[Federal Register Volume 59, Number 89 (Tuesday, May 10, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11145]


[[Page Unknown]]

[Federal Register: May 10, 1994]


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Part III





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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21 CFR Part 101




Food Labeling: Nutrient Content Claims, Definition of Term: Healthy; 
Final Rule
DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 91N-384H]
RIN 0905-AD08

 
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 amending its food 
labeling regulations to establish a definition for the term ``healthy'' 
under the Federal Food, Drug, and Cosmetic Act (the act). This final 
rule will provide a definition for this implied nutrient content claim 
and provide for its use on the food label. This action is in response 
to the Nutrition Labeling and Education Act of 1990 (the 1990 
amendments).

DATES: This regulation is effective May 8, 1994. Before January 1, 
1998, the sodium content of individual foods, main dish, and meal 
products shall be consistent with Sec. 101.65(d)(2)(ii)(A), 
(d)(2)(ii)(B), (d)(3)(ii)(A), (d)(3)(ii)(B), or (d)(4)(ii)(A), as 
appropriate. After January 1, 1998, the sodium content of individual 
foods, main dish, and meal products that bear the claim ``healthy'' 
shall be consistent with the requirements in 
Sec. 101.65(d)(2)(ii)(C)(1), (d)(2)(ii)(C)(2), (d)(3)(ii)(C)(1), 
(d)(3)(ii)(C)(2), or (d)(4)(ii)(B), as appropriate.

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. Introduction

    In the Federal Register of January 6, 1993 (58 FR 2302), FDA 
published a final rule entitled ``Food Labeling: Nutrient Content 
Claims, General Principles, Petitions, Definitions of Terms; 
Definitions of Nutrient Content Claims for the Fat, Fatty Acid, and 
Cholesterol Content of Food'' (hereinafter referred to as ``the general 
principles final rule'') that, among other things, provided for the use 
of implied nutrient content claims on the labels and in the labeling of 
individual foods and meal-type products. While the agency recognized 
that, as provided by section 403(r)(1)(A) of the act (21 U.S.C. 
343(r)(1)(A)), a food is prohibited from bearing an implied nutrient 
content claim on its label or in its labeling unless the claim is 
defined by FDA by regulation, it was unable to adopt a comprehensive 
set of definitions for implied nutrient content claims in the general 
principles final rule because of resource constraints and the strict 
timeframes under which that rulemaking was accomplished. Although the 
agency did not establish a comprehensive set of definitions, it did 
determine, among other things, that the term ``healthy'' is an implied 
nutrient content claim when it is used on the label or in labeling in a 
nutritional context, for example, when it appears in association with 
an explicit or implicit claim or statement about a nutrient (58 FR 2302 
at 2375). The agency said that, for example, in the statement 
``healthy, contains less than 3 g of fat,'' ``healthy'' is an implied 
nutrient content claim.
    Because of the complex nature of this term, the agency concluded 
that it was not possible to arrive at a final regulation for a 
definition of the term ``healthy'' as part of the general principles 
final rule (58 FR 2302, January 6, 1993). However, in that same issue 
of the Federal Register, FDA published a proposal entitled, ``Food 
Labeling: Nutrient Content Claims, Definition of Term: Healthy'' 
(hereinafter referred to as ``the healthy proposal''), to establish a 
definition for the implied nutrient content claim ``healthy'' for 
individual foods, main dishes, and meal products (58 FR 2944, January 
6, 1993). The agency tentatively concluded that foods labeled with the 
term ``healthy'' could be used with a variety of foods to assist 
consumers in maintaining healthy dietary practices, that is, to achieve 
a total diet that conforms to current dietary guidelines. In other 
words, FDA tentatively concluded that foods bearing a ``healthy'' claim 
should be those that, based on their nutrient profile, would assist 
consumers in achieving dietary recommendations. Consequently, the 
agency proposed to permit the use of the term ``healthy'' as an implied 
nutrient content claim on products that meet the definitions for ``low 
fat'' and ``low saturated fat'' and that do not exceed the disclosure 
levels for sodium and cholesterol (proposed Sec. 101.65(d)(2) (21 CFR 
101.65(d)(2))). (Disclosure levels are defined as levels of total fat, 
saturated fat, sodium, and cholesterol in a food above which a referral 
statement is required when the food bears a nutrient content claim (see 
Sec. 101.13(h) (21 CFR 101.13(h))). The agency further stated that when 
``healthy'' is not used as an implied nutrient content claim, it would 
be subject to the general misbranding provisions of section 403(a) of 
the act (58 FR 2944 at 2945).
    The agency advised that it intended to make any final rule that 
derived from the proposal effective on the date of applicability of the 
general principles final rule and the final rule on mandatory nutrition 
labeling (i.e., May 8, 1994) (58 FR 2944). However, FDA stated that if 
for some reason a final rule had not been issued by that date, 
``healthy'' would be subject to the general nutrient content claim 
requirements for implied claims or the general misbranding clause (58 
FR 2944).
    In a companion document in the January 6, 1993 issue of the Federal 
Register (58 FR 688), the Food Safety and Inspection Service (FSIS) of 
the U.S. Department of Agriculture (USDA) proposed a definition for 
``healthy'' or any other derivative of the term ``health'' on meat and 
poultry products. FSIS proposed to permit ``healthy'' to be used on the 
label or in labeling of a meat or poultry product that contains less 
than 10 grams (g) of fat, less than 4 g saturated fat, less than 95 
milligrams (mg) of cholesterol, and less than 480 mg of sodium per 100 
g and per reference amount customarily consumed (RACC) for individual 
foods and per 100 g and per labeled serving for meal-type products. 
FSIS further proposed that any use of the term ``healthy,'' whether in 
a brand name or in conjunction with a nutrient, must meet this 
definition.
    FDA received approximately 50 letters in response to the 
``healthy'' proposal. Each letter contained one or more comments. The 
letters were from a wide range of sources, including consumers, 
consumer organizations, professional associations, State and local 
government agencies, industry, and industry trade associations. Some of 
the comments supported various provisions of the proposal. Other 
comments suggested modifications, revisions, or revocations of various 
provisions of the proposal. A summary of the comments, the agency's 
responses to the comments, and a complete discussion of the agency's 
conclusions with respect to use of the term ``healthy'' follow.

II. Comments and Agency Response

A. Purpose in Defining ``Healthy''

    The agency views the term ``healthy'' as a unique nutrient content 
claim. This term not only characterizes the level of the nutrients in a 
food but implies a judgment about the food itself, based on its 
nutrient profile. Polls and surveys discussed in the comments that FDA 
received on the ``healthy'' proposal show that consumers have many 
ideas about what this term means. Some believe that it means that the 
food is low in fat and low in sodium; others believe that the term 
means that the food is low in cholesterol; while still others believe 
that the term means that consumption of the food would lead to a 
healthy diet. Taken together, however, these comments establish not 
only that ``healthy'' conveys a strong message about the nutrient 
content of a food, but that consumers associate it with the nutrient 
levels that have generally been recommended over the past few years.
    The agency finds, therefore, that the fundamental purpose of a 
``healthy'' claim is to highlight those foods that, based on their 
nutrient levels, are particularly useful in constructing a diet that 
conforms to current dietary guidelines. As stated in the ``healthy'' 
proposal (58 FR 2944 at 2946), and supported by the comments, foods 
labeled with the term ``healthy'' should be those that can be consumed 
to assist consumers in maintaining healthy dietary practices, that is, 
in achieving a total diet that conforms to current dietary 
recommendations. Thus, ``healthy'' is different from other nutrient 
content claims that FDA has defined in that, while the other nutrient 
content claims characterize only the level of the nutrient (or, in the 
case of ``light,'' nutrients) that is the subject of the claim, 
``healthy'' characterizes both the level of the nutrient in a food and, 
derivatively, the food itself.
    1. One comment stated that in order for a definition of ``healthy'' 
to be meaningful, unique nutrient criteria should be developed for each 
food category.
    The agency disagrees with this comment. Although the agency would 
consider it inappropriate if the definition of ``healthy'' were to 
exclude an entire category of foods that is recommended in dietary 
guidelines, FDA believes that to establish different criteria for each 
food category would not be helpful to consumers. Not only would 
consumers have to learn that the meaning of the term varied from food 
type to food type, but they would have to learn what the term meant in 
each food category if they were to use it in structuring a diet that 
conforms to dietary recommendations. Such a situation would defeat the 
purpose of the claim. Instead of being able to rely on the term as one 
that highlights foods that are particularly useful in structuring a 
healthy diet, consumers would be left to judge each food's place in the 
overall diet that they were consuming. For example, if the agency took 
into account the fact that some dairy products have a higher fat 
content than some other foods, and that some cheeses have a higher 
saturated fat content than some other foods, and so forth, consumers 
would be left with a situation in which even if they ate a significant 
number of foods labeled as ``healthy,'' they could have no confidence 
that their intake of these nutrients would be within dietary 
guidelines.
    The agency believes that the definition of ``healthy'' that it is 
establishing in this final rule will permit a sufficient number and 
variety of foods in all food categories to bear the term to help 
consumers achieve a total diet that is consistent with current dietary 
recommendations. Thus, the agency is not establishing a definition of 
``healthy'' that is based on unique nutrient criteria for each food 
category.
    2. A few comments stated that the definition of ``healthy'' should 
include alternative criteria that the product may meet to be able to 
bear the term. The comments argued that any product that can bear an 
approved health claim should be able to bear the term ``healthy.'' 
These comments asserted that for a food to make a health claim about 
one of its nutrients, it cannot contain levels of other nutrients that 
exceed disclosure levels. Thus, a food that can bear a health claim 
will not contain levels of a nutrient that will increase the risk of 
diet-related disease to the general population and in that regard 
represents a healthy food.
    The agency rejects these comments. A health claim is based on the 
relationship of a substance to a specific disease or health-related 
condition. While the provisions governing health claims do not permit 
such claims on products that contain nutrients at levels above the 
disclosure levels (see Sec. 101.14(e)), a product that bears a health 
claim may not be 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. While the agency 
recognizes that Congress anticipated that health claims can be used to 
reinforce the Surgeon General's recommendations and to help Americans 
maintain a healthful diet (H. Rept. 101-538, 101st Cong., 2d sess., 9-
10 (June 13, 1990)), the fundamental concerns that underlie a health 
claim are different from those that underlie the definition of 
``healthy.'' FDA's goal in defining ``healthy'' is to define the term 
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 dietary recommendations. The purpose of a 
health claim, on the other hand, is to make consumers aware of 
scientifically valid nutrient-disease relationships and of foods that 
have a level of the nutrient in question such that consumption of the 
food may help to affect the risk of developing the disease in question.
    In some circumstances these purposes overlap. In others they do 
not. For example, a woman in her 20's may wish to consume foods that 
are good sources of calcium, even though the levels of fat in such 
foods would not qualify them to bear a ``healthy'' claim. Thus, simply 
because a food qualifies to bear a health claim does not mean that it 
should also qualify to bear the term ``healthy.'' Consequently, the 
agency is not granting the comments' request to permit the term 
``healthy'' on foods that qualify to bear a health claim, unless, of 
course, the product also meets the definition of ``healthy.''
    3. Some comments argued that ``healthy'' is not an absolute claim 
but a relative claim, and that it should be regulated as such. These 
comments stated that when foods in a given product line have been 
reduced in fat, saturated fat, sodium, or cholesterol, and an 
appropriate reference food exists, the product should be able to make a 
``healthy'' claim. For instance, according to these comments, if a 
particular type of fat or oil, such as canola oil, has a lower amount 
of saturated fat than another type of oil, then the canola oil 
represents a healthier choice and should be able to bear the 
``healthy'' claim.
    The agency disagrees with these comments. As fully discussed above, 
the purpose of the ``healthy'' claim is to highlight those foods that, 
because of their nutrient profile, are useful in assisting consumers in 
structuring their diets to conform to dietary guidelines. The 
usefulness of a food labeled ``healthy'' is not based on how it 
compares to a similar food, but on how it contributes to achieving a 
total diet consistent with dietary recommendations. In contrast, the 
purpose of comparative claims is to distinguish those foods that 
contain modified levels of the specified nutrient when compared to the 
level of that nutrient in an appropriate reference food. Thus, the 
purpose of a ``healthy'' claim is significantly different from that of 
a comparative claim. While both types of claims can be beneficial to 
consumers in structuring their diets, they do different things. 
Therefore, the agency considers it inappropriate to define ``healthy'' 
as a comparative claim. However, the agency advises that products that 
bear a comparative claim such as ``reduced'' and ``less'' and meet the 
requirements for a ``healthy'' claim can bear both terms.

