[Federal Register Volume 60, Number 249 (Thursday, December 28, 1995)]
[Rules and Regulations]
[Pages 67164-67175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31197]
[[Page 67163]]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 101
Food Labeling; Final Rule and Proposed Rules
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 /
Rules and Regulations
[[Page 67164]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 90N-0134]
RIN 0910-AA19
Food Labeling: Reference Daily Intakes
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to establish Reference Daily Intakes (RDI's) for vitamin K,
selenium, manganese, chromium, molybdenum, and chloride, but not for
fluoride. The agency is also amending its regulations to modify the
units of measure that are used to declare the amount of biotin, folate,
calcium, and phosphorus in food. In addition, the agency is amending
its regulations to make consideration of selenium, chromium,
molybdenum, and chloride optional in making a determination as to
whether a food is nutritionally inferior to a food for which it
substitutes and that it resembles. These actions are intended to assist
consumers in understanding the nutritional significance of foods in the
context of a total daily diet and are in recognition of the fact that
the National Academy of Sciences (NAS) established Recommended Dietary
Allowances (RDA's) and Estimated Safe and Adequate Daily Dietary
Intakes (ESADDI's) for vitamin K, selenium, manganese, chromium,
molybdenum, and chloride either in 1980 or 1989.
EFFECTIVE DATE: January 1, 1997.
FOR FURTHER INFORMATION CONTACT: Camille E. Brewer, Center for Food
Safety and Applied Nutrition (HFS-165), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5483.
SUPPLEMENTARY INFORMATION
I. Background
In the Federal Register of January 4, 1994 (59 FR 427), FDA
published a proposed rule in a document entitled ``Food Labeling:
Reference Daily Intakes'' (hereinafter referred to as ``the January
1994 proposal''). This document grew out of earlier proposals that,
among other things, sought to amend FDA's label reference value
regulations to replace the United States Recommended Daily Allowances
(U.S. RDA's) with Reference Daily Intakes (RDI's) for protein and 26
vitamins and minerals.
In the Federal Register of July 19, 1990 (55 FR 29476), FDA
published its initial proposal on RDI's in a document entitled ``Food
Labeling Reference Daily Intakes and Daily Reference Values''
(hereinafter referred to as ``the July 1990 proposal''). Following the
passage of the Nutrition Labeling and Education Act of 1990 (Pub. L.
101-535) (hereinafter referred to as ``the 1990 amendments''), FDA
republished this proposal in modified form on November 27, 1991 (56 FR
60366) (hereinafter referred to as ``the supplementary proposal''). FDA
summarized and reviewed the comments to these proposals in a final rule
entitled ``Food Labeling; Reference Daily Intakes and Daily Reference
Values'' (58 FR 2206, January 6, 1993, and corrected at 58 FR 17104,
April 1, 1993) (hereinafter referred to as ``the RDI/DRV final rule'').
However, on October 6, 1992, before FDA issued the final rule,
Congress passed the Dietary Supplement Act of 1992 (Title II of Pub. L.
102-571) (hereinafter referred to as the ``DS act''). Section 202(a)(1)
of the DS act imposed a moratorium on the implementation of the 1990
amendments as they applied to dietary supplements of vitamins,
minerals, herbs, or other similar nutritional substances until December
15, 1993. Section 203 of the DS act prohibited FDA from promulgating
regulations before November 8, 1993, that required the use of, or that
were based on, recommended daily allowances of vitamins or minerals,
other than regulations establishing the U.S. RDA's specified in
Sec. 101.9(c)(7)(iv)(21 CFR 101.9(c)(7)(iv)) (1992), as in effect on
October 6, 1992.
The label reference values in Sec. 101.9(c)(7)(iv) (1992) were
based to a large extent on the 1968 RDA's (Ref. 1), and thus they are
more than 25 years old. These label values do not reflect the
significant advances in scientific knowledge about essential nutrient
requirements that have occurred over the last 20 years. Based on these
advances, in 1980, the NAS established, for the first time, ESADDI
values for vitamin K, biotin, pantothenic acid, copper, manganese,
fluoride, chromium, selenium, molybdenum, sodium, potassium, and
chloride (Ref. 2). In 1989, the NAS updated the values for vitamin K
and selenium, making them RDA's rather than ESADDI's (Ref. 3). At the
same time, the NAS continued to provide ESADDI values for manganese,
fluoride, chromium, and molybdenum, but NAS dropped the suggested
values for sodium, potassium, and chloride, giving instead estimated
minimum requirements for healthy persons at various ages (Ref. 3).
With its discretion constrained by section 203 of the DS act, and
yet faced with a need to establish a labeling scheme that manufacturers
could implement as quickly as possible, FDA simply adopted in its new
regulations the values in Sec. 101.9(c)(7)(iv) as in effect in 1992
(see RDI/DRV final rule). This solution created a new problem. Section
101.9(c)(7)(iv) (1992) did not contain label reference values for
vitamin K, selenium, manganese, chromium, molybdenum, chloride, and
fluoride, which were addressed in the 1989 RDA's (Ref. 3).
In its January 1994 proposal, FDA proposed to establish RDI's for
vitamin K, selenium, manganese, chromium, molybdenum, chloride, and
fluoride for the following reasons: Such values are necessary to permit
the declaration of these nutrients in the nutrition labeling of all
foods; they will assist consumers in understanding the significance of
the amount of these nutrients present in foods in the context of a
total daily diet; and these values will permit nutrient content claims
to be made for these nutrients.
FDA received approximately 65 letters in response to the January
1994 proposal. Each letter contained one or more comments. Many
comments supported the proposal generally or supported aspects of the
proposal. Other comments addressed issues outside the scope of the
proposal (e.g., nutrition education, freedom of choice, premarket
clearance, and fortification policies) and will not be discussed here.
Several comments suggested modifications or revisions of various
aspects of the proposal. A summary of the comments, the agency's
responses to the comments, and a discussion of the agency's conclusions
with respect to the RDI's for the seven nutrients follows:
II. Authority for Additional Label Reference Values
Section 2(b)(1)(A) of the 1990 amendments provides that the
Secretary of Health and Human Services (and, by delegation, FDA) shall
issue regulations that require that the required nutrition label
information be conveyed in a manner that enables the public to readily
observe and comprehend such information and to understand its relative
significance in the context of a total daily diet. FDA, in its food
labeling initiative, has tried generally to assist consumers in
understanding the nutrition label information relative to a total daily
diet (see 55 FR 29476) and to do so based on the most current
scientific and public health knowledge.
1. The majority of comments agreed with establishing RDI's for the
[[Page 67165]]
additional nutrients. These comments applauded FDA's intention to
broaden the list of nutrients for which RDI's are established and
stated that this action is in keeping with the intent of the 1990
amendments to provide additional useful information to consumers. On
the other hand, one comment questioned the wisdom of establishing new
RDI's before conducting surveys to gauge the extent to which the RDI's
can be comprehended and expressed concern the new RDI's would only add
to public confusion.
The agency does not agree with the latter comment. Before issuing
final food labeling rules on January 6, 1993, FDA and the food industry
conducted numerous focus groups and informal preference studies that
analyzed consumer understanding of different formats for presenting
nutrition information, including the question of whether consumers
could understand RDI's, which are incorporated into the ``Nutrition
Facts'' panel by means of the percent Daily Value (DV) declaration.
This research demonstrated that the percent DV format improved
consumers' abilities to make correct dietary judgments about a food in
the context of the total daily diet (58 FR 2070 at 2127). Therefore,
FDA finds that percent DV's, and the underlying RDI's can be, and are,
understood by consumers and used by them successfully. Therefore, FDA
finds that this comment provides no basis for not establishing RDI's
for the seven nutrients. Consistent with the vast majority of comments,
FDA is adopting these values except the value for fluoride, as
explained below.
III. Nutrient Selection and Determination of Values for RDI's
A. Basis for RDI's
2. Most comments strongly supported the use of the NAS' RDA's as
the basis for the establishment of RDI values. However, a couple of
comments objected to providing RDI's only for nutrients with RDA's. One
comment urged FDA to permit the inclusion of boron, nickel, silicon,
tin, and vanadium as nutrients to be declared within the nutrition
label. The comment stated that these nutrients have been recognized as
essential by leading experts on trace minerals.
Since the inception of the nutrition labeling program, FDA has
relied on the judgment of the NAS' Food and Nutrition Board concerning
the essentiality of particular nutrients in human nutrition and the
required levels of those nutrients (37 FR 6493, March 30, 1972). The
procedures followed by the NAS ensure that scientific consensus exists
for the essentiality in human nutrition of nutrients for which RDA's
and ESADDI's are established. In brief, these procedures include a
review of the available scientific literature by experts in the field
of human nutrition, requests for public input, consultation with other
knowledgeable experts, a review by the Food and Nutrition Board, and a
review by the National Research Council's Report Review Committee. The
types of evidence on which the RDA's are based include: (1) Studies of
subjects maintained on diets containing low or deficient levels of a
nutrient, followed by correction of the deficit with measured amounts
of the nutrient; (2) nutrient balance studies that measure nutrient
status in relation to intake; (3) biochemical measurements of tissue
saturation or adequacy of molecular function in relation to nutrient
intake; (4) nutrient intakes of fully breast-fed infants and of
apparently healthy people from their food supply; (5) epidemiological
observations of nutrient status in populations in relation to intake;
and (6) in some cases, extrapolation of data from animal experiments
(Ref. 3, p. 1).
