos. 91N-384H/PRC1, 91N-384H/PRC2, and 95P-024, respectively) 
requesting that the agency amend the definition of ``healthy.''
    Two of the petitioners, AFFI and NFPA, requested that FDA 
reconsider its decision to exempt only raw fruits and vegetables from 
the 10 percent nutrient contribution requirement. Both petitioners 
argued that precluding certain processed fruits and vegetables from 
bearing the term ``healthy,'' especially when they are nutritionally 
equivalent to raw fruits and vegetables, would undermine the intent of 
the definition for ``healthy,'' which is to assist consumers to 
construct a diet that conforms to current dietary guidelines. AFFI 
further argued in their petition that the blanching and freezing 
processes do not significantly change the nutrient profile of frozen 
fruits and vegetables. In support of this argument, AFFI presented data 
to FDA comparing nutrient profiles of various raw and frozen fruits and 
vegetables, single ingredient versions of the same fruits and 
vegetables.
    The third petition, submitted by ABA, requested that the agency 
amend the definition of ``healthy'' to permit the claim on enriched 
cereal-grain products that conform to the standards of identity in part 
136, 137, or 139 (21 CFR part 136, 137, or 139) and bread that conforms 
to the standard of identity for enriched bread in 21 CFR 136.115, 
except that it contains whole wheat or other grain products not 
permitted under that standard. ABA argued that most nutritional 
authorities agree that grain products play a central role in a healthy 
diet. In fact, the petitioner argued, precluding enriched cereal-grain 
products from bearing a ``healthy'' claim was 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.
    Having considered the arguments raised in the petitions, the agency 
tentatively concluded in the Federal Register of February 12, 1996 (61 
FR 5349), (hereinafter referred to as ``the 1996 healthy proposal''), 
that certain frozen fruit and vegetable products and enriched cereal-
grain products that conform to a standard of identity should not be 
barred from using the term ``healthy'' because these foods can be 
particularly useful in assisting consumers in achieving dietary goals. 
Accordingly, in that document, FDA proposed to amend the definition of 
``healthy'' 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.
    Interested parties were given until April 29, 1996, to comment. FDA 
received approximately 100 letters in response to the proposal, each 
containing one or more comments, from industry, trade organizations, 
consumers, consumer interest groups, and academia. The comments 
generally supported the proposal. Several comments addressed issues 
outside the scope of the proposal (e.g., changing the 10 percent 
nutrient contribution requirement to a 5 percent requirement, revising 
the nutrient contribution requirement so that it is based on the 
caloric contribution of the food, and changing the word ``enriched'' to 
``partially restored'') and they will not be discussed here. A number 
of comments suggested modifications and revisions in various provisions 
of the proposal. A summary of these comments and the agency's responses 
follow:

[[Page 14350]]

