67164 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Rules and Regulations

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

§ 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

§ 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 § 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
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Rules and Regulations 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

§ 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
67166 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Rules and Regulations

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
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Rules and Regulations 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 (μg). The

upper limit of the ESADDI range for

children 4 to 6 years of age is 120 μg.

Therefore, the agency is adopting an RDI

for chromium of 120 μg, rather than 130

μg. 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 § 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
67168 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Rules and Regulations

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

§ 101.9(c)(8)(iv). Consistent with this

action, FDA is not including a reference

to fluoride in § 101.3(e)(4)(ii) (21 CFR

101.3(e)(4)(ii)) and is removing a

reference to it in § 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 μg 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 μg. 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
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Rules and Regulations 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

§ 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

§ 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 § 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
67170 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Rules and Regulations

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 § 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 § 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., § 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

§ 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 § 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 § 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 § 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
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Rules and Regulations 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 § 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

§ 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 § 101.36 may continue to specify

the mg or μg 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 μg

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 § 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

§ 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, § 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 § 101.9(c)(7)(iii) per

reference amount customarily consumed and

of potassium listed under § 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 § 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 §§ 101.36 (b)(3), (b)(4),

and (b)(4)(vi).

Current § 101.36(b)(3) states that all

nutrients in § 101.9(c) that are present in
67172 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Rules and Regulations

a dietary supplement in quantitative

amounts by weight that exceed the

amount that can be declared as zero in

§ 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 § 101.36(b)(3) by

removing all reference to vitamin K,

chloride, chromium, manganese,

molybdenum, and selenium. Because

these nutrients are now included in

§ 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 § 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

§ 101.9(c)(8)(iv) or DRV as established in

§ 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

§ 101.9(c)(7), and that no percent shall

be given for sugars, vitamin K, chloride,

chromium, fluoride, manganese,

molybdenum, selenium.

FDA is modifying § 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

§ 101.36(b)(4) does not reference this

nutrient.

Current § 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 § 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

§ 101.36(b)(4)(vi) does not reference that

nutrient.

It should be noted that, while these

conforming amendments to § 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
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Rules and Regulations 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 §§ 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
67174 Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Rules and Regulations

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:

§ 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 § 101.9(c)(7)(iii) and of potassium

listed under § 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 § 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:

§ 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
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 / Rules and Regulations 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:

§ 101.36 Nutrition labeling of dietary

supplements of vitamins or minerals.

* * * * *

(b) * * *

(3) A listing of all nutrients required

in § 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

§ 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 § 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 § 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

§ 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 § 101.9(c)(8)(iv) or DRV as

established in § 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 § 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