[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR101.36]

[Page 79-91]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 101--FOOD LABELING--Table of Contents
 
   Subpart C--Specific Nutrition Labeling Requirements and Guidelines
 
Sec. 101.36  Nutrition labeling of dietary supplements.

    Source: 55 FR 60890, Nov. 27, 1991, unless otherwise noted.


    (a) The label of a dietary supplement that is offered for sale shall 
bear nutrition labeling in accordance with this regulation unless an 
exemption is provided for the product in paragraph (h) of this section.
    (b) The declaration of nutrition information on the label and in 
labeling shall contain the following information, using the subheadings 
and the format specified in paragraph (e) of this section.
    (1) Serving size. (i) The subheading ``Serving Size'' shall be 
placed under the heading ``Supplement Facts'' and aligned on the left 
side of the nutrition label. The serving size shall be determined in 
accordance with Secs. 101.9(b) and 101.12(b), Table 2. Serving size for 
dietary supplements shall be expressed using a term that is appropriate 
for the form of the supplement, such as ``tablets,'' ``capsules,'' 
``packets,'' or ``teaspoonfuls.''
    (ii) The subheading ``Servings Per Container'' shall be placed under 
the subheading ``Serving Size'' and aligned on the left side of the 
nutrition label, except that this information need not be provided when 
it is stated in the net quantity of contents declaration.
    (2) Information on dietary ingredients that have a Reference Daily 
Intake (RDI) or a Daily Reference Value (DRV) as established in 
Sec. 101.9(c) and their subcomponents (hereinafter referred to as 
``(b)(2)-dietary ingredients''). (i) The (b)(2)-dietary ingredients to 
be declared, that is, total calories, calories from fat, total fat, 
saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, 
sugars, protein, vitamin A, vitamin C, calcium and iron, shall be 
declared when

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they are present in a dietary supplement in quantitative amounts by 
weight that exceed the amount that can be declared as zero in nutrition 
labeling of foods in accordance with Sec. 101.9(c). Calories from 
saturated fat and polyunsaturated fat, monounsaturated fat, soluble 
fiber, insoluble fiber, sugar alcohol, and other carbohydrate may be 
declared, but they shall be declared when a claim is made about them. 
Any other vitamins or minerals listed in Sec. 101.9(c)(8)(iv) or (c)(9) 
may be declared, but they shall be declared when they are added to the 
product for purposes of supplementation, or when a claim is made about 
them. Any (b)(2)-dietary ingredients that are not present, or that are 
present in amounts that can be declared as zero in Sec. 101.9(c), shall 
not be declared (e.g., amounts corresponding to less than 2 percent of 
the RDI for vitamins and minerals). Protein shall not be declared on 
labels of products that, other than ingredients added solely for 
technological reasons, contain only individual amino acids.
    (A) The names and the quantitative amounts by weight of each (b)(2)-
dietary ingredient shall be presented under the heading ``Amount Per 
Serving.'' When the quantitative amounts by weight are presented in a 
separate column, the heading may be centered over a column of 
quantitative amounts, described by paragraph (b)(2)(ii) of this section, 
if space permits. A heading consistent with the declaration of the 
serving size, such as ``Each Tablet Contains,'' or ``Amount Per 2 
Tablets'' may be used in place of the heading ``Amount Per Serving.'' 
Other appropriate terms, such as capsule, packet, or teaspoonful, also 
may be used in place of the term ``Serving.''
    (B) The names of dietary ingredients that are declared under 
paragraph (b)(2)(i) of this section shall be presented in a column 
aligned on the left side of the nutrition label in the order and manner 
of indentation specified in Sec. 101.9(c), except that calcium and iron 
shall follow pantothenic acid, and sodium and potassium shall follow 
chloride. 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. The (b)(2)-dietary 
ingredients shall be listed according to the nomenclature specified in 
Sec. 101.9 or in paragraph (b)(2)(i)(B)(2) of this section.
    (1) When ``Calories'' are declared, they shall be listed first in 
the column of names, beneath a light bar separating the heading ``Amount 
Per Serving'' from the list of names. When ``Calories from fat'' or 
``Calories from saturated fat'' are declared, they shall be indented 
beneath ``Calories.''
    (2) The following synonyms may be added in parentheses immediately 
following the name of these (b)(2)-dietary ingredients: Vitamin C 
(ascorbic acid), thiamin (vitamin B1), riboflavin (vitamin 
B2), folate (folacin or folic acid), and calories (energy). 
Alternatively, the term ``folic acid'' or ``folacin'' may be listed 
without parentheses in place of ``folate.'' Energy content per serving 
may be expressed in kilojoule units, added in parentheses immediately 
following the statement of caloric content.
    (3) Beta-carotene may be declared as the percent of vitamin A that 
is present as beta-carotene, except that the declaration is required 
when a claim is made about beta-carotene. When declared, the percent 
shall be declared to the nearest whole percent, immediately adjacent to 
or beneath the name vitamin A (e.g., ``Vitamin A (90% as beta-
carotene)''). The amount of beta-carotene in terms of international 
units (IU) may be included in parentheses following the percent 
statement (e.g., ``Vitamin A (90% (4500 IU) as beta-carotene)'').
    (ii) The number of calories, if declared, and the quantitative 
amount by weight per serving of each dietary ingredient required to be 
listed under paragraph (b)(2)(i) of this section shall be presented 
either in a separate column aligned to the right of the column of names 
or immediately following the listing of names within the same column. 
The quantitative amounts by weight shall represent the weight of the 
dietary ingredient rather than the