II. Comments and Agency Response

A. General Comments

    1. One comment that supported the concept of extending use of the 
``healthy'' claim to processed fruits and vegetables and enriched grain 
products contended that the exemption approach is both discriminatory 
and piecemeal and that a new regulation providing a rational and 
consistent approach should be issued.
    Similarly, another comment stated that the 1996 healthy proposal 
would lead to inequity in the marketplace and confuse consumers. The 
comment asserted that the agency is creating ``regulatory chaos'' by a 
desire to fix a problem that in reality does not exist under the 
current regulations. The comment suggested that the importance of 
fruits and vegetables as part of a healthy diet, whether they are raw, 
frozen, or canned, can be highlighted on product labels under the 
existing regulation even if no exemption to the good source requirement 
is included in the rule. For example, fruit and vegetable products 
ineligible to bear the term ``healthy'' may bear information on general 
dietary guidance that promotes consumption of fruit and vegetable 
products as part of an overall healthy diet. Such language, in the 
absence of an expressed or implied claim, would not require the food 
bearing the label to meet the requirements of the ``healthy'' claim. 
The comment further asserted that the only thing the current regulation 
would prevent is the use of the word ``healthy'' in a nutritional 
context on the label to indicate that the food is, in and of itself, 
``healthy.'' Neither of these comments, however, presented any 
alternative approaches that the agency had not considered when it first 
established the definition for ``healthy.''
    The agency appreciates the concerns raised in the comments 
regarding the regulatory approach the agency is taking in this 
rulemaking in amending the definition of ``healthy.'' Still, it is not 
persuaded that this approach is discriminatory and will create 
regulatory chaos. To the contrary, by extending this exemption to other 
fruit and vegetable products and to enriched cereal-grain products that 
conform to a standard of identity, the agency will permit the 
``healthy'' claim on products that are particularly helpful in 
assisting consumers to achieve dietary goals yet are currently 
precluded from bearing the claim because they do not contain at least 
10 percent of the subject nutrients, and in many cases cannot be 
reformulated to do so. The agency believes that a failure to provide 
for these foods to bear ``healthy'' would decrease the utility of the 
claim in assisting consumers in achieving dietary goals. Therefore, the 
agency concludes that the approach it is taking in amending the 
definition of ``healthy'' in this rulemaking is equitable, consistent 
with dietary guidelines, and unlikely to confuse consumers regarding 
use of the term ``healthy.''
    In addition, the approach that FDA is taking in this final rule is 
similar to the approach that it took in establishing the definition of 
``healthy'' for seafood and game meats. As discussed in the 1996 
healthy proposal, 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 
because, in part, 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 this 
document, FDA is relying on the same general concept on which it based 
its decision to provide alternative criteria for raw, single ingredient 
seafood and game meats. Namely, the agency would consider it 
inappropriate if the requirements in the definition of ``healthy'' 
precluded use of the claim for fruits and vegetables and cereal-grain 
products, which play such 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 it to bear the claim. This regulatory approach 
ensures that the term ``healthy'' is used in a way that enables 
consumers to have confidence that the foods that bear this term will in 
fact be particularly useful in constructing diets that conform to 
dietary guidelines.
    The agency acknowledges that products described in the latter 
comment do have other claims available to them. However, the fact that 
these products have other claims available to them is not an adequate 
basis for the agency to find that they should be precluded from bearing 
the term ``healthy.'' The agency believes that the more compelling 
argument is that in cases where the frozen or canned version of the 
fruit or vegetable is nutritionally comparable to the raw version of 
the same fruit or vegetable, and it is as beneficial as the raw 
version, they should be eligible to bear the ``healthy'' claim under 
the same conditions as the raw version. Furthermore, consumers should 
be informed that these foods serve as appropriate and useful 
alternatives to raw fruits and vegetables in assisting them in 
achieving their dietary goals.

B. Single Ingredient Fruit and Vegetable Products

    The data that AFFI presented in supplemental comments to its 
petition comparing nutrient profiles of various raw fruits and 
vegetables and frozen, single ingredient versions of the same fruits 
and vegetables indicated that frozen fruits and vegetables generally 
are nutritionally comparable to raw fruits and vegetables. This 
indication is consistent with the agency's review of literature 
comparing raw fruits and vegetables to frozen and canned fruits and 
vegetables (Ref. 1). Based on a preliminary review of the AFFI data, 
the agency tentatively concluded in the 1996 healthy proposal that 
frozen, single ingredient fruits and vegetables should not be barred 
from bearing the term ``healthy'' because they are nutritionally 
comparable to raw fruits and vegetables. Moreover, like raw fruits and 
vegetables, they can contribute significantly to a healthy diet and to 
achieving compliance with dietary guidelines. Thus, the agency proposed 
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.
    2. Some comments were opposed to exempting frozen, single 
ingredient fruit and vegetable products and mixtures of frozen, single 
ingredient fruit and vegetable products from the 10 percent nutrient 
contribution requirement because, the comments contended, frozen, 
single ingredient fruits and vegetables were nutritionally inferior to 
the raw fruits and vegetables. These comments argued that allowing 
manufacturers to label their products as ``healthy'' when the food did 
not contain 10 percent of one of the six listed nutrients was not a 
good idea because of the way that frozen fruits and vegetables were 
processed (e.g., blanching, trimming, washing, chopping, and freezing). 
One of these comments asserted that frozen food products are not 
comparable to raw food products because frozen products tend to 
diminish in quality during transportation and storage due to 
temperature changes. The comment contended, therefore, that frozen 
fruit and vegetable products should bear the term ``healthy'' only when 
they meet all

[[Page 14351]]