B. Need for Definition

    4. A few comments asserted that FDA did not have the authority 
under the 1990 amendments to define ``healthy'' because the statute did 
not set forth an intent or direction to regulate words and expressions 
that do not relate to the absence, presence, or quantity of nutrients 
in a food, preventive claims, or curative claims, all of which are 
subject to scientific verification. The comments further asserted that 
the 1990 amendments did not authorize FDA to extend express or implied 
nutrient content claim regulations in a manner that would prohibit 
words or descriptive free speech that may be useful to consumers in 
selecting foods that are helpful in achieving a total diet consistent 
with current dietary recommendations.
    One comment from a foreign government advised that its policy is to 
not allow food products to be described as ``healthy,'' although their 
labeling may bear statements that the food can be consumed as part of a 
healthy diet. Thus, the comment argued that such a provision would be a 
barrier to free trade with the United States.
    Other comments supported the agency's position to establish a 
definition for ``healthy.'' These comments stated that if the term were 
not defined, products that had the term in their brand names before 
October 1989 would be permitted to continue to use the term under the 
``grandfather'' provision (Sec. 101.13(q)(1) implementing section 
403(r)(2)(C) of the act) and thus continue to mislead consumers. The 
comments contended that unevenly restricting usage of the term would 
allow one company to use ``healthy'' in a brand name and preclude other 
manufacturers with equivalent or superior products from using the term.
    The agency does not agree with the comments that argued that it 
does not have authority to define ``healthy.'' Nor is it persuaded by 
those comments that argued that by establishing a definition for this 
term, FDA would be prohibiting words or descriptive free speech that 
could be useful to consumers. Establishment of a definition for 
``healthy'' when it is used in a nutritional context is required by 
section 403(r)(1)(A) of the act itself. When used in such a context, 
``healthy'' is making an implied claim about the levels of the 
nutrients in the food; that is, that these levels are such that the 
food would be useful in achieving a total diet that conforms to current 
dietary recommendations (56 FR 60421 at 60423, November 27, 1991). Such 
a claim, under the terms of section 403(r)(1)(A), would misbrand a food 
unless it is made in accordance with a definition of the Secretary 
(and, by delegation, FDA) or with one of the other provisions in 
section 403(r)(2) of the act.
    The agency has no intention of depriving consumers of information 
that may be useful to them in selecting foods that are helpful in 
achieving a total diet that is consistent with current dietary 
recommendations. The whole purpose of this rulemaking is to ensure that 
``healthy'' is defined in a way that enables consumers to have 
confidence that the foods that bear this term will in fact be useful 
for the purpose highlighted by the comment. The agency also points out, 
as pointed out by some of the comments, that because ``healthy'' is an 
implied nutrient content claim that was in use in the brand names of 
some foods before October 25, 1989, the term could continue to be used 
in the brand names of those foods if FDA did not define the term. A 
survey of those brand names shows, however, that ``healthy'' means one 
thing on one product and something else on another (58 FR 2944 at 
2946). Thus, it would in fact be contrary to the interest of consumers 
for FDA not to define this term because continuing use of the term 
would be in a confusing and inconsistent manner. It would also mean 
that foods that came onto the market after October 25, 1989, including 
those that are as, or are even more, useful than those that bore the 
term before the October 1989 date, would be unable to bear the term. 
Such a situation makes no sense.
    FDA fully considered the question of whether the nutrient content 
claims regime established by the 1990 amendments interfered with free 
speech in the nutrient content claims final rule (58 FR 2302 at 2392). 
The agency concluded that it did not. The discussion of this issue in 
the nutrient content claims final rule is incorporated herein. The 
comments that argued that defining ``healthy'' would prohibit 
descriptive free speech did not provide any basis for questioning the 
agency's earlier conclusion. Thus, FDA rejects these comments.
    FDA notes that preventive claims and curative claims, mentioned in 
some of these comments, were not the subject of the 1990 amendments. 
These claims are drug claims, not food claims. The 1990 amendments 
addressed only foods.
    In response to the comment from the foreign government, the agency 
recognizes that as a consequence of its decision to define ``healthy,'' 
some manufacturers may have to maintain dual label inventories for 
products that are exported to countries that do not permit ``healthy'' 
on the label. While it is not FDA's intent to hamper free trade, FDA 
concludes, based on the considerations that it has set out above, that 
it is necessary for it to define this term.
    5. A few comments urged FDA to regulate the term ``healthy'' as an 
implied nutrient content claim regardless of whether it is used in a 
nutritional context. The comments asserted that such a regulatory 
approach would provide consistent treatment of the term between USDA 
and FDA because USDA had not proposed a contextual basis for the use of 
the term ``healthy.'' Further, the comments argued that to do otherwise 
could confuse consumers, who are not likely to recognize that the 
meaning of the term may vary when it appears on different food labels. 
One of these comments contended that if use of the term is not subject 
to regulation as an implied nutrient content claim when the use is not 
in a nutritional context, e.g., when it is used as part of a brand name 
without accompanying nutrient content claims, FDA will be creating a 
substantial loophole to the new regulations. The comment argued that 
this loophole will result in misleading uses of the term in food 
labeling.
    Another of these comments stated that the agency's proposed 
definition recognizes that the term is, in essence, a nutrient content 
claim for multiple nutritional characteristics, and that therefore, the 
agency should not require that there be other statements that create a 
nutritional context before a ``healthy'' claim is treated as an implied 
nutrient content claim. This comment stated that the use of ``healthy'' 
in a brand name should also be regulated as an implied nutrient content 
claim because companies whose products cannot meet the agency's 
criteria for the term as an implied nutrient content claim will simply 
place it in their products' brand names and not make any other nutrient 
claim, as a means of avoiding the agency's definition.
    The agency is not persuaded by these comments that ``healthy'' 
should be regulated as an implied nutrient content claim when not used 
in a nutritional context. The comments have not provided the agency 
with information on which to conclude that consumers would not be able 
to discern the context in which the claim appears on the label. The 
agency does not believe that the term ``healthy'' inherently implies 
the absence or presence of a nutrient in a particular amount, or that 
the food that bears the term necessarily has a nutrient profile that 
would be helpful to consumers in structuring a diet that conforms to 
dietary guidelines. Rather, such inferences are likely to be drawn only 
if the term ``healthy'' is accompanied by additional language or 
graphic material or is otherwise presented in a context that explicitly 
or implicitly suggests that the food has a particular nutrient profile.
    FDA believes that when ``healthy'' is used in a context in which it 
is not an implied nutrient content claim, the consumer will be able to 
understand that fact. For example, in the statement ``eat lots of 
fruits and vegetables for a healthy diet,'' the term ``healthy'' does 
not imply the absence or presence of a nutrient in a particular amount, 
nor does it imply that the food bearing the term is particularly useful 
in achieving dietary recommendations. Instead, the term is used to 
provide general dietary guidance. Thus, such a statement would not be a 
claim subject to the requirements of section 403(r) of the act.
    The determination as to whether the use of the term alone or in a 
brand name conveys a message about the usefulness of the food in 
achieving dietary recommendations because of its nutrient content is 
appropriately made on a case-by-case basis. Simply moving ``healthy'' 
from a claim elsewhere on the label to the brand name does not 
necessarily change the context in which the claim is made or cause the 
term not to be an implied claim. For example, the statement ``low in 
fat'' on the label of a food with the brand name ``Healthy Bites'' 
would place the term ``healthy'' into a nutritional context and subject 
it to the provisions of section 403(r) of the act. Likewise, the 
statement ``high in oat bran,'' that implies that the food is high in 
fiber, on the label of a food bearing the term ``healthy'' in the brand 
name would place the term into a nutritional context.
    Additionally, there may be instances when the use of a vignette on 
the label of a food bearing ``healthy'' would place the term in a 
nutritional context. Furthermore, the term ``healthy'' in a brand name 
may be placed in a nutritional context, even in the absence of other 
label claims, statements, or vignettes, for example, when the brand 
name covers a variety of products that are advertised and marketed as 
``healthy'' because of their nutrient profile. The agency advises that 
in such circumstances, the use of the brand name itself is conveying a 
message to consumers about the nutrient profile of the product. The 
product line is represented as including foods that are useful in 
assisting consumers in structuring a diet that is consistent with 
current dietary recommendations. Thus, the agency is establishing in 
this final rule a definition for ``healthy'' when it is used in a 
nutritional context on the label, in the labeling, or in the 
advertising for a food product. Such a context is established when 
``healthy'' appears in association with an explicit or implicit claim 
or statement about a nutrient, or when the term appears in a brand name 
that by virtue of its use implies that the product is useful in 
achieving dietary recommendations.
    Even when ``healthy'' is not used in a nutritional context, 
however, as fully discussed in the ``healthy'' proposal (58 FR 2944 at 
2945), the agency would have significant reservations about the use of 
this term if it appears on a product that has nutrients at levels that 
exceed their disclosure levels as established in Sec. 101.13(h). It 
seems highly unlikely that the use of this term on a product that 
contains a nutrient at a level that would not assist consumers in 
maintaining healthy dietary practices would not be misleading.
    Consequently, the agency concludes that it is possible that 
``healthy'' could be used in food labeling in a way that would not 
subject its use to regulation as a nutrient content claim, and the 
agency's regulatory approach appropriately must recognize that fact. 
Nonetheless, FDA finds that under section 403(a) of the act, it has 
ample authority to ensure that ``healthy'' is not used in a misleading 
manner, even when it is not used in a nutritional context.
    6. In its January 6, 1993, proposal, FDA solicited comment on 
whether it should adopt a regulation using its authority under the 
general misbranding sections of the act, sections 201(n) (21 U.S.C. 
321(n)), 403(a), and 701(a) (21 U.S.C. 371(a)), to provide further 
guidance on the circumstances under which use of ``healthy'' in a 
context that is not nutritional might be false or misleading and thus 
misbrand the product. The agency stated that if comments supported 
adopting such a regulation, FDA would consider doing so in this final 
rule. In response, two comments stated that FDA should provide further 
guidance on the circumstances under which use of the term ``healthy'' 
might be false or misleading but did not provide suggestions on how 
such circumstances should be defined. The majority of comments, 
however, did not ask FDA to provide further guidance. Many comments 
stated that the guidance in the preamble to the proposal is sufficient 
to regulate use of the term when it is not an implied nutrient content 
claim. In addition, some comments stated that it is appropriate to 
determine on a case-by-case basis whether the term, when not used in a 
nutritional context, violates the requirements of section 403(a) of the 
act and thus misbrands the product.
    The agency has concluded that the comments have not supported 
adoption of regulations under section 403(a) of the act on ``healthy'' 
when this term is not used in a nutritional context in labeling. Thus, 
FDA is not establishing additional regulations but will make a 
determination as to whether the use of the term is false or misleading 
under section 403(a) of the act on a case-by-case basis.

C. Terms Subject to Definition

    7. Several comments requested that FDA extend the definition of 
``healthy'' to terms like ``health,'' ``healthful,'' and other 
derivatives of ``healthy'' to be consistent with the use of the term 
proposed by USDA. A few of these comments asserted that unless the 
definition of ``healthy'' applies to the derivatives of this term, 
consumers will be confused by the use of the derivatives on the labels 
of products that do not qualify for the ``healthy'' definition.
    The agency finds merit in these comments and concludes that the 
definition of ``healthy'' should also apply to the use of any of its 
derivatives in a nutritional context. The agency believes that 
derivatives of ``healthy'' have the same general meaning and 
connotation as this term and, thus, when used in food labeling may be 
construed by consumers to imply that the products on which they appear 
will be helpful in maintaining healthy dietary practices. Therefore, 
the agency concludes that it is appropriate to require that when any of 
the derivatives of ``healthy'' are used in a nutritional context in 
food labeling, their use be in accordance with the definition of 
``healthy'' in Sec. 101.65.
    FDA finds that providing for the use of derivatives of ``healthy'' 
in the definition of that term is the logical outgrowth of the 
proposal. As stated above, USDA proposed this action, and FDA asked in 
its proposal whether its regulations should be consistent with USDA's. 
These comments urged that the coverage of the two agency's definitions 
should be consistent. FDA has concluded that it is appropriate to 
include the derivative terms in its definition because doing so will 
promote consistent use of these terms in the marketplace on both FDA 
and USDA regulated products.
    Accordingly, the agency is revising proposed Sec. 101.65(d)(2) to 
include derivatives of ``healthy'' in the definition of that term when 
they are used to characterize the level of a nutrient in a food. The 
derivatives of ``healthy'' include, but are not limited to, the terms 
``health,'' ``healthful,'' ``healthfully,'' ``healthfulness,'' 
``healthier,'' ``healthiest,'' ``healthily,'' and ``healthiness.''
    8. A few comments urged FDA to extend the definition of ``healthy'' 
to terms like ``wholesome,'' ``nutritious,'' ``good for you,'' and 
``food for today's diet.'' One of these comments further stated that if 
FDA adopts a stringent definition for ``healthy,'' and fails to apply 
it to synonymous terms, the food industry might simply replace 
``healthy'' with these other terms.
    While the agency recognizes that terms such as ``nutritious,'' 
``wholesome,'' and ``good for you'' can be implied nutrient content 
claims when they appear in a nutritional context on a label or in 
labeling, the agency does not believe that they are necessarily 
synonymous with ``healthy.'' FDA has concluded, as stated in the 
general principles final rule (58 FR 2302 at 2375), that it does not 
have sufficient information to determine whether definitions for the 
terms mentioned in these comments are needed, and what those 
definitions should be. The comments to the ``healthy'' proposal have 
not provided the agency with the information that it would need to 
develop definitions or to establish these terms as synonyms for the 
term ``healthy.'' Thus, the agency is not extending the definition of 
``healthy'' to these terms.
    However, the agency advises that when these terms appear in 
association with an explicit or implicit nutrient content claim or 
statement about a nutrient, they will be implied nutrient content 
claims and subject to the provisions of section 403(r) of the act. 
Thus, the use of such claims, if they are not defined by the agency, or 
if they are not exempted through the ``grandfather'' provision, would 
cause the product to be misbranded and subject to regulatory action. 
Furthermore, when these terms appear on the label other than in 
association with an explicit or implicit nutrient content claim or 
statement about a nutrient, they are subject to regulation under the 
general misbranding provisions of section 403(a) of the act. Therefore, 
if a firm is considering using such terms on its label or in its 
labeling in a nutritional context, it should petition FDA to define the 
term under section 403(r)(2)(A)(i) of the act.

