(a) The general principles and factors that the Food and Drug Administration (FDA) considered in arriving at the reference amounts customarily consumed per eating occasion (reference amounts) which are set forth in paragraph (b) of this section, are that:
(1) FDA calculated the reference amounts for persons 4 years of age or older to reflect the amount of food customarily consumed per eating occasion by persons in this population group. These reference amounts are based on data set forth in appropriate national food consumption surveys.
(2) FDA calculated the reference amounts for an infant or child under 4 years of age to reflect the amount of food customarily consumed per eating occasion by infants up to 12 months of age or by children 1 through 3 years of age, respectively. These reference amounts are based on data set forth in appropriate national food consumption surveys. Such reference amounts are to be used only when the food is specially formulated or processed for use by an infant or by a child under 4 years of age.
(3) An appropriate national food consumption survey includes a large sample size representative of the demographic and socioeconomic characteristics of the relevant population group and must be based on consumption data under actual conditions of use.
(4) To determine the amount of food customarily consumed per eating occasion, FDA considered the mean, median, and mode of the consumed amount per eating occasion.
(5) When survey data were insufficient, FDA took various other sources of information on serving sizes of food into consideration. These other sources of information included:
(i) Serving sizes used in dietary guidance recommendations or recommended by other authoritative systems or organizations;
(ii) Serving sizes recommended in comments;
(iii) Serving sizes used by manufacturers and grocers; and
(iv) Serving sizes used by other countries.
(6) Because they reflect the amount customarily consumed, the reference amount and, in turn, the serving size declared on the product label are based on only the edible portion of food, and not bone, seed, shell, or other inedible components.
(7) The reference amount is based on the major intended use of the food (e.g., milk as a beverage and not as an addition to cereal).
(8) The reference amounts for products that are consumed as an ingredient of other foods, but that may also be consumed in the form in which they are purchased (e.g., butter), are based on use in the form purchased.
(9) FDA sought to ensure that foods that have similar dietary usage, product characteristics, and customarily consumed amounts have a uniform reference amount.
(b) The following reference amounts shall be used as the basis for determining serving sizes for specific products:
Table 1--Reference Amounts Customarily Consumed Per Eating Occasion:
Infant and Toddler Foods \1 2 3 4\------------------------------------------------------------------------
Product category Reference amount Label statement \5\------------------------------------------------------------------------Cereals, dry instant........... 15 g............ -- cup (-- g)Cereals, prepared, ready-to- 110 g........... -- cup(s) (-- g)
serve.Other cereal and grain 7 g for infants -- cup(s) (-- g) for
products, dry ready-to-eat, and 20 g for ready-to-eat
e.g., ready-to-eat cereals, toddlers for cereals; -- piece(s)
cookies, teething biscuits, ready-to-eat (-- g) for others
and toasts. cereals; 7 g
for all others.Dinners, desserts, fruits, 15 g............ -- tbsp(s) (-- g); --
vegetables or soups, dry mix. cup(s) (-- g)Dinners, desserts, fruits, 110 g........... -- cup(s) (-- g); --
vegetables or soups, ready-to- cup(s) (-- mL)
serve, junior type.Dinners, desserts, fruits, 60 g............ -- cup(s) (-- g); --
vegetables or soups, ready-to- cup(s) (-- mL)
serve, strained type.Dinners, stews or soups for 170 g........... -- cup(s) (-- g); --
toddlers, ready-to-serve. cup(s) (-- mL)Fruits for toddlers, ready-to- 125 g........... -- cup(s) (-- g)
serve.Vegetables for toddlers, ready- 70 g............ -- cup(s) (-- g)
to- serve.Eggs/egg yolks, ready-to-serve. 55 g............ -- cup(s) (-- g)Juices, all varieties.......... 120 mL.......... 4 fl oz (120 mL)------------------------------------------------------------------------\1\ These values represent the amount of food customarily consumed per
eating occasion and were primarily derived from the 1977-1978 and the
1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
Department of Agriculture.\2\ Unless otherwise noted in the Reference amount column, the reference
amounts are for the ready-to-serve or almost ready-to-serve form of
the product (i.e., heat and serve, brown and serve). If not listed
separately, the reference amount for the unprepared form (e.g., dry
cereal) is the amount required to make the reference amount of the
prepared form. Prepared means prepared for consumption (e.g., cooked).\3\ Manufacturers are required to convert the reference amount to the
label serving size in a household measure most appropriate to their
specific product using the procedures in 21 CFR 101.9(b).\4\Copies of the list of products for each product category are
available from the Office of Nutritional Products, Labeling and
Dietary Supplements (HFS-800), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740.\5\ The label statements are meant to provide guidance to manufacturers
on the presentation of serving size information on the label, but they
are not required. The term ``piece'' is used as a generic description
of a discrete unit. Manufacturers should use the description of a unit
that is most appropriate for the specific product (e.g., sandwich for
sandwiches, cookie for cookies, and bar for frozen novelties).
