"Nutrition Facts" labels for foods specifically for children less than 4 years do not present % Daily Value or footnotes as used on general food supply labels. Also, foods specifically for children less than 2 years of age must not present information on calories from fat and calories from saturated fat and quantitative amounts for saturated fat, polyunsaturated fat, monounsaturated fat and cholesterol. In both cases, % Daily Value is declared only for protein, vitamins, and minerals.

Fruit dessert for children less than 2 years old		Fruit dessert for children ages 2 years to 4 years
21 CFR 101.9(j)(5)(i)		21 CFR 101.9(j)(5)(ii)

The nutrients listed below may be omitted from the list of nutrients and included in a single sentence when present at "zero" levels in a food. This is done by putting the label statement ("not a significant source of _________") immediately below the listing of vitamins A and C, calcium, and iron.

Nutrient	Level per serving	Label statement	Reference
Calories from fat	Less than 0.5 g fat	"Not a significant source of calories from fat"	21 CFR 101.9(c)(1)(ii)
Saturated fat	Less than 0.5g of total fat	"Not a significant source of saturated fat"	21 CFR 101.9(c)(2)(i)
Cholesterol	Less than 2 mg	"Not a significant source of cholesterol"	21 CFR 101.9(c)(3)
Dietary fiber	Less than 1g	"Not a significant source of dietary fiber"	21 CFR 101.9(c)(6)(i)
Sugars	Less than 1g	"Not a significant source of sugars"	21 CFR 101.9(c)(6)(ii)
Vitamins A and C, calcium, and iron	Less than 2% of RDI	"Not a significant source of _________" (listing the vitamins or minerals omitted)	21 CFR 101.9(c)(8)(iii)

A simplified "Nutrition Facts" label may be used if at least seven of the following nutrients are present in insignificant amounts: Calories, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron (slightly different rules for labeling foods intended for children less than 2 years). The five core nutrients, shown in bold in the adjoining example, must always appear on all "Nutrition Facts" labels regardless of amounts present in the food. In addition, any of the nutrients required on the full "Nutrition Facts" label that are naturally present or are added to the food must be "declared on the simplified "Nutrition Facts" label.



21 CFR 101.9(f) - List of nutrients, 101.9(f)(1) - "Insignificant" defined, 101.9(c) - "Insignificant" levels listed for nutrients

A "simplified format label" must include a statement listing "zero" level nutrients when nutrients are added to the food or voluntarily declared on the "Nutrition Facts" label, and when claims are made on the label. In this example, the manufacturer voluntarily lists polyunsaturated and monounsaturated fat, and therefore must add the statement "Not a significant source of _________" with the blank filled in by the names of nutrients present at insignificant levels.



21 CFR 101.9(f)(4)

In addition to the nutrients shown on the label in #15 (in chapter V, first part) manufacturers may add calories from saturated fat, or polyunsaturated fat, monounsaturated fat, potassium, soluble and insoluble fiber, sugar alcohol, other carbohydrates, vitamins and minerals for which RDI's have been established, or the percent of vitamin A that is present as beta-carotene.

21 CFR 101.9(c)

Only those nutrients listed in FDA's nutrition regulations, as mandatory or voluntary components of the nutrition label, may be included in the "Nutrition Facts" label.

21 CFR 101.9(c)

In addition to the nutrients shown on the sample labels in this booklet, other nutrients (listed in FDA's regulations, e.g., thiamin) must be included on a food's "Nutrition Facts" label if the nutrients are added to the food, if the label makes a nutrition claim (such as a nutrient content claim) about them, or if advertising or product literature provides information connecting the nutrients to the food.

21 CFR 101.9(a), 101.9(c), 101.9(c)(8)(ii), & 101.9(c)(8)(ii)(A)-(B)

Generally, FDA only requires that the label declare the vitamins A and C, and the minerals calcium and iron. The other enrichment vitamins and minerals must be declared when they are added directly to the packaged food (e.g., enriched bread), but not when the enriched product is added as an ingredient to another food.

NOTE: It is necessary to declare the other vitamins and minerals in the ingredient list. However, if unenriched flour is used, and the enrichment nutrients are added separately, those nutrients (i.e., thiamin, riboflavin, niacin, and folic acid) would have to be declared on the "Nutrition Facts" label.