D. Covered Products

    9. Some comments opposed FDA's proposal to define ``healthy'' on 
the grounds that this term is more appropriately applied to overall 
diets that include fresh fruits, vegetables, low fat dairy products, 
and grains than to an individual food, main dish, or meal product. 
These comments urged FDA to prohibit the use of the term on food labels 
because it describes the total diet, is misleading to consumers, 
reinforces the ``good food-bad food'' concept, and could easily lead a 
consumer to overconsume those products labeled as ``healthy'' rather 
than consuming a variety of foods. These comments further stated that 
consumers may rely on the claim rather than on specific information on 
the food label to determine the place of the food in the total diet. 
Finally, the comments contended that a ``healthy'' claim would 
undermine terms like ``low'' and ``reduced,'' and that selecting foods 
labeled ``healthy'' does not necessarily lead to a healthy diet.
    Other comments supported the use of ``healthy'' on individual foods 
and meal-type products. These comments asserted that there is no sound 
reason to limit the use of the term to meals or main dishes. These 
comments contended that if properly defined and regulated, the claim 
can be useful in assisting consumers in achieving current dietary 
recommendations.
    A few comments recommended the use of ``healthy'' only on meal-type 
products. One comment further stated that the 1990 amendments do not 
contain language indicating that nutrient content claims may be limited 
to meals or main dishes.
    FDA rejects the comments that argued that ``healthy'' is more 
appropriately applied to overall diets than to individual foods, main 
dishes, or meal products (main dishes and meal products may be referred 
to collectively as ``meal-type products''). As stated in the 
``healthy'' proposal, FDA believes that foods labeled with the term 
``healthy,'' whether they are individual foods, main dishes, or meals, 
can be used with a variety of foods to assist consumers in maintaining 
healthy dietary practices (58 FR 2944 at 2946). The comments have not 
provided convincing information to the contrary. In fact, polls and 
surveys that are discussed in other comments have shown that depending 
on the context in which the term is used, many consumers perceive 
``healthy'' in food labeling as describing some aspect of the nutrient 
content of the product. Because consumers perceive the term as 
describing the nutrient content of the food, the agency concludes that, 
if accurately defined, the term can be useful in helping consumers 
select those foods that will promote a diet consistent with dietary 
guidelines. Thus, the agency concludes that it is appropriate to 
establish regulations governing use of ``healthy'' as an implied 
nutrient content claim when it is used in such a context.
    As stated above, the polls and surveys discussed by the comments 
show that, in a nutritional context, ``healthy'' conveys a strong 
message about the nutrient content of a food. One of the goals of the 
1990 amendments was to encourage manufacturers to provide a wider 
selection of foods with improved nutrient content to facilitate diets 
that conform to guidelines. The agency believes that defining 
``healthy,'' particularly in the manner that FDA has done in this final 
rule, will encourage such innovation. The term will be reserved for 
those products that, based on their nutrient profile, will be useful in 
assisting consumers in structuring diets that conform to current 
dietary recommendations.
    The agency recognizes, as stated in one comment, that consumers may 
tend to rely on the ``healthy'' claim rather than reading specific 
information on the label. Thus, the agency accepts that it must define 
``healthy'' in a way that ensures that, even if consumers do not read 
the full label, foods that bear the term will be useful in structuring 
a healthy diet. FDA believes that such a definition can be crafted, and 
that it has in fact done so in Sec. 101.65(d).
    The agency further concludes that ``healthy'' should be permitted 
on both individual foods and meal-type products. Given the fact that 
both types of foods make significant contributions to the overall diet, 
FDA is aware of no reason why consumers should not be appropriately 
advised about the usefulness of individual foods, as well as of meal-
type products, in achieving a healthy diet. If the agency permitted the 
claim only on foods packaged as meal-type products, those consumers who 
chose to construct their diet primarily from foods packaged as 
individual foods would not have the same benefit of assistance in 
selecting foods that are useful in achieving a total diet that is 
consistent with current dietary recommendations. FDA finds, in deciding 
to define ``healthy,'' that such assistance can be appropriately given. 
Therefore, the agency is rejecting the comments that the use of 
``healthy'' should be limited to meal products.
    10. One comment suggested that if the term ``healthy'' is allowed 
on meal-type products, FDA should require label statements that state 
that additional foods such as lowfat milk, fruit, or whole grain bread 
or rolls be served with the meal, so that at least one serving of all 
five food groups suggested by the Food Guide Pyramid are included in 
the meal.
    The agency rejects this suggestion. The comment did not provide any 
information on which FDA could make a finding that the type of label 
statement suggested by the comment is necessary to ensure that 
consumers understand the proper place in the diet of a product labeled 
``healthy'' or how the food's use conforms to the recommendations of 
the Food Guide Pyramid. Consumers who follow the Food Guide Pyramid 
will have on the label, through the product's statement of identity, 
the Nutrition Facts declaration, and the ingredient statement, the 
information necessary to determine the components and nutritional 
profile of the product, and where the product fits into the Food Guide 
Pyramid. The agency believes that by using the information available on 
the label, consumers will be able to determine the basic food groups 
that are represented among the product's ingredients and the number of 
servings of each of these food groups that the product contributes. 
Consequently, the agency believes that consumers will be able to 
determine the types of food that should be used to supplement the 
``healthy'' product in order to meet the recommendations of the Food 
Guide Pyramid without any additional information in the labeling.
    Thus, FDA is not granting the request that additional label 
statements be required on products that meet the ``healthy'' 
definition. However, the agency will not object if manufacturers choose 
to offer guidance as to how their product may be used to achieve a diet 
that conforms with the Food Guide Pyramid, as long as the guidance is 
not false or misleading.
    11. One comment argued that the proposed definition for ``healthy'' 
was not appropriate for foods for babies, toddlers, and children. It 
stated that the nutrients included in the proposed definition (fat, 
saturated fat, sodium, and cholesterol) may not necessarily be 
undesirable for infants and young children. This comment urged FDA to 
establish separate criteria for the use of ``healthy'' on foods for 
babies, toddlers, and children. However, the comment did not offer any 
suggestions on how the claim should be defined.
    FDA recognizes that the definition for ``healthy'' that it is 
adopting in this final rule is not appropriate for foods for infants 
and children less than 2 years of age, in part because it is 
inconsistent with the guidance provided by various health authorities 
that fat and cholesterol should not be restricted in the diets of 
infants (Ref. 1). The regulation on general provisions for nutrient 
content claims provides in Sec. 101.13(b)(3) that nutrient content 
claims may not be made on foods intended specifically for use by 
infants and children less than 2 years of age unless a regulation 
specifically provides for such a claim on such foods. The agency finds 
that there is nothing in the record of this rulemaking that would 
support a conclusion that a ``healthy'' claim should be defined for 
foods intended for infants and children less than 2 years of age, nor 
would anything in the record allow the agency to decide what such a 
definition should be. Accordingly, the agency is not establishing 
separate criteria for the use of ``healthy'' on foods for infants and 
children less than 2 years of age. The agency notes, however, that 
interested persons may submit a petition under Sec. 101.69 (21 CFR 
101.69) with appropriate information that would provide a basis on 
which the agency could determine that a ``healthy'' claim would be 
appropriate on foods for infants and children less than 2 years of age.
    12. One comment stated that the proposed regulation governing the 
use of the ``healthy'' claim would be inappropriate for restaurant 
foods because restaurant foods differ markedly from foods sold at 
retail. The comment asserted that because the portion size of a 
restaurant food may be adjusted to meet the criteria for the claim, the 
definition of ``healthy'' should be on a per ounce basis. If the 
definition is not established on a per ounce basis, the comment 
continued, 10 ounces of food in a meal may not be able to bear the 
term, whereas a 5 ounce portion of the same food would qualify to bear 
the term. The comment recommended that different criteria be 
established for restaurant foods so that the larger portions of food 
served in restaurants would be able to qualify. It suggested that to 
bear a ``healthy'' claim, one composite ounce of the main food in the 
meal should not contain more than 30 percent of its calories from fat 
and not more than 10 percent of calories from saturated fat. The 
comment stated that, thus, the overall meal would meet the proposed 
requirement for ``healthy.''
    The agency advises that there is no basis for the concern expressed 
in this comment. While FDA recognizes that restaurant foods differ from 
packaged foods in the manner in which they are prepared and sold, it 
has determined that the differences between restaurant foods and 
packaged foods are not so great as to preclude restaurants from making 
claims based on the same criteria that apply to other foods (58 FR 2302 
at 2387). A restaurant food may bear a ``healthy'' claim if the 
restaurateur has a reasonable basis on which to believe that the food 
that bears the claim meets the definition of ``healthy'' established in 
this final rule. (Claims made on menus are currently exempt from the 
requirements of this final rule and are being addressed in an ongoing 
rulemaking (58 FR 33055, June 15, 1993).)
    The reasonable basis can be provided in a number of ways. The 
restaurateur could show, for example, that he or she relied on a 
trustworthy cookbook that gave values for the specified nutrients in 
the finished food, and that such levels comply with the requirements 
for the ``healthy'' claim. A restaurateur could also use recognized 
data bases for raw and processed foods to compute nutrient levels in 
the foods or meals and then not use methods of preparation that violate 
the appropriate use of those data bases (e.g., uncontrolled addition of 
ingredients or inappropriate substitutions of ingredients). Thus, the 
agency is not providing a different basis for the definition of 
``healthy'' for restaurant foods.
    Claims on restaurant foods that are individual foods must be based 
on the reference amount customarily consumed regardless of the portion 
size. For restaurant foods that are main dishes or meals, the claims 
are made on a per 100 g basis for the entire amount of food offered as 
a portion or a meal. These requirements should preclude the kind of 
misleading adjustments in serving size described in the comment.