Strong and uniform support was provided for the use of NAS RDA's as
the basis for nutrition label information during the initial
development of nutrition labeling regulations in 1972 as well as in
response to the July 1990 proposal and the supplementary proposal. FDA
noted in the RDI/DRV final rule that ``The majority of comments on this
topic * * * supported the continued use of the NAS RDA's as the basis
for developing label reference values for vitamins and minerals'' (58
FR 2206 at 2208). Based on the continuing support shown in the comments
submitted in the present rulemaking, the agency continues to believe
that the NAS' ``Recommended Dietary Allowances'' (Ref. 3) remains the
most widely accepted and respected source of information on human
nutrient requirements.
The lack of an RDA or ESADDI does not mean that other substances
should not be included in the diet. It does mean, however, that the
level of scientific agreement does not exist that would justify
highlighting these substances for special attention to ensure that they
are included in the diet at appropriate levels.
There are two criteria for determining which nutrients should be
considered for RDI's. The first and foremost is scientific consensus as
to the essentiality of the nutrient. Nutrients that are essential in
human nutrition warrant special consideration on the label to guarantee
that consumers have the means, through nutrition labeling, to account
for the nutrient in the total daily diet.
The second criterion is scientific agreement concerning the level
at which the nutrient should be consumed. The RDA's are defined as
``the levels of intake of essential nutrients that, on the basis of
scientific knowledge, are judged by the Food and Nutrition Board to be
adequate to meet the known nutrient needs of practically all healthy
persons'' (Ref. 3, p. 1). The ESADDI's are defined as ``a category of
safe and adequate intakes for essential nutrients when data were
sufficient to estimate a range of requirements, but insufficient for
developing an RDA'' (Ref. 3, pp. 6 and 7).
The criteria of essentiality and of recommended intakes provides
assurance that there is scientific agreement regarding the need for
certain nutrients and guidance regarding appropriate levels.
While the comment supporting the inclusion of boron, nickel,
silicon, tin, and vanadium submitted published reports of the
requirements for these nutrients in animal nutrition, it submitted no
data or other information that there is scientific consensus that these
minerals are essential in human nutrition, or that there is agreement
concerning recommended daily intake levels for these minerals. Because
of the lack of such data and the NAS' position that deficiencies of
these trace elements have not been established in humans, and, hence,
that there are no data from which human requirements can be established
(Ref. 3, p. 267), the agency is not establishing RDI's for boron,
nickel, silicon, tin, or vanadium. Therefore, in accordance with
Sec. 101.9(c), these nutrients cannot be declared within the nutrition
label on conventional foods. However, in a companion document in this
issue of the Federal Register entitled ``Food Labeling; Statement of
Identity, Nutrition Labeling and Ingredient Labeling of Dietary
Supplements,'' FDA is proposing regulations to implement the Dietary
Supplement Health and Education Act of 1994 (the DSHEA) that will, in
part, allow dietary ingredients for which RDI's have not been
established (e.g., boron) to be listed in the nutrition label of
dietary supplements.
3. One comment urged FDA to consider the promotion of optimal
health, instead of nutrient adequacy, in the determination of label
reference values.
As discussed in the response to the previous comment, the RDI's are
based on the NAS RDA's, and the agency is
[[Page 67166]]
not persuaded that a change in that basis is warranted. NAS is in the
process, however, of evaluating the basis on which it determines the
RDA's. In 1994, the Food and Nutrition Board (FNB) of the Institute of
Medicine of the NAS published a document entitled ``How Should the
Recommended Dietary Allowances Be Revised'' (Ref. 4). In this document,
NAS summarized its multi-step plan for reconceptualizing the RDA's and
announced its intention to examine alternate bases for determining the
RDA's. NAS stated:
Nutrition science, similar to all scientific endeavors, is
rapidly changing and evolving. Nutrition scientists and
practitioners continue to learn more with each passing day about
nutrition and its effect on health. The role of the RDAs at any time
is to provide the best consensus of nutrition science interpreted to
recommended values at that time. The FNB believes that the science
of nutrition has advanced significantly, and the next edition of the
RDAs will need to reflect this progress. One consideration is
expanding the RDA concept to include reducing the risk of chronic
disease. (Ref. 4, p. 14.)
To accomplish this task the FNB proposed to develop four reference
points: Deficient, average requirement, recommended dietary allowances,
and upper safe levels (Ref. 4, pp. 18-20). They also proposed to
develop a publication describing how the new RDA's could be used for
the variety of purposes to which they are put (e.g., for food labeling)
(Ref. 4, pp. 20-21).
FDA is committed to working with the NAS in its development of new
approaches for providing standards to serve as goals for good nutrition
and in the implementation of those approaches. The agency believes that
any action to change the basis for the RDI's should await completion of
the NAS process to ensure that such an action reflects scientific
consensus and to avoid the possible need for consecutive relabeling of
foods that might occur if FDA were to proceed to revise the RDI's
before NAS published new values.
B. Method for the Determination of RDI Values
4. Many comments supported the method that FDA used for determining
the proposed RDI's for the seven nutrients. One comment, however,
supported the proposal to establish RDI's for nutrients with RDA's
(i.e., vitamin K, selenium) but not for nutrients with ESADDI's (i.e.,
chloride, manganese, chromium, molybdenum, and fluoride). The comment
contended that FDA's proposed use of ESADDI's for establishing RDI's is
not scientifically sound. The comment argued that because ESADDI's are
merely estimates, established when scientific data are insufficient to
develop an RDA, RDI's should not be based on them. The comment also
stated that, because recommended levels are presented as a range of
values, using the midpoint of such a range is of questionable
scientific validity.
Another comment stated that using the midpoint of the ESADDI range
results in RDI's that are too high for manganese, chromium, and
molybdenum. The comment stated that the upper value of the ESADDI range
is the upper limit of safety for the specified age group. This comment
recommended that the lowest value of the ESADDI range be used for
determining the RDI for these nutrients because this level is more than
adequate to meet the needs of most individuals and is higher than usual
intakes. The comment stated that the proposed values would be difficult
to obtain by diet and would likely result in many people believing that
they are ``deficient'' when they are not.
Based on its consideration of the comments on the 1990 proposal and
on the supplementary proposal, FDA determined in the RDI/DRV final rule
that it is appropriate to establish label reference values for vitamins
and minerals by selecting the highest NAS RDA value from among those
for adults and persons 4 or more years of age (excluding pregnant and
lactating females) (58 FR 2206 at 2211). The agency concluded that use
of these values would ensure that the value set as the RDI would take
into account the intakes of vulnerable and at-risk groups. At the same
time, where several ESADDI ranges were established by the NAS for
specific age groups, FDA said that it would select the highest range,
and then use the midpoint of that range as the RDI (58 FR 2206 at
2212). In its July 1990 proposal, FDA based the proposed RDI's for
nutrients with ESADDI's presented as a series of ranges of values on
the midpoint of the highest ESADDI range (55 FR 29476 at 29481), and
most of the comments supported that approach. Accordingly, in the
current rulemaking, FDA used this method to derive the proposed values
for chloride, manganese, fluoride, chromium, and molybdenum (59 FR
429).
As stated previously, the vast majority of comments to the January
1994 proposal supported this approach. FDA disagrees with the comment
that it is not scientifically sound to base RDI's on ESADDI's. In the
July 1990 proposal, FDA acknowledged that available data regarding
nutrients with ESADDI's are not sufficient to allow NAS to set specific
RDA values. However, in ``Recommended Dietary Allowances,'' the NAS
does state that ESADDI's are established ``for essential nutrients when
data were sufficient to estimate a range of requirements'' (Ref. 3, p.
7). From this statement, the agency concludes that, for those nutrients
for which it has established ESADDI's, the NAS reviewed similar types
of evidence as that used in arriving at RDA's and applied the same
rigorous scientific approach, satisfying itself that the nutrients were
essential for human nutrition, and that, while the data were not
sufficient to set precise recommended levels, they were sufficient to
arrive at a scientifically supported range.
Accordingly, these nutrients meet the two criteria (discussed in
comment 2 of section III.B. of this document) used by FDA in
determining which nutrients should be considered for RDI's, namely,
that there is scientific consensus as to the essentiality of the
nutrient and scientific agreement concerning the level at which the
nutrient should be consumed. While for these nutrients that level is a
range rather than an exact amount, it nonetheless reflects the amount
of the nutrient known to be necessary to meet the nutrient needs of
individuals according to age group. Based on these facts, FDA concludes
that it is proper to establish RDI's for nutrients for which the NAS
has established ESADDI's.
This action is consistent with the agency's action in 1973 when it
established U.S. RDA values for biotin, pantothenic acid, copper, and
zinc based on discussions of nutrient requirements in the text of the
seventh edition of ``Recommended Dietary Allowances'' (Ref. 1) (38 FR
2125 and 2146, January 19, 1973). At that time, RDA's did not exist for
these four nutrients, and ESADDI's had not been introduced. Both then
and now, by providing a reference value, the agency allowed for the
nutrients to be listed in nutrition labeling so that manufacturers
could voluntarily provide consumers with information on the amount (in
terms of percent of a reference value) of these essential nutrients
that is present in a serving of food.