the requirements of the claim, including the 10 percent nutrient 
contribution requirement.
    Many of the comments supported the proposal 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. They agreed that these foods are 
nutritionally comparable to raw fruits and vegetables, can be used 
interchangeably in the diet with raw fruits and vegetables, can make a 
significant contribution to achieving dietary compliance, and the 
absence of a claim on frozen versions of a raw product that bears a 
claim could be misleading. In addition, the comments noted that the 
appearance of the ``healthy'' claim on frozen, single ingredient fruits 
and vegetables communicates something broad, powerful, and positive 
about the described food consistent with its role in achieving 
compliant diets and, therefore, would contribute to a balanced and 
healthful diet by encouraging increased consumption of these products 
in accordance with dietary guidelines.
    The agency disagrees with the first comments. While those comments 
stated that frozen food products are nutritionally inferior to raw 
fruits and vegetables, they did not provide the agency with any data or 
other information to support their position or to cause the agency to 
reconsider its tentative conclusion that frozen, single ingredient 
fruits and vegetables are nutritionally comparable to raw fruits and 
vegetables and can be used interchangeably in the diet.
    In efforts to evaluate the nutrient content of frozen fruits and 
vegetables compared to that of raw fruits and vegetables, the agency 
reviewed both the AFFI's supplemental data and similar data from the 
U.S. Department of Agriculture (USDA) (Ref. 2). The nutrient profiles 
of selected raw fruits and vegetables and frozen, single ingredient 
versions of the same fruits and vegetables revealed relatively 
equivalent nutrient profiles. The data reviewed by the agency did not 
support the argument raised in the comments that blanching and/or 
freezing fruits and vegetables generally reduces their nutrient 
content. In fact, some data showed that the nutrient content level for 
certain nutrients was higher in the frozen version of the food than in 
the raw version of the food. This is probably attributable to the fact 
that unprocessed (i.e., raw) fruits and vegetables may lose some of 
their nutrients over time under certain storage conditions (Ref. 1). 
Further, both sets of data supported the argument raised by the 
petitioners that frozen fruits and vegetables have comparable 
nutritional profiles when compared to the raw version. Therefore, the 
agency continues to believe that single ingredient frozen fruits and 
vegetables are nutritionally the same as raw fruits and vegetables. 
Moreover, these foods 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 concludes that because 
single ingredient, frozen fruit or vegetable products are nutritionally 
comparable to the raw versions, they would likely have the same 
inherent beneficial effects as the raw version. Precluding such foods 
from bearing the term ``healthy'' could undermine an important element 
of current dietary guidance, as well as the basis for the ``healthy'' 
claim that is to assist consumers in constructing a diet that conforms 
to dietary guidelines. Consumers should be informed, moreover, that 
these foods serve as appropriate and useful alternatives to raw fruits 
and vegetables in constructing diets consistent with current dietary 
recommendations even if the products do not meet the 10 percent 
nutrient contribution requirement. Therefore, the agency concludes that 
such foods should not be barred from bearing the term ``healthy.'' 
Accordingly, the agency is amending Sec. 101.65(d) to exempt frozen, 
single ingredient fruit and vegetable products and mixtures of frozen, 
single ingredient fruits and vegetables from the 10 percent nutrient 
contribution requirement.

C. Multi-Ingredient Fruit and Vegetable Products

    As discussed in the 1996 healthy proposal (61 FR 5349 at 5352), FDA 
tentatively concluded that providing an exemption for multi-ingredient 
fruit and vegetable products would be inconsistent with current dietary 
recommendations and, consequently, inconsistent with the basis of the 
``healthy'' claim because such foods may increase the consumption of 
certain undesirable nutrients and decrease consumption of 
micronutrients. Thus, FDA did not propose to extend the exemption to 
multi-ingredient fruit and vegetable products composed of ingredients 
other than fruits or vegetables that do not contain at least 10 percent 
of one of the six listed nutrients.
    3. Two comments requested that the agency reconsider its tentative 
position regarding the eligibility of multi-ingredient fruit and 
vegetable products (i.e., products that contain added oils, sodium, 
sauces, syrups, or similar ingredients) to bear the term ``healthy'' 
when the food did not meet the 10 percent nutrient contribution 
requirement. One comment contended that if a product contains minimal 
amounts of these added ingredients and the levels of fat, saturated 
fat, cholesterol, or sodium are not significantly increased, then the 
product should be granted an exemption. The comment opined that the 
addition of insignificant amounts of these nutrients should not cause 
the product to be inconsistent with the purpose of the ``healthy'' 
claim or incompatible with current dietary guidelines. The other 
comment argued that multi-ingredient fruit and vegetable products will 
likely be better tasting when compared to fruit and vegetable products 
without these ingredients and, therefore, are more likely to be 
selected by consumers in their efforts to meet the public health goal 
of increasing fruit and vegetable consumption.
    The agency is not persuaded by these comments that multi-ingredient 
fruit and vegetable products with added oils, sodium, sauces, syrups, 
or similar ingredients should be exempt from the 10 percent 
requirement. These foods do not have the same nutrient profile as 
fruits or vegetables not containing these added ingredients and 
therefore, have the potential, when used interchangeably in the diet 
with such fruits or vegetables, of increasing the dietary intake of 
substances that dietary guidelines recommend be decreased. 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 multi-ingredient fruit and vegetable products with added 
oils, sodium, sauces, syrups, or similar ingredients are just as useful 
and helpful as raw and single ingredient fruits and vegetables in 
achieving dietary goals, when in fact, they could increase dietary 
intake of less desirable nutrients. Furthermore, the usefulness of a 
food labeled ``healthy'' is not based on how it compares to a similar 
food (for example, in taste), but on how, because of its nutrient 
profile, it contributes to achieving a total diet consistent with 
dietary recommendations.
    The agency notes that the comment suggested minimal or 
insignificant amounts of these ingredients be permitted. The comments, 
however, did not provide a basis on which the agency could establish a 
minimal or insignificant amount. The agency notes,

