CFR-2012-title21-vol2-sec101-9 Carbohidratos Disponibles

Food and Drug Administration, HHS § 101.
Commerce for the common or usual name and place of business of the man-
name listed on the label, and, when re- ufacturer, packer, or distributor.
quired, the Latin binomial name may (b) The requirement for declaration
be listed before the part of the plant. of the name of the manufacturer, pack-
Any name in Latin form shall be in ac- er, or distributor shall be deemed to be
cordance with internationally accepted satisfied, in the case of a corporation,
rules on nomenclature, such as those only by the actual corporate name,
found in the International Code of Bo- which may be preceded or followed by
tanical Nomenclature and shall include the name of the particular division of
the designation of the author or au- the corporation. In the case of an indi-
thors who published the Latin name, vidual, partnership, or association, the
when a positive identification cannot name under which the business is con-
be made in its absence. The Inter- ducted shall be used.
national Code of Botanical Nomenclature (c) Where the food is not manufac-
(Tokyo Code), 1994 edition, a publica- tured by the person whose name ap-
tion of the International Association pears on the label, the name shall be
for Plant Taxonomy, is incorporated by qualified by a phrase that reveals the
reference in accordance with 5 U.S.C. connection such person has with such
552(a) and 1 CFR part 51. Copies of the food; such as ‘‘Manufactured for
International Code of Botanical Nomen- lll’’, ‘‘Distributed by lll’’, or any
clature may be obtained from Koeltz other wording that expresses the facts.
Scientific Books, D–61453 Konigstein, (d) The statement of the place of
Germany, and University Bookstore, business shall include the street ad-
Southern Illinois University, dress, city, State, and ZIP code; how-
Carbondale, IL 62901–4422, 618–536–3321, ever, the street address may be omitted
FAX 618–453–5207, or may be examined if it is shown in a current city direc-
at the Center for Food Safety and Ap- tory or telephone directory. The re-
plied Nutrition’s Library, 5100 Paint quirement for inclusion of the ZIP code
Branch Pkwy., College Park, MD 20740, shall apply only to consumer com-
or at the National Archives and modity labels developed or revised
Records Administration (NARA). For after the effective date of this section.
information on the availability of this In the case of nonconsumer packages,
material at NARA, call 202–741–6030, or the ZIP code shall appear either on the
go to: http://www.archives.gov/ label or the labeling (including in-
federallregister/ voice).
codeloflfederallregulations/ (e) If a person manufactures, packs,
ibrllocations.html. or distributes a food at a place other
(3) On labels of single-ingredient die- than his principal place of business, the
tary supplements that do not include label may state the principal place of
an ingredient list, the identification of business in lieu of the actual place
the Latin binomial name, when needed, where such food was manufactured or
and the part of the plant may be packed or is to be distributed, unless
prominently placed on the principal such statement would be misleading.
display panel or information panel, or
§ 101.9 Nutrition labeling of food.
included in the nutrition label.
(a) Nutrition information relating to
[42 FR 14308, Mar. 15, 1977, as amended at 43 food shall be provided for all products
FR 12858, Mar. 28, 1978; 43 FR 24519, June 6,
intended for human consumption and
1978; 48 FR 8054, Feb. 25, 1983; 55 FR 17433,
Apr. 25, 1990; 58 FR 2875, Jan. 6, 1993; 62 FR offered for sale unless an exemption is
49847, Sept. 23, 1997; 62 FR 64634, Dec. 8, 1997; provided for the product in paragraph
64 FR 50448, Sept. 17, 1999; 66 FR 17358, Mar. (j) of this section.
30, 2001; 66 FR 66742, Dec. 27, 2001; 68 FR 15355, (1) When food is in package form, the
Mar. 31, 2003] required nutrition labeling information
shall appear on the label in the format
§ 101.5 Food; name and place of busi- specified in this section.
ness of manufacturer, packer, or (2) When food is not in package form,
distributor. the required nutrition labeling infor-
(a) The label of a food in packaged mation shall be displayed clearly at
form shall specify conspicuously the the point of purchase (e.g., on a
19
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§ 101.9 21 CFR Ch. I (4–1–12 Edition)
counter card, sign, tag affixed to the maintenance program, serving size de-
product, or some other appropriate declared on a product label shall be deter-
vice). Alternatively, the required infor- mined from the ‘‘Reference Amounts
mation may be placed in a booklet, Customarily Consumed Per Eating Oc-
looseleaf binder, or other appropriate casion * * * *’’ (reference amounts)
format that is available at the point of that appear in § 101.12(b) using the pro-
purchase. cedures described below. For products
(3) Solicitation of requests for nutri- that are both intended for weight con-
tion information by a statement ‘‘For trol and available only through a
nutrition information write to weight-control program, a manufac-
lllllllllll ’’ on the label or turer may determine the serving size
in the labeling or advertising for a that is consistent with the meal plan of
food, or providing such information in the program. Such products must bear
a direct written reply to a solicited or a statement, ‘‘for sale only through the
unsolicited request, does not subject lll program’’ (fill in the blank with
the label or the labeling of a food ex- the name of the appropriate weight-
empted under paragraph (j) of this sec- control program, e.g., Smith’s Weight
tion to the requirements of this section Control), on the principal display
if the reply to the request conforms to panel. However, the reference amounts
the requirements of this section. in § 101.12(b) shall be used for purposes
(4) If any vitamin or mineral is added of evaluating whether weight-control
to a food so that a single serving pro- products that are available only
vides 50 percent or more of the Ref- through a weight-control program
erence Daily Intake (RDI) for the age qualify for nutrient content claims or
group for which the product is in- health claims.
tended, as specified in paragraph (i) For products in discrete units
(c)(8)(iv) of this section, of any one of (e.g., muffins, sliced products, such as
the added vitamins or minerals, unless sliced bread, or individually packaged
such addition is permitted or required products within a multiserving pack-
in other regulations, e.g., a standard of age) and for products which consist of
identity or nutritional quality guide- two or more foods packaged and pre-
line, or is otherwise exempted by the sented to be consumed together where
Commissioner, the food shall be consid- the ingredient represented as the main
ered a food for special dietary use with- ingredient is in discrete units (e.g.,
in the meaning of § 105.3(a)(1)(iii) of pancakes and syrup), the serving size
this chapter. shall be declared as follows:
(b) Except as provided in § 101.9(h)(3), (A) If a unit weighs 50 percent or less
all nutrient and food component quan- of the reference amount, the serving
tities shall be declared in relation to a size shall be the number of whole units
serving as defined in this section. that most closely approximates the ref-
(1) The term serving or serving size erence amount for the product cat-
means an amount of food customarily egory;
consumed per eating occasion by per- (B) If a unit weighs more than 50 per-
sons 4 years of age or older which is ex- cent, but less than 67 percent of the
pressed in a common household meas- reference amount, the manufacturer
ure that is appropriate to the food. may declare one unit or two units as
When the food is specially formulated the serving size;
or processed for use by infants or by (C) If a unit weighs 67 percent or
toddlers, a serving or serving size more, but less than 200 percent of the
means an amount of food customarily reference amount, the serving size
consumed per eating occasion by in- shall be one unit;
fants up to 12 months of age or by chil- (D) If a unit weighs 200 percent or
dren 1 through 3 years of age, respec- more of the reference amount, the
tively. manufacturer may declare one unit as
(2) Except as provided in paragraphs the serving size if the whole unit can
(b)(3), (b)(4), and (b)(6) of this section reasonably be consumed at a single-
and for products that are intended for eating occasion.
weight control and are available only (E) For products that have reference
through a weight-control or weight- amounts of 100 grams (g) (or milliliter
20
Food and Drug Administration, HHS § 101.9
(mL)) or larger and are individual units 1/12 cake, 1/8 pie, 1/4 pizza, 1/4 melon, 1/
within a multiserving package, if a 6 cabbage) that most closely approxi-
unit contains more than 150 percent mates the reference amount for the
but less than 200 percent of the ref- product category, and may be the frac-
erence amount, the manufacturer may tion of the package used to make the
decide whether to declare the indi- reference amount for the unprepared
vidual unit as 1 or 2 servings. product determined in § 101.12(c) or the
(F) The serving size for maraschino fraction of the large discrete unit rep-
cherries shall be expressed as 1 cherry resented as the main ingredient plus
with the parenthetical metric measure proportioned minor ingredients used to
equal to the average weight of a me- make the reference amount for the
dium size cherry. combined product determined in
(G) The serving size for products that § 101.12(f). In expressing the fractional
naturally vary in size (e.g., pickles, slice, manufacturers shall use 1/2, 1/3, 1/
shellfish, whole fish, and fillet of fish) 4, 1/5, 1/6, or smaller fractions that can
may be the amount in ounces that be generated by further division by 2 or
most closely approximates the ref- 3.
erence amount for the product cat- (iii) For nondiscrete bulk products
egory. Manufacturers shall adhere to (e.g., breakfast cereal, flour, sugar, dry
the requirements in paragraph mixes, concentrates, pancake mixes,
(b)(5)(vi) of this section for expressing macaroni and cheese kits), and for
the serving size in ounces. products which consist of two or more
(H) For products which consist of two foods packaged and presented to be
or more foods packaged and presented consumed together where the ingre-
to be consumed together where the in- dient represented as the main ingre-
gredient represented as the main ingredient is a bulk product (e.g., peanut
dient is in discrete units (e.g., pan- butter and jelly), the serving size shall
cakes and syrup), the serving size may be the amount in household measure
be the number of discrete units rep- that most closely approximates the ref-
resented as the main ingredient plus erence amount for the product cat-
proportioned minor ingredients used to egory and may be the amount of the
make the reference amount for the bulk product represented as the main
combined product determined in ingredient plus proportioned minor in-
§ 101.12(f). gredients used to make the reference
(I) For packages containing several amount for the combined product de-
individual single-serving containers, termined in § 101.12(f).
each of which is labeled with all re- (3) The serving size for meal products
quired information including nutrition and main dish products as defined in
labeling as specified in § 101.9 (that is, § 101.13 (l) and (m) that comes in single-
are labeled appropriately for individual serving containers as defined in para-
sale as single-serving containers), the graph (b)(6) of this section shall be the
serving size shall be 1 unit. entire content (edible portion only) of
(ii) For products in large discrete the package. Serving size for meal
units that are usually divided for con- products and main dish products in
sumption (e.g., cake, pie, pizza, melon, multiserving containers shall be based
cabbage), for unprepared products on the reference amount applicable to
where the entire contents of the pack- the product in § 101.12(b) if the product
age is used to prepare large discrete is listed in § 101.12(b). Serving size for
units that are usually divided for con- meal products and main dish products
sumption (e.g., cake mix, pizza kit), in multiserving containers that are not
and for products which consist of two listed in § 101.12(b) shall be based on the
or more foods packaged and presented reference amount according to
to be consumed together where the in- § 101.12(f).
gredient represented as the main ingre- (4) A variety pack, such as a package
dient is a large discrete unit usually di- containing several varieties of single-
vided for consumption (e.g., prepared serving units as defined in paragraph
cake packaged with a can of frosting), (b)(2)(i) of this section, and a product
the serving size shall be the fractional having two or more compartments
slice of the ready-to-eat product (e.g., with each compartment containing a
21
§ 101.9 21 CFR Ch. I (4–1–12 Edition)
different food, shall provide nutrition (vi) Ounces with an appropriate vis-
information for each variety or food ual unit of measure, as described in
per serving size that is derived from paragraph (b)(5)(iii) of this section,
the reference amount in § 101.12(b) ap- may be used for products that natu-
plicable for each variety or food and rally vary in size as provided for in
the procedures to convert the reference paragraph (b)(2)(i)(G) of this section.
amount to serving size in paragraph (vii) As provided for in § 101.9(h)(1),
(b)(2) of this section. for products that consist of two or
(5) For labeling purposes, the term more distinct ingredients or compo-
common household measure or common nents packaged and presented to be
household unit means cup, tablespoon, consumed together (e.g. dry macaroni
teaspoon, piece, slice, fraction (e.g., 1/4 and cheese mix, cake and muffin mixes
pizza), ounce (oz), fluid ounce (fl oz), or with separate ingredient packages,
other common household equipment pancakes and syrup), nutrition infor-
used to package food products (e.g., jar, mation may be declared for each com-
tray). In expressing serving size in ponent or as a composite. The serving
household measures, except as speci- size may be provided in accordance
fied in paragraphs (b)(5)(iv), (b)(5)(v), with the provisions of paragraphs
(b)(5)(vi), and (b)(5)(vii) of this section, (b)(2)(i), (b)(2)(ii), and (b)(2)(iii) of this
the following rules shall be used: section, or alternatively in ounces with
(i) Cups, tablespoons, or teaspoons an appropriate visual unit of measure,
shall be used wherever possible and ap- as described in paragraph (b)(5)(iii) of
propriate except for beverages. For this section (e.g., declared as separate
beverages, a manufacturer may use components: ‘‘3 oz dry macaroni (84 g/
fluid ounces. Cups shall be expressed in about 2/3 cup)’’ and ‘‘1 oz dry cheese
1/4- or 1/3-cup increments. Tablespoons mix (28 g/about 2 tbsp);’’ declared as a
shall be expressed as 1, 1 1/3, 1 1/2, 1 2/ composite value: ‘‘4 oz (112 g/about 2/3
3, 2, or 3 tablespoons. Teaspoons shall cup macaroni and 2 tbsp dry cheese
be expressed as 1/8, 1/4, 1/2, 3/4, 1, or 2 mix)’’).
teaspoons.
(viii) For nutrition labeling purposes,
(ii) If cups, tablespoons or teaspoons
a teaspoon means 5 milliliters (mL), a
are not applicable, units such as piece,
tablespoon means 15 mL, a cup means
slice, tray, jar, and fraction shall be
used. 240 mL, 1 fl oz means 30 mL, and 1 oz in
(iii) If paragraphs (b)(5)(i) and weight means 28 g.
(b)(5)(ii) of this section are not applica- (ix) When a serving size, determined
ble, ounces may be used with an appro- from the reference amount in § 101.12(b)
priate visual unit of measure such as a and the procedures described in this
dimension of a piece, e.g., 1 oz (28 g/ section, falls exactly half way between
about 1/2 pickle). Ounce measurements two serving sizes, e.g., 2.5 tbsp, manu-
shall be expressed in 0.5 oz increments facturers shall round the serving size
most closely approximating the ref- up to the next incremental size.
erence amount. (6) A product that is packaged and
(iv) A description of the individual sold individually and that contains less
container or package shall be used for than 200 percent of the applicable ref-
single serving containers and for indi- erence amount shall be considered to
vidually packaged products within be a single-serving container, and the
multiserving containers (e.g., can, box, entire content of the product shall be
package). A description of the indi- labeled as one serving except for prod-
vidual unit shall be used for other ucts that have reference amounts of 100
products in discrete units (e.g., piece, g (or mL) or larger, manufacturers may
slice, cracker, bar). decide whether a package that contains
(v) For unprepared products where more than 150 percent but less than 200
the entire contents of the package is percent of the reference amount is 1 or
used to prepare large discrete units 2 servings. Packages sold individually
that are usually divided for consump- that contain 200 percent or more of the
tion (e.g., cake mix, pizza kit), the applicable reference amount may be la-
fraction or portion of the package may beled as a single-serving if the entire
be used. content of the package can reasonably
22
be consumed at a single-eating occa- changes to the nutrient profile, the