E. The Definition

    The agency proposed in the Federal Register of January 6, 1993 (58 
FR 2944 at 2949), that the term ``healthy'' be permitted on products 
that meet the definitions for ``low fat'' and ``low saturated fat'' and 
that do not exceed the disclosure levels for sodium and cholesterol. 
The agency specifically solicited comment on whether the proposed 
definition of ``healthy'' was appropriate, or whether the definition 
should include a requirement that the food be ``low'' in a third 
nutrient i.e., sodium or cholesterol, or if the food should also be 
``low calorie.'' In addition, FDA asked for comment on whether a 
definition that may not permit lean meat and poultry to bear the claim 
would help consumers to achieve a total diet that is consistent with 
current dietary recommendations. Finally, the agency solicited comment 
on whether a product labeled ``healthy'' should supply a certain amount 
of specified essential vitamins, minerals, or other nutrients (e.g., 
protein).
1. Fat and Saturated Fat
    13. Many of the comments supported the ``low fat'' and ``low 
saturated fat'' requirements in the proposed definition of ``healthy.'' 
These comments agreed with the agency's position that a product labeled 
``healthy'' should have restricted amounts of fat and saturated fat, so 
that the product will be helpful to consumers in structuring a diet 
that conforms to dietary guidelines.
    Other comments argued that the proposed fat and saturated fat 
criteria are too stringent. A few of these comments contended that a 
food may be healthy if it has a moderate amount of fat or saturated fat 
and is low in other nutrients that also are of public health 
significance, such as cholesterol or sodium.
    A few comments suggested that the definition of ``healthy'' should 
be revised so that a product would be allowed to bear the term 
``healthy'' if the amounts of fat and saturated fat do not exceed the 
disclosure levels for these nutrients. A similar comment suggested that 
in addition to the disclosure levels as limits for fat and saturated 
fat, one of these nutrients should meet the ``low'' criterion. The 
comment contended that such a definition would provide greater 
flexibility for manufacturers to educate and assist consumers in 
maintaining healthy dietary practices.
    Another comment recommended that a food should be able to qualify 
to bear the term ``healthy'' if it contains one half the disclosure 
levels for fat and saturated fat. According to the comment, the 
definition would then be 10 percent daily value (DV) for individual 
foods, 15 percent DV for main dishes, and 20 percent DV for meals.
    The agency disagrees with the latter group of comments and 
concludes that the ``low fat'' and ``low saturated fat'' requirements 
in the proposal are appropriate for the definition of ``healthy.'' The 
agency rejects the comment that recommended using one half the 
disclosure levels as limits for fat and saturated fat. Aside from the 
fact that the comment did not provide a rationale for why such a 
definition would assist consumers in achieving diets consistent with 
dietary guidelines, the agency concludes that such a level would not 
sufficiently limit the amount of fat and saturated fat in a product 
labeled ``healthy'' to assist consumers in achieving dietary 
recommendations while giving them the flexibility of selecting a 
variety of other foods. Thus, such a level would defeat the purpose of 
the ``healthy'' claim.
    As for the use of disclosure levels, FDA finds that such levels 
cannot be used to limit or lower the daily intake of these nutrients. 
The disclosure levels established for fat and saturated fat, as well as 
other nutrients, were not intended to be used to limit or lower the 
daily intake of these nutrients but rather to ensure that a food that 
bears a nutrient content claim does not contain a nutrient at a level 
that may increase the risk of a diet-related disease (56 FR 60537 at 
60543). The agency's intent in defining the term ``healthy'' is to 
identify those foods that are particularly helpful in constructing a 
total diet that is consistent with dietary recommendations. FDA 
considers it likely that individuals will make an array of food 
choices, and tying the term ``healthy'' to the disclosure levels would 
mean allowing this term to appear on foods that will not contribute to 
achievement of the recommended levels. Such a result would not be 
consistent with the agency's purposes in defining this term.
    The agency finds that the requirements that fat and saturated fat 
levels meet the ``low'' definition are appropriate because these 
restrictions recognize the need to reduce dietary intake of fat and 
saturated fat as recommended by the Surgeon General and the Food and 
Nutrition Board (Refs. 2 and 3). Therefore, they will assist consumers 
in constructing a total diet that is consistent with dietary 
recommendations. Accordingly, the agency is not revising the criteria 
that it proposed with respect to the levels for fat and saturated fat 
in the definition of ``healthy.''
    14. One comment recommended that in addition to the requirement 
that fat and saturated fat meet the ``low'' definition, FDA should 
further limit the amount of these nutrients in main dishes and meal 
products that qualify to bear the term ``healthy.'' The comment 
proposed caps of 10 g of total fat and 4 g of saturated fat. In support 
of the suggested criteria, the comment stated that these caps would 
serve two purposes:
    (1) They would be consistent with USDA's proposed definition of 
``healthy,'' thereby avoiding confusion over the different levels of 
fat and saturated fat that may be in FDA-regulated products labeled 
``healthy'' and USDA-regulated products labeled ``healthy''; and
    (2) They would assure consumers that ``healthy'' foods are among 
the lowest in fat and saturated fat in the marketplace.
    The agency has not been persuaded by this comment that further 
limitations are necessary or appropriate for meal-type products labeled 
``healthy.'' As stated in response to the previous comment, FDA 
believes that the ``low'' criteria for fat and saturated fat recognize 
the need to reduce dietary intake of fat and saturated fat. FDA further 
believes that the ``low'' criteria are sufficient to assist consumers 
in restricting their fat and saturated fat intake, without being so 
restrictive that it would preclude a sufficient number and variety of 
foods from bearing the claim.
    Furthermore, FDA believes that the underlying intent of the comment 
in recommending caps was really to urge FDA and USDA to establish 
consistent and uniform definitions to minimize consumer confusion. In 
fact, the two agencies have consistent definitions of ``healthy.'' 
Elsewhere in this issue of the Federal Register, USDA is establishing a 
definition of the term ``healthy'' and its derivatives, as applied to 
meat and poultry products, that is consistent with the definition that 
FDA is establishing in this document.
    15. Another comment, which also recommended additional criteria for 
meal-type products, stated that in addition to the ``low fat'' and 
``low saturated fat'' requirements, foods labeled with the term 
``healthy'' should contain no more than 30 percent of calories from fat 
and less than 10 percent of calories from saturated fat.
    The agency advises that, as discussed in the ``healthy'' proposal 
(58 FR 2944 at 2947), the definitions for ``low fat'' and ``low 
saturated fat'' for meal and main dish products, include a second 
criterion that requires that the food bearing the claim contain no more 
than 30 percent of calories from fat and less than 10 percent of 
calories from saturated fat respectively. Consequently, no changes in 
Sec. 101.65(d) are necessary in response to the comment.
2. Sodium
    16. Several comments that supported the proposed requirement that a 
food bearing the term ``healthy'' be ``low fat'' and ``low saturated 
fat'' urged the agency to also require that the product meet the 
definition for ``low sodium.'' One comment cited the results of a 
national survey conducted by the National Consumers League (NCL) that 
showed that 81 percent of the respondents thought that a food labeled 
as ``healthy'' was low in fat and sodium. The comment contended that, 
thus, a definition for ``healthy'' that does not require the food to be 
low in sodium is inconsistent with consumer perception. Other comments 
also cited the NCL survey as well as other surveys that showed that 
consumers view the term ``healthy'' as a claim for sodium. Some 
comments stated that levels for sodium proposed by FDA are not 
consistent with the Dietary Guidelines' recommendation of limiting 
sodium intake to 2,400 mg a day. The comments argued that at the 
proposed levels for sodium, a packaged meal-type product, which 
typically provides 250 to 450 calories, could provide up to 40 percent 
of the DV for sodium. This amount of sodium from one meal could easily 
cause a consumer to exceed 2,400 mg of sodium per day.
    Other comments recommended that FDA adopt USDA's proposed limit of 
480 mg sodium. Several comments expressed the belief that sodium is a 
nutrient that is as closely associated with diet-related disease as 
either fat or saturated fat. They argued, therefore, that ``healthy'' 
should represent a substantially reduced level of sodium. Other 
comments stated that individual foods should meet the ``low'' 
definition for sodium (140 mg or less per reference amount), and that 
meal-type products should contain no more than 480 mg of sodium. One of 
these comments asserted that a level of sodium above 480 mg may not be 
helpful to consumers who will consume meal-type products labeled 
``healthy'' frequently as a way of achieving recommended DV's.
    Other comments on this issue supported the agency's proposal to 
permit the term ``healthy'' on products that did not exceed disclosure 
levels for sodium. These comments stated that a ``low sodium'' 
requirement would disqualify many products that are helpful in 
assisting consumers to meet recommended dietary goals.
    One comment argued that the proposed levels for sodium were too 
low, and that the agency should not regulate the amount of sodium in 
products permitted to bear the term ``healthy.'' The comment asserted 
that sodium is used in food as a necessary processing agent and 
preservative (e.g., for binding protein, for developing flavor 
profiles, and for retarding spoilage). This comment argued that there 
is not yet sufficient research to determine a precise ``minimum'' or 
necessary sodium content to guarantee safety against microbiological 
contamination. In addition, the comment asserted that sodium is used 
not only to assist in preservation but also for taste. It added that, 
if the sodium in a product is so low as to render the product tasteless 
or even bad tasting, consumers will not eat the product or will add 
salt at the table, which could result in greater sodium intake. The 
comment asserted that the goal should be to reduce the current overall 
dietary intake of sodium and not to set a specific sodium requirement 
that must be met before a product could bear the claim. During the 
comment review period, this respondent submitted a supplemental 
comment, restating the concern that the proposed sodium levels were 
inappropriate. However, the supplemental comment recommended that FDA 
revise its proposal to permit any product that contained 600 mg or less 
of sodium and that otherwise met the requirements to bear the claim 
``healthy.'' The comment stated that this recommendation was based in 
part on information that food with lower salt levels may not behave the 
same as foods with at least 600 mg of sodium with regard to moisture 
retention, flavor profile, and shelf life. However, the comment did not 
provide data to support its position.
    The agency has considered all of the comments and is persuaded that 
it is not appropriate to allow individual foods or main dish or meal 
products that contain amounts of sodium equal to the disclosure level 
to bear the term ``healthy.'' Based on information received in the 
comments, FDA finds that consumers expect ``healthy'' to be a claim for 
sodium in addition to other nutrients. FDA's proposal to use the 
disclosure levels as the limit for sodium and cholesterol was premised 
on its tentative view that to help consumers to comply with dietary 
recommendations, it was most important to highlight foods with low fat 
and saturated fat levels, and that it would be adequate to ensure that 
the amounts of sodium and cholesterol in foods that bore a ``healthy'' 
claim did not exceed disclosure levels. Having been persuaded that 
consumers will be using foods labeled as ``healthy'' to limit their 
sodium intake to achieve current dietary recommendations, the agency 
finds it appropriate to restrict the amount of sodium in a product that 
qualifies to bear the term. Foods that contain sodium at the disclosure 
level will not be useful for this purpose. (FDA will discuss 
cholesterol in the next section of this document.)
    While FDA agrees with the comments that argue that ``healthy'' 
should only be permitted on products that help the consumer in reducing 
sodium intake to meet dietary recommendations, FDA has not been 
persuaded that the best approach in achieving this goal is to 
incorporate a ``low sodium'' requirement in the definition of 
``healthy.'' FDA concludes that a definition that requires ``low'' 
sodium would be too restrictive because such a requirement would 
disqualify many products that would be useful in maintaining a diet 
that conforms to current dietary guidelines. Foods such as raw beet 
greens, canned white corn, canned carrots, many breakfast cereals, 
legumes, low fat dairy products, and other foods that are useful in 
following dietary guidelines would be disqualified with a ``low 
sodium'' requirement. While FDA recognizes that manufacturers will have 
to reformulate many of their processed products to meet the definition 
of ``healthy'' that it is adopting, the agency is concerned that many 
processed foods, as well as certain fresh foods, that would otherwise 
meet the definition would be disqualified with a ``low sodium'' 
requirement. The agency believes that for the 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.
    Further, as stated in the comments, sodium plays an important role 
in consumer acceptance of a product. FDA believes that if, in addition 
to the ``low fat'' and ``low saturated fat'' requirements, it were to 
define ``healthy'' to include a ``low sodium'' requirement, the appeal 
of many products would be diminished because of an unacceptable flavor 
profile, especially in foods where sodium has been added as a flavoring 
agent to compensate for the removal of fat. Thus, if consumers abandon 
the product or add salt to taste at the table, the food would lose its 
usefulness in assisting consumers in achieving dietary recommendations 
with respect to sodium intake. Thus, the agency has concluded that 
while the disclosure level is too high for sodium in a food bearing a 
``healthy'' claim, a ``low sodium'' criterion is not a viable option.
    The agency considered the recommendation by one of the comments 
that the sodium criterion for ``healthy'' be no more than 600 mg of 
sodium. It concluded that such a level for individual foods would be 
inappropriate because it exceeds the disclosure level and would not 
assist consumers in maintaining healthy dietary practices. Furthermore, 
such a criterion could cause frequent use of foods labeled ``healthy'' 
to result in an overall diet inconsistent with current dietary 
guidelines. If, for example, an individual at one of four eating 
occasions were to consume at least four individual foods that were 
labeled ``healthy,'' and each contained 600 mg of sodium, he or she 
would have reached the Reference Daily Intake (RDI) for sodium (i.e., 
2,400 mg) in that one eating occasion. Because of the ubiquity of 
sodium in the food supply, it is unlikely that at the remaining eating 
occasions all of the foods consumed would be free of sodium. Thus, in 
the course of a day, the person's overall sodium intake would exceed 
the RDI and result in an overall diet inconsistent with 
recommendations.
    With regard to meal-type products, a requirement that the food 
contain no more than 600 mg would be more helpful in meeting dietary 
guidelines than the disclosure levels of 720 mg and 960 mg for main 
dishes and meals, respectively. However, 600 mg of sodium in meals and 
main dishes would not provide consumers with the flexibility of eating 
other foods that do not restrict the amount of sodium but that can help 
in other ways to achieve current dietary recommendations. Although the 
comment that suggested a level of 600 mg raised a concern that lower 