The agency is not persuaded that using the lowest value of the
ESADDI range is a preferable method for determining RDI's for nutrients
with ESADDI's. The vast majority of comments received on this subject
in this rulemaking, as well as on the July 1990 proposal and on the
supplementary proposal, argued strongly for label reference values that
[[Page 67167]]
targeted vulnerable or at-risk groups by selecting the highest
recommended values. In the RDI/DRV final rule, FDA was persuaded by the
comments to use a ``population coverage approach'' that did, in fact,
rely on the highest NAS RDA values from among those persons 4 or more
years of age (excluding pregnant or lactating women). For those
nutrients with ESADDI values presented as ranges, the agency attempted
to be consistent with this approach by selecting the highest range and
then using the midpoint of that range.
Use of the lowest point in the ESADDI range would be inconsistent
with the population coverage approach because it would set the RDI at a
value considered by the NAS as the minimum adequate dietary intake
level, not at a value that is targeted at vulnerable or at risk groups.
The agency recognizes the need for some caution, however, because NAS
has stated that the upper limits of the ESADDI ranges of intake should
not be habitually exceeded because the toxic level for many trace
elements may be only several times usual intake (Ref. 3, p. 7).
Therefore, in recognition of NAS' expressed concern and based on
the comments, FDA is persuaded to modify its method for determining
RDI's for nutrients with ESADDI's. While FDA will look first to the
midpoint of the highest range, if that value exceeds the upper limit of
the range for any ESADDI age group within the age range for which the
RDI will apply (i.e., adults and children 4 or more years), FDA will
select as the RDI the lowest upper level of the ESADDI ranges that are
less than the midpoint of the highest ESADDI range. For example, a
review of the 1989 ESADDI values for manganese shows a range from 1.5
to 2 milligrams (mg) for children 4 to 6 years of age, from 2 to 3 mg
for children 7 to 10 years of age, and from 2 to 5 mg for children 11
years of age through adults (Ref. 3). The agency proposed an RDI for
use on labels of foods intended for adults and children 4 or more years
of age of 3.5 mg for manganese. This value was the midpoint in the
highest ESADDI range (2 to 5 mg). Under this new method for determining
RDI's for nutrients with ESADDI's, FDA is setting the RDI value at 2 mg
since the midpoint of the highest ESADDI range (3.5 mg) exceeds the
upper limit for 4 to 6 year old children (2 mg).
Other nutrients affected by this modified method are chromium and
molybdenum. FDA proposed an RDI for chromium of 130 micrograms
(g). The upper limit of the ESADDI range for children 4 to 6
years of age is 120 g. Therefore, the agency is adopting an
RDI for chromium of 120 g, rather than 130 g.
Likewise, FDA proposed an RDI for molybdenum of 160 mg. The upper limit
of the ESADDI range for children 4 to 6 years of age is 75 mg.
Therefore, the agency is adopting an RDI for molybdenum of 75 mg,
rather than 160 mg. FDA has revised Sec. 101.9(c)(8)(iv) to reflect
these new values for manganese, chromium, and molybdenum.
FDA reiterates that the RDI's do not represent dietary goals for
individuals. Their purpose is to provide an overall population
reference value for use on the food label (55 FR 29476 at 29481). As
such, they may underrepresent or exceed the needs of particular
individuals, particularly for manganese and molybdenum. Nonetheless, on
a population basis FDA concludes that these values are appropriate.
IV. Issues Concerning Specific Nutrients
A. Fluoride
5. A number of form letters opposed establishing an RDI for
fluoride. Most of these comments did not provide any justification for
their position. Some comments stated that fluoride has been shown to be
a poison when ingested in very small quantities. These comments
associated the ingestion of minute quantities of fluoride with several
adverse health effects (e.g., dental fluorosis, gastrointestinal
disorders, allergies) but provided no data or information to support
this position. Another comment said that FDA should not establish an
RDI for fluoride because fluoride has never been identified as an
essential nutrient. This comment also expressed concern about
difficulties that would be encountered with an RDI for fluoride, given
the variability in dietary intake levels of this substance resulting
from the use or nonuse of fluoridated water as well as the
unintentional consumption of fluoride from mechanically deboned meat
and fluoridated toothpastes, and about the harm that might occur if
foods (including supplements) began fortifying with fluoride.
Another comment recommended that either fluoride be deleted from
the list of nutrients for which RDI's are established, or that the
agency establish an upper limit at 1.3 parts per million for added
fluoride in foods and dietary supplements because this level would be
consistent with the agency's proposal for the addition of fluoride to
bottled water.
A couple of comments suggested that an RDI of 3 mg for fluoride
will become a formulation target level for manufacturers. One comment
stated that manufacturers of vitamin-mineral supplements may
incorporate an amount of fluoride corresponding to 100 percent of the
RDI and reflect this fact on the nutrition label. The comment argued
that if such formulations are produced, the intake of 3 mg fluoride
from the vitamin-mineral supplement in addition to the intake of
fluoride from the diet, drinking water, and fluoridated dentifrices
would pose a risk of dental fluorosis for young children and might lead
to excess skeletal fluoride accumulation.
A professional association of pediatric dentists supported
establishing an RDI for fluoride for nutrition labeling purposes.
However, the comment stated that establishing the RDI at 3 mg would
place millions of children from infancy through 16 years at risk for
dental fluorosis. The comment urged FDA to establish the RDI for
fluoride at 1 mg because this level is scientifically proven to provide
significant anti-caries protection without increasing the risk of
dental fluorosis. The comment stated that levels above 1 mg have shown
no greater anti-caries protection, while greatly increasing the risk of
dental fluorosis in children. Another comment suggested that the lowest
fluoride ESADDI of 1.5 mg be adopted as the RDI because this level
would be compatible with the available food supply, and because
fluoride has about 70 percent availability for absorption resulting in
an absorbed level of 1 mg.
The agency rejects the argument that an RDI should not be
established because low levels of ingested fluoride (i.e., levels at or
below the proposed RDI) represent significant health risks and are
associated with a variety of toxicities. The U.S. Department of Health
and Human Services, in a report titled ``Review of Fluoride, Benefits
and Risks'' (Ref. 5), examined the literature on the adverse effects of
ingested fluoride. The report could not substantiate that there are
adverse health effects or toxicities associated with low level fluoride
exposure in normal individuals. In 1993, the Subcommittee on the Health
Effects of Ingested Fluoride of the NAS Committee on Toxicology (the
Subcommittee) examined possible adverse health effects associated with
fluoride intake including dental fluorosis; bone fracture;
reproductive, renal, gastrointestinal, and immunological toxicities;
genotoxicity; and carcinogenicity. The Subcommittee found that it could
not conclude that adverse health effects were associated with current
levels of fluoride intake resulting from ingestion of drinking water
with a maximum contaminant
[[Page 67168]]
level for fluoride at 4 mg/liter (as set by the U.S. Environmental
Protection Agency) and of other sources of fluoride, such as
toothpaste, mouth rinses, dietary fluoride supplements, and foods
prepared with fluoridated water (Ref. 6). Therefore, FDA rejects the
argument that the ingestion of low levels of fluoride is associated
with adverse health effects and toxicities.
FDA wishes to clarify that the proposed RDI for fluoride was not
intended to be a target level for supplementation. The agency stated in
the July 1990 proposal that the proposed RDI for fluoride was to be
used only in conjunction with a declaration of the level of fluoride
that is naturally present in a food or that results from the use of a
fluoridated water supply in the processing operation (55 FR 29476 at
29482). This issue was addressed again in the RDI/DRV final rule (58 FR
2206 at 2215).
FDA is persuaded, however, that an RDI should not be established
for fluoride because fluoride does not meet the first criterion
discussed previously for determining which nutrients should be
considered for RDI's, namely, that there is scientific consensus as to
the essentiality of the nutrient. Fluoride is a unique nutrient in that
an ESADDI for it was included in the 10th edition of ``Recommended
Dietary Allowances,'' yet in the text of that publication, the NAS
states that the contradictory results of published studies ``do not
justify a classification of fluorine as an essential element, according
to accepted standards'' despite the fact that it is considered a
beneficial element for humans because of its valuable effects on dental
health (Ref. 3, p. 235). In proposing an RDI for fluoride, the agency
mistakenly proposed an RDI for each nutrient listed in the NAS' RDA and
ESADDI tables. The agency failed to focus on the fact that, unlike the
other nutrients listed, the supporting text did not conclude that
fluoride is an essential nutrient.
In addition, FDA is persuaded by the comments that establishing an
RDI for fluoride would have limited usefulness in assisting consumers
to understand the nutritional significance of the amount of fluoride in
a serving of food in comparison to the total amount consumed per day
because the primary sources of fluoride (i.e., community fluoridated
water supplies, toothpastes, mouth rinses, and fluoride supplements)
will not bear nutrition labeling. Approximately 132 million Americans
receive drinking water that contains either naturally occurring or
added fluoride (Refs. 5 and 6). This water supply contributes
significantly to the total daily dietary intake of fluoride.
Additionally, fluoride supplements that may contribute significantly to
the total daily dietary intake of fluoride of persons consuming them
are regulated as drugs because of their intended use (to prevent
disease) and, therefore are not subject to the food labeling
regulations. Consequently, because the primary sources of dietary
fluoride are beyond the purview of nutrition labeling regulations, the
agency concludes that the declaration of percent DV of fluoride within
nutrition labeling on a limited number of foods that are relatively
minor sources of the nutrient will be of little use in assisting
consumers in maintaining healthy dietary practices.