sion. amount of the finished product may be
(7) A label statement regarding a declared in parentheses at the end of
serving shall be the serving size ex- the serving size declaration (e.g., 1/2
pressed in common household measures cup (120 mL) concentrated soup (makes
as set forth in paragraphs (b)(2) 1 cup prepared)).
through (b)(6) of this section and shall (vi) To promote uniformity in label
be followed by the equivalent metric serving sizes in household measures de-
quantity in parenthesis (fluids in milli- clared by different manufacturers, FDA
liters and all other foods in grams) ex- has provided a guidance document enti-
cept for single-serving containers. tled, ‘‘Guidelines for Determining the
(i) For a single-serving container, the Gram Weight of the Household Meas-
parenthetical metric quantity, which ure.’’ The guidance document can be
will be presented as part of the net obtained from the Office of Nutritional
weight statement on the principal dis- Products, Labeling and Dietary Supple-
play panel, is not required except ments (HFS–800), Center for Food Safe-
where nutrition information is re- ty and Applied Nutrition, Food and
quired on a drained weight basis ac- Drug Administration, 5100 Paint
cording to § 101.9(b)(9). However, if a Branch Pkwy., College Park, MD 20740.
manufacturer voluntarily provides the (8) Determination of the number of
metric quantity on products that can servings per container shall be based
be sold as single servings, then the nu- on the serving size of the product de-
merical value provided as part of the termined by following the procedures
serving size declaration must be iden- described in this section.
tical to the metric quantity declara- (i) The number of servings shall be
tion provided as part of the net quan- rounded to the nearest whole number
tity of contents statement. except for the number of servings be-
(ii) The gram or milliliter quantity tween 2 and 5 servings and random
equivalent to the household measure weight products. The number of
should be rounded to the nearest whole servings between 2 and 5 servings shall
number except for quantities that are be rounded to the nearest 0.5 serving.
less than 5 g (mL). The gram (mL) Rounding should be indicated by the
quantity between 2 and 5 g (mL) should use of the term about (e.g., about 2
be rounded to the nearest 0.5 g (mL) servings, about 3.5 servings).
and the g (mL) quantity less than 2 g (ii) When the serving size is required
(mL) should be expressed in 0.1-g (mL) to be expressed on a drained solids
increments. basis and the number of servings varies
(iii) In addition, serving size may be because of a natural variation in unit
declared in ounce and fluid ounce, in size (e.g., maraschino cherries, pick-
parenthesis, following the metric les), the manufacturer may state the
measure separated by a slash where typical number of servings per con-
other common household measures are tainer (e.g., usually 5 servings).
used as the primary unit for serving (iii) For random weight products, a
size, e.g., 1 slice (28 g/1 oz) for sliced manufacturer may declare ‘‘varied’’ for
bread. The ounce quantity equivalent the number of servings per container
to the metric quantity should be ex- provided the nutrition information is
pressed in 0.1 oz increments. based on the reference amount ex-
(iv) If a manufacturer elects to use pressed in ounces. The manufacturer
abbreviations for units, the following may provide the typical number of
abbreviations shall be used: tbsp for ta- servings in parenthesis following the
blespoon, tsp for teaspoon, g for gram, ‘‘varied’’ statement.
mL for milliliter, oz for ounce, and fl (iv) For packages containing several
oz for fluid ounce. individual single-serving containers,
(v) For products that only require each of which is labeled with all re-
the addition of water or another ingre- quired information including nutrition
dient that contains insignificant labeling as specified in § 101.9 (that is,
amounts of nutrients in the amount are labeled appropriately for individual
added and that are prepared in such a sale as single-serving containers), the
way that there are no significant number of servings shall be the number
23
§ 101.9 21 CFR Ch. I (4–1–12 Edition)
of individual packages within the total eggs, butter, margarine), and multipur-
package. pose baking mixes are exempt from
(v) For packages containing several this requirement.
individually packaged multiserving (c) The declaration of nutrition infor-
units, the number of servings shall be mation on the label and in labeling of
determined by multiplying the number a food shall contain information about
of individual multiserving units in the the level of the following nutrients, ex-
total package by the number of cept for those nutrients whose inclu-
servings in each individual unit. sion, and the declaration of amounts, is
(9) The declaration of nutrient and voluntary as set forth in this para-
food component content shall be on the graph. No nutrients or food compo-
basis of food as packaged or purchased nents other than those listed in this
with the exception of raw fish covered
paragraph as either mandatory or vol-
under § 101.42 (see 101.44), packaged sin-
untary may be included within the nu-
gle-ingredient products that consist of
trition label. Except as provided for in
fish or game meat as provided for in
paragraphs (f) or (j) of this section, nu-
paragraph (j)(11) of this section, and of
foods that are packed or canned in trient information shall be presented
water, brine, or oil but whose liquid using the nutrient names specified and
packing medium is not customarily in the following order in the formats
consumed (e.g., canned fish, mara- specified in paragraphs (d) or (e) of this
schino cherries, pickled fruits, and section.
pickled vegetables). Declaration of nu- (1) ‘‘Calories, total,’’ ‘‘Total cal-
trient and food component content of ories,’’ or ‘‘Calories’’: A statement of
raw fish shall follow the provisions in the caloric content per serving, ex-
§ 101.45. Declaration of the nutrient and pressed to the nearest 5-calorie incre-
food component content of foods that ment up to and including 50 calories,
are packed in liquid which is not cus- and 10-calorie increment above 50 cal-
tomarily consumed shall be based on ories, except that amounts less than 5
the drained solids. calories may be expressed as zero. En-
(10) Another column of figures may ergy content per serving may also be
be used to declare the nutrient and expressed in kilojoule units, added in
food component information: parentheses immediately following the
(i) Per 100 g or 100 mL, or per 1 oz or statement of the caloric content.
1 fl oz of the food as packaged or pur- (i) Caloric content may be calculated
chased; by the following methods. Where either
(ii) Per one unit if the serving size of specific or general food factors are
a product in discrete units in a multi- used, the factors shall be applied to the
serving container is more than 1 unit; actual amount (i.e., before rounding) of
(iii) Per cup popped for popcorn in a food components (e.g., fat, carbo-
multiserving container.
hydrate, protein, or ingredients with
(11) If a product is promoted on the
specific food factors) present per serv-
label, labeling, or advertising for a use
ing.
that differs in quantity by twofold or
greater from the use upon which the (A) Using specific Atwater factors (i.
reference amount in § 101.12(b) was e., the Atwater method) given in Table
based (e.g., liquid cream substitutes 13, ‘‘Energy Value of Foods—Basis and
promoted for use with breakfast cere- Derivation,’’ by A. L. Merrill and B. K.
als), the manufacturer shall provide a Watt, United States Department of Ag-
second column of nutrition informa- riculture (USDA) Handbook No. 74
tion based on the amount customarily (slightly revised, 1973), which is incor-
consumed in the promoted use, in addi- porated by reference in accordance
tion to the nutrition information per with 5 U.S.C. 552(a) and 1 CFR part 51
serving derived from the reference and is available from the Office of Nu-
amount in § 101.12(b), except that non- tritional Products, Labeling and Die-
discrete bulk products that are used tary Supplements (HFS–800), Center for
primarily as ingredients (e.g., flour, Food Safety and Applied Nutrition,
sweeteners, shortenings, oils), or tradi- Food and Drug Administration, 5100
tionally used for multipurposes (e.g., Paint Branch Pkwy., College Park, MD
24
20740, or may be inspected at the Na- as provided in paragraph (d)(5) of this