sodium levels could affect the viability of some products, the agency 
is not aware of data that establish a threshold level of sodium needed 
for a wide variety of foods, and the comment did not provide any data 
to support its claim. While 600 mg sodium may be necessary to produce 
and distribute certain foods, FDA believes that there is a wide variety 
of foods for which such a level is not needed. There are currently many 
individual foods and meal-type products on the market that contain less 
than 600 mg sodium (Ref. 4).
    Based on the comments, the agency is persuaded that a mealtype 
product bearing the term ``healthy'' should contain no more than 480 mg 
of sodium per labeled serving. This level is the level for sodium that 
USDA is adopting in its definition of ``healthy'' for meal-type 
products. Such a requirement is appropriate because it is low enough to 
ensure that foods that comply with it will be helpful in assisting 
consumers in achieving current dietary goals and will also give 
consumers who eat such foods the flexibility to consume foods whose 
sodium content is not restricted, such as breakfast cereals and some 
dairy products. At the same time, the agency believes that, based on 
the sodium levels of products currently available, this level is not so 
low that it would significantly affect the appeal of meals or main 
dishes that contain this level of sodium. Thus, the agency is revising 
its definition of ``healthy'' in Sec. 101.65(d)(4)(ii)(B) to provide 
that if the food is a main dish or meal product the level of sodium in 
the product cannot exceed 480 mg.
    With regard to individual foods, the agency has scrutinized the 
comments in seeking an appropriate level for sodium. As previously 
discussed, the agency considers it inappropriate to include a ``low 
sodium'' criterion in the definition of ``healthy.'' It is not the 
agency's desire to so narrowly define the term ``healthy'' that it 
would disqualify many foods that are recommended to be included in the 
diet and that could assist consumers in meeting dietary goals. Nor is 
it the agency's desire to have a definition that permits nutrients at 
levels that would not be helpful in assisting consumers in achieving 
current dietary goals. While FDA has been persuaded that the definition 
of ``healthy'' should restrict the level of sodium so that foods 
bearing the claim will be helpful in reaching dietary goals, the agency 
does not believe that the levels suggested in comments represent 
appropriate sodium levels for individual foods.
    To fulfill the purposes of a ``healthy'' claim, FDA has concluded 
that the sodium criterion for ``healthy'' must be significantly less 
than the disclosure level that it proposed in the January 6, 1993, 
issue of the Federal Register (58 FR 2944 at 2949) and yet higher than 
``low sodium.'' In trying to arrive at such a level, FDA decided to 
examine the dietary effects of 25 percent and 50 percent reductions 
from the disclosure level. The agency has determined, as stated in the 
general principles final rule (58 FR 2302 at 2346), that a reduction of 
at least 25 percent in the level of the nutrient from the level of the 
same nutrient in an appropriate reference food is a significant 
reduction. Applying a 25 percent reduction to the disclosure level for 
sodium in individual foods, the agency arrived at a level of 360 mg 
(i.e., 480 mg  x  .25 = 120; 480 - 120 = 360). Likewise, applying a 50 
percent reduction to the disclosure level for sodium in individual 
foods, the agency arrived at a level of 240 mg.
    In evaluating the appropriateness of these levels as a sodium 
criterion for the term ``healthy,'' the agency found that a level of 
240 mg of sodium would, like ``low'' sodium, disqualify many foods that 
are recommended to be included in a healthy diet. Thus, the agency 
rejected this level. However, in evaluating a level of 360 mg of sodium 
the agency found:
    (1) That this level will assist consumers in constructing a diet 
consistent with dietary guidelines;
    (2) That it is an amount of sodium that could be reasonable for a 
wide variety of foods to use the ``healthy'' definition without 
compromising the appeal of the food (Ref. 4);
    (3) That the level is not so restrictive that it is likely to 
disqualify many foods that are recommended to be included in a healthy 
diet; and
    (4) That this level is consistent with the requirement that is 
being adopted by USDA elsewhere in this issue of the Federal Register. 
Because this level satisfies the criteria for an appropriate sodium 
level, FDA decided to adopt it.
    The agency notes that these factors distinguish the use of a 
percent reduction from the disclosure level for sodium from the use of 
a similarly derived level for fat, which the agency refused to do. As 
stated above, use of a level for fat that is derived from a percent 
reduction of the disclosure level would not adequately serve the 
purposes that are to be achieved by a ``healthy'' claim. However, for 
sodium, such reduction provides an appropriate level.
    Thus, the agency is revising its proposed definition of the term 
``healthy'' in Sec. 101.62 (d)(2)(ii) and (d)(3)(ii) to require that 
individual foods bearing the claim ``healthy'' contain no more than 360 
mg of sodium per reference amount customarily consumed (reference 
amount) and per labeled serving.
    The agency is concerned, however, that this approach will not 
effectively control misleading claims on nutrient-dense foods with 
small serving sizes. The agency has addressed a similar concern in the 
definition of ``low.'' As fully discussed in the general principles 
final rule (58 FR 2302 at 2317), the agency concluded that in order to 
prevent misleading ``low'' claims on nutrient-dense foods with small 
serving sizes, a weight-based criterion should be applied to these 
foods. Thus, the agency adopted a per 50 g requirement for foods with a 
reference amount of 30 g or less or 2 tablespoons or less. The agency 
believes that a similar approach is warranted in the definition of 
``healthy.'' Without a weight-based criterion for foods with small 
serving sizes, foods such as rye wafers would be able to bear the 
``healthy'' term, even though they may contain as much as 880 mg of 
sodium per 100 g of food. The agency would consider a ``healthy'' claim 
on such a product to be misleading. Thus, to prevent misleading claims 
on nutrient dense foods with small serving sizes, FDA is adopting the 
per 50 g criterion for foods with small serving sizes, consistent with 
the approach used for ``low'' claims. Specifically, foods that have 
reference amounts of 30 g or less or 2 tablespoons or less may bear the 
``healthy'' claim provided they contain no more than 360 mg of sodium 
per 50 g and meet all other requirements of the definition.
    Because section 403(r)(1)(A) of the act, which prohibits undefined 
nutrient content claims, is applicable May 8, 1994, and would preclude 
most ``healthy'' claims if that term is not defined, FDA has determined 
that it is essential that it provide a definition for that term by May 
8, 1994. However, the agency recognizes that the revisions in the 
sodium requirements for individual foods and main dishes and meal 
products, while the logical outgrowth of the proposal, will 
significantly limit the amount of sodium a food may contain for it to 
bear a ``healthy'' claim as compared to the proposal. Further, results 
of an informal survey in Washington, DC of products currently available 
in the marketplace (Ref. 4) show that many individual foods, main 
dishes, and meal products that are labeled as ``healthy,'' and that 
otherwise meet the definition of ``healthy'' established in this final 
rule, would not qualify for use of the term because the sodium level in 
such foods exceeds 360 mg in individual foods and 480 mg in main dish 
and meal products. The agency does not wish to severely disrupt the 
marketplace by establishing a definition or effective date for 
``healthy'' that would cause the majority of products that are 
currently labeled ``healthy,'' and that otherwise meet the definition, 
to be removed from the market. The agency, therefore, is providing time 
to give industry the opportunity to reformulate their products to meet 
the requirement that sodium not exceed 360 mg per reference amount and 
per labeled serving for individual foods and 480 mg per serving for 
main dish and meal products. While the effective date of the 
``healthy'' definition is May 8, 1994, products currently on the market 
that otherwise meet the definition of ``healthy'' will not have to 
conform to the criteria of 360 mg sodium for individual foods and 480 
mg sodium for meal-type products until January 1, 1998.
    However, while the agency believes that these requirements are 
appropriate, it is concerned that if, during this transitional period, 
FDA were to permit products currently on the market that contain 
uncontrolled levels of sodium to continue to bear the term ``healthy'' 
until January 1, 1998, such products would not be helpful in assisting 
consumers in reducing their sodium intake and would be inconsistent 
with current dietary recommendations. Therefore, the agency is 
establishing a requirement that will limit the amount of sodium allowed 
in individual foods, main dish products and meal products bearing the 
term ``healthy.'' In attempting to arrive at an appropriate level for 
sodium, the agency evaluated products that are currently available in 
the marketplace and that, with the exception of the sodium requirement, 
meet the definition for ``healthy.'' The agency also considered how 
these products are likely to be used in constructing overall diets that 
conform to current dietary guidelines.
    The agency determined that levels of 480 mg of sodium in individual 
foods and 600 mg of sodium in main dishes and meal products are 
appropriate levels during this transitional period. Such levels will 
assist consumers in reaching dietary goals by at least limiting their 
sodium intake, and they will not preclude products currently available 
and that otherwise meet the definition of ``healthy'' from continuing 
to bear the term while firms reformulate their products.
    Thus, individual foods that do not exceed 480 mg sodium per 
reference amount and per labeled serving and meet the other 
requirements of the ``healthy'' definition provided in Sec. 101.65(d) 
may bear the term until January 1, 1998. Likewise, main dishes and meal 
products that do not exceed 600 mg sodium per labeled serving and 
otherwise meet the ``healthy'' definition may bear the term until 
January 1, 1998.
3. Cholesterol
    17. Some comments supported the proposal that foods that contain 
less than the disclosure level for cholesterol would be eligible to 
bear the claim. A few comments, however, urged the agency to require 
that a product bearing the term ``healthy'' meet the ``low 
cholesterol'' criteria. One comment cited the results of the survey by 
NCL cited in section II.D.2. of this document that showed that 79 
percent of the respondents thought that a food labeled as ``healthy'' 
was low in cholesterol. Thus, the comment contended that a definition 
for ``healthy'' that does not require the food to be ``low'' in 
cholesterol is inconsistent with consumer perception.
    Another comment stated that foods labeled with the term ``healthy'' 
should contain no more than 60 mg or a significantly reduced amount of 
cholesterol.
    FDA has not been persuaded by the comments that the definition of 
``healthy'' should include a ``low'' cholesterol criterion. FDA finds 
that a definition that requires that a food be ``low'' in cholesterol 
would be too restrictive because such a requirement would disqualify 
products, including some seafood and game meat containing products, 
that otherwise meet the ``healthy'' definition and that would be useful 
in structuring diets that conform to current dietary guidelines. 
Although the agency recognizes that consumers may perceive ``healthy'' 
to mean ``low cholesterol'' (as shown by the NCL survey) and, thus, 
select foods labeled ``healthy'' to restrict their cholesterol intake, 
the agency has not been convinced by the comments that a product 
labeled ``healthy'' must meet a ``low cholesterol'' requirement to 
assist consumers in achieving current dietary recommendations. Unlike 
sodium, cholesterol is not ubiquitous in the food supply. Dietary 
cholesterol is found mainly in egg yolks, certain shellfish, organ 
meats, and, to a lesser extent, other meats and dairy products (Ref. 
5). Consequently, cholesterol is not likely to be present in 
significant amounts in many of the foods that are included in a healthy 
diet (e.g., fruits, vegetables, legumes, cereal grains).
    Furthermore, while the agency acknowledges that most dietary 
guidance recommends that serum cholesterol be lowered because of its 
relationship to cardiovascular disease, saturated fat is the major 
dietary determinant of total serum cholesterol levels in populations 
(Ref. 6). The definition for ``healthy'' that FDA is adopting in this 
final rule requires that the total amount of saturated fat in a product 
be low for it to qualify to bear the claim. Thus, the need to restrict 
the amount of dietary cholesterol is diminished in the presence of the 
``low saturated fat'' criterion. The agency finds that this criterion 
will adequately assist consumers in structuring a healthy diet with 
respect to dietary factors that could affect serum cholesterol levels. 
Therefore, for single ingredient products that are not raw seafood or 
game meat, FDA is requiring in Sec. 101.65(d)(2)(iii) that the level of 
cholesterol not exceed the disclosure level.
    Although it believes that the proposed criterion for cholesterol is 
appropriate for meal-type products as well, FDA is concerned that by 
adopting the proposed criterion, it would be establishing a requirement 
that is not totally consistent with the criterion established for 
cholesterol by USDA. In its final rule on the definition of 
``healthy,'' published elsewhere in this issue of the Federal Register, 
USDA is adopting a criterion that limits the amount of cholesterol in 
meal-type products to the disclosure level defined in Sec. 101.13(h)(3) 
permitted for main dishes, i.e., 90 mg per labeled serving. FDA 
examined the impact that such a requirement would have on meal products 
subject to its jurisdiction. (The disclosure level for meal products is 
120 mg per labeled serving.) A survey of the local marketplace as well 
as a review of product composition data submitted to the agency (Refs. 
4 and 7) has shown that meal products currently labeled ``healthy'' 
contain levels of cholesterol at or below 90 mg per labeled serving. 
Therefore, a requirement restricting the amount of cholesterol to 90 mg 
per labeled serving would not significantly affect FDA-regulated meals 
that currently bear the term ``healthy.'' Further, such a requirement 
would ensure that the meal products labeled ``healthy'' are among those 
most likely to assist consumers in achieving dietary recommendations.
    Thus, the agency does not consider it unreasonable to apply the 
cholesterol limitation for main dishes to its meal products as well. 
Accordingly, the agency is revising proposed Sec. 101.62(d) to require 
that main dish and meal products that contain less than 90 mg 
cholesterol per labeled serving, and that otherwise meet the definition 
of ``healthy,'' may bear the claim.
    18. One comment suggested that, in the absence of requiring ``low'' 
for all nutrients, the agency should require a disclosure statement, as 
it has done for terms such as ``light/lite,'' that states ``See ______ 
panel for information on cholesterol and sodium,'' as appropriate. This 
statement would appear immediately adjacent to the most prominent 
appearance of the term on the principal display panel of the label.
    In response to this comment, the agency points out that it has 
established requirements for label statements about nutrients that are 
present in amounts that exceed the disclosure levels in a product that 
makes a claim about another nutrient (Sec. 101.13(h)). In order for 
consumers to use such information effectively, it should be used with 
consistent meaning. The agency is reluctant to require use of 
disclosure statements on a different basis unless there is a well 
justified need. The comment did not provide justification for why it 
should, and the agency is therefore not adopting the suggestion. Thus, 
for ``light'' claims, ``healthy'' claims, and all other nutrient 
content claims, a statement in accordance with Sec. 101.13(h) 
immediately adjacent to the claim is required if the food contains fat, 
saturated fat, cholesterol, or sodium in an amount that exceeds the 
disclosure level.