[[Page 14352]]

however, that manufacturers should be advised that fruit and vegetable 
products composed of ingredients other than fruits or vegetables can be 
formulated and fortified in accordance with Sec. 104.20 to meet the 10 
percent contribution requirement, and, when so formulated, a food that 
meets the nutrient contribution requirement as well as the other 
requirements of the claim can bear the term ``healthy.'' Accordingly, 
FDA is not exempting multi-ingredient fruit and vegetable products that 
contain added oils, sodium, sauces, syrups, or similar ingredients from 
the 10 percent nutrient contribution requirement. As discussed below, 
however, certain nonnutritive ingredients (i.e., ingredients that do 
not change the levels of macro or micronutrients in the food) may be 
added under certain conditions.
    4. One comment stated that products that meet the standard of 
identity for fruit, fruit juices, and fruit products (e.g., applesauce) 
should also be exempt from the 10 percent nutrient contribution 
requirement. The comment stated that these products contribute to 
healthful diets. The comment contended that discriminating against 
apple products, in particular, would confuse consumers and discourage 
them from consuming fruit products such as apple slices and apple 
juice. The comment cited no basis for exempting these foods other than 
the fact that some of the foods cited in the comment met a standard of 
identity. The comment did not provide any data or other information to 
suggest which of these products were currently prohibited from bearing 
the ``healthy'' claim.
    Nevertheless, the agency considered it prudent to review the 
standards of identity to ensure that fruit products conforming to a 
standard of identity that are particularly helpful in assisting 
consumers in constructing diets consistent with dietary guidelines are 
not unfairly precluded from bearing the term because of the provisions 
in the standard. Several standards of identity governing fruit products 
permit the optional fortification of one or more of the six listed 
nutrients at levels sufficient to meet the 10 percent nutrient 
contribution requirement. There are fruit products under standards of 
identity that do not provide for fortification, that are consistent 
with the basis of the ``healthy'' claim, and that are not covered by 
the exemptions issued in this final rule. The agency reviewed USDA's 
database (Ref. 2) to determine whether these fruit products' nutrient 
profiles preclude them from bearing the term. Based on this review, the 
agency determined that these foods have nutrient profiles that would 
allow them to bear the term ``healthy'' even under the current 
regulations without an exemption. The agency therefore concludes that a 
general exemption for fruit products governed by the standards of 
identity is not warranted.