tional Archives and Records Adminis- section. Except as provided for in para-
tration (NARA). For information on graph (f) of this section, if ‘‘Calories
the availability of this material at from fat’’ is not required and, as a re-
NARA, call 202–741–6030, or go to: http:// sult, not declared, the statement ‘‘Not
www.archives.gov/federallregister/ a significant source of calories from
codeloflfederallregulations/ fat’’ shall be placed at the bottom of
ibrllocations.html.; the table of nutrient values in the
(B) Using the general factors of 4, 4, same type size.
and 9 calories per gram for protein, (iii) ‘‘Calories from saturated fat’’ or
total carbohydrate, and total fat, re-
‘‘Calories from saturated’’ (VOL-
spectively, as described in USDA Hand-
UNTARY): A statement of the caloric
book No. 74 (slightly revised 1973) pp. 9–
11, which is incorporated by reference content derived from saturated fat as
in accordance with 5 U.S.C. 552(a) and 1 defined in paragraph (c)(2)(i) of this
CFR part 51 (the availability of this in- section in a serving may be declared
corporation by reference is given in voluntarily, expressed to the nearest 5-
paragraph (c)(1)(i)(A) of this section); calorie increment, up to and including
(C) Using the general factors of 4, 4, 50 calories, and the nearest 10-calorie
and 9 calories per gram for protein, increment above 50 calories, except
total carbohydrate less the amount of that amounts less than 5 calories may
insoluble dietary fiber, and total fat, be expressed as zero. This statement
respectively, as described in USDA shall be indented under the statement
Handbook No. 74 (slightly revised 1973) of calories from fat as provided in para-
pp. 9–11, which is incorporated by ref- graph (d)(5) of this section.
erence in accordance with 5 U.S.C. (2) ‘‘Fat, total’’ or ‘‘Total fat’’: A
552(a) and 1 CFR part 51 (the avail- statement of the number of grams of
ability of this incorporation by ref- total fat in a serving defined as total
erence is given in paragraph (c)(1)(i)(A) lipid fatty acids and expressed as
of this section; triglycerides. Amounts shall be ex-
(D) Using data for specific food fac- pressed to the nearest 0.5 (1/2) gram in-
tors for particular foods or ingredients crement below 5 grams and to the near-
approved by the Food and Drug Admin-
est gram increment above 5 grams. If
istration (FDA) and provided in parts
the serving contains less than 0.5 gram,
172 or 184 of this chapter, or by other
the content shall be expressed as zero.
means, as appropriate; or
(E) Using bomb calorimetry data sub- (i) ‘‘Saturated fat,’’ or ‘‘Saturated’’:
tracting 1.25 calories per gram protein A statement of the number of grams of
to correct for incomplete digestibility, saturated fat in a serving defined as
as described in USDA Handbook No. 74 the sum of all fatty acids containing no
(slightly revised 1973) p. 10, which is in- double bonds, except that label dec-
corporated by reference in accordance laration of saturated fat content infor-
with 5 U.S.C. 552(a) and 1 CFR part 51 mation is not required for products
(the availability of this incorporation that contain less than 0.5 gram of total
by reference is given in paragraph fat in a serving if no claims are made
(c)(1)(i)(A) of this section). about fat, fatty acid, or cholesterol
(ii) ‘‘Calories from fat’’: A statement content, and if ‘‘calories from satu-
of the caloric content derived from rated fat’’ is not declared. Except as
total fat as defined in paragraph (c)(2) provided for in paragraph (f) of this
of this section in a serving, expressed section, if a statement of the saturated
to the nearest 5-calorie increment, up fat content is not required and, as a re-
to and including 50 calories, and the sult, not declared, the statement ‘‘Not
nearest 10-calorie increment above 50 a significant source of saturated fat’’
calories, except that label declaration shall be placed at the bottom of the
of ‘‘calories from fat’’ is not required table of nutrient values. Saturated fat
on products that contain less than 0.5
content shall be indented and expressed
gram of fat in a serving and amounts
as grams per serving to the nearest 0.5
less than 5 calories may be expressed as
zero. This statement shall be declared gram (1/2) gram increment below 5
25
§ 101.9 21 CFR Ch. I (4–1–12 Edition)
grams and to the nearest gram incre- cept that when polyunsaturated fat is
ment above 5 grams. If the serving con- declared, or when a claim about fatty
tains less than 0.5 gram, the content acids or cholesterol is made on the
shall be expressed as zero. label or in labeling of a food other than
(ii) ‘‘Trans fat’’ or ‘‘Trans’’: A state- one that meets the criteria in
ment of the number of grams of trans § 101.62(b)(1) for a claim for ‘‘fat free,’’
fat in a serving, defined as the sum of label declaration of monounsaturated
all unsaturated fatty acids that con- fat is required. Monounsaturated fat
tain one or more isolated (i.e., noncon- content shall be indented and expressed
jugated) double bonds in a trans con- as grams per serving to the nearest 0.5
figuration, except that label declara- (1/2) gram increment below 5 grams and
tion of trans fat content information is to the nearest gram increment above 5
not required for products that contain grams. If the serving contains less than
less than 0.5 gram of total fat in a serv- 0.5 gram, the content shall be expressed
ing if no claims are made about fat, as zero.
fatty acid or cholesterol content. The (3) ‘‘Cholesterol’’: A statement of the
word ‘‘trans’’ may be italicized to indi- cholesterol content in a serving ex-
cate its Latin origin. Trans fat content pressed in milligrams to the nearest 5-
shall be indented and expressed as milligram increment, except that label
grams per serving to the nearest 0.5 (1/ declaration of cholesterol information
2)-gram increment below 5 grams and is not required for products that con-
to the nearest gram increment above 5 tain less than 2 milligrams cholesterol
grams. If the serving contains less than in a serving and make no claim about
0.5 gram, the content, when declared, fat, fatty acids, or cholesterol content,
shall be expressed as zero. Except as or such products may state the choles-
provided for in paragraph (f) of this terol content as zero. Except as pro-
section, if a statement of the trans fat vided for in paragraph (f) of this sec-
content is not required and, as a result, tion, if cholesterol content is not re-
not declared, the statement ‘‘Not a sig- quired and, as a result, not declared,
nificant source of trans fat’’ shall be the statement ‘‘Not a significant
placed at the bottom of the table of nu- source of cholesterol’’ shall be placed
trient values. at the bottom of the table of nutrient
(iii) ‘‘Polyunsaturated fat’’ or ‘‘Poly- values in the same type size. If the food
unsaturated’’ (VOLUNTARY): A state- contains 2 to 5 milligrams of choles-
ment of the number of grams of poly- terol per serving, the content may be
unsaturated fat in a serving defined as stated as ‘‘less than 5 milligrams.’’
cis,cis-methylene-interrupted poly- (4) ‘‘Sodium’’: A statement of the
unsaturated fatty acids may be de- number of milligrams of sodium in a
clared voluntarily, except that when specified serving of food expressed as
monounsaturated fat is declared, or zero when the serving contains less
when a claim about fatty acids or cho- than 5 milligrams of sodium, to the
lesterol is made on the label or in la- nearest 5-milligram increment when
beling of a food other than one that the serving contains 5 to 140 milli-
meets the criteria in § 101.62(b)(1) for a grams of sodium, and to the nearest 10-
claim for ‘‘fat free,’’ label declaration milligram increment when the serving
of polyunsaturated fat is required. contains greater than 140 milligrams.
Polyunsaturated fat content shall be (5) ‘‘Potassium’’ (VOLUNTARY): A
indented and expressed as grams per statement of the number of milligrams
serving to the nearest 0.5 (1/2) gram in- of potassium in a specified serving of
crement below 5 grams and to the near- food may be declared voluntarily, ex-
est gram increment above 5 grams. If cept that when a claim is made about
the serving contains less than 0.5 gram, potassium content, label declaration
the content shall be expressed as zero. shall be required. Potassium content
(iv) ‘‘Monounsaturated fat’’ or shall be expressed as zero when the
‘‘Monounsaturated’’ (VOLUNTARY): A serving contains less than 5 milligrams
statement of the number of grams of of potassium, to the nearest 5-milli-
monounsaturated fat in a serving de- gram increment when the serving con-
fined as cis-monounsaturated fatty tains less than or equal to 140 milli-
acids may be declared voluntarily ex- grams of potassium, and to the nearest
26
10-milligram increment when the serv- gram, the content may be expressed as
ing contains more than 140 milligrams. zero.
(6) ‘‘Carbohydrate, total’’ or ‘‘Total (B) ‘‘Insoluble fiber’’ (VOLUNTARY):
carbohydrate’’: A statement of the A statement of the number of grams of
number of grams of total carbohydrate insoluble dietary fiber in a serving may
in a serving expressed to the nearest be declared voluntarily except that
gram, except that if a serving contains when a claim is made on the label or in
less than 1 gram, the statement ‘‘Con- labeling about insoluble fiber, label
tains less than 1 gram’’ or ‘‘less than 1 declaration shall be required. Insoluble
gram’’ may be used as an alternative, fiber content shall be indented under
or if the serving contains less than 0.5 dietary fiber and expressed to the near-
gram, the content may be expressed as est gram except that if a serving con-
zero. Total carbohydrate content shall tains less than 1 gram, the statement
be calculated by subtraction of the sum ‘‘Contains less than 1 gram’’ or ‘‘less
of the crude protein, total fat, mois- than 1 gram’’ may be used as an alter-
ture, and ash from the total weight of native, and if the serving contains less
the food. This calculation method is than 0.5 gram, the content may be ex-
described in A. L. Merrill and B. K. pressed as zero.
Watt, ‘‘Energy Value of Foods—Basis (ii) ‘‘Sugars’’: A statement of the
and Derivation,’’ USDA Handbook 74 number of grams of sugars in a serving,
(slightly revised 1973) pp. 2 and 3, which except that label declaration of sugars
is incorporated by reference in accord- content is not required for products
that contain less than 1 gram of sugars
ance with 5 U.S.C. 552(a) and 1 CFR
in a serving if no claims are made
part 51 (the availability of this incorpo-
about sweeteners, sugars, or sugar al-
ration by reference is given in para-
cohol content. Except as provided for
graph (c)(1)(i)(A) of this section).
in paragraph (f) of this section, if a
(i) ‘‘Dietary fiber’’: A statement of statement of the sugars content is not
the number of grams of total dietary required and, as a result, not declared,
fiber in a serving, indented and ex- the statement ‘‘Not a significant
pressed to the nearest gram, except source of sugars’’ shall be placed at the