[[Page 81]]

weight of the source of the dietary ingredient (e.g., the weight of 
calcium rather than that of calcium carbonate).
    (A) These amounts shall be expressed in the increments specified in 
Sec. 101.9(c)(1) through (c)(7), which includes increments for sodium 
and potassium.
    (B) The amounts of vitamins and minerals, excluding sodium and 
potassium, shall be the amount of the vitamin or mineral included in one 
serving of the product, using the units of measurement and the levels of 
significance given in Sec. 101.9(c)(8)(iv), except that 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 zinc is given in whole 
milligrams (mg), but the quantitative amount may be declared in tenths 
of a mg).
    (iii) The percent of the Daily Value of all dietary ingredients 
declared under paragraph (b)(2)(i) of this section shall be listed, 
except that the percent for protein may be omitted as provided in 
Sec. 101.9(c)(7); no percent shall be given for subcomponents for which 
DRV's have not been established (e.g., 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 total fat, 
saturated fat, cholesterol, total carbohydrate, dietary fiber, vitamin 
K, selenium, manganese, chromium, molybdenum, chloride, sodium, or 
potassium.
    (A) When information on the percent of Daily Values is listed, this 
information shall be presented in one column aligned under the heading 
of ``% Daily Value'' and to the right of the column of 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.'' When the acronym ``DV'' is unexplained in the heading and 
a footnote is required under (b)(2)(iii)(D), (b)(2)(iii)(F), or 
(b)(3)(iv) of this section, the footnote shall explain the acronym (e.g. 
``Daily Value (DV) not established'').
    (B) The percent of Daily Value shall be calculated by dividing the 
quantitative amount by weight of each (b)(2)-dietary ingredient by the 
RDI as established in Sec. 101.9(c)(8)(iv) or the DRV as established in 
Sec. 101.9(c)(9) for the specified dietary ingredient and multiplying by 
100, except that the percent of Daily Value for protein, when present, 
shall be calculated as specified in Sec. 101.9(c)(7)(ii). The 
quantitative amount by weight of each dietary ingredient in this 
calculation shall be the unrounded amount, except that for total fat, 
saturated fat, cholesterol, sodium, potassium, total carbohydrate, and 
dietary fiber, the quantitative amount by weight declared on the label 
(i.e, rounded amount) may be used. The numerical value shall be followed 
by the symbol for percent (i.e., %).
    (C) The percentages based on RDI's and on DRV's shall be expressed 
to the nearest whole percent, except that for dietary ingredients for 
which DRV's have been established, ``Less than 1%'' or ``<1%'' shall be 
used to declare the ``% Daily Value'' when the quantitative amount of 
the dietary ingredient by weight is great enough to require that the 
dietary ingredient be listed, but the amount is so small that the ``% 
Daily Value'' when rounded to the nearest percent is zero (e.g., a 
product that contains 1 gram of total carbohydrate would list the 
percent Daily Value as ``Less than 1%'' or ``<1%'').
    (D) If the percent of Daily Value is declared for total fat, 
saturated fat, total carbohydrate, dietary fiber, or protein, a symbol 
shall follow the value listed for those nutrients that refers to the 
same symbol that is placed at the bottom of the nutrition label, below 
the bar required under paragraph (e)(6) of this section and inside the 
box, that is followed by the statement ``Percent Daily Values are based 
on a 2,000 calorie diet.''
    (E) The percent of Daily Value shall be based on RDI and DRV values 
for adults and children 4 or more years of age, unless the product is 
represented or purported to be for use by infants, children less than 4 
years of age, pregnant women, or lactating women, in which case the 
column heading shall