Table 2--Reference Amounts Customarily Consumed Per Eating Occasion:
General Food Supply \1 2 3 4\------------------------------------------------------------------------
Product category Reference amount Label statement\5\------------------------------------------------------------------------Bakery products:
Biscuits, croissants, 55 g............ -- piece(s) (-- g)
bagels, tortillas, soft
bread sticks, soft
pretzels, corn bread, hush
puppies.
Breads (excluding sweet 50 g............ -- piece(s) (-- g)
quick type), rolls. for sliced bread and
distinct pieces
(e.g., rolls); 2 oz
(56 g/-- inch slice)
for unsliced bread
Bread sticks--see crackers. ................ .....................
Toaster pastries--see ................ .....................
coffee cakes.
Brownies................... 40 g............ -- piece(s) (-- g)
for distinct pieces;
fractional slice (--
g) for bulk
Cakes, heavy weight (cheese 125 g........... -- piece(s) (-- g)
cake; pineapple upside- for distinct pieces
down cake; fruit, nut, and (e.g., sliced or
vegetable cakes with more individually
than or equal to 35 packaged products);
percent of the finished -- fractional slice
weight as fruit, nuts, or (-- g) for large
vegetables or any of these discrete units
combined) \6\.
Cakes, medium weight 80 g............ -- piece(s) (-- g)
(chemically leavened cake for distinct pieces
with or without icing or (e.g., cupcake); --
filling except those fractional slice (--
classified as light weight g) for large
cake; fruit, nut, and discrete units
vegetable cake with less
than 35 percent of the
finished weight as fruit,
nuts, or vegetables or any
of these combined; light
weight cake with icing;
Boston cream pie; cupcake;
eclair; cream puff) \7\.
Cakes, light weight (angel 55 g............ -- piece(s) (-- g)
food, chiffon, or sponge for distinct pieces
cake without icing or (e.g., sliced or
filling) \8\. individually
packaged products);
-- fractional slice
(-- g) for large
discrete units
Coffee cakes, crumb cakes, 55 g............ -- piece(s) (-- g)
doughnuts, Danish, sweet for sliced bread and
rolls, sweet quick type distinct pieces
breads, muffins, toaster (e.g., doughnut); 2
pastries. oz (56 g/visual unit
of measure) for bulk
products (e.g.,
unsliced bread)
Cookies.................... 30 g............ -- piece(s) (-- g)
Crackers that are usually 15 g............ -- piece(s) (-- g)
not used as snack, melba
toast, hard bread sticks,
ice cream cones \9\.
Crackers that are usually 30 g............ -- piece(s) (-- g)
used as snacks.
Croutons................... 7 g............. -- tbsp(s) (-- g); --
cup(s) (-- g); --
piece(s) (-- g) for
large pieces
French toast, pancakes, 110 g prepared -- piece(s) (-- g); --
variety mixes. for french cup(s) (-- g) for
toast and dry mix
pancakes; 40 g
dry mix for
variety mixes.
Grain-based bars with or 40 g............ -- piece(s) (-- g)
without filling or
coating, e.g., breakfast
bars, granola bars, rice
cereal bars.
Ice cream cones--see ................ .....................
crackers.
Pies, cobblers, fruit 125 g........... -- piece(s) (--g) for
crisps, turnovers, other distinct pieces; --
pastries. fractional slice (--
g) for large
discrete units
Pie crust.................. 1/6 of 8 inch 1/6 of 8 inch crust
crust; \1/8\ of (-- g); \1/8\ of 9
9 inch crust. inch crust (-- g)
Pizza crust................ 55 g............ -- fractional slice
(-- g)
Taco shells, hard.......... 30 g............ -- shell(s) (-- g)
Waffles.................... 85 g............ -- piece(s) (-- g)Beverages:
Carbonated and 240 mL.......... 8 fl oz (240 mL)
noncarbonated beverages,
wine coolers, water.
Coffee or tea, flavored and 240 mL prepared. 8 fl oz (240 mL)
sweetened.Cereal and Other Grain
Products:
Breakfast cereals (hot 1 cup prepared; -- cup(s) (-- g)
cereal type), hominy grits. 40 g plain dry
cereal; 55 g
flavored,
sweetened dry
cereal.
Breakfast cereals, ready-to- 15 g............ -- cup(s) (-- g)
eat, weighing less than 20
g per cup, e.g., plain
puffed cereal grains.
Breakfast cereals, ready-to- 30 g............ -- cup(s) (-- g)
eat weighing 20 g or more
but less than 43 g per
cup; high fiber cereals
containing 28 g or more of
fiber per 100 g.
Breakfast cereals, ready-to- 55 g............ -- piece(s) (-- g)
eat, weighing 43 g or more for large distinct
per cup; biscuit types. pieces (e.g.,
biscuit type);--
cup(s) (-- g) for
all others
Bran or wheat germ......... 15 g............ -- tbsp(s) (-- g); --
cup(s) (-- g)
Flours or cornmeal......... 30 g............ -- tbsp(s) (-- g); --
cup(s) (-- g)
Grains, e.g., rice, barley, 140 g prepared; -- cup(s) (-- g)
plain. 45 g dry.