that if a serving contains less than 1 bottom of the table of nutrient values
gram, declaration of dietary fiber is in the same type size. Sugars shall be
not required or, alternatively, the defined as the sum of all free mono-
statement ‘‘Contains less than 1 gram’’ and disaccharides (such as glucose,
or ‘‘less than 1 gram’’ may be used, and fructose, lactose, and sucrose). Sugars
if the serving contains less than 0.5 content shall be indented and expressed
gram, the content may be expressed as to the nearest gram, except that if a
zero. Except as provided for in para- serving contains less than 1 gram, the
graph (f) of this section, if dietary fiber statement ‘‘Contains less then 1 gram’’
content is not required and as a result, or ‘‘less than 1 gram’’ may be used as
not declared, the statement ‘‘Not a sig- an alternative, and if the serving con-
nificant source of dietary fiber’’ shall tains less than 0.5 gram, the content
be placed at the bottom of the table of may be expressed as zero.
nutrient values in the same type size. (iii) ‘‘Sugar alcohol’’ (VOLUNTARY):
(A) ‘‘Soluble fiber’’ (VOLUNTARY): A statement of the number of grams of
A statement of the number of grams of sugar alcohols in a serving may be de-
soluble dietary fiber in a serving may clared voluntarily on the label, except
be declared voluntarily except when a that when a claim is made on the label
claim is made on the label or in label- or in labeling about sugar alcohol or
ing about soluble fiber, label declara- sugars when sugar alcohols are present
tion shall be required. Soluble fiber in the food, sugar alcohol content shall
content shall be indented under dietary be declared. For nutrition labeling pur-
fiber and expressed to the nearest poses, sugar alcohols are defined as the
gram, except that if a serving contains sum of saccharide derivatives in which
less than 1 gram, the statement ‘‘Con- a hydroxyl group replaces a ketone or
tains less than 1 gram’’ or ‘‘less than 1 aldehyde group and whose use in the
gram’’ may be used as an alternative, food is listed by FDA (e.g., mannitol or
and if the serving contains less than 0.5 xylitol) or is generally recognized as
27
§ 101.9 21 CFR Ch. I (4–1–12 Edition)
safe (e.g., sorbitol). In lieu of the term protein content by weight: The state-
‘‘sugar alcohol,’’ the name of the spe- ment ‘‘not a significant source of pro-
cific sugar alcohol (e.g., ‘‘xylitol’’) tein,’’ or a listing aligned under the
present in the food may be used in the column headed ‘‘Percent Daily Value’’
nutrition label provided that only one of the corrected amount of protein per
sugar alcohol is present in the food. serving, as determined in paragraph
Sugar alcohol content shall be in- (c)(7)(ii) of this section, calculated as a
dented and expressed to the nearest percentage of the Daily Reference
gram, except that if a serving contains Value (DRV) or Reference Daily Intake
less than 1 gram, the statement ‘‘Con- (RDI), as appropriate, for protein and
tains less then 1 gram’’ or ‘‘less than 1 expressed as Percent of Daily Value.
gram’’ may be used as an alternative, When the protein quality in a food as
and if the serving contains less than 0.5 measured by the Protein Efficiency
gram, the content may be expressed as Ratio (PER) is less than 40 percent of
zero. the reference standard (casein) for a
(iv) ‘‘Other carbohydrate’’ (VOL- food represented or purported to be for
UNTARY): A statement of the number infants, the statement ‘‘not a signifi-
of grams of other carbohydrates may cant source of protein’’ shall be placed
be declared voluntarily. Other carbo- adjacent to the declaration of protein
hydrates shall be defined as the dif- content. Protein content may be cal-
ference between total carbohydrate and culated on the basis of the factor of 6.25
the sum of dietary fiber, sugars, and times the nitrogen content of the food
sugar alcohol, except that if sugar al- as determined by the appropriate
cohol is not declared (even if present), method of analysis as given in the ‘‘Of-
it shall be defined as the difference be- ficial Methods of Analysis of the AOAC
tween total carbohydrate and the sum International’’ (formerly the Associa-
of dietary fiber and sugars. Other car- tion of Official Analytical Chemists),
bohydrate content shall be indented 15th Ed. (1990), which is incorporated
and expressed to the nearest gram, ex- by reference in accordance with 5
cept that if a serving contains less U.S.C. 552(a) and 1 CFR part 51, except
than 1 gram, the statement ‘‘Contains when the official procedure for a spe-
less than 1 gram’’ or ‘‘less than 1 cific food requires another factor. Cop-
gram’’ may be used as an alternative, ies may be obtained from AOAC
and if the serving contains less than 0.5 INTERNATIONAL, 481 North Frederick
gram, the content may be expressed as Ave., suite 500, Gaithersburg, MD 20877,
zero. or may be inspected at the National
(7) ‘‘Protein’’: A statement of the Archives and Records Administration
number of grams of protein in a serv- (NARA). For information on the avail-
ing, expressed to the nearest gram, ex- ability of this material at NARA, call
cept that if a serving contains less 202–741–6030, or go to: http://
than 1 gram, the statement ‘‘Contains www.archives.gov/federallregister/
less than 1 gram’’ or ‘‘less than 1 codeloflfederallregulations/
gram’’ may be used as an alternative, ibrllocations.html.
and if the serving contains less than 0.5 (i) A statement of the corrected
gram, the content may be expressed as amount of protein per serving, as de-
zero. When the protein in foods rep- termined in paragraph (c)(7)(ii) of this
resented or purported to be for adults section, calculated as a percentage of
and children 4 or more years of age has the RDI or DRV for protein, as appro-
a protein quality value that is a propriate, and expressed as Percent of
tein digestibility-corrected amino acid Daily Value, may be placed on the
score of less than 20 expressed as a per- label, except that such a statement
cent, or when the protein in a food rep- shall be given if a protein claim is
resented or purported to be for children made for the product, or if the product
greater than 1 but less than 4 years of is represented or purported to be for
age has a protein quality value that is use by infants or children under 4 years
a protein digestibility-corrected amino of age. When such a declaration is pro-
acid score of less than 40 expressed as a vided, it shall be placed on the label
percent, either of the following shall be adjacent to the statement of grams of
placed adjacent to the declaration of protein and aligned under the column
28
headed ‘‘Percent Daily Value,’’ and ex- (iii) For the purpose of labeling with
pressed to the nearest whole percent. a percent of the Daily Reference Value
However, the percentage of the RDI for (DRV) or RDI, a value of 50 grams of
protein shall not be declared if the food protein shall be the DRV for adults and
is represented or purported to be for children 4 or more years of age, and the
use by infants and the protein quality RDI for protein for children less than 4
value is less than 40 percent of the ref- years of age, infants, pregnant women,
erence standard. and lactating women shall be 16 grams,
(ii) The ‘‘corrected amount of protein 14 grams, 60 grams, and 65 grams, re-
(gram) per serving’’ for foods rep- spectively.
resented or purported for adults and (8) Vitamins and minerals: A state-
children 1 or more years of age is equal ment of the amount per serving of the
to the actual amount of protein (gram) vitamins and minerals as described in
per serving multiplied by the amino this paragraph, calculated as a percent
acid score corrected for protein digest- of the RDI and expressed as percent of
ibility. If the corrected score is above Daily Value.
1.00, then it shall be set at 1.00. The (i) For purposes of declaration of per-
protein digestibility-corrected amino cent of Daily Value as provided for in
acid score shall be determined by paragraphs (d), (e), and (f) of this sec-
methods given in sections 5.4.1, 7.2.1, tion, foods represented or purported to
and 8.00 in ‘‘Protein Quality Evalua- be for use by infants, children less than
tion, Report of the Joint FAO/WHO Ex- 4 years of age, pregnant women, or lac-
pert Consultation on Protein Quality tating women shall use the RDI’s that
Evaluation,’’ Rome, 1990, except that are specified for the intended group.
when official AOAC procedures de- For foods represented or purported to
scribed in section (c)(7) of this para- be for use by both infants and children
graph require a specific food factor under 4 years of age, the percent of
other than 6.25, that specific factor Daily Value shall be presented by sepa-
shall be used. The ‘‘Report of the Joint rate declarations according to para-
FAO/WHO Expert Consultation on Pro- graph (e) of this section based on the
tein Quality Evaluation’’ as published RDI values for infants from birth to 12
by the Food and Agriculture Organiza- months of age and for children under 4
tion of the United Nations/World years of age. Similarly, the percent of
Health Organization is incorporated by Daily Value based on both the RDI val-
reference in accordance with 5 U.S.C. ues for pregnant women and for lac-
552(a) and 1 CFR part 51. Copies are tating women shall be declared sepa-
available from the Center for Food rately on foods represented or pur-
Safety and Applied Nutrition (HFS– ported to be for use by both pregnant
800), Food and Drug Administration, and lactating women. When such dual
5100 Paint Branch Pkwy., College Park, declaration is used on any label, it
MD 20740, or may be inspected at the shall be included in all labeling, and
National Archives and Records Admin- equal prominence shall be given to
istration (NARA). For information on both values in all such labeling. All
the availability of this material at other foods shall use the RDI for adults
NARA, call 202–741–6030, or go to: http:// and children 4 or more years of age.
www.archives.gov/federallregister/ (ii) The declaration of vitamins and
codeloflfederallregulations/ minerals as a percent of the RDI shall
ibrllocations.html. For foods rep- include vitamin A, vitamin C, calcium,
resented or purported for infants, the and iron, in that order, and shall in-
corrected amount of protein (grams) clude any of the other vitamins and
per serving is equal to the actual minerals listed in paragraph (c)(8)(iv)
amount of protein (grams) per serving of this section when they are added as
multiplied by the relative protein qual- a nutrient supplement, or when a claim
ity value. The relative protein quality is made about them. Other vitamins
value shall be determined by dividing and minerals need not be declared if
the subject food protein PER value by neither the nutrient nor the compo-
the PER value for casein. If the rel- nent is otherwise referred to on the
ative protein value is above 1.00, it label or in labeling or advertising and
shall be set at 1.00. the vitamins and minerals are:
29
§ 101.9 21 CFR Ch. I (4–1–12 Edition)
(A) Required or permitted in a stand- Vitamin D, 400 International Units