Accordingly, because there is no consensus on the essentiality of
fluoride, and because declaration of a percent DV for this nutrient
would be of little value to consumers, the agency is removing fluoride
from the RDI list in Sec. 101.9(c)(8)(iv). Consistent with this action,
FDA is not including a reference to fluoride in Sec. 101.3(e)(4)(ii)
(21 CFR 101.3(e)(4)(ii)) and is removing a reference to it in
Sec. 101.36 (b)(3), (b)(3)(i), (b)(3)(ii), (b)(4), and (b)(4)(vi) (21
CFR 101.36(b)(3),(b)(3)(i), (b)(3)(ii), (b)(4), and (b)(4)(vi)).
B. Selenium and Chromium
6. Several form letters from consumers encouraged FDA to establish
RDI's for selenium and chromium that are higher than the proposed
levels because the proposed levels did not take prevention into
account. A few comments cited therapeutic benefits of high doses of
selenium and chromium.
The agency is not persuaded to establish higher RDI's for selenium
and chromium. As discussed in comment 3 of section III.B. of this
document, the NAS is considering expanding the RDA concept to include
reducing the risk of disease. If that occurs, the recommended levels of
some nutrients can be expected to rise. As stated previously, FDA
intends to work cooperatively with the NAS in its deliberations and to
propose to implement recommendations resulting from that process.
7. One comment recommended that consumers be cautioned against
ingesting levels of selenium in excess of the RDI to prevent potential
toxicity because the toxic level may only be a few times greater than
the average daily intake.
FDA does not agree with this comment. The 10th edition of the RDA
states that national food composition data in the United States
indicate that the adult mean dietary intake of selenium was 108
g per day between 1974 and 1982 (Ref. 3). Toxicities have not
been seen in persons who ingested less than 1 mg per day and generally
much more (Ref. 3). Such levels are many times the RDI being
established for selenium at 70 g. However, even if the agency
were persuaded of the need to consider a label warning statement about
selenium, it would be outside the scope of this rulemaking.
C. Chloride
8. One comment noted that the RDI for every nutrient should be
based on the most current scientific information available and should
rely on the 10th edition of ``Recommended Dietary Allowances.'' The
comment stated that the ESADDI for chloride (as well as for sodium and
potassium) was eliminated from the 10th edition because it was
difficult to justify. The comment contended that if FDA were to use the
ESADDI for chloride as the basis for an RDI, it would be disregarding
the best judgment of the scientific experts who establish the RDA's.
Furthermore, the comment stated that it would be unscientific to
establish an RDI for chloride in the absence of either an RDA or an
ESADDI. All other comments addressing this issue supported the proposed
RDI for chloride.
The agency is not persuaded that it is unscientific to establish an
RDI for chloride. There is a clear consensus that chloride meets the
first criterion discussed previously for determining which nutrients
should be considered for RDI's, that is, that it be essential. As
stated by the NAS, ``the principal electrolytes (sodium, potassium, and
chloride) * * * are essential dietary components, in that they must be
acquired from the diet * * *'' (Ref. 3, p. 247).
In regard to the second criterion (i.e., that there is scientific
agreement concerning the level at which the nutrient should be
consumed), in the case of chloride and the other electrolytes, there is
scientific agreement concerning the estimated minimum required level
for consumption (Ref. 3, table 11-1). While these levels are given in a
separate table from the RDA and ESADDI levels in the 10th edition of
the ``Recommended Dietary Allowances,'' there is nonetheless scientific
consensus in support of them.
Since the estimated minimum required levels for these nutrients
were based on estimates of only what is needed for growth and
replacement of obligatory losses (Ref. 3), and other RDI values
represent higher levels that are ``adequate to meet known nutrient
[[Page 67169]]
needs of practically all healthy persons,'' FDA looked to the 9th
edition of ``Recommended Dietary Allowances'' (Ref. 2), which provided
ESADDI values for chloride, in arriving at the value that the agency
first proposed as the RDI for chloride for adults and children 4 or
more years of age (i.e., 3,150 mg) (55 FR 29476 at 29482). In the RDI/
DRV final rule, FDA stated that, using the ``population coverage
approach,'' this value would raise to 3,400 mg. This value, which the
agency is adopting as the RDI for chloride, is 4.5 times the highest
estimated minimum required level of 750 mg specified in the 10th
edition of ``Recommended Dietary Allowances'' (Ref. 3, table 11-1).
This value is proportional to the DRV for sodium, 2,400 mg, which is
4.8 times its highest estimated minimum required level of 500 mg (Ref.
3, table 11-1). Because dietary chloride comes almost entirely from
sodium chloride, and because chloride loss tends to parallel losses of
sodium (Ref. 3, p. 258), it is logical that the RDI's for both of these
nutrients be in roughly the same proportion to their respective
estimated minimum required levels.
Potassium has a Daily Reference Value (DRV) of 3,500 mg which is
1.75 times its highest estimated minimum value. The agency points out
that it is not necessary that the label reference value for potassium
be in the same proportion to the estimated minimum required levels for
sodium or chloride because neither the intake nor obligatory losses for
potassium are in direct proportion to those of sodium and chloride
(Ref. 3, p. 256).
V. Determination of Nutritional Inferiority of Substitute Foods
The RDI/DRV final rule discussed the effect of the label reference
values on alternative products (e.g., reduced fat foods, reduced sodium
foods) formulated to achieve nutritional equivalency with their
traditional counterparts in accordance with Sec. 101.3(e)(4). The
agency acknowledged that an increase in the number of nutrients for
which RDI's are established would mean that efforts to obtain
nutritional equivalency may require the addition of additional
nutrients to some substitute foods (58 FR 2206 at 2225).
In recognition of this fact and because there are no listed sources
for selenium, fluoride, chromium, and molybdenum that can be used to
add these nutrients to foods (i.e., FDA has not authorized the use of
any food additives or listed any substances as generally recognized as
safe (GRAS) that are sources of supplementation of these four
nutrients), the agency proposed in Sec. 101.3(e)(4)(ii) in the January
1994 proposal that these nutrients need not be considered in
determining nutritional inferiority (59 FR 427).
9. One comment agreed with the agency's position on determinations
of nutritional inferiority. A few comments from the food industry
supported the proposal that selenium, fluoride, chromium, and
molybdenum not be considered in determining nutritional inferiority of
an substitute product. These comments expressed concern, however, that
the proposed inclusion of vitamin K in determinations of nutritional
inferiority will lead to the unnecessary fortification of existing
substitute foods and be a serious disincentive for manufacturers to
continue to develop and market ``healthier'' products. The comments
suggested that FDA include vitamin K among the nutrients that need not
be considered in determining nutritional inferiority.
The comments cited several factors in support of their suggestion,
including the lack of practical analytical methodology for determining
levels of vitamin K in food, the need to analyze current substitute
food products for vitamin K, the lack of a data base on vitamin K
content of foods, and the fact that there are a variety of technical
issues (e.g., compatibility with the product, ability to achieve
uniform distribution, stability during processing and storage, and
flavor maintenance) that would need to be resolved with respect to this
nutrient. The comments also stated that food manufacturers would be
required to seek appropriate ingredient sources for vitamin K,
determine product formulations and performance characteristics with the
new ingredients, and change product labels if the nutrient is added to
the modified products. A couple of comments requested guidance
regarding analytical methods for vitamin K. One comment stated that
current intakes of vitamin K appear to be adequate based on estimated
intakes and that vitamin K is synthesized by intestinal microflora.
FDA has carefully reviewed the comments but has concluded that
vitamin K should be considered in determining whether substitute foods
are nutritionally inferior to the foods for which they substitute. The
authority for the provisions of Sec. 101.3 on substitute foods is
section 403(c) of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 343(c)). When this section of the act was adopted in 1938,
Congress was seeking to protect the consumer from the uninformed
purchase of an inferior substitute product that could be mistaken for a
traditional food product (38 FR 2138, January 19, 1973). In 1973, in
proposed regulations pertaining to ``imitation foods,'' the agency
noted that vast strides in food technology had taken place since
section 403(c) of the act was enacted, and that since 1938 many new
wholesome and nutritious food products had entered the marketplace,
some of which resembled and substituted for traditional foods (38 FR
2138). The agency stated that it was no longer the case that such
products were necessarily substandard compared to the traditional foods
for which they were substituted. However, FDA still believed that the
consumer must be protected from unwittingly purchasing a product that
is different from what he or she may reasonably expect (38 FR 2138).
FDA continues to believe that, as substitute products proliferate, it
is important to ensure that these products contain essential nutrients
in amounts consistent with the reference food, so that consumers can
continue to have confidence that a varied diet will supply adequate
nutrition. For this reason the agency disagrees that the consideration
of vitamin K in determining the status of substitute foods is
unnecessary.
Moreover, the agency disagrees that adequacy of intake is a
sufficient reason to make the addition of vitamin K optional in
substitute foods. Contrary to the comments, a recent analysis of data
from FDA's Total Diet Study indicates that 25 to 30 year old women and
men are consuming less than the current RDA for vitamin K (Ref. 10).