D. Canned and Processed Fruit and Vegetable Products

    The agency stated in the 1996 healthy proposal (61 FR 5349 at 5352) 
that if appropriate data were submitted, the agency was prepared to 
extend the exemption from the 10 percent nutrient contribution 
requirement to other single ingredient processed fruit and vegetable 
products. The agency solicited comments and data on the effects of 
other types of processing (e.g., drying and canning) and on how these 
processes affect the nutritional profile of fruits and vegetables.
    5. Three comments requested that the agency exempt canned fruits 
and vegetables from the minimum nutrient contribution requirement. In 
support of this request, one of the comments contained data comparing 
the nutrient profiles of canned fruits and vegetables to raw and frozen 
versions of the fruits and vegetables.\1\ This comment stated that an 
exemption should be granted for a broad category of fruit and vegetable 
products, including canned varieties packed in a medium that may 
contain other ingredients such as water, spices, flavors, or other 
additives that do not weaken the requirement that the food be composed 
solely of fruits and vegetables, for the purpose of bearing the 
``healthy'' claim.
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    \1\ The data submitted to the agency were presented in three 
appendices, A, B, and C. The Appendix A data directly compared 
nutrient levels of several versions of the subject fruit or 
vegetable, including raw, frozen, and canned. The Appendix B data 
compared nutrient levels before and after heating of each version of 
the fruit or vegetable (i.e., nutrient levels of frozen products 
were compared to nutrient levels of frozen products that had been 
heated). Appendix C contained data comparing nutrient profiles of 
raw products that had been cooked with other versions of the fruit 
or vegetable that were either cooked or uncooked.
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    The agency has considered the requests made in the comments as well 
as reviewed the data submitted in each of the appendices. The data in 
Appendix A were obtained from laboratory analysis and directly compared 
nutrient levels of raw and processed versions of the subject fruit or 
vegetable on a per 100-gram basis. The agency considers the data in 
Appendix A to be the most relevant in terms of demonstrating the 
effects of canning on the nutritional profile of fruits and vegetables. 
The data in Appendix A show that fruits and vegetables that are 
subjected to freezing and canning processes generally maintain nutrient 
levels comparable to the raw version. These data were collected nearly 
2 decades ago and may not be reflective of current canning technology 
and its effect on nutrient levels, however. Consequently, the agency 
reviewed the literature to assess: (1) Whether current canning 
technologies differ significantly from those used 20 years ago; and (2) 
if so, whether use of these current technologies results in processed 
fruits or vegetables with significantly altered nutrient levels as 
compared to the raw version.
    This review indicates that any improvements in canning technologies 
that have occurred over the last 20 years have not significantly 
altered nutrient levels in canned foods when compared to raw food (Ref. 
3). Consequently, the agency concludes that canned, single ingredient 
fruit and vegetable products generally have comparable nutrient 
profiles to the raw and frozen versions of the fruit and vegetable. 
Accordingly, the agency is revising proposed Sec. 101.65(d)(2)(iv) to 
include canned, single ingredient fruit and vegetable products in the 
list of foods that are exempt from the 10 percent nutrient contribution 
requirement. In deciding to extend this exemption to canned, single 
ingredient fruit and vegetable products, the agency is acknowledging 
that these products are nutritionally comparable to, and as beneficial 
as, raw fruits and vegetables and, therefore, can be used 
interchangeably in the diet with raw fruits and vegetables. 
Consequently, these products, like frozen, single ingredient fruits and 
vegetables, should be permitted to bear the ``healthy'' claim under the 
same conditions as raw fruits and vegetables. Moreover, canned, single 
ingredient fruits and vegetables, like raw and frozen, single 
ingredient fruits and vegetables, can be particularly helpful in 
assisting consumers in achieving dietary goals and should not be 
precluded from bearing a ``healthy'' claim.
    Furthermore, the agency is concerned that an inappropriate message 
could be sent to consumers if a ``healthy'' claim were permitted to 
appear on the raw or frozen version of the fruit or vegetable product 
but were precluded from appearing on the canned version. Such a 
situation might not only confuse consumers, it would also be 
inconsistent with the 1995 Dietary Guidelines. These guidelines state 
that ``the availability of fresh fruits and vegetables varies by season 
and region of the country, but frozen and canned vegetables ensure a 
plentiful supply of these healthful foods throughout the

[[Page 14353]]

year.'' The guidelines therefore recognize that canned as well as 
frozen fruits and vegetables can be used interchangeably in the diet 
with, and are just as helpful as, raw fruits and vegetables. Moreover, 
consumers should be informed that these foods serve as appropriate and 
useful alternatives to raw fruits and vegetables in assisting them in 
achieving their dietary goals.
    In response to the request that the agency permit the addition of 
ingredients such as water, spices, flavors, or other additives, the 
agency would not object to the addition of ingredients that do not 
change the level of macro or micronutrients in the food because fruits 
or vegetables with such added ingredients would be nutritionally 
comparable to the raw version and can be used interchangeably in the 
diet with raw versions. On the one hand, the addition of oils, sodium, 
sauces, syrups, and other ingredients that could change the level of 
nutrients, as compared to raw foods, could increase the consumption of 
undesirable nutrients beyond that of the raw version, as well as imply 
that these products have nutritional profiles comparable to the raw 
version, when in fact they do not. Consequently, the agency finds no 
basis on which fruit and vegetable products with added oils, sauces, 
sodium, and syrups should be exempt from the 10 percent requirement. On 
the other hand, fruit and vegetable products that have nonnutritive 
added ingredients (such as water, spices, or flavors) maintain 
comparable nutrient profiles to the raw versions, and, therefore, 
should be permitted to bear the claim under the same conditions as the 
raw versions. Accordingly, the agency is amending Sec. 101.65(d)(2)(iv) 
from the proposal to clarify that foods comprised solely of fruits and 
vegetables may have added ingredients such as water, spices, flavors or 
other additives that do not change the level of nutrients in the food. 
This change from the proposal substantially lengthens the description 
of the exemption for frozen and canned single ingredient fruits and 
vegetables. The agency has therefore placed the exemptions to the 10 
percent nutrient contribution requirement at the end of 
Sec. 101.165(d)(2)(iv), paragraphs A through C. In addition, the agency 
has deleted the phrase ``per labeled serving,'' an error in the 
proposed codified language, from the final codified language so that 
the description of the 10 percent nutrient contribution itself conforms 
to the preexisting codified description in Sec. 101.165(d)(2)(iv).)
    6. A few comments opposed exempting canned fruits and vegetables 
from the 10 percent nutrient contribution requirement because, the 
comments argued, some canned fruits and vegetables are high in sugar 
and salt and should not bear the term ``healthy.''
    While the agency appreciates the concerns raised in the comments, 
the agency notes that it is not, in this rulemaking, providing an 
exemption for foods containing ingredients that would increase the 
amount of sugar or salt beyond that occurring in the raw version of the 
fruit or vegetable. The agency points out, however, that not granting 
an exemption to these foods would not prohibit fruits and vegetables 
with added sugar or salt from bearing the ``healthy'' claim because 
such foods that contain 10 percent or more of one of the six listed 
nutrients, and otherwise meet the requirements for the claim, are not 
precluded from bearing the claim.