F. Need for Additional Criteria

    In its January 6, 1993, proposal (58 FR 2944), FDA solicited 
comment on whether it should include additional requirements in the 
definition of ``healthy'' such as a ``low calorie'' criterion or a 
requirement that a food that bears a ``healthy'' claim supply a certain 
amount of specified essential vitamins, minerals, or other nutrients.
    19. The majority of comments supported a requirement that a food 
must contribute certain essential nutrients to bear a ``healthy'' 
claim. They asserted that the definition of ``healthy'' is unbalanced 
without the requirement for a prescribed amount of these nutrients 
because a food labeled ``healthy'' should not only limit the amount of 
fat, saturated fat, cholesterol, and sodium but should also contribute 
certain essential nutrients. Thus, according to the comments, a claim 
that is to be used to assist consumers in achieving a healthy diet 
should include a requirement that the food provide certain essential 
nutrients.
    The comments further asserted that the proposed definition is a one 
dimensional approach because it fails to adequately account for current 
dietary recommendations as they relate to intake of certain nutrients, 
such as vitamins, minerals, and other essential nutrients. The comments 
contended that dietary guidelines stress the importance of essential 
nutrients, and that foods that fail to contribute essential nutrients, 
but that are permitted to be labeled as ``healthy,'' would likely 
mislead consumers. The comments supported their statements by 
submitting results from a recent poll in which 63 percent of 
respondents expected a product labeled ``healthy'' to be a good source 
of some important vitamins and minerals.
    One comment stated that without the requirement for inclusion of 
some nutrients, the definition would be trivialized or compromised by 
its use on products of little or no nutritional value, because foods 
like jelly beans, soda, and certain candies could qualify to bear the 
term. Another comment stated that such a requirement could assist 
consumers in identifying foods that are nutrient dense and at the same 
time contain a minimum of components that according to current dietary 
recommendations should be limited for healthy eating.
    Other comments opposed inclusion of any requirement that a product 
labeled with the term ``healthy'' provide certain nutrients in addition 
to limiting the amount of fat, saturated fat, sodium, and cholesterol 
in the product. These comments contended that the addition of a 
nutrient contribution requirement would limit a manufacturer's ability 
to formulate processed foods that have an increased nutritional 
quality, and such a requirement would take away an incentive to produce 
foods of this type.
    Another comment that was opposed to a requirement that a food 
supply certain nutrients to qualify to bear a ``healthy'' claim stated 
that foods that are widely viewed as healthy and that contribute needed 
variety to a healthy diet, such as apple juice, grape juice, and whole 
wheat bread, would not meet this requirement and therefore would not be 
able to bear the ``healthy'' claim.
    Although the agency recognizes that certain varieties of apple 
juice and grape juice may not be able to bear the claim, the agency 
disagrees that whole wheat bread will not be able to bear a ``healthy'' 
claim. Nutrient profile data analyses (Ref. 4) show that whole wheat 
bread will meet the 10 percent nutrient contribution requirement set 
forth in this final rule. The agency believes that the ``healthy'' 
claim should be reserved for those foods that are particularly helpful 
to consumers in achieving dietary recommendations. Conceptually, a 
healthy diet not only restricts nutrients that have been shown to be 
related to disease but also includes those nutrients that are important 
in sustaining body function and reducing the risk of disease. The 
agency would be concerned that without a requirement that a food that 
bears a ``healthy'' claim contribute at least one essential nutrient to 
the diet, consumers using ``healthy'' foods frequently might not 
consume enough of these nutrients. Thus, the agency agrees with those 
comments that stated that a product bearing the claim ``healthy'' 
should also contribute essential vitamins, minerals, or other nutrients 
to the diet. Accordingly, FDA is revising the definition of ``healthy'' 
to include a nutrient contribution criterion.
    20. One comment suggested that the agency use the Index of 
Nutritional Quality (INQ) system as a mechanism to facilitate the 
definition of ``healthy.'' The INQ is a ratio that compares the percent 
of the Reference Daily Intake (RDI) or Daily Reference Value (DRV) of 
the nutrient in the food to the percent of the reference caloric intake 
that is contributed by the food. In other words, the INQ relates a 
food's contribution to nutrient allowances to its contribution to 
energy requirements. The comment stated that a positive nutrient 
contribution could be determined using this criterion. The comment 
proposed that a ``healthy'' food should have an INQ above 1 for at 
least four nutrients or an INQ above 2 for at least two nutrients.
    While the agency finds some merit to this comment, it believes that 
a less complex requirement would be more useful to consumers in 
understanding how to construct a total diet consistent with dietary 
guidelines. The use of the INQ system would also not be consistent with 
the approach used in defining other nutrient content claims and would 
likely confuse and mislead consumers regarding the nutrient profile of 
the food. Moreover, the RDI's of several of the essential nutrients 
that the comment recommended be included in the definition of 
``healthy'' are not based on caloric density. Thus, the agency believes 
that it would be inappropriate to base a nutrient contribution 
requirement on the caloric contribution of the food. Therefore, FDA 
rejects the suggestion that it base a nutrient contribution requirement 
on the INQ system.
    21. Many comments urged FDA to require that foods labeled 
``healthy'' provide at least 10 percent of the RDI or DRV of the 
essential nutrients that are of sufficient public health significance 
to warrant their inclusion in the nutrition label. Specifically, the 
comments requested requirements for vitamin A, vitamin C, protein, 
calcium, iron, or fiber. These comments asserted that the number of 
these nutrients required should increase with the food's contribution 
to the total daily intake. Under this suggested approach, an individual 
food would have to contain at least 10 percent of the DV of one of the 
six nutrients mentioned above per reference amount and per labeled 
serving, a main dish would have to contain at least 10 percent of the 
DV of at least two of the six per serving, and a meal would have to 
contain at least 10 percent of the RDI or DRV of three of the six per 
serving.
    The agency agrees with the suggestion that the required nutrients 
should be those that are of sufficient public health significance to 
warrant their inclusion in the nutrition label. Thus, the agency is 
revising its definition of ``healthy'' in Sec. 101.65(d) to include a 
requirement that to bear the term, a product must provide a specified 
amount of vitamin A, vitamin C, protein, calcium, iron, or fiber, all 
of which have been highlighted by leading health authorities as being 
important to the public health (Refs. 2, 3, 5, and 8).
    In addition, the agency believes that it is reasonable to expect 
main dish and meal products to contribute more than one specified 
nutrient to the food because the contribution of a main dish and meal 
product to the total daily diet is greater than that of an individual 
food. The approach taken by the agency in defining nutrient content 
claims on main dish and meal products is generally that main dishes 
approximate two individual foods and meals approximate three individual 
foods. The suggestion in the comments that main dishes provide two 
nutrients, and that meals provide three is consistent with this 
approach. Thus, the agency is revising its definition of ``healthy'' to 
include a requirement that to bear the term, a product must provide a 
specified amount of one, two, or three (depending on the food, i.e., 
individual food, main dish, or meal) of the six nutrients mentioned 
above.
    The agency also finds merit in those comments that suggested that 
the definition of ``healthy'' include a requirement that a food bearing 
the claim contribute at least 10 percent of the DV of the nutrients it 
provides. The agency has long held that a food is not a significant 
source of a nutrient unless that nutrient is present in the food at a 
level equal to, or in excess of, 10 percent of the U.S. Recommended 
Daily Allowances (U.S. RDA) in a serving. In the general principles 
final rule (58 FR 2302 at 2414), FDA adopted regulations requiring that 
to bear a ``good source'' claim for a nutrient, the food must contain 
at least 10 percent of the RDI or DRV of the nutrient. Thus, FDA finds 
that it is appropriate to require that a food labeled ``healthy'' be at 
least a ``good source'' of the specified nutrients that it provides.
    Therefore, FDA is providing in Sec. 101.65(d) that for a food to 
bear the claim ``healthy,'' an individual food must contain 10 percent 
of the RDI or DRV of one of the following per reference amount--vitamin 
A, vitamin C, calcium, iron, protein or fiber; a main dish must contain 
10 percent of the RDI or DRV of two of the six nutrients per serving; 
and a meal must contain at least 10 percent of the RDI or DRV of three 
of the six per serving.
    The agency points out that while the amount of the nutrient is the 
same as that required for a ``good source'' claim (i.e., 10 percent), 
the nutrient contribution provision for ``healthy'' for main dish and 
meal products does not require that the 10 percent of the RDI or DRV be 
contributed by a single food in the main dish or meal. (The provisions 
governing a ``good source'' claim require that a single food in the 
main dish or meal product contribute at least 10 percent of the RDI or 
DRV of the nutrient in question before the product can bear the claim.) 
The requirement for ``healthy'' would not be met, however, if the main 
dish or the meal contributed only a single nutrient at a level that is 
20 percent or 30 percent of the RDI or DRV. The nutrient contribution 
requirement is met when the entire serving of the food provides at 
least 10 percent of the RDI or DRV of each of the number of nutrients 
required.
    22. While many comments supported the addition of a nutrient 
contribution requirement in the definition of ``healthy,'' they were 
divided on the question of whether products could be fortified to meet 
the claim. Some comments argued that fortification should not be 
permitted because products like jelly beans, soda, or salad dressing 
could qualify if fortification were permitted. Other comments argued 
that products that have otherwise met the definition but do not contain 
the essential nutrients should be permitted to be fortified.
    The agency has carefully considered these comments. In the general 
principles proposal (56 FR 60421) and final rule (58 FR 2302), the 
agency considered the appropriateness of fortifying a food to meet the 
requirements for bearing the nutrient content claim ``more.'' Although 
the agency stated its concern that random fortification could lead to 
deceptive and misleading claims, it concluded that fortification in 
accordance with the policy on fortification of foods in Sec. 104.20 (21 
CFR 104.20) would ensure that the fortification was rational, and that 
a ``more'' claim based on rational fortification would not be 
misleading.
    The agency believes that it is reasonable to take a similar 
approach in the definition of ``healthy.'' The agency is not persuaded 
by the comments opposing fortification that it should prohibit 
fortification of foods to meet the nutrient contribution requirement of 
the ``healthy'' claim. Such action would be inconsistent with the goal 
of encouraging manufacturers to improve the nutritional quality of 
foods to assist consumers in structuring a diet that conforms with 
current dietary recommendations. Thus, the agency is not prohibiting 
fortification of foods in the definition of ``healthy.''
    However, the agency is concerned that random fortification of foods 
could result in deceptive or misleading ``healthy'' claims. Thus, 
consistent with the provisions governing the ``more'' claim, the agency 
believes that following the principles stated in its fortification 
policy as provided in Sec. 104.20, in fortifying a food to qualify to 
bear the term ``healthy'' will ensure that those foods are not 
indiscriminately fortified for the sole purpose of making the claim. 
The fundamental objective of the fortification policy is to establish a 
uniform set of principles that serve as a model for the rational 
addition of nutrients to foods. Accordingly, the agency is providing in 
Sec. 101.65(d)(2)(v), (d)(3)(iv) and (d)(4)(v) that a food may be 
fortified to meet the positive nutrient requirement in the definition 
of ``healthy,'' provided that the fortification is in accordance with 
the policy on fortification of foods in Sec. 104.20.
    Although, as fully discussed in the technical amendments document 
to the general principles final rule, (58 FR 44021 at 44026, August 18, 
1993), the agency believes that the principles established in the 
fortification policy are appropriate in determining conditions for 
rational fortification, the agency notes that Sec. 104.20 was developed 
at a time when less technology was available for food formulation, and 
when food consumption behaviors and recommendations varied from those 
considered appropriate today. Thus, FDA is concerned that limiting 
fortification only to the nutrients that are explicitly mentioned in 
Sec. 104.20 would preclude beneficial nutrients from being used in food 
fortification. However, the agency does not consider it appropriate to 
establish a fortification policy for ``healthy'' that is different than 
the fortification policy established for ``more'' claims. As discussed 
in the technical amendments document (58 FR 44021 at 44026), the 
agency's intention is to initiate rulemaking to permit rational 
fortifications other than those described in Sec. 101.40 to qualify for 
``more'' claims. At the time of such rulemaking, the agency will 
reconsider the provisions on fortification established in this final 
rule.
    23. One comment stated that requiring a fruit or vegetable to meet 
the definition of ``good source'' for any of the six nutrients 
mentioned above would eliminate cucumbers, grapes, green beans, and 
iceberg lettuce from bearing a ``healthy'' claim. The comment argued 
that all fruits and vegetables that meet the proposed definition for 
``healthy'' should be allowed to use the term without having to meet 
any nutrient contribution requirement. The comment contended that 
fruits and vegetables are inherently healthy and are the only food 
group for which such a general statement can be made.
    After considering this comment, the agency is providing one narrow 
exception to the requirement that foods be a good source of one of the 
six nutrients of public health significance to qualify to bear a 
``healthy'' claim. Current dietary guidance emphasizes consumption of 
fruits and vegetables, and diets high in fruits and vegetables have 
been associated with various specific health benefits, including lower 
occurrence of coronary heart disease and some cancers (Refs. 2 and 5). 
Consistent with this guidance, FDA believes that 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 nutrients of public health 
significance. Precluding such foods from being termed ``healthy'' could 
confuse consumers and undermine an important element of current dietary 
guidance. FDA will therefore allow use of the term ``healthy'' in 
connection with raw fruits and vegetables that do not meet the nutrient 
content requirement, if the other elements of the ``healthy'' 
definition are met.
    FDA is not prepared at this time to extend this exemption to 
processed fruits and vegetables, however. When processed, these foods 
are exposed to substances and conditions, such as sodium, heat, and 
liquid packing media, that commonly affect their nutritional profile 
and may alter their inherent beneficial qualities. They are also 
subject to a range of processing techniques, including canning, 
cooking, and freezing, that may have various effects. FDA does not 
currently have an adequate basis to evaluate these effects and thus is 
not prepared at this time to extend this exemption to all fruit and 
vegetable products. Processed fruits and vegetables will be subject to 
the requirement that they be a good source of one of the six nutrients 
of public health significance specified above. FDA welcomes information 
on whether to propose changes in the nutrient content requirement for 
fruits, vegetables, or other food categories, in order to allow the use 
of the term ``healthy'' on other foods that would not otherwise meet 
this aspect of the ``healthy'' definition that may be useful in helping 
achieve compliance with dietary guidelines.
    24. A few comments urged the agency to include an additional 
criterion that a product bearing the term ``healthy'' must be ``low'' 
in calories. Another comment suggested that such a product meet the 
``low'' definition for sugars. However, these comments did not offer 
any information that was not considered by the agency at the time it 
issued the ``healthy'' proposal.
    The agency has not been persuaded by the comments that it is 
necessary to include a ``low calorie'' or ``low sugar'' criterion in 
the definition of ``healthy'' for the claim to be useful and not 
misleading to consumers. The information provided in the comments did 
not show that consumers expect ``healthy'' to be a claim about the 
caloric content of the food. Furthermore, the purpose of defining the 
term would be defeated if the term were defined so narrowly that it is 
appropriate only for people on weight-loss diets. Thus, the agency is 
not requiring that a food be ``low calorie'' or ``low'' in sugar to 
bear the term ``healthy.''