Although it is widely assumed that the daily vitamin K requirement is
met by bacterial synthesis of vitamin K in the form of menaquinones,
the relative contribution of this form of vitamin K remains uncertain
(Ref. 9), and recent studies underscore the importance of the dietary
intake of vitamin K (Refs. 7, 8, and 9). However, adequacy of intake of
a nutrient is not the issue in deciding whether the nutrient should be
considered in determining nutritional inferiority. The agency's
consistent view has been that, as stated previously, if a nutrient is
essential, it should be considered in such determinations unless there
are factors that demonstrate that it is inappropriate to do so.
No evidence was submitted in the comments to support the argument
that the addition of this nutrient to alternative products will be a
disincentive for the development and marketing of substitute foods, nor
were any examples presented that demonstrated that the fortification of
an appropriate food with vitamin K would be impossible. FDA appreciates
that manufacturers may need to reformulate
[[Page 67170]]
and relabel some products. However, the number of such products will
likely be very small because available databases reveal that many foods
do not contain measurable amounts of vitamin K (Refs. 11, 12, and 13).
A ``measurable amount'' of an essential nutrient is defined as 2
percent or more of the RDI for that nutrient per reference amount
customarily consumed (see Sec. 101.3(e)(4)(ii) as revised in this final
rule). FDA has stated that analysis is not needed for nutrients where
reliable databases or scientific knowledge establish that a nutrient is
not present in the product (58 FR 2079 at 2109). For example, current
databases (Refs. 11, 12, and 13) show that foods that consist primarily
of sugar and water (e.g., soft drinks, hard candies, honey), as well as
many oils, beverages, fruits, and fish, do not contain measurable
amounts of vitamin K, so there is no need to analyze such foods for it.
Conversely, green leafy vegetables, legumes, and certain oil products
(e.g., soybean oil), which are important sources of vitamin K, are not
generally reformulated as substitute foods. The primary categories of
substitute foods that may need to be reformulated or relabeled appear
to be those that substitute for foods containing eggs, milk, grains, or
those oils that contain vitamin K.
The agency is not persuaded by the comments that there is a lack of
analytical methods for vitamin K, or that technological barriers to
analyzing foods for vitamin K, or to adding vitamin K to foods, are
insurmountable. The Association of Official Analytical Chemists (AOAC)
International has authorized methods for analyzing vitamin K for infant
formula (Refs. 14 and 15). In addition, there are High Performance
Liquid Chromatographic methods available that are being used in
university and government laboratories in the United States for the
analysis of vitamin K in a wide, diverse portion of the food supply
(Refs. 16, 17, and 18). These methods could be utilized by commercial
laboratories if there was a demand for information on the vitamin K
content of food products other than infant formula. The agency believes
that such methods can be readily adapted for use by industry. However,
the agency considers it inadvisable to explicitly recommend a specific
analytical method for vitamin K. The applicability of a specific method
to products of different matrices varies. If FDA were to require the
use of a specific method, it could give the erroneous impression that
other methods that are more appropriate to a matrix, or that utilize
newer techniques, could not, or would not, be acceptable. In accordance
with Sec. 101.9(g)(2), FDA advises that manufacturers should select the
most appropriate method for the matrix involved.
The agency also is not persuaded by the comments that there is a
scarcity of ingredient sources of vitamin K. Vitamin K is required for
addition to infant formula as specified in part 107 (21 CFR part 107)
and is found in many dietary supplement products. These facts evidence
that ingredient sources are available to supply this nutrient.
In summary, the consideration of vitamin K in determinations of
nutritional inferiority is consistent with the original intention of
the imitation food provisions (i.e., Sec. 101.3(e)(4)) that consumers
be protected from the uninformed purchase of nutritionally inferior
substitute products. Because the lack of vitamin K would make a food
inferior to the one for which it substitutes, the agency concludes that
its addition should be required according to the criteria established
in Sec. 101.3(e)(4).
FDA appreciates that there are presently some gaps in knowledge
about the vitamin K content of foods and technological issues related
to its addition to foods. However, as noted previously, considerable
recent scientific activity has occurred and knowledge is evolving
rapidly (Refs. 10 through 17). Therefore, based on its review of
current data, FDA concludes that there are adequate analytical methods,
food composition data, and technological expertise available to support
consideration of vitamin K when determining nutritional inferiority of
substitute foods. FDA will continue to monitor the evolving scientific
knowledge regarding vitamin K content of food and will work with
industry on specific foods or issues, should problems arise.
10. Several comments noted that chloride and manganese are not of
public health concern and encouraged FDA to modify Sec. 101.3(e)(4)(ii)
to state that these minerals need not be considered when determining
nutritional inferiority. A few comments specifically noted that no
chloride deficiencies have been found except among infants fed chloride
deficient formulas as the sole source of the diet. These comments also
argued that requiring the inclusion of chloride in nutritional
inferiority determinations would jeopardize the development and
continued availability of certain reduced sodium foods. The comments
said that if this provision was not changed, manufacturers would be
required to add chloride to the modified products to compensate for the
amount originally contributed by salt, and that the addition of
chloride-containing salts would seriously affect the flavor and
acceptability of many such products.
As explained in the preceding comment, the requirement for a
determination of nutritional inferiority that is set forth in
Sec. 101.3(e)(4) is intended to ensure that alternative products are
nutritionally comparable to the foods for which they substitute. In
promulgating these regulations, FDA tentatively concluded that the term
``imitation'' should only be applied to substitute foods that are
nutritionally inferior to the foods for which they substitute (38 FR
2138). In response to comments received, FDA confirmed this view and
defined nutritional inferiority as any reduction in the content of an
essential vitamin or mineral or of protein that is present in a
``measurable amount,'' with ``measurable amount'' defined as 2 percent
or more of the U.S. RDA of that nutrient per serving (38 FR 20703,
August 2, 1973). Adequacy of intake of a particular nutrient or concern
over whether the nutrient was of public health concern (e.g., due to
widespread deficiencies) was not considered to be an issue in
determining whether a substitute food was nutritionally inferior to the
food for which it is a substitute.
Consistent with the agency's longstanding definition of nutritional
inferiority in Sec. 101.3(e)(4), FDA finds that the adequacy of current
dietary intakes of a nutrient is not determinative of the issue.
Therefore, the agency is not persuaded by this argument to drop
chloride and manganese from consideration in determining nutritional
inferiority. The agency concludes that the lack of manganese would make
a food inferior to the one which it replaces.
However, FDA is persuaded that a change in its position on
inclusion of chloride in determinations of nutritional inferiority is
warranted given its commitment to lower sodium intake, consistent with
the ``Dietary Guidelines for Americans'' (Refs. 19 and 20) and ``The
Surgeon General's Report on Nutrition and Health'' (Ref. 21). The
Surgeon General's report pointed to the need for moderation in sodium
consumption, not only because there is a benefit to persons whose blood
pressure rises with increased sodium intake, but also because there is
no biological marker for individual sodium sensitivity. The report
notes that there is no apparent harm to the general population from
moderate sodium restriction (Ref. 21, p. 13). Because salt (i.e.,
sodium chloride) is the major source of dietary chloride, the agency is
[[Page 67171]]
persuaded that it is contradictory to encourage a reduction in sodium
intake and yet to require that chloride be considered in determining
nutritional inferiority. When salt is removed from a product, chloride
follows.
Therefore, FDA concludes that it is reasonable to delete the
requirement for inclusion of chloride in the determination of
nutritional inferiority. The agency points out, however, that chloride
must be included in total replacement formulas, medical foods, and
infant formula, as needed, to ensure that there are adequate levels of
this essential nutrient in the diet of persons consuming a limited
variety of foods.
Accordingly, the agency is retaining the requirement in
Sec. 101.3(e)(4)(ii) that manganese, but not chloride, be included in
determinations of nutritional inferiority in substitute foods.
VI. Age/Sex Groupings
In the January 1994 proposal, FDA pointed out that in following the
provisions of the DS act and retaining the label reference values in
Sec. 101.9(c)(7)(iv)(1992), the agency did not adopt label reference
values for use on foods that are represented or purported to be for use
by infants, children under 4 years of age, or pregnant or lactating
women (59 FR 427 at 429). Given the continuing questions about how to
arrive at such values, FDA deferred action on this issue. The agency
stated that it intended to address the issue of RDI's for the various
age groups in a future rulemaking (59 FR 427 at 430). It also stated
that, until such rulemaking is completed, labels of dietary supplements
of vitamins or minerals that are intended for these specific groups and
that are regulated under Sec. 101.36 may continue to specify the mg or
g amounts of vitamin K, selenium, manganese, chromium,
molybdenum, and chloride with an asterisk in the percent DV column (59
FR 427 at 430). The asterisk would refer to a footnote stating ``Daily
Value not established.'' However, because quantitative amounts are not
listed for vitamins and minerals on labels of conventional foods, only
the percent DV, FDA noted that the subject nutrients may not be
declared on labels of foods in conventional food form that are
represented or purported to be for use by infants, children less than 4
years of age, or pregnant or lactating women until such time as RDI's
are established for such groups. The agency requested comment on how to
list the subject nutrients on the labels of conventional foods that are
represented or purport to be for use by infants, children under 4, and
pregnant and lactating women (59 FR 427 at 430).
11. A couple of comments that supported establishing RDI's for the
seven subject nutrients suggested that the agency establish RDI's for
infants, children under 4 years of age, and pregnant or lactating women
by using the same quantitative reasoning that it used to determine
RDI's for children age 4 and above.