Pastas, plain.............. 140 g prepared; -- cup(s) (-- g); --
55 g dry. piece(s) (-- g) for
large pieces (e.g.,
large shells or
lasagna noodles) or
2 oz (56 g/visual
unit of measure) for
dry bulk products
(e.g., spaghetti)
Pastas, dry, ready-to-eat, 25 g............ -- cup(s) (-- g)
e.g., fried canned chow
mein noodles.
Starches, e.g., cornstarch, 10 g............ -- tbsp (-- g)
potato starch, tapioca,
etc..
Stuffing................... 100 g........... -- cup(s) (-- g)Dairy Products and Substitutes:
Cheese, cottage............ 110 g........... -- cup (-- g)
Cheese used primarily as 55 g............ -- cup (-- g)
ingredients, e.g., dry
cottage cheese, ricotta
cheese.
Cheese, grated hard, e.g., 5 g............. -- tbsp (-- g)
Parmesan, Romano.
Cheese, all others except 30 g............ -- piece(s) (-- g)
those listed as separate for distinct
categories--includes cream pieces;-- tbsp(s) (--
cheese and cheese spread. g) for cream cheese
and cheese spread; 1
oz (28 g/visual unit
of measure) for bulk
Cheese sauce--see sauce
category.
Cream or cream substitutes, 15 mL........... 1 tbsp (15 mL)
fluid.
Cream or cream substitutes, 2 g............. -- tsp (-- g)
powder.
Cream, half & half......... 30 mL........... 2 tbsp (30 mL)
Eggnog..................... 120 mL.......... 1/2 cup (120 mL); 4
fl oz (120 mL)
Milk, condensed, undiluted. 30 mL........... 2 tbsp (30 mL)
Milk, evaporated, undiluted 30 mL........... 2 tbsp (30 mL)
Milk, milk-based drinks, 240 mL.......... 1 cup (240 mL); 8 fl
e.g., instant breakfast, oz (240 mL)
meal replacement, cocoa.
Shakes or shake 240 mL.......... 1 cup (240 mL); 8 fl
substitutes, e.g., dairy oz (240 mL)
shake mixes, fruit frost
mixes.
Sour cream................. 30 g............ -- tbsp (-- g)
Yogurt..................... 225 g........... -- cup (-- g)
Desserts:
Ice cream, ice milk, frozen 1/2 cup-includes -- piece(s) (-- g)
yogurt, sherbet: all the volume for for individually
types, bulk and novelties coatings and wrapped or packaged
(e.g., bars, sandwiches, wafers for the products; \1/2\ cup
cones). novelty type (-- g) for others
varieties.
Frozen flavored and 85 g............ -- piece(s) (-- g)
sweetened ice and pops, for individually
frozen fruit juices: all wrapped or packaged
types, bulk and novelties products; -- cup(s)
(e.g., bars, cups). (-- g) for others
Sundae..................... 1 cup........... 1 cup (-- g)
Custards, gelatin or 1/2 cup......... -- piece(s) (-- g)
pudding. for distinct unit
(e.g., individually
packaged products);
\1/2\ cup (-- g) for
bulkDessert Toppings and Fillings:
Cake frostings or icings... 35 g............ -- tbsp(s) (-- g)
Other dessert toppings, 2 tbsp.......... 2 tbsp (-- g); 2 tbsp
e.g., fruits, syrups, (30 mL)
spreads, marshmallow
cream, nuts, dairy and
nondairy whipped toppings.
Pie fillings............... 85 g............ -- cup(s) (-- g)Egg and Egg Sustitutes:
Egg mixtures, e.g., egg foo 110 g........... -- piece(s) (-- g)
young, scrambled eggs, for discrete pieces;
omelets. -- cup(s) (-- g)
Eggs (all sizes) \9\....... 50 g............ 1 large, medium, etc.
(-- g)
Egg substitutes............ An amount to -- cup(s) (-- g); --
make 1 large cup(s) (-- mL)
(50 g) egg.Fats and Oils:
Butter, margarine, oil, 1 tbsp.......... 1 tbsp (-- g); 1 tbsp
shortening. (15 mL)
Butter replacement, powder. 2 g............. -- tsp(s) (-- g)
Dressings for salads....... 30 g............ -- tbsp (-- g); --
tbsp (-- mL)
Mayonnaise, sandwich 15 g............ -- tbsp (-- g)
spreads, mayonnaise-type
dressings.