[[Page 82]]

clearly state the intended group. If the product is for persons within 
more than one group, the percent of Daily Value for each group shall be 
presented in separate columns as shown in paragraph (e)(10)(ii) of this 
section.
    (F) For declared subcomponents that have no DRV's and, on the labels 
of dietary supplements of vitamins and minerals that are represented or 
purported to be for use by infants, children less that 4 years of age, 
or pregnant or lactating women, for total fat, saturated fat, 
cholesterol, total carbohydrate, dietary fiber, vitamin K, selenium, 
manganese, chromium, molybdenum, chloride, sodium, or potassium, a 
symbol (e.g., an asterisk) shall be placed in the ``Percent Daily 
Value'' column that shall refer to the same symbol that is placed at the 
bottom of the nutrition label, below the last heavy bar and inside the 
box, and followed by the statement ``Daily Value not established.''
    (G) When calories, calories from fat, or calories from saturated fat 
are declared, the space under the ``% Daily Value'' column shall be left 
blank for these items. When there are no other (b)(2)-dietary 
ingredients listed for which a value must be declared in the ``% Daily 
Value'' column, the column may be omitted as shown in paragraph 
(e)(10)(vii) of this section. When the ``% Daily Value'' column is not 
required, but the dietary ingredients listed are subject to paragraph 
(b)(2)(iii)(F) of this section, the symbol required in that paragraph 
shall immediately follow the quantitative amount by weight for each 
dietary ingredient listed under ``Amount Per Serving.''
    (iv) The quantitative amount by weight and the percent of Daily 
Value may be presented on a ``per unit'' basis in addition to on a ``per 
serving'' basis, as required in paragraph (b)(2)(ii) of this section. 
This information shall be presented in additional columns and clearly 
identified by appropriate headings.
    (3) Information on dietary ingredients for which RDI's and DRV's 
have not been established. (i) Dietary ingredients for which FDA has not 
established RDI's or DRV's and that are not subject to regulation under 
paragraph (b)(2) of this section (hereinafter referred to as ``other 
dietary ingredients'') shall be declared by their common or usual name 
when they are present in a dietary supplement, in a column that is under 
the column of names described in paragraph (b)(2)(i)(B) of this section 
or, as long as the constituents of an other dietary ingredient are not 
listed, in a linear display, under the heavy bar described in paragraph 
(e)(6) of this section, except that if no (b)(2)-dietary ingredients are 
declared, other dietary ingredients shall be declared directly beneath 
the heading ``Amount Per Serving'' described in paragraph (b)(2)(i)(A) 
of this section.
    (ii) The quantitative amount by weight per serving of other dietary 
ingredients shall be presented in the same manner as the corresponding 
information required in paragraph (b)(2)(ii) of this section or, when a 
linear display is used, shall be presented immediately following the 
name of the other dietary ingredient. The quantitative amount by weight 
shall be the weight of the other dietary ingredient listed and not the 
weight of any component, or the source, of that dietary ingredient.
    (A) These amounts shall be expressed using metric measures in 
appropriate units (i.e., 1,000 or more units shall be declared in the 
next higher set of units, e.g., 1,100 mg shall be declared as 1.1 g).
    (B) For any dietary ingredient that is a liquid extract from which 
the solvent has not been removed, the quantity listed shall be the 
volume or weight of the total extract. Information on the condition of 
the starting material shall be indicated when it is fresh and may be 
indicated when it is dried. Information may be included on the 
concentration of the dietary ingredient and the solvent used, e.g., 
``fresh dandelion root extract, x (y:z) in 70% ethanol,'' where x is the 
number of milliliters (mL) or mg of the entire extract, y is the weight 
of the starting material and z is the volume (mL) of solvent. Where the 
solvent has been partially removed (not to dryness), the final 
concentration, when indicated, shall be stated (e.g., if the original 
extract was 1:5 and 50 percent of the solvent was removed, then the 
final concentration shall be stated as 1:2.5). Where the name of the