G. Treatment of Flesh Foods

    25. Virtually all of the comments requested that FDA and USDA 
harmonize their definitions of ``healthy.'' One comment contended that 
if the agencies cannot agree on a single consistent definition of the 
word ``healthy'' for any category of products, they should simply 
prohibit use of the term on those products. Some comments recommended 
that FDA adopt USDA's definition. Those comments supporting the USDA 
definition argued that such a definition would permit certain fish, 
poultry, and lean meats to bear the term ``healthy,'' which is 
consistent with the current dietary recommendations of the Surgeon 
General and the Food and Nutrition Board (Refs. 2 and 3), which 
recommend consumption of fish, skinless poultry, and lean meats. The 
comments contended that FDA's proposed definition would permit very 
few, if any, fresh cut meats to bear the term. These comments urged 
that the two agencies coordinate their definitions so that consumers 
receive the assistance that they need to implement dietary 
recommendations.
    The agency agrees with the comments that requested consistency in 
the FDA and USDA definitions of ``healthy.'' Both FDA and USDA 
recognize that having different definitions for the same nutrient 
content claim could lead to consumer confusion and undermine the 
usefulness and credibility of the claim. FDA and USDA have jointly 
reached a decision to consistently define ``healthy'' as it applies to 
the foods regulated by the two agencies. Thus, elsewhere in this issue 
of the Federal Register, USDA is establishing a definition of the term 
``healthy'' as it applies to meat and poultry products that is 
consistent with the relevant aspects of the definition set forth in 
this final rule.
    In their efforts to achieve a consistent definition, USDA and FDA 
are adopting regulations that:
    (1) Provide for the use of the term ``healthy'' on ``extra lean'' 
raw, single ingredient meats, poultry, fish, and game meats,
    (2) Require that all other products that bear the term be ``low'' 
in total fat and saturated fat and contain limited amounts of sodium 
and cholesterol, and
    (3) Require that there be minimum levels of certain essential 
nutrients in the product. In addition, consistent with USDA's approach, 
FDA has, as stated above, extended the definition of ``healthy'' to 
include any of the derivatives of the term, such as ``healthful'' and 
``healthier.''
    The agency believes that such an approach is appropriate because 
establishment of a consistent definition with USDA will ensure that the 
term is used in a credible, consistent, useful, and nonmisleading 
manner. Moreover, a consistent definition will help consumers identify 
products in all food categories that will be helpful to them in 
constructing a diet that is consistent with dietary recommendations.
    26. In the ``healthy'' proposal, as stated above, FDA solicited 
comment on whether the proposed definition of ``healthy'' would assist 
consumers in achieving a total diet consistent with dietary 
recommendations given that under the proposed definition, lean meat and 
seafood would not be able to bear the claim. Many comments requested 
that FDA revise its proposed definition so that lean meats and seafood 
would be able to bear the claim or, in the alternative, to establish 
additional criteria for those foods. The comments stated that such 
action was consistent with current dietary recommendations to include 
fish and lean meats as part of a healthy diet. The comments further 
stated that to not provide a definition for ``healthy'' that would 
permit seafood and game meats to bear the term would create an 
inequitable situation in the marketplace between comparable FDA-
regulated and USDA-regulated products because access to the term would 
depend on whether the product is under FDA or USDA jurisdiction.
    The agency agrees with the comments. As previously discussed, the 
agency believes that the fundamental purpose of the ``healthy'' claim 
is to highlight those foods that are particularly useful in 
constructing a diet that conforms to current dietary guidelines. The 
agency would consider it inappropriate if the requirements in the 
definition of ``healthy'' precluded use of the claim for an entire 
category of foods that play an important role in the diet and that 
dietary guidelines recommend be included in a healthy diet. Thus, FDA 
concludes that the definition of ``healthy'' should permit use of the 
term on those seafood and game meats that can be used to assist 
consumers in constructing a diet consistent with dietary 
recommendations but that do not meet the ``low'' fat and ``low'' 
saturated fat criteria. Therefore, FDA is making provision in the 
definition of ``healthy'' for certain seafood and game meat products 
(Sec. 101.65(d)(3)).
    In arriving at a definition for ``healthy'' on seafood and game 
meats, the agency considered whether to limit the definition to raw, 
single ingredient seafood and game meats or to extend it to foods such 
as processed seafood and game meat products and multiple ingredient 
products. The agency took the latter approach in establishing 
definitions for the nutrient content claims ``lean'' and ``extra lean'' 
and provided for claims about the fat and saturated fat content of a 
product that could not meet the ``low fat'' and ``low saturated fat'' 
criteria. In the nutrient content claims final rule (58 FR 2302 at 
2423), FDA adopted provisions permitting the ``lean'' and ``extra 
lean'' claim on nonflesh foods as well as flesh foods. (The agency 
notes, however, as fully discussed in the August 18, 1993, issue of the 
Federal Register (58 FR 44028) pursuant to that rulemaking, the agency 
has reconsidered both definitions and is now less certain than before 
that the definition for ``lean,'' and possibly ``extra lean,'' that it 
developed from data on flesh foods is appropriate for food products 
that do not contain flesh foods as ingredients. The agency will 
consider additional rulemaking to reexamine how the term ``lean'' and 
``extra lean'' should apply to nonflesh foods.)
    With respect to ``healthy,'' however, because FDA believes that 
seafood and game meat products, whether individual foods, main dishes, 
or meals composed of more than one ingredient, can be formulated to be 
low in fat and low in saturated fat, it is not making special provision 
for formulated products. FDA finds that special provision is warranted 
only for raw, single ingredient seafood and game meats. The latter 
products do not have the advantage of being subject to reformulation to 
reduce the fat, saturated fat, and cholesterol levels inherently in 
these foods, yet they are recommended by the Surgeon General and the 
Food and Nutrition Board as foods to include in a healthy diet. Use of 
the ``healthy'' claim will highlight the foods in this category that 
are particularly useful in constructing a diet that is consistent with 
dietary recommendations. Finally, the agency agrees that precluding the 
use of ``healthy'' on raw, single ingredient seafood and game meats 
would likely confuse consumers, who would see the claim on USDA 
regulated products but not on comparable FDA regulated products that 
could be used interchangeably in a healthy diet.
    Thus, the agency has concluded that providing for use of the term 
``healthy'' on the labels of raw, single ingredient seafood and game 
meat products would be of value to consumers in maintaining healthy 
dietary practices. Accordingly, FDA is revising its definition of 
``healthy'' so that certain raw, single ingredient seafood and game 
meats may bear the claim.
    27. Several comments recommended that FDA use USDA's proposed 
definition of ``healthy'' (i.e., the product contains less than 10 g of 
fat, less than 4 g saturated fat, less than 95 mg of cholesterol, and 
less than 480 mg sodium per 100 g and per reference amount to define 
when the term may be used on seafood and game meat products. One 
comment suggested that the fat limitation should be 5 g per 100 g. A 
similar comment suggested that products meeting the ``extra lean'' 
definition should be allowed to use the term ``healthy.''
    These comments asserted that establishing criteria in the 
definition of ``healthy'' that would permit its use on lean seafood and 
game meats would provide uniformity among regulations governing 
competitive products (i.e., comparable products that are regulated by 
USDA and FDA). The comments argued that such a provision would avoid 
unfair competition in the marketplace, as well as provide alternative 
choices for foods that are recommended to be included in a healthy 
diet.
    In deciding to establish a definition for ``healthy'' on raw, 
single ingredient seafood and game meats, the agency carefully 
considered these comments. The agency recognizes that, because foods in 
this category inherently contain relatively high levels of fat, 
saturated fat, and cholesterol, and cannot meet the ``low fat'' and 
``low saturated fat'' criteria, the definition of ``healthy'' for raw, 
single ingredient seafood and game meats will necessarily permit higher 
levels of fat and saturated fat in these foods than in other foods. 
However, the agency is not persuaded that the most appropriate approach 
is to adopt the definition proposed by USDA.
    The agency concludes that a more appropriate approach is to adopt 
criteria that will permit raw, single ingredient seafood and game meat 
products that meet the ``extra lean'' definition for fat, saturated 
fat, and cholesterol, and otherwise meet the definition of ``healthy'' 
that is established in this final rule for other individual foods, to 
bear the ``healthy'' claim. Such action is consistent with FDA's basic 
conclusion that foods labeled as ``healthy'' should be useful in 
assisting consumers in achieving a total diet consistent with dietary 
recommendations. Products meeting the ``extra lean'' criteria will 
better meet the goal of minimizing fat and saturated fat intake than 
products that meet the ``lean'' criteria. Accordingly, the agency is 
including the definition of ``healthy'' for raw, single ingredient 
seafood and game meats in Sec. 101.65(d)(3). Under this provision, raw, 
single ingredient fish and game meat that contain, per reference amount 
and per 100 g, less than 5 g of fat, less than 2 g of saturated fat, 
less than 95 mg of cholesterol, and otherwise meet the requirements 
established in this final rule, may bear the term ``healthy.''
    FDA recognizes that the definition of ``healthy'' for raw, single 
ingredient seafood and game meats allows the claim to be used when the 
level of cholesterol in the food exceeds its disclosure level (i.e., 60 
mg cholesterol per reference amount and per labeled serving). The 
agency considered whether to prohibit the claim when the product 
contained more than 60 mg cholesterol. However, the agency concluded 
that it would be of benefit to consumers to permit the claim on raw, 
single ingredient seafood and game meat products that have a 
cholesterol content exceeding the disclosure level because the claim 
identifies the foods in this category that are particularly useful to 
consumers in structuring diets consistent with dietary guidelines. When 
the cholesterol level in a food labeled ``healthy'' exceeds FDA's 
disclosure level, the food is subject to the requirement in 
Sec. 101.13(h) that requires a disclosure statement referring the 
consumer to the nutrition information panel for additional information 
about cholesterol content.

III. Effective Date

    As discussed above, in response to comment 16, FDA is adopting May 
8, 1994, as the effective date of this regulation to establish the 
definition of the term ``healthy.'' Section 403(r)(1)(A) of the act, 
which prohibits undefined nutrient content claims, is applicable May 8, 
1994. Thus, FDA has determined that it is essential that the agency 
provide a definition for the term ``healthy'' that is effective on that 
date. If ``healthy'' were not defined by May 8, 1994, products 
currently on the market that bear the term and that are not 
``grandfathered'' would be misbranded and subject to regulatory action. 
The agency also recognizes, however, that many of the products that are 
marketed with a ``healthy'' claim do not meet all of the requirements 
established in this final rule, and that because of the timeframes in 
which this final rule is being issued, will not have sufficient time to 
reformulate their products.
    The agency has no desire to cause the significant market disruption 
that would result from either not defining ``healthy'' or vigorous 
enforcement of the definition that FDA is adopting. Accordingly, the 
agency intends to exercise its enforcement discretion judiciously with 
respect to products that bear this term. Over the next 18 months, the 
agency is unlikely to object to products that currently bear 
``healthy'' in their labeling, so long as their manufacturers are 
making good faith efforts to bring their products into compliance with 
Sec. 101.65(d) and their labeling is otherwise in full compliance with 
the law. The agency advises, however, that it expects that new products 
that come onto the market during this period will fully comply with the 
definition of ``healthy.''
    The agency expects that by January 1, 1996, all products that bear 
the term ``healthy'' will comply fully with Sec. 101.65(d). The agency 
notes that the period between publication of this final rule and 
January 1, 1996, is comparable to the amount of time that manufacturers 
were given to comply with the requirement of the general principles 
final rule (58 FR 2302). The agency notes, however, that 
Sec. 101.65(d)(2), (d)(3), and (d)(4) will be in effect, and that it 
retains the right to take action on a ``healthy'' claim before January 
1, 1996, if it concludes that the facts of the particular case warrant 
such action.
    With regard to the two-tier sodium requirement, before January 1, 
1998, individual foods that contain more than 480 mg sodium per 
reference amount and per labeled serving, and main dish and meal 
products that contain more than 600 mg sodium per labeled serving, may 
not bear the ``healthy'' claim. After January 1, 1998, products bearing 
a ``healthy'' claim must comply with the 360 mg sodium per reference 
amount and per serving and 480 mg sodium per labeled serving 
requirement for individual foods and main dish and meal products, 
respectively.

IV. Economic Impact

    FDA has examined the economic implications of the final rule on the 
definition of ``healthy'' as required by 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 final 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 final rule will not have 
a significant impact on a substantial number of small businesses.

A. Regulatory Options

1. No Definition
    FDA could choose not to define the term ``healthy.'' However, in 
the general principles final rule, FDA determined that the term 
``healthy'' is an implied nutrient content claim. If FDA does not 
define the term, its use in labeling except on those products using the 
claim in their brand name prior to October 29, 1989 or in a 
nonnutritional context, would misbrand the food. This option would 
result in large costs, including labeling costs, and a valuable signal 
used by consumers to alert them to foods that may assist them in 
meeting dietary goals would be lost.
    FDA could alternatively decide to propose to reverse its previous 
determination that the term ``healthy'' is an implied nutrient content 
claim. However, FDA could only make such an amendment if the agency was 
persuaded that its original determination was in error. FDA has 
received no information that would support such a conclusion. Further, 
such an action would require separate rulemaking and could not take 
effect until well after the May 8, 1994 deadline. Thus, until FDA 
published a final rule, this alternative would have the same impact as 
not defining the term ``healthy.''
2. Different Definition of ``Healthy''
    FDA could determine that an alternative definition of the term 
``healthy'' would be appropriate. The major difference between the 
proposed rule and the final rule in the definition of ``healthy'' is in 
the prescribed levels of sodium. FDA originally proposed to set the 
allowable sodium levels at the disclosure levels for individual foods 
and meal-type products. However, as described earlier in this document, 
comments stated that the disclosure levels are too high and would 
result in ``healthy'' claims that are of little help to consumers 
trying to meet dietary goals.
    Alternatively, FDA could determine that ``healthy'' products must 
meet FDA's definition for ``low sodium'', and some comments suggested 
that approach. However, this option would result in significant costs 
because very few products now labeled as ``healthy'' would be able to 
make the claim. Also, comments indicated that the technology to reduce 
sodium levels to ``low sodium'' levels does not currently exist for 
many products because sodium functions as a protein binder, a 
preservative, and as flavoring. Such a reduction in sodium would cause 
most products to be unpalatable to consumers.

B. Costs of the Final Regulation

    FDA believes that the costs of the final ``healthy'' regulation 
will not be substantial, as many products currently using the term 
already meet the definition, are very close to doing so, or can 
satisfactorily reformulate their product over the time period the 
agency is permitting for implementation of this regulation.
    There are at least 35 brands that include the term ``healthy'' in 
the brand name. FDA does not know how many products or labels are sold 
under these brands. Nor is FDA able to estimate the number of products 
with labels using the term ``healthy'' other than in the brand name. 
FDA has specific information, including nutrition information, on the 
products of four brands. Two of these brands do not include products 
regulated by FDA (i.e. all of the brands' products are regulated by 
USDA). The remaining two brands have approximately 44 FDA regulated 
products sold with ``healthy'' in the brand name. After examining the 
nutritient content of these foods, FDA has determined that at least 12 
products will not meet FDA's interim definition of ``healthy,'' and 
that an additional 5 products will not meet the final definition of 
``healthy.'' The primary disqualifier is the sodium content of the 
products. In addition, a few products do not meet the ``low fat'' 
requirement.
    The manufacturers of products not meeting the definition of 
``healthy'' have three options for bringing their products into 
compliance: Reformulate the products to meet the definition, cease 
marketing the products, or relabel the product.
1. Reformulation
    Whether or not a firm will choose to reformulate their products 
will depend on the relative cost of reformulation compared to dropping 
the product, and on whether the product will continue to be palatable 
to consumers. FDA has very little information on the cost of 
reformulation, which will depend on the extent of reformulation that is 
necessary. Of the 17 products identified as not meeting the definition 
of ``healthy,'' FDA estimates that four have sodium contents so close 
to the defined level that these products can be easily modified. The 
cost of reformulating these products is expected to be small. However, 
the cost of reformulating several other products are expected to be 
higher because the current sodium or fat content significantly exceeds 
the defined amount, or because modifications are required in more than 
one nutrient (i.e. reductions in both fat and sodium content). The 
longer compliance period will allow firms extra time to develop the 
technology to reduce the sodium content of their foods and will provide 
consumers with time to adjust their tastes to lower sodium levels.
2. Loss of Brand Names/Products
    Some manufacturers might not be able to reformulate their products 
or may determine that the costs of reformulation are prohibitive. The 
manufacturers may choose to market their products under a different 
brand name. New resources must also be expended in marketing the 
product and in informing consumers that the product has a new name. A 
brand name is an intangible asset representing capital just as a 
tangible asset is capital. Brand names act as signals that help 
consumers identify quality differences and shop more efficiently. 
Manufacturers invest real resources in developing and maintaining their 
brand identities. One comment to the proposal stated that one 
particular firm had ``hundreds of millions of dollars invested in the 
[brand] name.''
    In order to calculate the value of a brand name lost to certain 
products, FDA compared average selling prices for 44 products sold 
under a ``healthy'' brand with prices of other non-``healthy'' branded 
products within the same product class. The average premium earned by 
products with the word ``healthy'' in the brand name is $0.57 per 16 
oz. equivalent unit (all products regardless of package size are 
converted to 16 oz. units). Multiplying by the average sales volume of 
the ``healthy'' brands leads to an annual cost per discontinued product 
of approximately $800,000.
    FDA acknowledges that it could be a cost to the individual 
manufacturers of products currently branded ``healthy'' if the brand 
names were, in fact, removed from the market. The loss of a brand name 
to the extent that it does not convey false or misleading information 
is a societal loss, as is the loss of any productive asset. FDA is 
unable to calculate how much of the consumer surplus (the difference in 
the market price and the price consumers are willing to pay for the 
product) is due to consumer misinformation about the nutritional 
profile of products that have borne the term ``healthy.'' Although most 
of these products are nutritionally labeled on the nutrition panel, 
some consumers use the term ``healthy'' as a signal to buy the product 
and do not read the information on the nutrition panel on the back of 
the product. For those individuals, existing consumer surplus would be 
reduced with the better information that will be provided under the 
consistent science-based definition, established by this final rule.
3. Relabeling
    Manufacturers of those products that make ``healthy'' claims on 
products that are not sold under ``healthy'' brand names may choose to 
relabel products without the claim when reformulation is either too 
costly or not technologically feasible. In its regulatory impact 
analysis of the final rules to amend the food labeling regulations (58 
FR 2927, January 6, 1993), FDA determined an average printing and 
redesign cost per product of $2,200 for an 18-month compliance period, 
the compliance period applicable to those products not meeting the 
interim definition of ``healthy.'' Those products that meet the interim 
definition but not the final definition will have approximately 3\1/2\ 
years to comply. The relabeling cost applicable to the longer 
compliance period is significantly less per product, approaching zero, 
because more products will be able to incorporate mandated label 
changes with regularly scheduled changes. As stated previously, FDA has 
no information regarding the number of products that make ``healthy'' 
claims but do not use the term in the brand name. Therefore, FDA cannot 
determine how many products would be relabeled as a result of this 
regulation.