Spray types................ 0.25 g.......... About -- seconds
spray (-- g)Fish, Shellfish, Game Meats
\10\, and Meat or Poultry
Substitutes:
Bacon substitutes, canned 15 g............ -- piece(s) (-- g)
anchovies, \11\ anchovy for discrete pieces;
pastes, caviar. -- tbsp(s) (-- g)
for others
Dried, e.g., jerky......... 30 g............ -- piece(s) (-- g)
Entrees with sauce, e.g., 140 g cooked.... -- cup(s) (-- g); 5
fish with cream sauce, oz (140 g/visual
shrimp with lobster sauce. unit of measure) if
not measurable by
cup
Entrees without sauce, 85 g cooked; 110 -- piece(s) (-- g)
e.g., plain or fried fish g uncooked \12\. for discrete pieces;
and shellfish, fish and -- cup(s) (-- g); --
shellfish cake. oz (-- g/visual unit
of measure) if not
measurable by cup
\13\
Fish, shellfish or game 55 g............ -- piece(s) (-- g)
meat \10\, canned \11\. for discrete pieces;
-- cup(s) (-- g); 2
oz (56 g/-- cup) for
products that are
difficult to measure
the g weight of cup
measure (e.g.,
tuna); 2 oz (56 g/--
pieces) for products
that naturally vary
in size (e.g.,
sardines)
Substitute for luncheon 55 g............ -- piece(s) (-- g)
meat, meat spreads, for distinct pieces
Canadian bacon, sausages (e.g., slices,
and frankfurters. links); -- cup(s) (--
g); 2 oz (56 g/
visual unit of
measure) for
nondiscrete bulk
product
Smoked or pickled \11\ 55 g............ -- piece(s) (-- g)
fish, shellfish, or game for distinct pieces
meat \10\; fish or (e.g., slices,
shellfish spread. links) or -- cup(s)
(-- g); 2 oz (56 g/
visual unit of
measure) for
nondiscrete bulk
product
Substitutes for bacon bits--
see miscellaneous category.Fruits and Fruit Juices:
Candied or pickled \11\.... 30 g............ -- piece(s) (-- g)
Dehydrated fruits--see ................ .....................
snacks category.
Dried...................... 40 g............ -- piece(s) (-- g)
for large pieces
(e.g., dates, figs,
prunes); -- cup(s)
(-- g) for small
pieces (e.g.,
raisins)
Fruits for garnish or 4 g............. 1 cherry (-- g)
flavor, e.g., maraschino
cherries \11\.
Fruit relishes, e.g., 70 g............ -- cup(s) (-- g)
cranberry sauce, cranberry
relish.
Fruits used primarily as 30 g............ See footnote 13
ingredients, avocado.
Fruits used primarily as 55 g............ -- piece(s) (-- g)
ingredients, others for large fruits; --
(cranberries, lemon, lime). cup(s) (-- g) for
small fruits
measurable by cup
\13\
Watermelon................. 280 g........... See footnote 13
All other fruits (except 140 g........... -- piece(s) (-- g)
those listed as separate for large pieces
categories), fresh, (e.g., strawberries,
canned, or frozen. prunes, apricots,
etc.); -- cup(s) (--
g) for small pieces
(e.g., blueberries,
raspberries, etc.)
\13\
Juices, nectars, fruit 240 mL.......... 8 fl oz (240 mL)
drinks.
Juices used as ingredients, 5 mL............ 1 tsp (5 mL)
e.g., lemon juice, lime
juice.Legumes:
Bean cake (tofu) \11\, 85 g............ -- piece(s) (-- g)
tempeh. for discrete pieces;
3 oz (84 g/visual
unit of measure) for
bulk products
Beans, plain or in sauce... 130 g for beans -- cup (-- g)
in sauce or
canned in
liquid and
refried beans
prepared; 90 g
for others
prepared; 35 g
dry.Miscellaneous Category:
Baking powder, baking soda, 0.6 g........... -- tsp (-- g)
pectin.
Baking decorations, e.g., 1 tsp or 4 g if -- piece(s) (-- g)
colored sugars and not measurable for discrete pieces;
sprinkles for cookies, by teaspoon. 1 tsp (-- g)
cake decorations.
Batter mixes, bread crumbs. 30 g............ -- tbsp(s) (-- g);--
cup(s) (-- g)
Cooking wine............... 30 mL........... 2 tbsp (30 mL)
Dietary supplements........ The maximum -- tablet(s), --
amount capsule(s), --
recommended, as packet(s), -- tsp(s)
appropriate, on (-- g), etc.
the label for
consumption per
eating
occasion, or,
in the absence
of
recommendations
, 1 unit, e.g.,
tablet,
capsule,
packet,
teaspoonsful,
etc..
Drink mixers (without Amount to make -- fl oz (-- mL)
alcohol). 240 mL drink
(without ice).
Chewing gum \9\............ 3 g............. -- piece(s) (-- g)
Meat, poultry and fish Amount to make -- tsp(s) (-- g); --
coating mixes, dry; one reference tbsp(s) (-- g)
seasoning mixes, dry, amount of final
e.g., chili seasoning dish.
mixes, pasta salad
seasoning mixes.
Salad and potato toppers, 7 g............. -- tbsp(s) (-- g)
e.g., salad crunchies,
salad crispins,
substitutes for bacon bits.