ardized food (e.g., thiamin, riboflavin, Vitamin E, 30 International Units
and niacin in enriched flour) and that Vitamin K, 80 micrograms
Thiamin, 1.5 milligrams
standardized food is included as an in- Riboflavin, 1.7 milligrams
gredient (i.e., component) in another Niacin, 20 milligrams
food; or Vitamin B6, 2.0 milligrams
(B) Included in a food solely for tech- Folate, 400 micrograms
nological purposes and declared only in Vitamin B12, 6 micrograms
the ingredient statement. The declara- Biotin, 300 micrograms
Pantothenic acid, 10 milligrams
tion may also include any of the other
Phosphorus, 1,000 milligrams
vitamins and minerals listed in para- Iodine, 150 micrograms
graph (c)(8)(iv) of this section when Magnesium, 400 milligrams
they are naturally occurring in the Zinc, 15 milligrams
food. The additional vitamins and min- Selenium, 70 micrograms
erals shall be listed in the order estab- Copper, 2.0 milligrams
lished in paragraph (c)(8)(iv) of this Manganese, 2.0 milligrams
Chromium, 120 micrograms
section. Molybdenum, 75 micrograms
(iii) The percentages for vitamins Chloride, 3,400 milligrams
and minerals shall be expressed to the
nearest 2-percent increment up to and (v) The following synonyms may be
including the 10-percent level, the added in parentheses immediately fol-
nearest 5-percent increment above 10 lowing the name of the nutrient or die-
percent and up to and including the 50- tary component:
percent level, and the nearest 10-per- Calories—Energy
cent increment above the 50-percent Vitamin C—Ascorbic acid
level. Amounts of vitamins and min- Thiamin—Vitamin B1
erals present at less than 2 percent of Riboflavin—Vitamin B2
the RDI are not required to be declared Folate—Folic acid or Folacin.
Alternatively, folic acid or folacin may be
in nutrition labeling but may be de-
listed without parentheses in place of
clared by a zero or by the use of an as- folate.
terisk (or other symbol) that refers to
another asterisk (or symbol) that is (vi) A statement of the percent of vi-
placed at the bottom of the table and tamin A that is present as beta-caro-
that is followed by the statement tene may be declared voluntarily.
‘‘Contains less than 2 percent of the When the vitamins and minerals are
Daily Value of this (these) nutrient listed in a single column, the state-
(nutrients)’’ or ‘‘Contains < 2 percent ment shall be indented under the infor-
of the Daily Value of this (these) nutri- mation on vitamin A. When vitamins
ent (nutrients).’’ Alternatively, except and minerals are arrayed horizontally,
as provided for in paragraph (f) of this the statement of percent shall be pre-
section, if vitamin A, vitamin C, cal- sented in parenthesis following the dec-
cium, or iron is present in amounts less laration of vitamin A and the percent
than 2 percent of the RDI, label dec- DV of vitamin A in the food (e.g.,
laration of the nutrient(s) is not re- ‘‘Percent Daily Value: Vitamin A 50 (90
quired if the statement ‘‘Not a signifi- percent as beta-carotene)’’). When de-
cant source of l (listing the vitamins clared, the percentages shall be ex-
or minerals omitted)’’ is placed at the pressed in the same increments as are
bottom of the table of nutrient values. provided for vitamins and minerals in
Either statement shall be in the same paragraph (c)(8)(iii) of this section.
type size as nutrients that are in- (9) For the purpose of labeling with a
dented. percent of the DRV, the following
(iv) The following RDI’s and nomen- DRV’s are established for the following
clature are established for the fol- food components based on the reference
lowing vitamins and minerals which caloric intake of 2,000 calories:
are essential in human nutrition: Unit of measure-
Food component DRV
ment
Vitamin A, 5,000 International Units
Vitamin C, 60 milligrams Fat ....................................... gram (g) ............... 65
Calcium, 1,000 milligrams Saturated fatty acids ........... do ......................... 20
Iron, 18 milligrams Cholesterol .......................... milligrams (mg) .... 300
30
Food component Unit of measure- DRV

