[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