FDA advises that it intends to propose to establish RDI's for
infants, children less than 4 years, and pregnant and lactating women
in the near future. In that proposal, the agency intends to address all
nutrients for which RDI's have been established for adults and children
4 or more years of age.
12. One manufacturer of dietary supplement products suggested that
consumers of conventional foods represented for or purported to be for
use by infants, children less than 4 years of age, or pregnant or
lactating women would be best served by allowing quantitative
information (i.e., mg or g amounts) of vitamin K, selenium,
manganese, chromium, molybdenum, and chloride to be listed in nutrition
labeling of such products, with an accompanying asterisk and footnote
that a DV has not been established, until such time as RDI's are
established for those groups. The comment stated that while this
information might not be all that meaningful to the average consumer,
there are a significant number of sophisticated people who could put
this information to good use in making intelligent food choices.
FDA has considered the suggested change and finds that while there
may be merit to it, it would necessitate major changes in the nutrition
label of such products that were not foreshadowed in the proposed rule.
The agency had discussed simply the use of asterisks with the footnote
stating that a DV had not been established (59 FR 427 at 430), but the
agency received no support in the comments for that modification. In
accordance with the Administrative Procedures Act, it would be
necessary to propose a change in Sec. 101.9 to allow quantitative
amounts by weight of vitamin K, selenium, manganese, chromium,
molybdenum, and chloride to be declared in nutrition labeling of
conventional foods represented or purported for use by infants,
children under 4, and pregnant or lactating women in advance of the
establishment of RDI's for those groups. Given that the agency intends
to propose to establish RDI's for the additional groups, that action
can be accomplished as expeditiously as the one suggested by this
comment, thereby negating the need for such additional rulemaking.
VII. Conforming Amendments
A. Section 101.3(e)(4)
As a result of questions that FDA received since the publication of
the January 6, 1993 final rules, the agency has come to recognize that
it inadvertently deleted the term ``per average or usual serving'' from
Sec. 101.3(e)(4)(ii) when it amended that paragraph as a part of the
RDI/DRV final rule (58 FR 2206). Section 101.3(e)(4)(ii) defines a
measurable amount of an essential nutrient in a food for the purposes
of determining nutritional inferiority. FDA is correcting that error in
this final rule.
However, to make this paragraph consistent with other regulations
that FDA issued in implementing the 1990 amendments (e.g., serving size
and nutrient content claim regulations in 21 CFR 101.12 and 101.13,
respectively), the term ``per reference amount customarily consumed''
should be used instead of ``per average or usual serving'' to ensure
that the comparison of products reflects the true characteristics of
the product, not the container size. This concept underlies FDA's
consideration of claims characterizing the levels of nutrients in foods
(58 FR 2302 at 2314). FDA is not replacing the accompanying term ``per
average or usual portion'' because FDA concluded in the final rule on
serving size that the term ``portion'' is considered to be
interchangeable with ``serving'' size and, therefore, deleted that term
from the regulations (58 FR 2229 at 2232).
Accordingly, Sec. 101.3(e)(4)(ii) is corrected to read as follows:
For the purpose of this section, a measurable amount of an
essential nutrient in a food shall be considered to be 2 percent or
more of the Daily Reference Value (DRV) of protein listed under
Sec. 101.9(c)(7)(iii) per reference amount customarily consumed and
of potassium listed under Sec. 101.9(c)(9) per reference amount
customarily consumed and 2 percent or more of the Reference Daily
Intake (RDI) of any vitamin or mineral listed under
Sec. 101.9(c)(8)(iv) per reference amount customarily consumed
except that selenium, molybdenum, chromium, and chloride need not be
considered.
B. Section 101.36
As noted in the proposed rule (59 FR 427 at 430), the amendments to
the nutrition labeling regulations that FDA is making in this final
rule necessitate that FDA revise Secs. 101.36 (b)(3), (b)(4), and
(b)(4)(vi).
Current Sec. 101.36(b)(3) states that all nutrients in
Sec. 101.9(c) that are present in
[[Page 67172]]
a dietary supplement in quantitative amounts by weight that exceed the
amount that can be declared as zero in Sec. 101.9(c) must be declared
in nutrition labeling. This section goes on to state that those
nutrients that are not present, or that are present in amounts that
would be declared as zero, shall not be declared. The section states,
in addition, that potassium, vitamin K, chloride, chromium, fluoride,
manganese, molybdenum, and selenium shall be declared, except when
present in quantitative amounts by weight that allow a declaration of
zero.
FDA is modifying Sec. 101.36(b)(3) by removing all reference to
vitamin K, chloride, chromium, manganese, molybdenum, and selenium.
Because these nutrients are now included in Sec. 101.9(c)(8)(iv), they
can be listed in nutrition labeling without the need for a specific
provision that authorizes such listing. As discussed under comment 5 of
section IV.A of this document, the agency is also modifying this
section to remove all references to fluoride to reflect the agency's
decision not to establish an RDI for this nutrient.
Current Sec. 101.36(b)(4) states that the nutrition label shall
contain a listing of the percent of the DV (i.e., the percent of the
RDI as established in Sec. 101.9(c)(8)(iv) or DRV as established in
Sec. 101.9(c)(9)), where appropriate, of all nutrients listed in the
nutrition label, except that the percent DV for protein may be omitted
as provided in Sec. 101.9(c)(7), and that no percent shall be given for
sugars, vitamin K, chloride, chromium, fluoride, manganese, molybdenum,
selenium.
FDA is modifying Sec. 101.36(b)(4) by limiting the exception that
no percent DV shall be given for vitamin K, selenium, manganese,
chromium, molybdenum, and chloride to only products represented or
purported for use by infants, children less than 4 years of age, and
pregnant or lactating women. Because RDI's are now established for
these nutrients for adults and children 4 or more years of age, the
percent DV of these nutrients can be calculated on products represented
or purported for use by that group. Because FDA is not adopting an RDI
for fluoride, revised Sec. 101.36(b)(4) does not reference this
nutrient.
Current Sec. 101.36(b)(4)(vi) states that when no percent DV is
given for sugars, vitamin K, chloride, chromium, fluoride, manganese,
molybdenum, or selenium, an asterisk shall be placed in the ``% Daily
Value'' column that shall refer to another asterisk that is placed at
the bottom of the nutrition label that is followed by the statement
``Daily Value not established.'' FDA is modifying this regulation to
state that when no percent is given for sugars, or, for labels of
dietary supplements of vitamins and minerals that are represented or
purported to be for use by infants, children less than 4 years of age,
or pregnant or lactating women, when no percent is given for vitamin K,
selenium, manganese, chromium, molybdenum, or chloride, an asterisk
shall be placed in the ``Percent Daily Value'' column that shall refer
to another asterisk that is placed at the bottom of the nutrition label
and followed by the statement ``Daily Value not established.'' This
action is needed until the rulemaking (discussed in comment 11 of
section VI of this document) to establish RDI's for infants, children
less than 4 years of age, and pregnant or lactating women is complete.
While there are no RDI's codified for these groups for any nutrients,
in its June 18, 1993, proposal pertaining to nutrition labeling of
dietary supplements (58 FR 33715 at 33721), FDA encouraged
manufacturers of products represented or purported to be for use by
infants, children less than 4 years of age, or pregnant or lactating
women to use label reference values for these groups given in the
preamble of the RDI/DRV final rule on January 6, 1993 (58 FR 2206 at
2213). Since the table of label reference values at the bottom of page
2213 in that document addresses only the vitamins and minerals in
current Sec. 101.9(c)(8)(iv), there are no values for vitamin K,
selenium, manganese, chromium, molybdenum, or chloride that can be used
to calculate the percent DV of these nutrients on labels of products
represented or purported to be for use by infants, children less than 4
years of age, or pregnant or lactating women at this time.
Again, because FDA is not adopting an RDI for fluoride, revised
Sec. 101.36(b)(4)(vi) does not reference that nutrient.
It should be noted that, while these conforming amendments to
Sec. 101.36 modify that current regulation, they will be superseded by
any final regulations resulting from the proposed rule published in a
companion document in this issue of the Federal Register entitled
``Food Labeling: Statement of Identity, Nutrition Labeling and
Ingredient Labeling of Dietary Supplements.''
VIII. Other Provisions
FDA did not receive any comments that dealt with, or objected to,
the other provisions of the proposal (e.g., units of measure for
calcium, phosphorus, biotin, and folate and the conforming amendments).
In the absence of any basis for doing otherwise, FDA is adopting those
provisions as proposed.
IX. Effective Date
13. Several comments suggested that FDA reevaluate the effective
date discussed in the proposed rule. These comments suggested a longer
effective date because the proposed inclusion of vitamin K, chloride,
and manganese in nutritional equivalency determinations would require
that the composition of virtually all existing substitute foods be
reevaluated. One comment suggested a 3-year extension of the effective
date because food manufacturers are just completing a massive
relabeling effort of all packaged foods in the marketplace. One comment
from a printing company stated that it would have to change 2,600
labels very shortly if the effective date was adopted as proposed. The
comment noted that new labels for dietary supplements will use an
asterisk referring to the statement ``No Daily Value established'' for
the subject nutrients. The comment stated that if the final rule did
not issue by June 1994, the company would not be able to implement the
new RDI values with the label changes it was making in response to the
1990 amendments. The comment requested that the final rule issue by
June 1994 or establish an effective date after July 1996. Another
comment suggested that establishing the effective date after July 1996
would reduce the impact of making two label changes to the same label.