(d)(10) of this section shall also be in
ment type no smaller than 6 point.
Total carbohydrate .............. grams (g) ............. 300 (iv) The headings required by para-
Fiber .................................... do ......................... 25 graphs (d)(2), (d)(4), and (d)(6) of this
Sodium ................................ milligrams (mg) .... 2,400
Potassium ........................... do ......................... 3,500
section (i.e., ‘‘Nutrition Facts,’’
Protein ................................. grams (g) ............. 50 ‘‘Amount per Serving,’’ and ‘‘% Daily
Value*’’), the names of all nutrients
(d)(1) Nutrient information specified that are not indented according to re-
in paragraph (c) of this section shall be quirements of paragraph (c) of this sec-
presented on foods in the following for- tion (i.e., ‘‘Calories,’’ ‘‘Total Fat,’’
mat, as shown in paragraph (d)(12) of ‘‘Cholesterol,’’ ‘‘Sodium,’’ ‘‘Total Car-
this section, except on foods on which bohydrate,’’ and ‘‘Protein’’), and the
dual columns of nutrition information percentage amounts required by para-
are declared as provided for in paragraph (d)(7)(ii) of this section shall be
graph (e) of this section, on those food highlighted by bold or extra bold type
products on which the simplified for- or other highlighting (reverse printing
mat is required to be used as provided is not permitted as a form of high-
for in paragraph (f) of this section, on lighting) that prominently distin-
foods for infants and children less than guishes it from other information. No
4 years of age as provided for in para- other information shall be highlighted.
graph (j)(5) of this section, and on foods (v) A hairline rule that is centered
in small or intermediate-sized pack- between the lines of text shall separate
ages as provided for in paragraph (j)(13) ‘‘Amount Per Serving’’ from the cal-
of this section. In the interest of uni- orie statements required in paragraph
formity of presentation, FDA urges (d)(5) of this section and shall separate
that the nutrition information be pre- each nutrient and its corresponding
sented using the graphic specifications percent Daily Value required in para-
set forth in appendix B to part 101. graphs (d)(7)(i) and (d)(7)(ii) of this sec-
(i) The nutrition information shall be tion from the nutrient and percent
set off in a box by use of hairlines and Daily Value above and below it, as
shall be all black or one color type, shown in paragraph (d)(12) of this sec-
printed on a white or other neutral tion.
contrasting background whenever prac- (2) The information shall be pre-
tical. sented under the identifying heading of
(ii) All information within the nutri- ‘‘Nutrition Facts’’ which shall be set in
tion label shall utilize: a type size larger than all other print
(A) Except as provided for in para- size in the nutrition label and, except
graph (c)(2)(ii) of this section, a single for labels presented according to the
easy-to-read type style, format provided for in paragraph (d)(11)
(B) Upper and lower case letters, of this section, unless impractical,
(C) At least one point leading (i.e., shall be set the full width of the infor-
space between two lines of text) except mation provided under paragraph (d)(7)
that at least four points leading shall of this section, as shown in paragraph
be utilized for the information required (d)(12) of this section.
by paragraphs (d)(7) and (d)(8) of this (3) Information on serving size shall
section as shown in paragraph (d)(12), immediately follow the heading as
and shown in paragraph (d)(12) of this sec-
(D) Letters should never touch. tion. Such information shall include:
(iii) Information required in para- (i) ‘‘Serving Size’’: A statement of
graphs (d)(3), (d)(5), (d)(7), and (d)(8) of the serving size as specified in para-
this section shall be in type size no graph (b)(7) of this section.
smaller than 8 point. Except for the (ii) ‘‘Servings Per Container’’: The
heading ‘‘Nutrition Facts,’’ the infor- number of servings per container, ex-
mation required in paragraphs (d)(4), cept that this statement is not re-
(d)(6), and (d)(9) of this section and all quired on single serving containers as
other information contained within the defined in paragraph (b)(6) of this sec-
nutrition label shall be in type size no tion or on other food containers when
smaller than 6 point. When provided, this information is stated in the net
the information described in paragraph quantity of contents declaration.
31
§ 101.9 21 CFR Ch. I (4–1–12 Edition)
(4) A subheading ‘‘Amount Per Serv- that the percent for protein may be
ing’’ shall be separated from serving omitted as provided in paragraph (c)(7)
size information by a bar as shown in of this section. The percent shall be
paragraph (d)(12) of this section. calculated by dividing either the
(5) Information on calories shall im- amount declared on the label for each
mediately follow the heading ‘‘Amount nutrient or the actual amount of each
Per Serving’’ and shall be declared in nutrient (i.e., before rounding) by the
one line, leaving sufficient space be- DRV for the nutrient, except that the
tween the declaration of ‘‘Calories’’ percent for protein shall be calculated
and ‘‘Calories from fat’’ to allow clear as specified in paragraph (c)(7)(ii) of
differentiation, or, if ‘‘Calories from this section. The numerical value shall
saturated fat’’ is declared, in a column be followed by the symbol for percent
with total ‘‘Calories’’ at the top, fol- (i.e., %).
lowed by ‘‘Calories from fat’’ (in- (8) Nutrient information for vitamins
dented), and ‘‘Calories from saturated and minerals shall be separated from
fat’’ (indented). information on other nutrients by a
(6) The column heading ‘‘% Daily bar and shall be arrayed horizontally
Value,’’ followed by an asterisk (e.g., (e.g., Vitamin A 4%, Vitamin C 2%,
‘‘% Daily Value*’’), shall be separated Calcium 15%, Iron 4%) or may be listed
from information on calories by a bar in two columns as shown in paragraph
as shown in paragraph (d)(12) of this (d)(12) of this section, except that when
section. The position of this column more than four vitamins and minerals
heading shall allow for a list of nutri- are declared, they may be declared
ent names and amounts as described in vertically with percentages listed
paragraph (d)(7) of this section to be to under the column headed ‘‘% Daily
the left of, and below, this column Value.’’
heading. The column headings ‘‘Per- (9) A footnote, preceded by an aster-
cent Daily Value,’’ ‘‘Percent DV,’’ or isk, shall be placed beneath the list of
‘‘% DV’’ may be substituted for ‘‘% vitamins and minerals and shall be sep-
Daily Value.’’ arated from that list by a hairline.
(7) Except as provided for in para- (i) The footnote shall state:
graph (j)(13) of this section, nutrient Percent Daily Values are based on a
information for both mandatory and 2,000 calorie diet.
any voluntary nutrients listed in para- Your daily values may be higher or
graph (c) of this section that are to be lower depending on your calorie needs.
declared in the nutrition label, except
Calories: 2,000 2,500
vitamins and minerals, shall be de-
clared as follows: Total fat ....................... Less than 65 g 80 g
(i) The name of each nutrient, as Saturated fat ................ Less than 20 g 25 g
specified in paragraph (c) of this sec- Cholesterol .................. Less than 300 mg 300 mg
Sodium ........................ Less than 2,400 mg 2,400 mg
tion, shall be given in a column and Total carbohydrate ...... 300 g 375 g
followed immediately by the quan- Dietary fiber ................. 25 g 30 g
titative amount by weight for that nu-
trient appended with a ‘‘g’’ for grams (ii) If the percent of Daily Value is
or a ‘‘mg’’ for milligrams as shown in given for protein in the Percent of
paragraph (d)(12) of this section. The Daily Value column as provided in
symbol ‘‘<’’ may be used in place of paragraph (d)(7)(ii) of this section, pro-
‘‘less than.’’ tein shall be listed under dietary fiber,
(ii) A listing of the percent of the and a value of 50 g shall be inserted on
DRV as established in paragraphs the same line in the column headed
(c)(7)(iii) and (c)(9) of this section shall ‘‘2,000’’ and a value of 65 g in the col-
be given in a column aligned under the umn headed ‘‘2,500’’.
heading ‘‘% Daily Value’’ established (iii) If potassium is declared in the
in paragraph (d)(6) of this section with column described in paragraph (d)(7)(i)
the percent expressed to the nearest of this section, potassium shall be list-
whole percent for each nutrient de- ed under sodium and the DRV estab-
clared in the column described in para- lished in paragraph (c)(9) of this sec-
graph (d)(7)(i) of this section for which tion shall be inserted on the same line
a DRV has been established, except in the numeric columns.
32
(iv) The abbreviations established in graph (d)(10) of this section may be pre-
paragraph (j)(13)(ii)(B) of this section sented beneath either side or along the
may be used within the footnote. full length of the nutrition label.
(10) Caloric conversion information (ii) If the space beneath the manda-
on a per gram basis for fat, carbo- tory declaration of iron is not adequate
hydrate, and protein may be presented to accommodate any remaining vita-
beneath the information required in mins and minerals to be declared or the
paragraph (d)(9) of this section, sepa- information required in paragraph
rated from that information by a hair- (d)(9) of this section, the remaining in-
line. This information may be pre- formation may be moved to the right
sented horizontally as shown in para- and set off by a line that distinguishes
graph (d)(12) of this section (i.e., ‘‘Cal- it and sets it apart from the nutrients
ories per gram: fat 9, carbohydrate 4, and the percent DV information given
protein 4’’) or vertically in columns. to the left. The caloric conversion in-
(11)(i) If the space beneath the infor- formation provided for in paragraph
mation on vitamins and minerals is not (d)(10) of this section may be presented
adequate to accommodate the informa- beneath either side or along the full
tion required in paragraph (d)(9) of this length of the nutrition label.
section, the information required in (iii) If there is not sufficient contin-
paragraph (d)(9) may be moved to the uous vertical space (i.e., approximately
right of the column required in para- 3 in) to accommodate the required
graph (d)(7)(ii) of this section and set components of the nutrition label up to
off by a line that distinguishes it and and including the mandatory declara-
sets it apart from the percent Daily tion of iron, the nutrition label may be
Value information. The caloric conver- presented in a tabular display as shown
sion information provided for in para- below.
33
ER11JY03.000</GPH>
§ 101.9 21 CFR Ch. I (4–1–12 Edition)
(12) The following sample label illus- (13)(i) Nutrition labels on the outer
trates the provisions of paragraph (d) label of packages of products that con-
of this section. tain two or more separately packaged
foods that are intended to be eaten in-
dividually (e.g., variety packs of cere-
als or snack foods) or of packages that
are used interchangeably for the same
type of food (e.g., round ice cream con-
tainers) may use an aggregate display.
(ii) Aggregate displays shall comply
with the format requirements of para-
graph (d) of this section to the max-
imum extent possible, except that the
identity of each food shall be specified
immediately under the ‘‘Nutrition
Facts’’ title, and both the quantitative
amount by weight (i.e., g/mg amounts)
and the percent Daily Value for each
nutrient shall be listed in separate col-
umns under the name of each food. The
following sample label illustrates an
aggregate display.
34
ER11JY03.001</GPH>
(14) In accordance with § 101.15(c)(2), (b) of this section, or for two or more
when nutrition labeling must appear in groups for which RDI’s are established
a second language, the nutrition infor- (e.g., both infants and children less
mation may be presented in a separate than 4 years of age) as shown in para-
nutrition label for each language or in graph (e)(5) of this section. When such
one nutrition label with the informa- dual labeling is provided, equal promi-
tion in the second language following nence shall be given to both sets of val-
that in English. Numeric characters ues. Information shall be presented in a
that are identical in both languages format consistent with paragraph (d) of
need not be repeated (e.g., ‘‘Protein/ this section, except that:
Proteinas 2 g’’). All required informa- (1) Following the subheading of
tion must be included in both lan- ‘‘Amount Per Serving,’’ there shall be
guages. two or more column headings accu-
(e) Nutrition information may be pre- rately describing the forms of the same
sented for two or more forms of the food (e.g., ‘‘Mix’’ and ‘‘Baked’’), the
same food (e.g., both ‘‘as purchased’’ combinations of food, the units, or the
and ‘‘as prepared’’) or for common com- RDI groups that are being declared.
binations of food as provided for in The column representing the product
paragraph (h)(4) of this section, for dif- as packaged and according to the label
ferent units (e.g., slices of bread or per
serving size based on the reference
100 grams) as provided for in paragraph
35
ER11JY03.002</GPH>
§ 101.9 21 CFR Ch. I (4–1–12 Edition)
amount in § 101.12(b) shall be to the left (B) If such additional quantitative in-
of the numeric columns. formation is given in a footnote, it
(2) When the dual labeling is pre- shall be declared in the same order as
sented for two or more forms of the the nutrients are listed in the nutri-
same food, for combinations of food, or tion label. The additional quantitative
for different units, total calories and information may state the total nutri-
calories from fat (and calories from ent content of the product identified in
saturated fat, when declared) shall be the second column or the nutrient
listed in a column and indented as
amounts added to the product as pack-
specified in paragraph (d)(5) of this sec-
aged for only those nutrients that are
tion with quantitative amounts de-
clared in columns aligned under the present in different amounts than the
column headings set forth in paragraph amounts declared in the required quan-
(e)(1) of this section. titative information. The footnote
(3) Quantitative information by shall clearly identify which amounts
weight required in paragraph (d)(7)(i) of are declared. Any subcomponents de-
this section shall be specified for the clared shall be listed parenthetically
form of the product as packaged and after principal components (e.g., 1/2 cup
according to the label serving size skim milk contributes an additional 40
based on the reference amount in calories, 65 mg sodium, 6 g total carbo-
§ 101.12(b). hydrate (6 g sugars), and 4 g protein).
(i) Quantitative information by (ii) Total fat and its quantitative
weight may be included for other forms amount by weight shall be followed by
of the product represented by the addi- an asterisk (or other symbol) (e.g.,
tional column(s) either immediately ‘‘Total fat (2 g)*’’) referring to another
adjacent to the required quantitative asterisk (or symbol) at the bottom of
information by weight for the product the nutrition label identifying the
as packaged and according to the label form(s) of the product for which quan-
serving size based on the reference
titative information is presented.
amount in § 101.12(b) or as a footnote.
(A) If such additional quantitative (4) Information required in para-
information is given immediately adja- graphs (d)(7)(ii) and (d)(8) of this sec-
cent to the required quantitative infor- tion shall be presented under the sub-
mation, it shall be declared for all nu- heading ‘‘% DAILY VALUE’’ and in
trients listed and placed immediately columns directly under the column
following and differentiated from the headings set forth in paragraph (e)(1) of
required quantitative information this section.
(e.g., separated by a comma). Such in- (5) The following sample label illus-
formation shall not be put in a sepa- trates the provisions of paragraph (e)
rate column. of this section:
36
(f) The declaration of nutrition infor- dietary fiber, sugars, protein, vitamin
mation may be presented in the sim- A, vitamin C, calcium, and iron.
plified format set forth herein when a (1) An ‘‘insignificant amount’’ shall
food product contains insignificant be defined as that amount that allows
amounts of eight or more of the fol- a declaration of zero in nutrition label-
lowing: Calories, total fat, saturated ing, except that for total carbohydrate,
fat, trans fat, cholesterol, sodium, total dietary fiber, and protein, it shall be an
carbohydrate, dietary fiber, sugars, amount that allows a declaration of
protein, vitamin A, vitamin C, calcium, ‘‘less than 1 gram.’’
and iron; except that for foods intended (2) The simplified format shall in-
for children less than 2 years of age to clude information on the following nu-
which § 101.9(j)(5)(i) applies, nutrition trients:
information may be presented in the (i) Total calories, total fat, total car-
simplified format when a food product bohydrate, protein, and sodium;
contains insignificant amounts of six (ii) Calories from fat and any other
or more of the following: Calories, nutrients identified in paragraph (f) of
total fat, sodium, total carbohydrate, this section that are present in the
37
ER11JY03.003</GPH>
§ 101.9 21 CFR Ch. I (4–1–12 Edition)
food in more than insignificant a lot. Unless a particular method of