[[Page 83]]

solvent used is not included in the nutrition label, it is required to 
be listed in the ingredient statement in accordance with Sec. 101.4(g).
    (C) For a dietary ingredient that is an extract from which the 
solvent has been removed, the weight of the ingredient shall be the 
weight of the dried extract.
    (iii) The constituents of a dietary ingredient described in 
paragraph (b)(3)(i) of this section may be listed indented under the 
dietary ingredient and followed by their quantitative amounts by weight 
per serving, except that dietary ingredients described in paragraph 
(b)(2) of this section shall be listed in accordance with that section. 
When the constituents of a dietary ingredient described in paragraph 
(b)(3)(i) of this section are listed, all other dietary ingredients 
shall be declared in a column; however, the constituents themselves may 
be declared in a column or in a linear display.
    (iv) Other dietary ingredients shall bear a symbol (e.g., an 
asterisk) in the column under the heading of ``% Daily Value'' that 
refers to the same symbol placed at the bottom of the nutrition label 
and followed by the statement ``Daily Value not established,'' except 
that when the heading ``% Daily Value'' is not used, the symbol shall 
follow the quantitative amount by weight for each dietary ingredient 
listed.
    (c) A proprietary blend of dietary ingredients shall be included in 
the list of dietary ingredients described in paragraph (b)(3)(i) of this 
section and identified by the term ``Proprietary Blend'' or other 
appropriately descriptive term or fanciful name and may be highlighted 
by bold type. Except as specified in this paragraph, all other 
requirements for the listing of dietary ingredients in dietary 
supplements are applicable.
    (1) Dietary ingredients contained in the proprietary blend that are 
listed under paragraph (b)(2) of this section shall be declared in 
accordance with paragraph (b)(2) of this section.
    (2) Dietary ingredients contained in the proprietary blend that are 
listed under paragraph (b)(3) of this section (i.e., ``other dietary 
ingredients'') shall be declared in descending order of predominance by 
weight, in a column or linear fashion, and indented under the term 
``Proprietary Blend'' or other appropriately descriptive term or 
fanciful name.
    (3) The quantitative amount by weight specified for the proprietary 
blend shall be the total weight of all other dietary ingredients 
contained in the proprietary blend and shall be placed on the same line 
to the right of the term ``Proprietary Blend'' or other appropriately 
descriptive term or fanciful name underneath the column of amounts 
described in paragraph (b)(2)(ii) of this section. A symbol (e.g., 
asterisk), which refers to the same symbol placed at the bottom of the 
nutrition label that is followed by the statement ``Daily Value not 
established,'' shall be placed under the heading ``% Daily Value,'' if 
present, or immediately following the quantitative amount by weight for 
the proprietary blend.
    (4) The sample label shown in paragraph (e)(10)(v) of this section 
illustrates one method of nutrition labeling a proprietary blend of 
dietary ingredients.
    (d) The source ingredient that supplies a dietary ingredient may be 
identified within the nutrition label in parentheses immediately 
following or indented beneath the name of a dietary ingredient and 
preceded by the words ``as'' or ``from'', e.g., ``Calcium (as calcium 
carbonate),'' except that manner of presentation is unnecessary when the 
name of the dietary ingredient (e.g., Oriental ginseng) or its synonym 
(e.g., ascorbic acid) is itself the source ingredient. When a source 
ingredient is identified in parentheses within the nutrition label, or 
when the name of the dietary ingredient or its synonym is the source 
ingredient, it shall not be required to be listed again in the 
ingredient statement that appears outside of the nutrition label. When a 
source ingredient is not identified within the nutrition label, it shall 
be listed in an ingredient statement in accordance with Sec. 101.4(g), 
which shall appear outside and immediately below the nutrition label or, 
if there is insufficient space below the nutrition label, immediately 
contiguous and to the right of the nutrition label.

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    (1) Source ingredients shall be identified in accordance with 
Sec. 101.4 (i.e., shall be listed by common or usual name, and the 
listing of botanicals shall specify the part of the plant from which the 
ingredient is derived) regardless of whether they are listed in an 
ingredient statement or in the nutrition label.
    (2) When source ingredients are listed within the nutrition label, 
and two or more are used to provide a single dietary ingredient, all of 
the sources shall be listed within the parentheses in descending order 
by weight.
    (3) Representations that the source ingredient conforms to an 
official compendium may be included either in the nutrition label or in 
the ingredient list (e.g., ``Calcium (as calcium carbonate USP)'').
    (e) Nutrition information specified in this section shall be 
presented as follows:

    (1) The title, ``Supplement Facts,'' shall be set in a type size 
larger than all other print size in the nutrition label and, unless 
impractical, shall be set full width of the nutrition label. The title 
and all headings shall be bolded to distinguish them from other 
information.
    (2) The nutrition information shall be enclosed in a box by using 
hairlines.
    (3) All information within the nutrition label shall utilize:
    (i) A single easy-to-read type style,
    (ii) All black or one color type, printed on a white or other 
neutral contrasting background whenever practical,
    (iii) Upper- and lowercase letters, except that all uppercase 
lettering may be utilized for packages that have a total surface area 
available to bear labeling of less than 12 square inches,
    (iv) At least one point leading (i.e., space between lines of text), 
and
    (v) Letters that do not touch.
    (4) Except as provided for small and intermediate-sized packages 
under paragraph (i)(2) of this section, information other than the 
title, headings, and footnotes shall be in uniform type size no smaller 
than 8 point. Type size no smaller than 6 point may be used for column 
headings (e.g., ``Amount Per Serving'' and ``% Daily Value'') and for 
footnotes (e.g., ``Percent Daily Values are based on a 2,000 calorie 
diet'').
    (5) A hairline rule that is centered between the lines of text shall 
separate each dietary ingredient required in paragraph (b)(2) and (b)(3) 
of this section from the dietary ingredient above and beneath it, as 
shown in paragraph (e)(10) of this section.
    (6) A heavy bar shall be placed:
    (i) Beneath the subheading ``Servings Per Container'' except that if 
``Servings Per Container'' is not required and, as a result, not 
declared, the bar shall be placed beneath the subheading ``Serving 
Size,''
    (ii) Beneath the last dietary ingredient to be listed under 
paragraph (b)(2)(i) of this section, if any, and
    (iii) Beneath the last other dietary ingredient to be listed under 
paragraph (b)(3) of this section, if any.
    (7) A light bar shall be placed beneath the headings ``Amount Per 
Serving'' and ``% Daily Value.''
    (8) If the product contains two or more separately packaged dietary 
supplements that differ from each other (e.g., the product has a packet 
of supplements to be taken in the morning and a different packet to be 
taken in the afternoon), the quantitative amounts and percent of Daily 
Value may be presented as specified in this paragraph in individual 
nutrition labels or in one aggregate nutrition label as illustrated in 
paragraph (e)(10)(iii) of this section.
    (9) In the interest of uniformity of presentation, FDA urges that 
the information be presented using the graphic specifications set forth 
in appendix B to part 101, as applicable.
    (10) The following sample labels are presented for the purpose of 
illustration:


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[GRAPHIC] [TIFF OMITTED] TR23SE97.010


[[Page 86]]


[GRAPHIC] [TIFF OMITTED] TR23SE97.011


[[Page 87]]


[GRAPHIC] [TIFF OMITTED] TR23SE97.012


[[Page 88]]


[GRAPHIC] [TIFF OMITTED] TR23SE97.013


    (11) If space is not adequate to list the required information as 
shown in the sample labels in paragraph (e)(10) of this section, the 
list may be split and continued to the right as long as the headings are 
repeated. The list to the right shall be set off by a line that 
distinguishes it and sets it apart from

[[Page 89]]

the dietary ingredients and percent of Daily Value information given to 
the left. The following sample label illustrates this display:
[GRAPHIC] [TIFF OMITTED] TR23SE97.014



[[Page 90]]