E. Enriched Cereal Grain Products

    In the 1996 healthy proposal, FDA proposed 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. This exemption is 
justified because foods made in accordance with these standards are 
precluded from meeting the 10 percent nutrient contribution requirement 
and because they are the types of food that meet the basis of the 
``healthy'' definition and are recommended in dietary guidelines. Foods 
labeled with the term ``healthy'' should be those that can be used to 
achieve a total diet that conforms to current dietary recommendations 
(see 58 FR 2944 at 2946, January 6, 1993). Current dietary guidelines 
recommend 6 to 11 servings of breads, cereals, rice, and pasta per day. 
Because most Americans do not achieve 6 to 11 servings per day, 
increased consumption of grain products is also recommended in dietary 
guidelines. The appearance of a ``healthy'' claim on enriched cereal-
grain products would likely encourage consumers to select these 
products as part of a healthy diet. Furthermore, precluding 
standardized enriched cereal-grain products from bearing the term 
``healthy'' may confuse consumers because they might incorrectly regard 
such products as not particularly beneficial in achieving diets 
consistent with dietary guidelines.
    Comments responding to this issue (with the exception of comment 7, 
in section II.E of this document) supported FDA's proposal, and stated 
that permitting a ``healthy'' claim on enriched cereal-grain products 
would likely encourage consumers to select these products as part of a 
healthy diet. Accordingly, FDA is amending the definition of the term 
``healthy'' in Sec. 101.65(d)(2)(iv) as proposed to exempt enriched 
grain products that conform to a standard of identity in part 136, 137, 
or 139 from the 10 percent nutrient contribution requirement.
    7. Two comments opined that the healthy claim should be reserved 
only for breads that contain flour that is 50 percent whole grain. The 
comments contended that breads that are made from enriched flour and do 
not contain at least 50 percent whole grain flour should not be labeled 
as ``healthy.'' The comments further contended that valuable nutrients 
such as the B-vitamins, vitamin E, dietary fiber, and minerals are not 
adequately supplied in enriched flour.
    The agency disagrees with these comments. While the agency 
recognizes that during the milling process of wheat, the B-vitamins, 
vitamin E, dietary fiber and certain minerals may be lost, the 
enrichment requirement in the standards of identity restores several of 
these nutrients. Moreover, as discussed previously in section II.E of 
this document, standardized enriched cereal-grain products are the 
types of products that are consistent with the basis of the ``healthy'' 
claim and should not be precluded from bearing the claim. The comments 
are asking the agency to base the requirement to bear the ``healthy'' 
claim on the presence and percentage of a particular ingredient in a 
food rather than on the presence and percentage of particular nutrients 
that are important to the food's overall nutritional profile. Such an 
approach would require the agency to change the underlying principles 
of the ``healthy'' claim, which focuses on the food's overall 
nutritional profile. Further, it would require the agency to develop a 
list of ingredients that could qualify a food to bear a ``healthy'' 
claim. The agency believes that such an approach is neither equitable 
nor feasible. Consequently, the agency is not granting the comments' 
request that only breads containing 50 percent whole grain flour be 
labeled as ``healthy.''
    8. Another comment stated that all breakfast cereals should be 
exempt from the 10 percent nutrient contribution requirement. The 
comment opined that the presence of the term ``healthy'' on breakfast 
cereals would increase their consumption that, in turn, would increase 
consumption of cereal-grain products. Such consumption, the comment 
argued, would be entirely consistent with, and supportive of, the