amounts; and analysis is specified in paragraph (c) of
(iii) Any vitamins and minerals list- this section, composites shall be ana-
ed in paragraph (c)(8)(iv) of this section lyzed by appropriate methods as given
when they are required to be added as in the ‘‘Official Methods of Analysis of
a nutrient supplement to foods for the AOAC International,’’ 15th Ed.
which a standard of identity exists. (1990), which is incorporated by ref-
(iv) Any vitamins or minerals listed erence in accordance with 5 U.S.C.
in paragraph (c)(8)(iv) of this section 552(a) or 1 CFR part 51 or, if no AOAC
voluntarily added to the food as nutri- method is available or appropriate, by
ent supplements. other reliable and appropriate analyt-
(3) Other nutrients that are naturally ical procedures. The availability of this
present in the food in more than insig- incorporation by reference is given in
nificant amounts may be voluntarily paragraph (c)(7) of this section.
declared as part of the simplified for- (3) Two classes of nutrients are de-
mat. fined for purposes of compliance:
(4) If any nutrients are declared as (i) Class I. Added nutrients in for-
provided in paragraphs (f)(2)(iii), tified or fabricated foods; and
(f)(2)(iv), or (f)(3) of this section as part (ii) Class II. Naturally occurring (in-
of the simplified format or if any nutri- digenous) nutrients. If any ingredient
tion claims are made on the label or in which contains a naturally occurring
labeling, the statement ‘‘Not a signifi- (indigenous) nutrient is added to a
cant source of lll’’ (with the blank food, the total amount of such nutrient
filled in with the name(s) of any nutri- in the final food product is subject to
ent(s) identified in § 101.9(f) and cal- class II requirements unless the same
ories from fat that are present in insig- nutrient is also added.
nificant amounts) shall be included at (4) A food with a label declaration of
the bottom of the nutrition label. a vitamin, mineral, protein, total car-
(5) Except as provided for in para- bohydrate, dietary fiber, other carbo-
graphs (j)(5) and (j)(13) of this section, hydrate, polyunsaturated or
nutrient information declared in the monounsaturated fat, or potassium
simplified format shall be presented in shall be deemed to be misbranded
the same manner as specified in para- under section 403(a) of the Federal
graphs (d) or (e) of this section, except Food, Drug, and Cosmetic Act (the act)
that the footnote required in paragraph unless it meets the following require-
(d)(9) of this section is not required. ments:
When the footnote is omitted, an aster- (i) Class I vitamin, mineral, protein, di-
isk shall be placed at the bottom of the etary fiber, or potassium. The nutrient
label followed by the statement ‘‘Per- content of the composite is at least
cent Daily Values are based on a 2,000 equal to the value for that nutrient de-
calorie diet’’ and, if the term ‘‘Daily clared on the label.
Value’’ is not spelled out in the head- (ii) Class II vitamin, mineral, protein,
ing, a statement that ‘‘DV’’ represents total carbohydrate, dietary fiber, other
‘‘Daily Value.’’ carbohydrate, polyunsaturated or
(g) Compliance with this section monounsaturated fat, or potassium. The
shall be determined as follows: nutrient content of the composite is at
(1) A collection of primary containers least equal to 80 percent of the value
or units of the same size, type, and for that nutrient declared on the label.
style produced under conditions as Provided, That no regulatory action
nearly uniform as possible, designated will be based on a determination of a
by a common container code or mark- nutrient value that falls below this
ing, or in the absence of any common level by a factor less than the varia-
container code or marking, a day’s pro- bility generally recognized for the ana-
duction, constitutes a ‘‘lot.’’ lytical method used in that food at the
(2) The sample for nutrient analysis level involved.
shall consist of a composite of 12 sub- (5) A food with a label declaration of
samples (consumer units), taken 1 from calories, sugars, total fat, saturated
each of 12 different randomly chosen fat, trans fat, cholesterol, or sodium
shipping cases, to be representative of shall be deemed to be misbranded
38
under section 403(a) of the act if the (9) When it is not technologically fea-
nutrient content of the composite is sible, or some other circumstance
greater than 20 percent in excess of the makes it impracticable, for firms to
value for that nutrient declared on the comply with the requirements of this
label. Provided, That no regulatory ac- section (e.g., to develop adequate nutri-
tion will be based on a determination ent profiles to comply with the require-
of a nutrient value that falls above this ments of paragraph (c) of this section),
level by a factor less than the varia- FDA may permit alternative means of
bility generally recognized for the ana- compliance or additional exemptions
lytical method used in that food at the to deal with the situation. Firms in
level involved. need of such special allowances shall
(6) Reasonable excesses of a vitamin, make their request in writing to the
mineral, protein, total carbohydrate, Center for Food Safety and Applied Nu-
dietary fiber, other carbohydrate, poly- trition (HFS–800), Food and Drug Ad-
unsaturated or monounsaturated fat, ministration, 5100 Paint Branch Pkwy.,
or potassium over labeled amounts are College Park, MD 20740.
acceptable within current good manu- (h) Products with separately pack-
facturing practice. Reasonable defi- aged ingredients or foods, with assort-
ciencies of calories, sugars, total fat, ments of food, or to which other ingre-
saturated fat, trans fat, cholesterol, or dients are added by the user may be la-
sodium under labeled amounts are ac- beled as follows:
ceptable within current good manufac- (1) If a product consists of two or
turing practice. more separately packaged ingredients
(7) Compliance will be based on the enclosed in an outer container or of as-
metric measure specified in the label sortments of the same type of food
statement of serving size. (e.g., assorted nuts or candy mixtures)
(8) Compliance with the provisions in the same retail package, nutrition
set forth in paragraphs (g)(1) through labeling shall be located on the outer
(g)(6) of this section may be provided container or retail package (as the case
by use of an FDA approved data base may be) to provide information for the
that has been computed following FDA consumer at the point of purchase.
guideline procedures and where food However, when two or more food prod-
samples have been handled in accord- ucts are simply combined together in
ance with current good manufacturing such a manner that no outer container
practice to prevent nutrition loss. FDA is used, or no outer label is available,
approval of a data base shall not be each product shall have its own nutri-
considered granted until the Center for tion information, e.g., two boxes taped
Food Safety and Applied Nutrition has together or two cans combined in a
agreed to all aspects of the data base in clear plastic overwrap. When sepa-
writing. The approval will be granted rately packaged ingredients or assort-
where a clear need is presented (e.g., ments of the same type of food are in-
raw produce and seafood). Approvals tended to be eaten at the same time,
will be in effect for a limited time, e.g., the nutrition information may be spec-
10 years, and will be eligible for re- ified per serving for each component or
newal in the absence of significant as a composite value.
changes in agricultural or industry (2) If a product consists of two or
practices. Approval requests shall be more separately packaged foods that
submitted in accordance with the pro- are intended to be eaten individually
visions of § 10.30 of this chapter. Guid- and that are enclosed in an outer con-
ance in the use of data bases may be tainer (e.g., variety packs of cereals or
found in the ‘‘FDA Nutrition Labeling snack foods), the nutrition information
Manual—A Guide for Developing and shall:
Using Data Bases,’’ available from the (i) Be specified per serving for each
Office of Nutritional Products, Label- food in a location that is clearly visible
ing and Dietary Supplements (HFS– to the consumer at the point of pur-
800), Center for Food Safety and Ap- chase; and
plied Nutrition, Food and Drug Admin- (ii) Be presented in separate nutri-
istration, 5100 Paint Branch Pkwy., tion labels or in one aggregate nutri-
College Park, MD 20740. tion label with separate columns for
39
§ 101.9 21 CFR Ch. I (4–1–12 Edition)
the quantitative amount by weight and mation under paragraph (h) of this sec-
the percent Daily Value for each food. tion if it is not specifically listed in a
(3) If a package contains a variety of promotional catalogue as being present
foods, or an assortment of foods, and is in the gift package, and:
in a form intended to be used as a gift, (A) It is used in small quantities pri-
the nutrition labeling shall be in the marily to enhance the appearance of
form required by paragraphs (a) the gift package; or
through (f) of this section, but it may (B) It is included in the gift package
be modified as follows: as a free gift or promotional item.
(i) Nutrition information may be pre- (4) If a food is commonly combined
sented on the label of the outer pack- with other ingredients or is cooked or
age or in labeling within or attached to otherwise prepared before eating, and
the outer package. directions for such combination or
(ii) In the absence of a reference preparations are provided, another col-
amount customarily consumed in umn of figures may be used to declare
§ 101.12(b) that is appropriate for the nutrition information on the basis of
variety or assortment of foods in a gift the food as consumed in the format re-
package, 1 ounce for solid foods, 2 fluid quired in paragraph (e) of this section
ounces for nonbeverage liquids (e.g., (e.g., a dry ready-to-eat cereal may be
syrups), and 8 fluid ounces for bev- described with one set of Percent Daily
erages may be used as the standard Values for the cereal as sold (e.g., per
serving size for purposes of nutrition ounce), and another set for the cereal
labeling of foods subject to this para- and milk as suggested in the label (e.g.,
graph. However, the reference amounts per ounce of cereal and 1/2 cup of vita-
customarily consumed in § 101.12(b) min D fortified skim milk); and a cake
shall be used for purposes of evaluating mix may be labeled with one set of Per-
whether individual foods in a gift pack- cent Daily Values for the dry mix (per
age qualify for nutrient content claims serving) and another set for the serving
or health claims. of the final cake when prepared): Pro-
(iii) The number of servings per con- vided, That, the type and quantity of
tainer may be stated as ‘‘varied.’’ the other ingredients to be added to
(iv) Nutrition information may be the product by the user and the specific
provided per serving for individual method of cooking and other prepara-
foods in the package, or, alternatively, tion shall be specified prominently on
as a composite per serving for reason- the label.
able categories of foods in the package (i) Except as provided in paragraphs
having similar dietary uses and similar (j)(13) and (j)(17) of this section, the lo-
significant nutritional characteristics. cation of nutrition information on a
Reasonable categories of foods may be label shall be in compliance with
used only if accepted by FDA. In deter- § 101.2.
mining whether a proposed category is (j) The following foods are exempt
reasonable, FDA will consider whether from this section or are subject to spe-
the values of the characterizing nutri- cial labeling requirements:
ents in the foods proposed to be in the (1)(i) Food offered for sale by a person
category meet the compliance criteria who makes direct sales to consumers
set forth in paragraphs (g)(3) through (e.g., a retailer) who has annual gross
(g)(6) of this section. Proposals for such sales made or business done in sales to
categories may be submitted in writing consumers that is not more than
to the Office of Nutritional Products, $500,000 or has annual gross sales made
Labeling and Dietary Supplements or business done in sales of food to con-
(HFS–800), Center for Food Safety and sumers of not more than $50,000, Pro-
Applied Nutrition, Food and Drug Ad- vided, That the food bears no nutrition
ministration, 5100 Paint Branch Pkwy., claims or other nutrition information
College Park, MD 20740. in any context on the label or in label-
(v) If a food subject to paragraph ing or advertising. Claims or other nu-
(j)(13) of this section because of its trition information subject the food to
small size is contained in a gift pack- the provisions of this section.
age, the food need not be included in (ii) For purposes of this paragraph,
the determination of nutrition infor- calculation of the amount of sales shall
40
be based on the most recent 2-year av- (v) Sold by a distributor who prin-
erage of business activity. Where firms cipally sells food to such facilities: Pro-
have been in business less than 2 years, vided, That:
reasonable estimates must indicate (A) This exemption shall not be
that annual sales will not exceed the available for those foods that are man-
amounts specified. For foreign firms ufactured, processed, or repackaged by
that ship foods into the United States, that distributor for sale to any persons
the business activities to be included other than restaurants or other estab-
shall be the total amount of food sales, lishments that serve food for imme-
as well as other sales to consumers, by diate human consumption, and
the firm in the United States. (B) The manufacturer of such prod-
(2) Food products which are: ucts is responsible for providing the
nutrition information on the products
(i) Served in restaurants, Provided,
if there is a reasonable possibility that
That the food bears no nutrition claims
the product will be purchased directly
or other nutrition information in any by consumers.
context on the label or in labeling or (3) Food products that are:
advertising. Claims or other nutrition (i) Of the type of food described in
information subject the food to the paragraphs (j)(2)(i) and (j)(2)(ii) of this
provisions of this section; section,
(ii) Served in other establishments in (ii) Ready for human consumption,
which food is served for immediate (iii) Offered for sale to consumers but
human consumption (e.g., institutional not for immediate human consump-
food service establishments, such as tion,
schools, hospitals, and cafeterias; (iv) Processed and prepared primarily
transportation carriers, such as trains in a retail establishment, and
and airplanes; bakeries, delicatessens, (v) Not offered for sale outside of
and retail confectionery stores where that establishment (e.g., ready-to-eat
there are facilities for immediate con- foods that are processed and prepared
sumption on the premises; food service on-site and sold by independent deli-
vendors, such as lunch wagons, ice catessens, bakeries, or retail confec-
cream shops, mall cookie counters, tionery stores where there are no fa-
vending machines, and sidewalk carts cilities for immediate human consump-
where foods are generally consumed tion; by in-store delicatessen, bakery,
immediately where purchased or while or candy departments; or at self-serv-
the consumer is walking away, includ- ice food bars such as salad bars), Pro-
ing similar foods sold from convenience vided, That the food bears no nutrition
stores; and food delivery systems or es- claims or other nutrition information
tablishments where ready-to-eat foods in any context on the label or in label-
are delivered to homes or offices), Pro- ing or advertising. Claims or other nu-
trition information subject the food to
vided, That the food bears no nutrition
the provisions of this section.
claims or other nutrition information
(4) Foods that contain insignificant
in any context on the label or in label-
amounts of all of the nutrients and
ing or advertising. Claims or other nu- food components required to be in-
trition information subject the food to cluded in the declaration of nutrition
the provisions of this section; information under paragraph (c) of this
(iii) Sold only in such facilities, Pro- section, Provided, That the food bears
vided, That the food bears no nutrition no nutrition claims or other nutrition
claims or other nutrition information information in any context on the label
in any context on the label or in label- or in labeling or advertising. Claims or
ing or advertising. Claims or other nu- other nutrition information subject the
trition information subject the food to food to the provisions of this section.
the provisions of this section; An insignificant amount of a nutrient
(iv) Used only in such facilities and or food component shall be that
not served to the consumer in the amount that allows a declaration of
package in which they are received zero in nutrition labeling, except that
(e.g., foods that are not packaged in infor total carbohydrate, dietary fiber,
dividual serving containers); or and protein, it shall be an amount that
41
§ 101.9 21 CFR Ch. I (4–1–12 Edition)
allows a declaration of ‘‘less than 1 agement of a disease or condition for