    (f)(1) Compliance with this section will be determined in accordance 
with Sec. 101.9(g)(1) through (g)(8), except that the sample for 
analysis shall consist of a composite of 12 subsamples (consumer 
packages) or 10 percent of the number of packages in the same inspection 
lot, whichever is smaller, randomly selected to be representative of the 
lot. The criteria on class I and class II nutrients given in 
Sec. 101.9(g)(3) and (g)(4) also are applicable to other dietary 
ingredients described in paragraph (b)(3)(i) of this section. Reasonable 
excesses of these other dietary ingredients over labeled amounts are 
acceptable within current good manufacturing practice.
    (2) When it is not technologically feasible, or some other 
circumstance makes it impracticable, for firms to comply with the 
requirements of this section, FDA may permit alternative means of 
compliance or additional exemptions to deal with the situation in 
accordance with Sec. 101.9(g)(9). Firms in need of such special 
allowances shall make their request in writing to the Office of 
Nutritional Products, Labeling and Dietary Supplements (HFS-800), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740.
    (g) Except as provided in paragraphs (i)(2) and (i)(5) of this 
section, the location of nutrition information on a label shall be in 
compliance with Sec. 101.2.
    (h) Dietary supplements are subject to the exemptions specified as 
follows in:
    (1) Section 101.9(j)(1) for foods that are offered for sale by a 
person who makes direct sales to consumers (i.e., a retailer) who has 
annual gross sales or business done in sales to consumers that is not 
more than $500,000 or has annual gross sales made or business done in 
sales of food to consumers of not more than $50,000, and whose labels, 
labeling, and advertising do not provide nutrition information or make a 
nutrient content or health claim;
    (2) Section 101.9(j)(18) for foods that are low-volume products 
(that is, they meet the requirements for units sold in 
Sec. 101.9(j)(18)(i) or (j)(18)(ii)); that, except as provided in 
Sec. 101.9(j)(18)(iv), are the subject of a claim for an exemption that 
provides the information required under Sec. 101.9(j)(18)(iv), that is 
filed before the beginning of the time period for which the exemption is 
claimed, and that is filed by a person, whether it is the manufacturer, 
packer, or distributor, that qualifies to claim the exemption under the 
requirements for average full-time equivalent employees in 
Sec. 101.9(j)(18)(i) or (j)(18)(ii), and whose labels, labeling, and 
advertising do not provide nutrition information or make a nutrient 
content or health claim;
    (3) Section 101.9(j)(9) for foods shipped in bulk form that are not 
for distribution to consumers in such form and that are for use solely 
in the manufacture of other dietary supplements or that are to be 
processed, labeled, or repacked at a site other than where originally 
processed or packed.
    (i) Dietary supplements are subject to the special labeling 
provisions specified in:
    (1) Section 101.9(j)(5)(i) for foods, other than infant formula, 
represented or purported to be specifically for infants and children 
less than 2 years of age, in that nutrition labels on such foods shall 
not include calories from fat, calories from saturated fat, saturated 
fat, polyunsaturated fat, monounsaturated fat, and cholesterol;
    (2) Section 101.9(j)(13) for foods in small or intermediate-sized 
packages, except that:
    (i) All information within the nutrition label on small-sized 
packages, which have a total surface area available to labeling of less 
than 12 square inches, shall be in type size no smaller than 4.5 point;
    (ii) All information within the nutrition label on intermediate-
sized packages, which have from 12 to 40 square inches of surface area 
available to bear labeling, shall be in type size no smaller than 6 
point, except that type size no smaller than 4.5 point may be used on 
packages that have less than 20 square inches available for labeling and 
more than 8 dietary ingredients to be listed and on packages that have 
20 to 40 square inches available for labeling and more than 16 dietary 
ingredients to be listed.
    (iii) When the nutrition information is presented on any panel under 
Sec. 101.9(j)(13)(ii)(D), the ingredient list

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shall continue to be located immediately below the nutrition label, or, 
if there is insufficient space below the nutrition label, immediately 
contiguous and to the right of the nutrition label as specified in 
Sec. 101.4(g).
    (iv) When it is not possible for a small or intermediate-sized 
package that is enclosed in an outer package to comply with these type 
size requirements, the type size of the nutrition label on the primary 
(inner) container may be as small as needed to accommodate all of the 
required label information provided that the primary container is 
securely enclosed in outer packaging, the nutrition labeling on the 
outer packaging meets the applicable type size requirements, and such 
outer packaging is not intended to be separated from the primary 
container under conditions of retail sale.
    (v) Where there is not sufficient space on a small or intermediate-
sized package for a nutrition label that meets minimum type size 
requirements of 4.5 points if hairlines are used in accordance with 
paragraph (e)(5) of this section, the hairlines may be omitted and 
replaced by a row of dots connecting the columns containing the name of 
each dietary ingredient and the quantitative amounts (by weight and as a 
percent of Daily Value).
    (3) Section 101.9(j)(15) for foods in multiunit food containers;
    (4) Section 101.9(j)(16) for foods sold in bulk containers; and
    (5) Section 101.9(j)(17) for foods in packages that have a total 
surface area available to bear labeling greater than 40 square inches 
but whose principal display panel and information panel do not provide 
sufficient space to accommodate all required label information, except 
that the ingredient list shall continue to be located immediately below 
the nutrition label, or, if there is insufficient space below the 
nutrition label, immediately contiguous and to the right of the 
nutrition label as specified in Sec. 101.4(g).
    (j) Dietary supplements shall be subject to the misbranding 
provisions of Sec. 101.9(k).

[62 FR 49849, Sept. 23, 1997, as amended at 63 FR 30620, June 5, 1998; 
66 FR 56035, Nov. 6, 2001]