Salt, salt substitutes, 1/4 tsp......... 1/4 tsp (--g); --
seasoning salts (e.g., piece(s) (--g) for
garlic salt). discrete pieces
(e.g., individually
packaged products)
Spices, herbs (other than 1/4 tsp or 0.5 g 1/4 tsp (-- g); --
dietary supplements). if not piece(s) (-- g) if
measurable by not measurable by
teaspoon. teaspoons (e.g., bay
leaf)Mixed Dishes:
Measurable with cup, e.g., 1 cup........... 1 cup (-- g)
casseroles, hash, macaroni
and cheese, pot pies,
spaghetti with sauce,
stews, etc..
Not measurable with cup, 140 g, add 55 g -- piece(s) (-- g)
e.g., burritos, egg rolls, for products for discrete pieces;
enchiladas, pizza, pizza with gravy or -- fractional slice
rolls, quiche, all types sauce topping, (-- g) for large
of sandwiches. e.g., enchilada discrete units
with cheese
sauce, crepe
with white
sauce \14\.
Nuts and Seeds:
Nuts, seeds, and mixtures, 30 g............ -- piece(s) (-- g)
all types: sliced, for large pieces
chopped, slivered, and (e.g., unshelled
whole. nuts);-- tbsp(s) (--
g) ;-- cup(s) (-- g)
for small pieces
(e.g., peanuts,
sunflower seeds)
Nut and seed butters, 2 tbsp.......... 2 tbsp (-- g)
pastes, or creams.
Coconut, nut and seed 15 g............ -- tbsp(s) (-- g); --
flours. cup (-- g)Potatoes and Sweet Potatoes/
Yams:
French fries, hash browns, 70 g prepared; -- piece(s) (-- g)
skins, or pancakes. 85 g for frozen for large distinct
unprepared pieces (e.g.,
french fries. patties, skins); 2.5
oz (70 g/-- pieces)
for prepared fries;
3 oz (84 g/--
pieces) for
unprepared fries
Mashed, candied, stuffed, 140 g........... -- piece(s) (-- g)
or with sauce. for discrete pieces
(e.g., stuffed
potato); -- cup(s)
(-- g)
Plain, fresh, canned, or 110 g for fresh -- piece(s) (-- g)
frozen. or frozen; 125 for discrete
g for vacuum pieces;-- cup(s) (--
packed; 160 g g) for sliced or
for canned in chopped products
liquid.Salads:
Gelatin salad.............. 120 g........... -- cup (-- g)
Pasta or potato salad...... 140 g........... -- cup(s) (-- g)
All other salads, e.g., 100 g........... -- cup(s) (-- g)
egg, fish, shellfish,
bean, fruit, or vegetable
salads.Sauces, Dips, Gravies and
Condiments:
Barbecue sauce, hollandaise 2 tbsp.......... 2 tbsp (-- g); 2 tbsp
sauce, tartar sauce, other (30 mL)
sauces for dipping (e.g.,
mustard sauce, sweet and
sour sauce), all dips
(e.g., bean dips, dairy-
based dips, salsa).
Major main entree sauces, 125 g........... -- cup (-- g); -- cup
e.g., spaghetti sauce. (-- mL)
Minor main entree sauces 1/4 cup......... 1/4 cup (-- g); \1/4\
(e.g., pizza sauce, pesto cup (60 mL)
sauce), other sauces used
as toppings (e.g., gravy,
white sauce, cheese
sauce), cocktail sauce.
Major condiments, e.g., 1 tbsp.......... 1 tbsp (-- g); 1 tbsp
catsup, steak sauce, soy (15 mL)
sauce, vinegar, teriyaki
sauce, marinades.
Minor condiments, e.g., 1 tsp........... 1 tsp (-- g); 1 tsp
horseradish, hot sauces, (5 mL)
mustards, worcestershire
sauce.Snacks:
All varieties, chips, 30 g............ -- cup(s) (-- g) for
pretzels, popcorns, small pieces (e.g.,
extruded snacks, fruit- popcorn) -- piece(s)
based snacks (e.g., fruit (-- g) for large
chips,) grain-based snack pieces (e.g., large
mixes. pretzels; pressed
dried fruit sheet);
1 oz (28 g/visual
unit of measure) for
bulk products (e.g.,
potato chips)Soups:
All varieties.............. 245 g........... -- cup (-- g); -- cup
(-- mL)Sugars and Sweets:
Baking candies (e.g., 15 g............ -- piece(s) (-- g)
chips). for large pieces; --
tbsp(s) (-- g) for
small pieces; \1/2\
oz (14 g/visual unit
of measure) for bulk
products
Hard candies, breath mints. 2 g............. -- piece(s) (-- g)
Hard candies, roll-type, 5 g............. -- piece(s) (-- g)
mini-size in dispenser
packages.