C. Benefits of the Final Regulation

    In its cost-benefit for the food labeling regulations in January 
1993, FDA noted many significant benefits of improved nutrition 
labeling--including decreased rates of cancer, coronary heart disease, 
obesity, hypertension, and allergic reactions to food. The agency 
concluded that, as consumers are given more informative labeling, 
uncertainty and ignorance concerning the nutritional values of the 
foods they eat will decrease, and many consumers will select more 
nutritious, healthier foods. The improved health status of Americans 
expected to result from those rules was estimated to range from $4.4 
billion to $26.5 billion over the next 20 years.
    FDA believes that the use of the term ``healthy'' will contribute 
substantially to those benefits. ``Healthy'' is a powerful term for 
consumers who are trying to construct diets that fit within the dietary 
guidelines and is also important for food manufacturers who wish to 
market foods to those consumers interested in improving their diets. 
The agency believes that this definition of ``healthy'' will ensure 
that consumers wishing to meet the dietary guidelines with respect to 
fat, saturated fat, cholesterol, and sodium will be greatly helped in 
doing so, and it will provide food processors anxious to produce 
products that can be labeled ``healthy'' with established nutrient 
levels that they can formulate their products to achieve. As products 
labeled as being ``healthy'' in compliance with this final rule appear 
on the market, they will substantially contribute to the overall goal 
of improving the diet and health of Americans.
    Thus FDA believes that the primary benefit of this definition will 
accrue to consumers who select these products based on a desire to meet 
the dietary guidelines, particularly with respect to fat, saturated 
fat, cholesterol, and sodium. It is possible that some products that 
are currently marketed as ``healthy'' but that do not fit the 
definition, and thus are not useful in achieving dietary goals, will be 
removed from the market, thus increasing benefits. It is also possible 
that a small number of products that could assist some consumers in 
reducing their consumption of fat, saturated fat, sodium, or 
cholesterol will be unable to bear the claim ``healthy,'' thus 
potentially reducing benefits. Some products may be reformulated to 
meet the requirements for the claim but may lose sales from lack of 
consumer taste satisfaction. It is likely, however, given the selling 
power of the term ``healthy,'' that this rule will increase the number 
of products bearing the term ``healthy.''
    With a set definition for the term ``healthy,'' firms will see the 
advantage of making products that can bear the ``healthy'' claim 
without the potential for either federal challenge or competition from 
products that are less helpful in meeting dietary goals but are also 
marketed as ``healthy.'' Currently, products marketed as ``healthy'' 
have dramatically different nutritional profiles. For example, two very 
similar frozen entrees produced by two ``healthy'' brands have sodium 
contents per serving of 400 mg and 770 mg. Under FDA's new definition, 
the lower sodium product will not have to compete with higher sodium 
products that claim to be ``healthy.''
    In addition, in defining the term ``healthy,'' FDA is reducing 
information costs to consumers. With a set definition, consumers will 
be assured that the claim signals reliable information about the 
nutritional content of the product.
    FDA is unsure of the size of the benefit derived from the specific 
levels of sodium required in the definition of ``healthy.'' All 
consumers have some probability of a benefit from reducing sodium 
levels. FDA's definition of ``healthy'' is intended to assist in 
meeting dietary goals that are based on the Surgeon General's 
recommendation that all Americans reduce their sodium intake. The 1988 
Surgeon General's Report on Nutrition and Health states:

    Although not all individuals are equally susceptible to the 
effects of sodium, several observations suggest that it would be 
prudent for most Americans to reduce sodium intake. These include 
the lack of a practical biological marker for individual sodium 
sensitivity, the benefit to persons whose blood pressures do rise 
with sodium intake, and the lack of harm from moderate sodium 
restriction.

(Ref. 2, p. 13).

D. Regulatory Flexibility

    FDA is unaware of small firms marketing their products as 
``healthy.'' It is unlikely that this definition will have a 
significant effect on small firms.

E. Summary

    FDA has examined the costs and the benefits of the final rule and 
has determined that it is not an economically significant rule as 
defined by Executive Order 12866. Although many products currently 
marketed as ``healthy'' will not meet the definition, many will require 
only minor reformulation. The remaining products requiring more 
significant modifications of nutrient content will either undergo more 
costly reformulation, be relabeled, or will no longer be sold. In 
addition FDA has determined that the benefits of the regulation derive 
from an incentive to food manufacturers to produce more ``healthy'' 
products and from improved information to consumers that facilitates 
selection of foods that help consumers meet dietary goals.

V. Environmental Impact

    The agency has previously considered the environmental effects of 
the action being taken in this final rule. As announced in its 
nutrition labeling proposed rules published in the Federal Register of 
November 27, 1991 (56 FR 60366 et al.), the agency determined under 21 
CFR 25.24(a)(8) and (a)(11) that these actions are of a type that do 
not individually or cumulatively have a significant effect on the human 
environment. Therefore, neither an environmental assessment nor an 
environmental impact statement is required.

VI. References

    The following references have been placed on display in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday.

    1. National Heart, Lung, and Blood Institute, NCEP, ``Report of 
the Expert Panel on Blood Cholesterol Levels in Children and 
Adolescents,'' DHHS, Public Health Service, National Institutes of 
Health, April 7, 1991.
    2. ``The Surgeon General's Report on Nutrition and Health,'' 
DHHS, Public Health Service Publication No. 88-50210 (Government 
Printing Office Stock No. 017-001-00465-1), U.S. Government Printing 
Office, Washington DC, 1988.
    3. Committee on the Nutrition Components of Food Labeling, Food 
and Nutrition Board, IOM, NAS, ``Nutrition Labeling, Issues and 
Directions for the 1990's,'' Washington, DC, National Academy Press, 
1990.
    4. Satchell, F.B., Division of Programs and Enforcement Policy 
(HFS-158), Center for Food Safety and Applied Nutrition, memorandum 
to file; (a) ``Nutrient Profiles of Individual Foods, Main Dishes 
and Meal Products that Currently Bear the Term `Healthy,''' August 
30, 1993; (b) Modification of USDA's Nutrient Data Base for Standard 
Reference Release 9, ``Effects of Disclosure, `Low,' and Essential 
Nutrient Requirements on Individual Foods,'' August 2, 1993.
    5. Committee on Diet and Health, Food and Nutrition Board, 
Commission on Life Sciences, National Research Council, NAS, ``Diet 
and Health: Implications for Reducing Chronic Disease Risk,'' 
National Academy Press, Washington DC, 1989.
    6. DHHS, PHS, ``Healthy People 2000: National Health Promotion 
and Disease Prevention Objectives,'' DHHS (PHS) Publication No. 91-
50213, DHHS, Washington, DC, pp. 112, 113, 117, 118, 120-125, 1991.
    7. Satchell, F.B., Division of Programs and Enforcement Policy 
(HFS-158), Center for Food Safety and Applied Nutrition, memorandum 
to file, ``Nutritional Data of Products with `Healthy' in the Brand 
Name,'' August 30, 1993.
    8. Life Sciences Research Office, Federation of American 
Societies for Experimental Biology, ``Nutrition Monitoring in the 
United States. An Update Report on Nutrition Monitoring,'' chs. 3 
and 4, prepared for DHHS, Government Printing Office, Washington, 
DC, 1989.

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: 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 adding new paragraphs (d)(2) 
through (d)(4) to read as follows:


Sec. 101.65  Implied nutrient content claims and related label 
statements.

* * * * *
    (d) * * *
    (2) The term ``healthy'' or any derivative of the term ``healthy,'' 
such as ``health,'' ``healthful,'' ``healthfully,'' ``healthfulness,'' 
``healthier,'' ``healthiest,'' ``healthily,'' and ``healthiness'' may 
be used on the label or in labeling of a food, other than raw, single 
ingredient seafood or game meat products, main dish products as defined 
in Sec. 101.13(m), and meal products as defined in Sec. 101.13(l), as 
an implied nutrient content claim to denote foods that are useful in 
constructing a diet that is consistent with dietary recommendations 
provided that:
    (i) The food meets the definition of ``low'' for fat and saturated 
fat;
    (ii)(A) The food has a reference amount customarily consumed 
greater than 30 grams (g) or greater than 2 tablespoons and, before 
January 1, 1998, contains 480 milligrams (mg) sodium or less per 
reference amount customarily consumed, per labeled serving; or
    (B) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and, before January 1, 1998, contains 480 
mg sodium or less per 50 g (for dehydrated foods that must be 
reconstituted before typical consumption with water or a diluent 
containing an insignificant amount as defined in Sec. 101.9(f)(1), of 
all nutrients per reference amount customarily consumed, the per 50 g 
criterion refers to the ``as prepared'' form);
    (C)(1) The food has a reference amount customarily consumed greater 
than 30 g or greater than 2 tablespoons and, after January 1, 1998, 
contains 360 mg sodium or less per reference amount customarily 
consumed, per labeled serving; or
    (2) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and, after January 1, 1998, contains 360 
mg sodium or less per 50 g (for dehydrated foods that must be 
reconstituted before typical consumption with water or a diluent 
containing an insignificant amount as defined in Sec. 101.9(f)(1), of 
all nutrients per reference amount customarily consumed, the per 50 g 
criterion refers to the ``as prepared'' form);
    (iii) Cholesterol is not present at a level exceeding the 
disclosure level as described in Sec. 101.13(h);
    (iv) The food, other than a raw fruit or vegetable, contains at 
least 10 percent of the Reference Daily Intake (RDI) or Daily Reference 
Value (DRV) per reference amount customarily consumed, per labeled 
serving of vitamin A, vitamin C, calcium, iron, protein, or fiber;
    (v) Where compliance with paragraph (d)(2)(iv) of this section is 
based on a nutrient that has been added to the food, that fortification 
is in accordance with the policy on fortification of foods in 
Sec. 104.20 of this chapter; and
    (vi) The food complies with definitions and declaration 
requirements established in part 101 of this chapter for any specific 
nutrient content claim on the label or in labeling.
    (3) The term ``healthy'' or its derivatives may be used on the 
label or in labeling of raw, single ingredient seafood or game meat as 
an implied nutrient content claim provided that:
    (i) The food contains less than 5 g total fat, less than 2 g 
saturated fat, and less than 95 mg cholesterol per reference amount 
customarily consumed and per 100 g;
    (ii)(A) The food has a reference amount customarily consumed 
greater than 30 g or greater than 2 tablespoons and, before January 1, 
1998, contains 480 mg sodium or less per reference amount customarily 
consumed, per labeled serving; or
    (B) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and, before January 1, 1998, contains 480 
mg sodium or less per 50 g (for dehydrated foods that must be 
reconstituted before typical consumption with water or a diluent 
containing an insignificant amount as defined in Sec. 101.9(f)(1), of 
all nutrients per reference amount customarily consumed, the per 50 g 
criterion refers to the ``as prepared'' form);
    (C)(1) The food has a reference amount customarily consumed greater 
than 30 g or greater than 2 tablespoons and, after January 1, 1998, 
contains 360 mg sodium or less per reference amount customarily 
consumed, per labeled serving; or
    (2) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and, after January 1, 1998, contains 360 
mg sodium or less per 50 g (for dehydrated foods that must be 
reconstituted before typical consumption with water or a diluent 
containing an insignificant amount as defined in Sec. 101.9(f)(1), of 
all nutrients per reference amount customarily consumed, the per 50 g 
criterion refers to the ``as prepared'' form);
    (iii) 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;
    (iv) Where compliance with paragraph (d)(3)(iii) of this section is 
based on a nutrient that has been added to the food, that fortification 
is in accordance with the policy on fortification of foods in 
Sec. 104.20 of this chapter; and
    (v) The food complies with definitions and declaration requirements 
established in this part for any specific nutrient content claim on the 
label or in labeling.
    (4) The term ``healthy'' or its derivatives may be used on the 
label or in labeling of main dish products, as defined in 
Sec. 101.13(m), and meal products, as defined in Sec. 101.13(l) as an 
implied nutrient content claim provided that:
    (i) The food meets the definition of ``low'' for fat and saturated 
fat;
    (ii)(A) Before January 1, 1998, sodium is not present at a level 
exceeding 600 mg per labeled serving, or
    (B) After January 1, 1998, sodium is not present at a level 
exceeding 480 mg per labeled serving;
    (iii) Cholesterol is not present at a level exceeding 90 mg per 
labeled serving;
    (iv) The food contains at least 10 percent of the RDI or DRV per 
labeled serving of two (for main dish products) or three (for meal 
products) of the following nutrients--vitamin A, vitamin C, calcium, 
iron, protein, or fiber;
    (v) Where compliance with paragraph (d)(4)(iv) of this section is 
based on a nutrient that has been added to the food, that fortification 
is in accordance with the policy on fortification of foods in 
Sec. 104.20 of this chapter; and
    (vi) The food complies with definitions and declaration 
requirements established in this part for any specific nutrient content 
claim on the label or in labeling.

    Dated: April 29, 1994.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 94-11145 Filed 5-5-94; 10:27 am]
BILLING CODE 4160-01-P