[[Page 14354]]

government's current dietary recommendations and the intent of the 
NLEA. The comment provided no other rationale for exempting breakfast 
cereals from the 10 percent requirement.
    While the agency agrees that increased consumption of breakfast 
cereals would mean increased consumption of cereal-grain products, the 
agency is not persuaded that breakfast cereals should be exempt from 
the nutrient contribution requirement. There is no evidence to suggest 
that breakfast cereals as a category of foods are precluded from 
bearing the term because of the food's inability to meet the 10 percent 
requirement. On the contrary, breakfast cereals that meet the other 
requirements of the claim generally are a ``good source'' of at least 
one of the listed nutrients. Furthermore, breakfast cereals are not 
governed by a standard of identity and have the flexibility of 
modifying their formulation to meet the requirements of the claim. 
Consequently, FDA is not establishing an exemption for breakfast 
cereals.
    9. A number of comments urged the agency to allow cereal-grain 
products that are eligible to bear a health claim to also bear the term 
``healthy.'' The comments stated that these products play a major role 
in a healthful diet and precluding these products would confuse 
consumers and undermine the ability of health claims to assist 
consumers in making appropriate dietary choices.
    The agency strongly disagrees with these comments. The agency would 
like to reiterate and clarify its position on this subject. The 
fundamental concerns that underlie a health claim are different from 
those that underlie the definition of ``healthy.'' FDA's goal is to 
define ``healthy'' in such a way that it will highlight foods that, 
because of their nutrient content, will be most helpful to consumers in 
constructing a diet that is consistent with all of the dietary 
recommendations. The purpose of a health claim, by contrast, is to 
highlight scientifically valid nutrient-disease relationships as well 
as foods that have a level of the substance in question such that 
consumption of the food may help to affect the risk of developing the 
disease in question. In some cases these purposes overlap, in others 
they do not.
    Because a health claim is based on the relationship of a substance 
to a specific disease or health-related condition (59 FR 24232 at 
24233), a product that bears a health claim may not necessarily be 
particularly helpful in assisting consumers in lowering their daily 
intake of those nutrients that are not the subject of the claim, but of 
which reduced daily intake has been recommended. For example, a food 
must be ``low fat'' to bear the claim ``healthy,'' whereas some health 
claims do not require the food to be ``low fat.'' The agency therefore 
acknowledges that there are foods that will be eligible to bear a 
health claim that will not be eligible to bear the term ``healthy.'' 
This fact is not an inconsistency in FDA's regulations because, as 
described above, these two claims are different and have different 
functions.
    The comments have not persuaded the agency that FDA's goal in 
defining the term ``healthy'' would be met if the agency permitted a 
food to bear the term ``healthy'' just because it qualifies for a 
health claim. Therefore, FDA is not amending the definition of 
``healthy'' to permit foods to bear the term simply because the food 
qualifies to bear a health claim. The agency notes, however, that foods 
that bear health claims and that meet the requirements for ``healthy'' 
may also bear the term ``healthy.''

III. Economic Analysis

A. Benefit/Cost Analysis

    FDA has examined the impacts of this final rule under Executive 
Order 12866. 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). According to 
Executive Order 12866, a regulatory action is ``economically 
significant'' if it meets any one of a number of specified conditions, 
including having an annual effect on the economy of $100 million or 
adversely affecting in a material way a sector of the economy, 
competition, or jobs. A regulation is considered ``significant'' under 
Executive Order 12866 if it raises novel legal or policy issues. FDA 
finds that this final rule is neither economically significant nor a 
significant regulatory action as defined by Executive Order 12866.
    In addition, FDA has determined that this rule does not constitute 
a significant rule under the Unfunded Mandates Reform Act of 1995 
requiring cost-benefit and other analyses. A significant rule is 
defined in Section 1531(a) as ``a Federal mandate that may result in 
the expenditure by State, local, and tribal governments in the 
aggregate, or by the private sector, of $100,000,000 (adjusted annually 
for inflation) in any 1 year * * *''.
    Finally, in accordance with the Small Business Regulatory 
Enforcement Fairness Act of 1996, the administrator of the Office of 
Information and Regulatory Affairs of the Office of Management and 
Budget has determined that this final rule is not a major rule for the 
purpose of Congressional review.
    FDA is proposing to permit certain processed fruits and vegetables, 
and enriched cereal-grain products that conform to a standard of 
identity to bear the term ``healthy.'' FDA has determined that these 
products are particularly helpful in assisting consumers to achieve 
dietary goals.
    In the benefit/cost analysis for the proposed rule, FDA stated that 
the benefit of this rule is to provide more beneficial information to 
consumers. FDA received comments stating that the rule will have a 
positive impact on the demand for fruits and vegetables if it helps 
people to understand the relative nutritiousness of fresh versus frozen 
or canned produce. Several comments also stated the rule would result 
in health benefits if it caused consumption of fruits and vegetables to 
increase.
    Although it is possible that this rule will have some marginal 
impact on the overall demand for fruits and vegetables, it is unlikely 
that any increase in demand that might occur would be significant. It 
is likely, however, that demand will shift from products that are 
higher in fat, sugars, and sodium, such as multi-ingredient vegetable 
products with added oils, to products that are lower in fat, sugars, 
and sodium irrespective of whether the switching that may occur is 
within or between product types. The real benefit of use of the term 
``healthy'' depends not on whether it favors one type of product over 
another, but on whether it provides consumers with a tool with which 
they can select foods that will help to achieve dietary goals.
    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 that will be revised as a result of this 
rule. FDA estimates however, that, the cost of revising a label to 
include a ``healthy'' claim is approximately $3,000 per label.