gram.’’ Examples of foods that are ex- which distinctive nutritional require-
empt under this paragraph include cof- ments, based on recognized scientific
fee beans (whole or ground), tea leaves, principles, are established by medical
plain unsweetened instant coffee and evaluation. A food is subject to this ex-
tea, condiment-type dehydrated vege- emption only if:
tables, flavor extracts, and food colors. (i) It is a specially formulated and
(5)(i) Foods, other than infant for- processed product (as opposed to a nat-
mula, represented or purported to be urally occurring foodstuff used in its
specifically for infants and children natural state) for the partial or exclu-
less than 2 years of age shall bear nu- sive feeding of a patient by means of
trition labeling, except as provided in oral intake or enteral feeding by tube;
paragraph (j)(5)(ii) and except that (ii) It is intended for the dietary
such labeling shall not include calories management of a patient who, because
from fat (paragraph (c)(1)(ii) of this of therapeutic or chronic medical
section), calories from saturated fat needs, has limited or impaired capacity
((c)(1)(iii)), saturated fat ((c)(2)(i)), to ingest, digest, absorb, or metabolize
polyunsaturated fat ((c)(2)(ii)), ordinary foodstuffs or certain nutri-
monounsaturated fat ((c)(2)(iii)), and ents, or who has other special medi-
cholesterol ((c)(3)). cally determined nutrient require-
(ii) Foods, other than infant formula, ments, the dietary management of
represented or purported to be specifi- which cannot be achieved by the modi-
cally for infants and children less than fication of the normal diet alone;
4 years of age shall bear nutrition la-
(iii) It provides nutritional support
beling, except that:
specifically modified for the manage-
(A) Such labeling shall not include
ment of the unique nutrient needs that
declarations of percent of Daily Value
result from the specific disease or con-
for total fat, saturated fat, cholesterol,
dition, as determined by medical eval-
sodium, potassium, total carbohydrate,
uation;
and dietary fiber;
(B) Nutrient names and quantitative (iv) It is intended to be used under
amounts by weight shall be presented medical supervision; and
in two separate columns. (v) It is intended only for a patient
(C) The heading ‘‘Percent Daily receiving active and ongoing medical
Value’’ required in paragraph (d)(6) of supervision wherein the patient re-
this section shall be placed imme- quires medical care on a recurring
diately below the quantitative infor- basis for, among other things, instruc-
mation by weight for protein; tions on the use of the medical food.
(D) Percent of Daily Value for pro- (9) Food products shipped in bulk
tein, vitamins, and minerals shall be form that are not for distribution to
listed immediately below the heading consumers in such form and that are
‘‘Percent Daily Value’’; and for use solely in the manufacture of
(E) Such labeling shall not include other foods or that are to be processed,
the footnote specified in paragraph labeled, or repacked at a site other
(d)(9) of this section. than where originally processed or
(6) Dietary supplements, except that packed.
such foods shall be labeled in compli- (10) Raw fruits, vegetables, and fish
ance with § 101.36. subject to section 403(q)(4) of the act,
(7) Infant formula subject to section except that the labeling of such foods
412 of the act, as amended, except that should adhere to guidelines in § 101.45.
such foods shall be labeled in compli- This exemption is contingent on the
ance with part 107 of this chapter. food bearing no nutrition claims or
(8) Medical foods as defined in section other nutrition information in any
5(b) of the Orphan Drug Act (21 U.S.C. context on the label or in labeling or
360ee(b)(3)). A medical food is a food advertising. Claims or other nutrition
which is formulated to be consumed or information subject the food to nutri-
administered enterally under the su- tion labeling in accordance with
pervision of a physician and which is § 101.45. The term fish includes fresh-
intended for the specific dietary man- water or marine fin fish, crustaceans,
42
and mollusks, including shellfish, am- packages that qualify for and use this
phibians, and other forms of aquatic exemption an address or telephone
animal life. number that a consumer can use to ob-
(11) Packaged single-ingredient prod- tain the required nutrition information
ucts that consist of fish or game meat (e.g., ‘‘For nutrition information, call
(i.e., animal products not covered 1–800–123–4567’’).
under the Federal Meat Inspection Act (B) When such products bear nutri-
or the Poultry Products Inspection tion labeling, either voluntarily or be-
Act, such as flesh products from deer, cause nutrition claims or other nutri-
bison, rabbit, quail, wild turkey, or os- tion information is provided, all re-
trich) subject to this section may pro- quired information shall be in type size
vide required nutrition information for no smaller than 6 point or all upper-
a 3-ounce cooked edible portion (i.e., on case type of 1/16 inches minimum
an ‘‘as prepared’’ basis), except that: height, except that individual serving-
(i) Such products that make claims size packages of food served with meals
that are based on values as packaged in restaurants, institutions, and on
must provide nutrition information on board passenger carriers, and not in-
an as packaged basis, and tended for sale at retail, may comply
(ii) Nutrition information is not re- with § 101.2(c)(5).
quired for custom processed fish or (ii) Foods in packages that have a
game meats. total surface area available to bear la-
(12) Game meats (i.e., animal prod- beling of 40 or less square inches may
ucts not covered under the Federal modify the requirements of paragraphs
Meat Inspection Act or the Poultry (c) through (f) and (i) of this section by
Products Inspection Act, such as flesh one or more of the following means:
products from deer, bison, rabbit, (A) Presenting the required nutrition
quail, wild turkey, or ostrich) may pro- information in a tabular or, as pro-
vide required nutrition information on vided below, linear (i.e., string) fashion
labeling in accordance with the provi- rather than in vertical columns if the
sions of paragraph (a)(2) of this section. product has a total surface area avail-
(13)(i) Foods in small packages that able to bear labeling of less than 12
have a total surface area available to square inches, or if the product has a
bear labeling of less than 12 square total surface area available to bear la-
inches, Provided, That the labels for beling of 40 or less square inches and
these foods bear no nutrition claims or the package shape or size cannot ac-
other nutrition information in any commodate a standard vertical column
context on the label or in labeling or or tabular display on any label panel.
advertising. Claims or other nutrition Nutrition information may be given in
information subject the food to the a linear fashion only if the label will
provisions of this section. not accommodate a tabular display.
(A) The manufacturer, packer, or dis- (1) The following sample label illus-
tributor shall provide on the label of trates the tabular display.
43
ER11JY03.004</GPH>
§ 101.9 21 CFR Ch. I (4–1–12 Edition)
(2) The following sample label illus- voluntarily for the nutrient names for
trates the linear display. When nutri- ‘‘Calories,’’ ‘‘Total fat,’’ ‘‘Cholesterol,’’
tion information is given in a linear ‘‘Sodium,’’ ‘‘Total carbohydrate,’’ and
fashion, bolding is required only on the ‘‘Protein.’’
title ‘‘Nutrition Facts‘‘ and is allowed
(B) Using any of the following abbre- (ii) The unit containers are securely
viations: enclosed within and not intended to be
Serving size—Serv size
separated from the retail package
Servings per container—Servings under conditions of retail sale; and
Calories from fat—Fat cal (iii) Each unit container is labeled
Calories from saturated fat—Sat fat cal with the statement ‘‘This Unit Not La-
Saturated fat—Sat fat beled For Retail Sale’’ in type size not
Monounsaturated fat—Monounsat fat less than 1/16-inch in height, except
Polyunsaturated fat—Polyunsat fat that this statement shall not be re-
Cholesterol—Cholest quired when the inner unit containers
Total carbohydrate—Total carb
bear no labeling at all. The word ‘‘in-
Dietary fiber—Fiber
Soluble fiber—Sol fiber
dividual’’ may be used in lieu of or im-
Insoluble fiber—Insol fiber mediately preceding the word ‘‘Retail’’
Sugar alcohol—Sugar alc in the statement.
Other carbohydrate—Other carb (16) Food products sold from bulk
containers: Provided, That nutrition in-
(C) Omitting the footnote required in
formation required by this section be
paragraph (d)(9) of this section and
displayed to consumers either on the
placing another asterisk at the bottom
of the label followed by the statement labeling of the bulk container plainly
‘‘Percent Daily Values are based on a in view or in accordance with the pro-
2,000 calorie diet‘‘ and, if the term visions of paragraph (a)(2) of this sec-
‘‘Daily Value’’ is not spelled out in the tion.
heading, a statement that ‘‘DV’’ rep- (17) Foods in packages that have a
resents ‘‘Daily Value.’’ total surface area available to bear la-
(D) Presenting the required nutrition beling greater than 40 square inches
information on any label panel. but whose principal display panel and
(14) Shell eggs packaged in a carton information panel do not provide suffi-
that has a top lid designed to conform cient space to accommodate all re-
to the shape of the eggs are exempt quired information may use any alter-
from outer carton label requirements nate panel that can be readily seen by
where the required nutrition informa- consumers for the nutrition label. The
tion is clearly presented immediately space needed for vignettes, designs, and
beneath the carton lid or in an insert other nonmandatory label information
that can be clearly seen when the car- on the principal display panel may be
ton is opened. considered in determining the suffi-
(15) The unit containers in a multi- ciency of available space on the prin-
unit retail food package where: cipal display panel for the placement of
(i) The multiunit retail food package the nutrition label. Nonmandatory
labeling contains all nutrition infor- label information on the information
mation in accordance with the require- panel shall not be considered in deter-
ments of this section; mining the sufficiency of available
44
ER11JY03.005</GPH>
space for the placement of the nutri- (iii) If a person claims an exemption
tion label. under paragraphs (j)(18)(i) or (j)(18)(ii)
(18) Food products that are low-vol- of this section for a food product and
ume (that is, they meet the require- then, during the period of such exemp-
ments for units sold in paragraphs tion, the number of full-time equiva-
(j)(18)(i) or (j)(18)(ii) of this section); lent employees of such person exceeds
that, except as provided in paragraph the appropriate number, or the number
(j)(18)(iv) of this section, are the sub- of food products sold in the United
ject of a claim for an exemption that States exceeds the appropriate number,
provides the information required or, if at the end of the period of such
under paragraph (j)(18)(iv) of this sec- exemption, the food product no longer
tion, that is filed before the beginning qualifies for an exemption under the
of the time period for which the exemp- provisions of paragraphs (j)(18)(i) or
tion is claimed, and that is filed by a (j)(18)(ii) of this section, such person
person, whether it is the manufacturer, shall have 18 months from the date
packer, or distributor, that qualifies to that the product was no longer quali-
claim the exemption under the require- fied as a low-volume product of a small
ments for average full-time equivalent business to comply with this section.
employees in paragraphs (j)(18)(i) or (iv) A notice shall be filed with the
(j)(18)(ii) of this section; and whose la- Office of Nutritional Products, Label-
bels, labeling, and advertising do not ing and Dietary Supplements (HFS–
provide nutrition information or make 800), Center for Food Safety and Ap-
a nutrient content or health claim. plied Nutrition, Food and Drug Admin-
(i) For food products first introduced istration, 5100 Paint Branch Pkwy.,
into interstate commerce before May 8, College Park, MD 20740 and contain the
1994, the product shall be exempt for following information, except that if
the period: the person is not an importer and has
(A) Between May 8, 1995, and May 7, fewer than 10 full-time equivalent em-
1996, if, for the period between May 8, ployees, that person does not have to
1994, and May 7, 1995, the person claim- file a notice for any food product with
ing the exemption employed fewer than annual sales of fewer than 10,000 total
an average of 300 full-time equivalent units:
employees and fewer than 400,000 units
(A) Name and address of person re-
of that product were sold in the United
questing exemption. This should in-
States; and
clude a telephone number or FAX num-
(B) Between May 8, 1996, and May 7,
ber that can be used to contact the per-
1997, if for the period between May 8,
son along with the name of a specific
1995, and May 7, 1996, the person claim-
ing the exemption employed fewer than contact;
an average of 200 full-time equivalent (B) Names of the food products (in-
employees and fewer than 200,000 units cluding the various brand names) for
of that product were sold in the United which exemption is claimed;
States. (C) Name and address of the manufac-
(ii) For all other food products, the turer, distributor, or importer of the
product shall be eligible for an exemp- food product for which an exemption is
tion for any 12-month period if, for the claimed, if different than the person
preceding 12 months, the person claim- that is claiming the exemption;
ing the exemption employed fewer than (D) The number of full-time equiva-
an average of 100 full-time equivalent lent employees. Provide the average
employees and fewer than 100,000 units number of full-time equivalent individ-
of that product were sold in the United uals employed by the person and its af-
States, or in the case of a food product filiates for the 12 months preceding the
that was not sold in the 12-month pe- period for which a small business ex-
riod preceding the period for which exemption is claimed for a product. The
emption is claimed, fewer than 100,000 average number of full-time equivalent
units of such product are reasonably employees is to be determined by divid-
anticipated to be sold in the United ing the total number of hours of salary
States during the period for which ex- or wages paid to employees of the per-
emption is claimed. son and its affiliates by the number of
45
§ 101.9 21 CFR Ch. I (4–1–12 Edition)
hours of work in a year, 2,080 hours (B) Food product means food in any
(i.e., 40 hours × 52 weeks); sized package which is manufactured
(E) Approximate total number of by a single manufacturer or which
units of the food product sold by the bears the same brand name, which
person in the United States in the 12- bears the same statement of identity,
month period preceding that for which and which has similar preparation
a small business exemption is claimed. methods.
Provide the approximate total number (C) Person means all domestic and
of units sold, or expected to be sold, in foreign affiliates, as defined in 13 CFR
a 12-month period for each product for 121.401, of the corporation, in the case
which an exemption is claimed. For of a corporation, and all affiliates, as
products that have been in production defined in 13 CFR 121.401, of a firm or
for 1 year or more prior to the period other entity, when referring to a firm
for which exemption is claimed, the 12- or other entity that is not a corpora-
month period is the period imme- tion.
diately preceding the period for which (D) Full-time equivalent employee
an exemption is claimed. For other means all individuals employed by the
products, the 12-month period is the pe- person claiming the exemption. This
riod for which an exemption is claimed; number shall be determined by divid-
and ing the total number of hours of salary
(F) The notice shall be signed by a re- or wages paid directly to employees of
sponsible individual for the person who the person and of all of its affiliates by
can certify the accuracy of the infor- the number of hours of work in a year,
mation presented in the notice. The in- 2,080 hours (i.e., 40 hours×52 weeks).
dividual shall certify that the informa- (k) A food labeled under the provi-
tion contained in the notice is a com- sions of this section shall be deemed to
plete and accurate statement of the av- be misbranded under sections 201(n)
erage number of full-time equivalent and 403(a) of the act if its label or la-
employees of this person and its affili- beling represents, suggests, or implies:
ates and of the number of units of the (1) That the food, because of the pres-
product for which an exemption is ence or absence of certain dietary prop-
claimed sold by the person. The indi- erties, is adequate or effective in the
vidual shall also state that should the prevention, cure, mitigation, or treat-
average number of full-time equivalent ment of any disease or symptom. Infor-
employees or the number of units of mation about the relationship of a die-
food products sold in the United States tary property to a disease or health-re-
by the person exceed the applicable lated condition may only be provided
numbers for the time period for which in conformance with the requirements
exemption is claimed, the person will of § 101.14 and part 101, subpart E.
notify FDA of that fact and the date on (2) That the lack of optimum nutri-
which the number of employees or the tive quality of a food, by reason of the
number of products sold exceeded the soil on which that food was grown, is or
standard. may be responsible for an inadequacy
(v) FDA may by regulation lower the or deficiency in the quality of the daily
employee or units of food products re- diet.
quirements of paragraph (j)(18)(ii) of (3) That the storage, transportation,
this section for any food product first processing, or cooking of a food is or
introduced into interstate commerce may be responsible for an inadequacy
after May 8, 2002, if the agency deter- or deficiency in the quality of the daily
mines that the cost of compliance with diet.
such lower requirement will not place (4) That a natural vitamin in a food
an undue burden on persons subject to is superior to an added or synthetic vi-
it. tamin.
(vi) For the purposes of this para- [58 FR 2175, Jan. 6, 1993]
graph, the following definitions apply: EDITORIAL NOTE: For FEDERAL REGISTER ci-
(A) Unit means the packaging or, if tations affecting § 101.9, see the List of CFR
there is no packaging, the form in Sections Affected, which appears in the
which a food product is offered for sale Finding Aids section of the printed volume
to consumers. and at www.fdsys.gov.
46

CFR-2012-title21-vol2-sec101-9 Carbohidratos Disponibles

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CFR-2012-title21-vol2-sec101-9 Carbohidratos Disponibles

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Food and Drug Administration, HHS § 101.

be consumed at a single-eating occa- changes to the nutrient profile, the

20740, or may be inspected at the Na- as provided in paragraph (d)(5) of this

(A) Required or permitted in a stand- Vitamin D, 400 International Units

Food component Unit of measure- DRV

food in more than insignificant a lot. Unless a particular method of

allows a declaration of ‘‘less than 1 agement of a disease or condition for

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