Hard candies, others....... 15 g............ -- piece(s) (-- g)
for large pieces;--
tbsp(s) (-- g) for
``mini-size''
candies measurable
by tablespoon; \1/2\
oz (14 g/visual unit
of measure) for bulk
products
All other candies.......... 40 g............ -- piece(s) (-- g);
1\1/2\ oz (42 g/
visual unit of
measure) for bulk
products
Confectioner's sugar....... 30 g............ -- cup (-- g)
Honey, jams, jellies, fruit 1 tbsp.......... 1 tbsp (-- g); 1 tbsp
butter, molasses. (15 mL)
Marshmallows............... 30 g............ -- cup(s) (-- g) for
small pieces; --
piece(s) (-- g) for
large pieces
Sugar...................... 4 g............. -- tsp (-- g) ; --
piece(s) (-- g) for
discrete pieces
(e.g., sugar cubes,
individually
packaged products)
Sugar substitutes.......... An amount -- tsp(s) (-- g) for
equivalent to solids; -- drop(s)
one reference (-- g) for liquid; --
amount for piece(s) (-- g)
sugar in (e.g., individually
sweetness. packaged products)
Syrups..................... 30 mL for syrups 2 tbsp (30 mL) for
used primarily syrups used
as an primarily as an
ingredient ingredient; \1/4\
(e.g., light or cup (60 mL) for all
dark corn others
syrup); 60 mL
for all others.Vegetables:
Vegetables primarily used 4 g............. -- piece(s) (-- g); --
for garnish or flavor, tbsp(s) (-- g) for
e.g., pimento, parsley. chopped products
Chili pepper, green onion.. 30 g............ -- piece(s) (-- g)
\13\; -- tbsp(s) (--
g); -- cup(s) (-- g)
for sliced or
chopped products
All other vegetables 85 g for fresh -- piece(s) (-- g)
without sauce: fresh, or frozen; 95 g for large pieces
canned, or frozen. for vacuum (e.g., brussel
packed; 130 g sprouts); -- cup(s)
for canned in (-- g) for small
liquid, cream- pieces (e.g., cut
style corn, corn, green peas); 3
canned or oz (84 g/visual unit
stewed of measure) if not
tomatoes, measurable by cup
pumpkin, or \13\
winter squash.
All other vegetables with 110 g........... -- piece(s) (-- g)
sauce: fresh, canned, or for large pieces
frozen. (e.g., brussel
sprouts); -- cup(s)
(-- g) for small
pieces (e.g., cut
corn, green peas); 4
oz (112 g/visual
unit of measure) if
not measurable by
cup
Vegetable juice............ 240 mL.......... 8 fl oz (240 mL)
Olives \11\................ 15 g............ -- piece(s) (-- g); --
tbsp(s) (-- g) for
sliced products
Pickles, all types \11\.... 30 g............ 1 oz (28 g/visual
unit of measure)
Pickle relishes............ 15 g............ -- tbsp (-- g)
Vegetable pastes, e.g., 30 g............ -- tbsp (-- g)
tomato paste.
Vegetable sauces or purees, 60 g............ -- cup (-- g); -- cup
e.g, tomato sauce, tomato (-- mL)
puree.------------------------------------------------------------------------\1\ These values represent the amount (edible portion) of food
customarily consumed per eating occasion and were primarily derived
from the 1977-1978 and the 1987-1988 Nationwide Food Consumption
Surveys conducted by the U.S. Department of Argiculture.\2\ Unless otherwise noted in the Reference Amount column, the reference
amounts are for the ready-to-serve or almost ready-to-serve form of
the product (i.e., heat and serve, brown and serve). If not listed
separately, the reference amount for the unprepared form (e.g., dry
mixes; concentrates; dough; batter; fresh and frozen pasta) is the
amount required to make the reference amount of the prepared form.
Prepared means prepared for consumption (e.g., cooked).\3\ Manufacturers are required to convert the reference amount to the
label serving size in a household measure most appropriate to their
specific product using the procedures in 21 CFR 101.9(b).\4\ Copies of the list of products for each product category are
available from the Office of Nutritional Products, Labeling and
Dietary Supplements (HFS-800), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740.\5\ The label statements are meant to provide guidance to manufacturers
on the presentation of serving size information on the label, but they
are not required. The term ``piece'' is used as a generic description
of a discrete unit. Manufacturers should use the description of a unit
that is most appropriate for the specific product (e.g., sandwich for
sandwiches, cookie for cookies, and bar for ice cream bars). The
guidance provided is for the label statement of products in ready-to-
serve or almost ready-to-serve form. The guidance does not apply to
the products which require further preparation for consumption (e.g.,
dry mixes, concentrates) unless specifically stated in the product
category, reference amount, or label statement column that it is for
these forms of the product. For products that require further
preparation, manufacturers must determine the label statement
following the rules in Sec. 101.9(b) using the reference amount
determined according to Sec. 101.12(c).\6\ Includes cakes that weigh 10 g or more per cubic inch.\7\ Includes cakes that weigh 4 g or more per cubic inch but less than
10 g per cubic inch.\8\ Includes cakes that weigh less than 4 g per cubic inch.\9\ Label serving size for ice cream cones and eggs of all sizes will be
1 unit. Label serving size of all chewing gums that weigh more than
the reference amount that can reasonably be consumed at a single-
eating occasion will be 1 unit.\10\ Animal products not covered under the Federal Meat Inspection Act
or the Poultry Products Inspection Act, such as flesh products from
deer, bison, rabbit, quail, wild turkey, geese, ostrich, etc.\11\ If packed or canned in liquid, the reference amount is for the
drained solids, except for products in which both the solids and
liquids are customarily consumed (e.g., canned chopped clam in juice).\12\ The reference amount for the uncooked form does not apply to raw
fish in Sec. 101.45 or to single-ingredient products that consist of
fish or game meat as provided for in Sec. 101.9(b)(j)(11).\13\ For raw fruit, vegetables, and fish, manufacturers should follow
the label statement for the serving size specified in Appendices A and
B to the regulation entitled ``Food Labeling; Guidelines for Voluntary
Nutrition Labeling; and Identification of the 20 Most Frequently
Consumed Raw Fruits, Vegetables, and Fish; Definition of Substantial
Compliance; Correction'' (56 FR 60880 as amended 57 FR 8174, March 6,
1992).\14\ Pizza sauce is part of the pizza and is not considered to be sauce
topping.