The comment noted that it is impossible for producers to undertake
analysis, reformulation and relabeling of all the alternative products
affected by this proposal within the 30 days allowed between
publication of the final rule and the effective date.
One comment requested that the final rule on RDI's become effective
30 days after its publication with the clarification that the values
may be used at that time but are not mandatory on the labels of food or
dietary supplements until at least July 1, 1996, 1 year from the
implementation deadline for the food labeling regulations for dietary
supplements.
FDA points out that it published a notice on February 9, 1995 (60
FR 7711), indicating it will not enforce its regulations on nutrition
labeling and nutrient content claims for dietary supplements until
after December 31, 1996. Therefore, the July 1, 1995, date is not
longer determinative. This delay allows FDA time to modify its
regulations to respond to the DSHEA.
The agency is persuaded by the comments that it is necessary to
reconsider the amount of time that it
[[Page 67173]]
may take the food industry to implement these new rules. The proposed
30-day effective date was intended to permit the inclusion of the
subject nutrients in nutrition labeling as quickly as possible. The
agency believes that many companies want, and will be able, to
implement these rules quickly, while others will need more time to make
the necessary changes.
Accordingly, while companies who wish to add vitamin K, selenium,
manganese, chromium, molybdenum, and chloride to the nutrition labeling
on their products may do so immediately, FDA is changing the effective
date to January 1, 1997, in recognition of the analytical work and
formulation changes that may be needed with some food products to come
into compliance with revised Secs. 101.3(e)(4)(ii) and 101.9(c)(8)(iv).
This effective date provides approximately 12 months for industry to
implement the subject changes, sufficient time to accomplish an orderly
and economical adjustment to the subject rules. It is also consistent
with the effective date established in the DSHEA and proposed in the
document addressing nutrition labeling of dietary supplements published
elsewhere in this issue of the Federal Register. The agency encourages
industry to comply with these new rules earlier than the effective date
wherever it is feasible to do so.
X. Economic Impact
FDA has examined the economic implications of the final rule 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 that agencies analyze options for
regulatory relief for small businesses. FDA finds that this final rule
is not a 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. Costs
14. FDA received several comments rejecting the agency's analysis
of the costs of this regulation as proposed. One comment stated that
the cost of evaluating the manganese, vitamin K, and chloride content
of substitute foods and relabeling affected products would exceed the
agency's estimates. Another comment explained that a lack of a
practical analytical method for vitamin K in food systems and other
technical issues would lead to major costs.
FDA agrees that including manganese and vitamin K in the
consideration of nutritional equivalency will lead to increased costs
of analyzing and relabeling substitute products. Because FDA has
reevaluated its decision regarding chloride, there will be no increased
costs attributable to that substance.
As stated previously in this document, analysis is not needed for
nutrients where reliable data bases establish, or scientific knowledge
establishes, that a nutrient is not present in the product. Current
data bases show that foods that consist primarily of sugar and water,
as well as many oils, beverages, fruits, and fish, do not contain
measurable amounts of vitamin K, so there is no need to analyze for it
in products substituting for such foods. Conversely, green leafy
vegetables, legumes, and certain oil products, which are major sources
of vitamin K, are not generally reformulated as substitute foods.
Therefore, FDA expects that only a limited number of products will
require analysis for vitamin K. Likewise, manganese is prevalent in
cereal grains, green leafy vegetables, and tea. Therefore, FDA predicts
that only a limited number of products will require analysis for
manganese. However, when there is a reasonable expectation that either
nutrient occurs in the food, an analysis for the nutrient will be
necessary, and the manufacturers of those products will bear the cost
of testing for the nutrient.
FDA does not have an estimate of the cost of testing for vitamin K
in foods other than infant formulas or dietary supplements, although
such testing has been performed in university settings. The cost of
testing for vitamin K in infant formulas or dietary supplements is
approximately $187 per product (Ref. 22). The cost of testing for
manganese is approximately $34 per product (Ref. 23). While FDA cannot
determine the exact cost of testing for these nutrients because the
total number of products that must be tested is unknown, the cost per
test and the fact that vitamin K and manganese levels will be
significant in only a small number of foods lead the agency to conclude
that the costs that will be engendered by this final rule will not
approach the levels that represent a significant rule.
15. Several comments objected to the economic analysis on the basis
that the short lead time of the proposed effective date would lead to
increased costs. One comment objected to the proposed effective date
given due to the impossibility of evaluating foods for nutritional
equivalency and relabeling of affected products within the 30-day
effective date proposed. Another comment stated that extending the
effective date would reduce the impact of making two label changes.
FDA agrees that the proposed effective date would lead to increased
costs. However, because FDA is extending the effective date to give
firms approximately 12 months, the analysis need not be changed in
response to these comments.
B. Benefits
This regulation allows manufacturers to declare certain nutrients
within the nutrition panel and to make content claims about those
nutrients. This regulation will create benefits to the extent that the
additional information allowed on labels will help consumers make
healthy dietary choices.
This regulation also establishes requirements for determining
nutritional inferiority such that substitute products must contain
equivalent amounts of vitamin K and manganese as the products for which
they substitute.
There are currently no widespread deficiencies of either vitamin K
or manganese in the United States. Although it is theoretically
possible that additional deficiencies could occur if enough consumers
switch to substitute products containing inferior amounts of the
nutrient, the likelihood of widespread deficiencies is small because
the number of foods containing significant amounts of the nutrients
that could be substituted is small. Also, it is unlikely that the
deficiencies that might occur would result in anything other than minor
effects. Therefore, the health benefits of including vitamin K and
manganese in tests for nutritional equivalency are small and
unmeasurable.
C. Summary
The agency has examined the economic impact of this final rule and
has determined that it is not significant as defined by Executive Order
12866.
XI. Environmental Impact
The agency has previously considered the environmental effects of
this rule as announced in the proposed rule (59 FR 427). At that time,
the agency determined under 21 CFR 25.24(a)(11) that this action is of
a type that does not individually or cumulatively have a significant
effect on the human
[[Page 67174]]
environment. No new information or comments have been received that
would affect the agency's previous determination that there is no
significant impact on the human environment and that an environmental
impact statement is not required.
XII. Paperwork Reduction Act
This final rule contains no information collection or recordkeeping
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).
XIII. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Food and Nutrition Board, Division of Biology and
Agriculture, National Research Council, ``Recommended Dietary
Allowances,'' 7th ed., publication 1694, Printing and Publishing
Office, NAS, Washington, DC, 1968.
2. Committee on Dietary Allowances, Food and Nutrition Board,
Commission on Life Sciences, National Research Council,
``Recommended Dietary Allowances,'' 9th revised ed., Washington, DC,
National Academy Press, 1980.
3. Subcommittee on the 10th Edition of the RDA's, Food and
Nutrition Board, Commission on Life Sciences, National Research
Council, ``Recommended Dietary Allowances,'' 10th revised ed.,
Washington, DC, National Academy Press, 1989.
4. Food and Nutrition Board, Institute of Medicine, National
Academy of Sciences, ``How Should the Recommended Dietary Allowances
Be Revised,'' Washington, DC, National Academy Press, 1994.
5. Ad Hoc Subcommittee on Fluoride of the Committee to
Coordinate Environmental Health and Related Programs, Public Health
Service, Department of Health and Human Services, ``Review of
Fluoride Benefits and Risks,'' 1991.
6. Subcommittee on Health Effects of Ingested Fluoride,
Committee on Toxicology, Board on Environmental Studies and
Toxicology, Commission on Life Sciences, National Research Council,
National Academy Press, ``Health Effects of Ingested Fluoride,''
Washington, DC, 1993.
7. Suttie, J. W., ``Vitamin K and Human Nutrition,'' Journal of
the American Dietetic Association, 92585-92590, 1992.
8. Suttie, J. W., L. L. Mummah- Schendel, D. V. Shah, B. J.
Lyle, J. L. Greger, ``Vitamin K Deficiency from Dietary Vitamin K
Restriction in Humans,'' American Journal of Clinical Nutrition,
47475-47480, 1988.
9. Ferland, G., J. A. Sadowski, M. O'Brien, ``Dietary Induced
Subclinical Vitamin K Deficiency in Normal Human Subjects,'' Journal
of Agricultural and Food Chemistry, 911761-911768, 1993.
10. Booth, S. L., J. A. T. Pennington, J. A. Sadowski, ``Food
Sources and Dietary Intakes of Phylloquinone,'' unpublished
manuscript.
11. United States Department of Agriculture, Human Nutrition
Information Service, Nutrient Data Research Branch, Nutrition
Monitoring Division, ``Provisional Table on the Vitamin K Content of
Foods,'' revised June 1990.
12. Booth, S. L., J. A. Sadowski, J. L. Weirauch, G. Ferland,
``Vitamin K1 (Phylloquinone) Content of Foods A Provisional
Table,'' Journal of Food Composition and Analysis, 6:109-120, 1993.
13. Pennington, J. A. T., ``Bowes & Church, Food Values of
Portions Commonly Used, Sixteenth Edition.'' J. B. Lippincott Co.,
p. 421, 1994.