B. Small Entity Analysis

    FDA has examined the impacts of this final rule as required by the 
Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a 
significant impact on a

[[Page 14355]]

substantial number of small entities, the Regulatory Flexibility Act 
requires agencies to analyze options that would minimize the economic 
impact of that rule on small entities. Under the Regulatory Flexibility 
Act (5 U.S.C. 605(b)), FDA certifies that this final rule will not have 
a significant impact on a substantial number of small entities.
    FDA received one comment to the analysis of the proposed rule 
regarding the potential impact on small entities. The comment suggested 
that if consumption shifts from raw to processed produce as a result of 
this rule, the impact on small farmers would be detrimental.
    The comment did not provide any data with which FDA could evaluate 
the potential for shifts in consumption from raw to processed produce 
or any resulting impact on small farmers. FDA notes, however, that it 
is unlikely that this rule would cause consumption to shift from raw to 
processed produce. As stated previously, the likely substitution is 
from those fruits and vegetables that are too high in fat or sodium to 
qualify for the term ``healthy'' to those raw or processed fruits and 
vegetables that do qualify as ``healthy.''
    FDA further notes that, even if demand for processed produce 
increased relative to raw produce, the impact on small farmers should 
not be detrimental. There is no reason to expect that small farmers 
would not be able to sell their produce to processors if the demand for 
processed produce increases.
    Only those processed products that would meet the current 
definition of the term ``healthy'' other than the minimum nutrient 
contribution requirement will be affected by this rule. Because there 
is no change in the definition as it applies to those products 
currently using the term, only those entities desiring to take 
advantage of the new exemption will bear any cost of this regulation. 
No firm of any size will voluntarily bear the cost of changing a label 
to bear the term ``healthy'' unless doing so will be advantageous to 
the firm. Therefore, FDA concludes that no small entity will be 
adversely affected by this rule.

IV. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the proposed rule (61 FR 5349, February 12, 
1996; corrected May 21, 1996 (61 FR 25421)). No new information or 
comments have been received that would affect the agency's previous 
determination that there is no significant impact on the human 
environment and that an environmental impact statement is not required.

V. Paperwork Reduction Act of 1995

    In the 1996 healthy proposal, FDA stated its tentative conclusion 
that the proposed rule contains no reporting, recordkeeping, labeling 
or other third party disclosure requirements and asked for comments on 
whether the proposed rule imposed any paperwork burden. No comments 
were received addressing the question of paperwork burden. FDA 
concludes that the labeling provisions in this document are not subject 
to review by the Office of Management and Budget because they do not 
constitute a ``collection of information'' under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Rather, the labeling 
statements are a ``public disclosure of information originally supplied 
by the Federal Government to the recipient for the purpose of 
disclosure to the public'' (5 CFR 1320(c)(2)).

VI. References

    1. Karmas, E., and R. S. Harris, ``Nutritional Evaluation of 
Food Processing, 3d Ed.,'' Van Nostrand Reinhold Co., Inc., New 
York, chapters 3, 4, and 11, 1988.
    2. 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 No. 9, ``Processed Fruit 
and Vegetable Products that Qualify to Bear the Term `Healthy','' 
June 17, 1994, and July 17, 1995.
    3. University of Illinois at Urbana-Champaign, Department of 
Food Science and Human Nutrition, ``Nutrient Conservation in Canned, 
Frozen and Fresh Foods,'' October 1997.

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, 21 CFR part 
101 is amended as follows:

PART 101--FOOD LABELING

    1. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 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) The food contains at least 10 percent of the Reference Daily 
Intake (RDI) or Daily Reference Value (DRV) per reference amount 
customarily consumed of vitamin A, vitamin C, calcium, iron, protein, 
or fiber, except for the following:
    (A) Raw fruits and vegetables;
    (B) Frozen or canned single ingredient fruits and vegetables and 
mixtures of frozen or canned single ingredient fruits and vegetables, 
except that ingredients whose addition does not change the nutrient 
profile of the fruit or vegetable may be added;
    (C) Enriched cereal-grain products that conform to a standard of 
identity in part 136, 137, or 139 of this chapter.
* * * * *

    Dated: March 18, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-7667 Filed 3-24-98; 8:45 am]
BILLING CODE 4160-01-F