(c) If a product requires further preparation, e.g., cooking or the addition of water or other ingredients, and if paragraph (b) of this section provides a reference amount for the product in the prepared but not the unprepared form, then the reference amount for the unprepared product shall be determined using the following rules:
(1) Except as provided for in paragraph (c)(2) of this section, the reference amount for the unprepared product shall be the amount of the unprepared product required to make the reference amount for the prepared product as established in paragraph (b) of this section.
(2) For products where the entire contents of the package is used to prepare one large discrete unit usually divided for consumption, the reference amount for the unprepared product shall be the amount of the unprepared product required to make the fraction of the large discrete unit closest to the reference amount for the prepared product as established in paragraph (b) of this section.
(d) The reference amount for an imitation or substitute food or altered food, such as a ``low calorie'' version, shall be the same as for the food for which it is offered as a substitute.
(e) If a food is modified by incorporating air (aerated), and thereby the density of the food is lowered by 25 percent or more in weight than that of an appropriate reference regular food as described in Sec. 101.13(j)(1)(ii)(A), and the reference amount of the regular food is in grams, the manufacturer may determine the reference amount of the aerated food by adjusting for the difference in density of the aerated food relative to the density of the appropriate reference food provided that the manufacturer will show FDA detailed protocol and records of all data that were used to determine the density-adjusted reference amount for the aerated food. The reference amount for the aerated food shall be rounded to the nearest 5-g increment. Such products shall bear a descriptive term indicating that extra air has been incorporated (e.g., whipped, aerated). The density-adjusted reference amounts described in paragraph (b) of this section may not be used for cakes except for cheese cake. The differences in the densities of different types of cakes having different degrees of air incorporation have already been taken into consideration in determining the reference amounts for cakes in Sec. 101.12(b). In determining the difference in density of the aerated and the regular food, the manufacturer shall adhere to the following:
(1) The regular and the aerated product must be the same in size, shape, and volume. To compare the densities of products having nonsmooth surfaces (e.g., waffles), manufacturers shall use a device or method that ensures that the volumes of the regular and the aerated products are the same.
(2) Sample selections for the density measurements shall be done in accordance with the provisions in Sec. 101.9(g).
(3) Density measurements of the regular and the aerated products shall be conducted by the same trained operator using the same methodology (e.g., the same equipment, procedures, and techniques) under the same conditions.
(4) Density measurements shall be replicated a sufficient number of times to ensure that the average of the measurements is representative of the true differences in the densities of the regular and the ``aerated'' products.
(f) For products that have no reference amount listed in paragraph (b) of this section for the unprepared or the prepared form of the product and that consist of two or more foods packaged and presented to be consumed together (e.g., peanut putter and jelly, cracker and cheese pack, pancakes and syrup, cake and frosting), the reference amount for the combined product shall be determined using the following rules:
(1) For bulk products (e.g., peanut butter and jelly), the reference amount for the combined product shall be the reference amount, as established in paragraph (b) of this section, for the ingredient that is represented as the main ingredient plus proportioned amounts of all minor ingredients.
(2) For products where the ingredient represented as the main ingredient is one or more discrete units (e.g., cracker and cheese pack, pancakes and syrup, cake and frosting), the reference amount for the combined product shall be either the number of small discrete units or the fraction of the large discrete unit that is represented as the main ingredient that is closest to the reference amount for that ingredient as established in paragraph (b) of this section plus proportioned amounts of all minor ingredients.
(3) If the reference amounts are in compatible units, they shall be summed (e.g., the reference amount for equal volumes of peanut butter and jelly for which peanut butter is represented as the main ingredient would be 4 tablespoons (tbsp) (2 tbsp peanut butter plus 2 tbsp jelly). If the reference amounts are in incompatible units, the weights of the appropriate volumes should be used (e.g., 110 grams (g) pancakes plus the gram weight of the proportioned amount of syrup).