21 CFR 101.9(c)(8)(ii)(A)-(B), & 101.9(c)(8)(iv)

The serving size declaration is made up of two parts: a "household measure term" followed by its metric equivalent in grams (g). For beverages, the household measures may be declared as either fluid ounces, cups, or fractions of a cup with the metric equivalent in milliliters (mL). The examples below show permitted declarations.

Food	Examples
Cookies	"1 cookie (28 g)" or "1 cookie (28 g/1 oz)"
Milk, juices, soft drinks	"8 fl oz (240 mL)," or "1 cup (240 mL)" for multiserving containers, or the container (e.g., "1 can") for single serving containers
Grated cheese	"1 tablespoon (5 g)" or "1 tablespoon (5 g/0.2 oz)

21 CFR 101.9(b)(2), 101.9(b)(5), 101.9(b)(7), & 101.12(b)

Yes, the reference amount is used to derive a serving size for a particular product. The following example shows how to use the reference amount to determine the serving size for a 16 oz (454g) pizza:

1st step: From the reference amounts table (21 CFR 101.12(b)), you determine that the reference amount for pizza is 140g.

2nd step: Calculate the fraction of the pizza that is closest to the reference amount of 140g (calculations shown for a pie of net weight 16oz/454g pizza):

1/3 X 454g = 151g
1/4 X 454g = 113g

Note that 151g is closer than 113g to the reference amount for pizza (140g)

3rd step: The serving size is the fraction closest to the reference amount together with the actual gram weight for that fraction of the pizza:

Example: "Serving Size 1/3 pie (151g)"

Therefore, the serving size is "1/3 pizza (151g)" for this example, whereas the reference amount is 140g for all pizzas.

Note: Sections 101.9(b)(2)(i) (discrete units), 101.9.(b)(2)(ii) (large discrete units), and 101.9(b)(2)(iii) (bulk products) describe how to use the reference amount to derive a serving size.

21 CFR 101.12(b)

The following example shows how to calculate the serving size for a biscuit mix product and similar products that require further preparation:

1st step: From the reference amounts table (21 CFR 101.12(b)), determine that the reference amount for biscuits is 55g.

2nd step: Determine amount of mix needed to make a 55g biscuit.

3rd step: Determine closest permitted fraction of tablespoon or cup that contains the amount of mix closest to the amount determined in step 2.

4th step: The serving size is the fraction of a tablespoon or cup of biscuit mix determined in step 3 together with the actual gram weight of that measure of biscuit mix as the serving size.

Use the form "Serving Size __ cup (__ g)," the blanks filled in with correct values for the product.

Reference amounts: 21 CFR 101.12(b)&(c)

It is not necessary to adjust the size of your cookies to fit the reference amount. For example, if four cookies weigh 28 grams (and five cookies weigh 35 grams), declare the number of cookies nearest the reference amount and label with the exact weight of that number of cookies for the serving size: "Serving size 4 cookies (28g)" or "4 cookies (28g/1 oz)."

Reference amounts: 21 CFR 101.12(b)

For cups, these fractions of a cup are allowed household measures: 1/4 cup, 1/3 cup, 1/2 cup, 2/3 cup, 3/4 cup, 1 cup, 1-1/4 cup, etc. If serving sizes are declared in fluid ounces, declare the serving size in whole numbers (such as 4 fl oz, 5 fl oz, 6 fl oz, etc). For tablespoons, the following fractions of a tablespoon are allowed: 1, 1 1/3, 1 1/2, 1 2/3, 2, and 3 tablespoons. For teaspoons, the fractions of a teaspoon shall be expressed as 1/8, 1/4, 1/2, 3/4, 1, or 2 teaspoons.

21 CFR 101.9(b)(5)(i)

These fractions must be used in serving sizes for foods such as cakes or pies: "1/2", "1/3", "1/4", "1/5", "1/6", "1/8", "1/9", "1/10", "1/12" and smaller fractions that can be arrived at by further division by 2 or 3.

21 CFR 101.9(b)(2)(ii)

The slices are treated as "discrete units." One slice is a single serving if it weighs from 67% to less than 200% of the reference amount. Larger slices (weighing more than 200% of reference amount) may be declared as a serving if the whole slice can reasonably be eaten at a single-eating occasion. For slices weighing between 50%-67% of the reference amount, the serving size may be declared as either one or two slices. For slices weighing less than 50% of the reference amount, the serving size is the number of slices closest to the reference amount.

21 CFR 101.9(b)(2)(i)
Reference amounts: 21 CFR 101.12