5.16. What are the special aspects of the "Nutrition Facts" labels for products intended for infants and small children?
"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)
5.17. Which nutrients may be summarized in a sentence after the vitamin and mineral listing instead of showing "0 g" on the "Nutrition Facts" label?
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.
||Level per serving
|Calories from fat
||Less than 0.5 g fat
||"Not a significant source of calories from fat"
||21 CFR 101.9(c)(1)(ii)
||Less than 0.5g of total fat
||"Not a significant source of saturated fat"
||21 CFR 101.9(c)(2)(i)
||Less than 2 mg
||"Not a significant source of cholesterol"
||21 CFR 101.9(c)(3)
||Less than 1g
||"Not a significant source of dietary fiber"
||21 CFR 101.9(c)(6)(i)
||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)
5.18. Is there a "Nutrition Facts" format for a food in which most nutrients are present in insignificant amounts?
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
5.19. When should a statement be used on simplified format labels to list nutrients present at insignificant amounts?
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)
5.20. What other nutrients can be declared on the "Nutrition Facts" label?
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)
5.21. Is there a restriction against certain nutrients on the "Nutrition Facts" label?
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)
5.22. When must voluntary nutrients be listed?
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)
5.23. When should the vitamins and minerals in flour be listed on the "Nutrition Facts" label?
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)
5.24. What terms must be used for the serving size?
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.
||"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
||"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)
5.25. Is a "reference amount" different from a serving size?
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:
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)
5.26. How is the serving size calculated for the "Nutrition Facts" label on a biscuit mix product?
The following example shows how to calculate the serving size for a biscuit mix product and similar products that require further preparation:
Reference amounts: 21 CFR 101.12(b)&(c)
5.27. Is it necessary to reformulate the size of a product such as cookies so that the serving size weighs exactly the reference amount (i.e., 30g)?
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)
5.28. What fractions must be used to express serving sizes in common household measures?
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)
5.29. For foods that are usually cut into pieces before serving, what fractions must be used in the serving size declaration?
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)
5.30. For a multi-serving package, what is the serving size for a product that is sliced thinner or thicker than the reference amount?
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
Food and Drug Administration Center for Food Safety and Applied Nutrition
A Food Labeling Guide, September 1994 (Editorial revisions June, 1999)