(g) The reference amounts set forth in paragraphs (b) through (f) of this section shall be used in determining whether a product meets the criteria for nutrient content claims, such as ``low calorie,'' and for health claims. If the serving size declared on the product label differs from the reference amount, and the product meets the criteria for the claim only on the basis of the reference amount, the claim shall be followed by a statement that sets forth the basis on which the claim is made. That statement shall include the reference amount as it appears in paragraph (b) of this section followed, in parenthesis, by the amount in common household measure if the reference amount is expressed in measures other than common household measures (e.g., for a beverage, ``Very low sodium, 35 mg or less per 240 mL (8 fl oz)'').
(h) The Commissioner of Food and Drugs, either on his or her own initiative or in response to a petition submitted pursuant to part 10 of this chapter, may issue a proposal to establish or amend a reference amount in paragraph (b) of this section. A petition to establish or amend a reference amount shall include:
(1) Objective of the petition;
(2) A description of the product;
(3) A complete sample product label including nutrition label, using the format established by regulation;
(4) A description of the form (e.g., dry mix, frozen dough) in which the product will be marketed;
(5) The intended dietary uses of the product with the major use identified (e.g., milk as a beverage and chips as a snack);
(6) If the intended use is primarily as an ingredient in other foods, list of foods or food categories in which the product will be used as an ingredient with information on the prioritization of the use;
(7) The population group for which the product will be offered for use (e.g., infants, children under 4 years of age);
(8) The names of the most closely related products (or in the case of foods for special dietary use and imitation or substitute foods, the names of the products for which they are offered as substitutes);
(9) The suggested reference amount (the amount of edible portion of food as consumed, excluding bone, seed, shell, or other inedible components) for the population group for which the product is intended with full description of the methodology and procedures that were used to determine the suggested reference amount. In determining the reference amount, general principles and factors in paragraph (a) of this section should be followed.
(10) The suggested reference amount shall be expressed in metric units. Reference amounts for fluids shall be expressed in milliliters. Reference amounts for other foods shall be expressed in grams except when common household units such as cups, tablespoons, and teaspoons, are more appropriate or are more likely to promote uniformity in serving sizes declared on product labels. For example, common household measures would be more appropriate if products within the same category differ substantially in density, such as frozen desserts.
(i) In expressing the reference amounts in milliliters, the following rules shall be followed:
(A) For volumes greater than 30 milliliters (mL), the volume shall be expressed in multiples of 30 mL.
(B) For volumes less than 30 mL, the volume shall be expressed in milliliters equivalent to a whole number of teaspoons or 1 tbsp, i.e., 5, 10, or 15 mL.
(ii) In expressing the reference amounts in grams, the following general rules shall be followed:
(A) For quantities greater than 10 g, the quantity shall be expressed in the nearest 5-g increment.
(B) For quantities less than 10 g, exact gram weights shall be used.
(11) A petition to create a new subcategory of food with its own reference amount shall include the following additional information:
(i) Data that demonstrate that the new subcategory of food will be consumed in amounts that differ enough from the reference amount for the parent category to warrant a separate reference amount. Data must include sample size; and the mean, standard deviation, median, and modal consumed amount per eating occasion for the petitioned product and for other products in the category, excluding the petitioned product. All data must be derived from the same survey data.
(ii) Documentation supporting the difference in dietary usage and product characteristics that affect the consumption size that distinguishes the petitioned product from the rest of the products in the category.
(12) A claim for categorical exclusion under Sec. 25.30 or Sec. 25.32 of this chapter or an environmental assessment under Sec. 25.40 of this chapter, and
(13) In conducting research to collect or process food consumption data in support of the petition, the following general guidelines should be followed.
(i) Sampled population selected should be representative of the demographic and socioeconomic characteristics of the target population group for which the food is intended.
(ii) Sample size (i.e., number of eaters) should be large enough to give reliable estimates for customarily consumed amounts.
(iii) The study protocol should identify potential biases and describe how potential biases are controlled for or, if not possible to control, how they affect interpretation of results.
(iv) The methodology used to collect or process data should be fully documented and should include: study design, sampling procedures, materials used (e.g., questionnaire, and interviewer's manual), procedures used to collect or process data, methods or procedures used to control for unbiased estimates, and procedures used to correct for nonresponse.
(14) A statement concerning the feasibility of convening associations, corporations, consumers, and other interested parties to engage in negotiated rulemaking to develop a proposed rule consistent with the Negotiated Rulemaking Act (5 U.S.C. 561). [58 FR 44051, Aug. 18, 1993; 58 FR 60109, Nov. 15, 1993, as amended at 59 FR 371, Jan. 4, 1994; 59 FR 24039, May 10, 1994; 62 FR 40598, July 29, 1997; 62 FR 49848, Sept. 23, 1997; 63 FR 14818, Mar. 27, 1998; 64 FR 12890, Mar. 16, 1999; 66 FR 56035, Nov. 6, 2001]