14. Tanner, J. T., S. A. Barnett, and M. K. Mountford,
``Analysis of Milk-Based Infant Formula. Phase IV. Iodide, Linoleic
Acid, and Vitamins D and K: U.S. Food and Drug Administration-Infant
Formula Council Collaborative Study,'' Journal of the Association of
Official Analytical Chemists International, 76:1042-1056, 1993.
15. Bueno, P. M., and M. C. Villabobos, Reverse Phase High
Pressure Liquid Chromatographic Determination of Vitamin K1 in
Infant Formulas, Journal of the Association of Official Analytical
Chemists, 66:1063-1066, 1983.
16. Booth S. L., K. W. Davidson, J. A. Sadowski, ``Evaluation of
an HPLC Method for the Determination of Phylloquinone (Vitamin
K1) in Various Food Matrices,'' Journal of Agricultural and
Food Chemistry, 42:295-300, 1994.
17. Haroon, Y., M. J. Shearer, S. Rahim, W. G. Gunn, G.
McEnergy, P. Barkhan, ``The Content of Phylloquinone (Vitamin
K1) in Human Milk, Cow's Milk and Infant Formula Foods
Determined by High-Performance Liquid Chromatography'', Journal of
Nutrition 112:1105-1117, 1982.
18. Ferland, G., J. A. Sadowski, ``Vitamin K1
(Phylloquinone) Content of Green Vegetables Effects of Plant
Maturation and Geographical Growth Location,'' Journal of
Agricultural and Food Chemistry, 40:1874- 1877, 1992.
19. U.S. Department of Agriculture and U.S. Department of Health
and Human Services, ``Nutrition and Your Health, Dietary Guidelines
for Americans,'' Washington, DC, Home and Garden Bulletin, No. 232,
U.S. Government Printing Office, 1990.
20. U.S. Department of Agriculture and U.S. Department of Health
and Human Services, ``Nutrition and Your Health, Dietary Guidelines
for Americans,'' Washington, DC, Home and Garden Bulletin, No. 232,
Second Edition, U.S. Government Printing Office, 1985.
21. U.S. Department of Health and Human Services, Public Health
Service, ``The Surgeon General's Report on Nutrition and Health,''
Washington, DC, DHHS (PHS) Publication No. 88-50210, U.S. Government
Printing Office, p. 13, 1988.
22. Bush, Laina M., memorandum of telephone conversation with
Wayne Ellefson, Hazelton Laboratories, April 23, 1995.
23. Bush, Laina M., memorandum of telephone conversation with
John McKay, Lancaster Laboratories, January 11, 1995.
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 is revised 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 101.3 is amended by revising paragraph (e)(4)(ii) to
read as follows:
Sec. 101.3 Identity labeling of food in packaged form.
* * * * *
(e) * * *
(4) * * *
(ii) For the purpose of this section, a measurable amount of an
essential nutrient in a food shall be considered to be 2 percent or
more of the Daily Reference Value (DRV) of protein listed under
Sec. 101.9(c)(7)(iii) and of potassium listed under Sec. 101.9(c)(9)
per reference amount customarily consumed and 2 percent or more of the
Reference Daily Intake (RDI) of any vitamin or mineral listed under
Sec. 101.9(c)(8)(iv) per reference amount customarily consumed, except
that selenium, molybdenum, chromium, and chloride need not be
considered.
* * * * *
3. Section 101.9 is amended by revising paragraph (c)(8)(iv) to
read as follows:
Sec. 101.9 Nutrition labeling of food.
* * * * *
(c) * * *
(8) * * *
(iv) The following RDI's and nomenclature are established for the
following vitamins and minerals which are essential in human nutrition:
Vitamin A, 5,000 International Units
Vitamin C, 60 milligrams
Calcium, 1,000 milligrams
Iron, 18 milligrams
Vitamin D, 400 International Units
Vitamin E, 30 International Units
Vitamin K, 80 micrograms
Thiamin, 1.5 milligrams
Riboflavin, 1.7 milligrams
Niacin, 20 milligrams
Vitamin B6, 2.0 milligrams
Folate, 400 micrograms
Vitamin B12, 6 micrograms
Biotin, 300 micrograms
Pantothenic acid, 10 milligrams
Phosphorus, 1,000 milligrams
Iodine, 150 micrograms
Magnesium, 400 milligrams
Zinc, 15 milligrams
[[Page 67175]]
Selenium, 70 micrograms
Copper, 2.0 milligrams
Manganese, 2.0 milligrams
Chromium, 120 micrograms
Molybdenum, 75 micrograms
Chloride, 3,400 milligrams
* * * * *
4. Section 101.36 is amended by revising the introductory text of
paragraph (b)(3), paragraphs (b)(3)(i), (b)(3)(ii), the introductory
text of paragraph (b)(4), and paragraphs (b)(4)(vi) to read as follows:
Sec. 101.36 Nutrition labeling of dietary supplements of vitamins or
minerals.
* * * * *
(b) * * *
(3) A listing of all nutrients required in Sec. 101.9(c) that are
present in the dietary supplement in quantitative amounts by weight
that exceed the amount that can be declared as zero in Sec. 101.9(c).
Those nutrients that are not present, or present in amounts that would
be declared as zero, shall not be declared. In addition, potassium
shall be declared except when present in quantitative amounts by weight
that allow a declaration of zero. The name of each nutrient listed
shall be immediately followed by the quantitative amount by weight of
the nutrient. Nutrient names and quantitative amounts shall be
presented in a column under the heading ``Amount Per Serving'' and
aligned on the left side of the nutrition label. The heading ``Amount
Per Serving'' shall be separated from other information on the label by
a bar above and beneath it, except that when calories are listed, the
bar shall be placed beneath the calorie declaration. When the serving
size of the product is one unit (e.g., 1 tablet), a heading consistent
with the declaration of serving size, such as ``Amount per Tablet'' or
``Each Tablet Contains,'' may be used in place of the heading ``Amount
per Serving.'' Other appropriate terms, such as capsule, packet, or
teaspoonful, may be used in place of the term ``Serving.''
(i) These amounts shall be expressed in the increments specified in
Sec. 101.9(c), except that the amounts of vitamins and minerals,
excluding sodium and potassium, declared on the nutrition label shall
be the actual amount of the vitamin or mineral included in the dietary
supplement, using the units of measure and the levels of significance
given in Sec. 101.9(c). In declaring the amounts of vitamins and
minerals, zeros following decimal points may be dropped, and additional
levels of significance may be used when the number of decimal places
indicated is not sufficient to express lower amounts (e.g., the RDI for
copper is given in whole milligrams, but the quantitative amount may be
declared in tenths of a milligram). Amounts for chloride and manganese
shall be expressed in mg, and, amounts for chromium, molybdenum,
selenium, and vitamin K shall be expressed in micrograms. These values
shall be expressed in whole numbers.
(ii) Nutrients that are present shall be listed in the order
specified in Sec. 101.9(c); except that, when present, vitamin K shall
follow vitamin E; calcium and iron shall follow pantothenic acid;
selenium shall follow zinc; and manganese, chromium, molybdenum,
chloride, sodium, and potassium shall follow copper. This results in
the following order for vitamins and minerals: Vitamin A, vitamin C,
vitamin D, vitamin E, vitamin K, thiamin, riboflavin, niacin, vitamin
B6, folate, vitamin B12, biotin, pantothenic acid, calcium, iron,
phosphorus, iodine, magnesium, zinc, selenium, copper, manganese,
chromium, molybdenum, chloride, sodium, and potassium. A bar shall
separate the last nutrient to be listed from the bottom of the
nutrition label, as shown in the sample labels in paragraph (c)(9) of
this section.
* * * * *
(4) A listing of the percent of the Daily Value (i.e., the percent
of the RDI as established in Sec. 101.9(c)(8)(iv) or DRV as established
in Sec. 101.9(c)(9)), where appropriate, of all nutrients listed in the
nutrition label, except that the percent for protein may be omitted as
provided in Sec. 101.9(c)(7), no percent shall be given for sugars, and
for labels of dietary supplements of vitamins and minerals that are
represented or purported to be for use by infants, children less than 4
years of age, or pregnant or lactating women, no percent shall be given
for vitamin K, selenium, manganese, chromium, molybdenum, or chloride.
This information shall be presented in one column aligned under the
heading of ``% Daily Value'' and to the right of the column of nutrient
names and amounts. The headings ``% Daily Value (DV),'' ``% DV,''
``Percent Daily Value,'' or ``Percent DV'' may be substituted for ``%
Daily Value.'' The heading ``% Daily Value'' shall be placed on the
same line as the heading ``Amount per Serving'' or placed beneath this
heading and the bar underneath it, except that ``% Daily Value'' shall
be placed beneath this bar when calorie information is required to be
declared. Calorie information shall be placed beneath ``Amount Per
Serving'' and above the bar.
* * * * *
(vi) When no percent is given for sugars, or for labels of dietary
supplements of vitamins and minerals that are represented or purported
to be for use by infants, children less than 4 years of age, or
pregnant or lactating women, when no percent is given for vitamin K,
selenium, manganese, chromium, molybdenum, or chloride, an asterisk
shall be placed in the ``Percent Daily Value'' column that shall refer
to another asterisk that is placed at the bottom of the nutrition label
and followed by the statement ``Daily Value not established.''
* * * * *
Dated: September 26, 1995.
William B. Schultz
Deputy Commissioner for Policy.
[FR Doc. 95-31197 Filed 12-27-95; 8:45 am]
BILLING CODE 4160-01-P