[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]
_______________________________________________________________________
Part III
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
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