40

recommended in comments, serving size used by

manufactures and grocers, or serving sizes used by
other countries. Adjustments in the reference amounts
can be initiated by the FDA or in response to a petition. The labeled serving size and reference amount
are important since the use of nutrient content claims
is dependent on the serving size and the reference
amount. The use of nutrient content claims is outlined
in Sect. 3.2.3.

3.2.1.3 Simplified Format

A simplified format for nutrition information on FDAregulated foods may be used if seven or more of the
13 required nutrients are present in only insignificant
amounts (but does not include Calories from fat) (e.g.,
soft drinks) [21 CFR 101.9 (f)]. For such foods, information on five core nutrients (Calories, total fat, total
carbohydrate, protein, and sodium) must be given.
However, if other mandatory nutrients are present in
more than insignificant amounts they must be listed.
Insignificant is defined generally as the amount that
allows a declaration of zero on the nutrition label.
However, in the cases of protein, total carbohydrate,
and dietary fiber, insignificant is the amount that
allows a statement of less than 1 gram. The footnotes
required with the basic format are not required for the
simplified format label, except that the statement Percent Daily Values are based on a 2000 Calorie diet
must be included. The statement Not a significant
source of _____ is optional on the simplified format
label of an FDA-regulated product, unless a nutrient
claim is made on the label or optional nutrients (e.g.,
potassium) are voluntarily listed on the nutrition label,
or if any vitamins or minerals are required to be added
as a nutrient supplement to foods for which a standard
of identity exists.
For USDA-regulated foods, a simplified nutrition
label format may be used when any required nutrient
other than a core nutrient (Calories, total fat, sodium,
carbohydrate, or protein) is present in an insignificant amount [9 CFR 317.309 (f) (1) and (4), 381.409
(f) (1) and (4)]. Any required nutrient, other than a
core nutrient, that is present in an insignificant amount
may be omitted from the tabular listing if it is listed in
a footnote, Not a significant source of _____. This
option also exists for FDA-regulated foods, but it is
known as a shortened format [21 CFR 101.9 (c); see
listing for each noncore nutrient].

Part I

3-4
table

General Information

Foods Exempt from Mandatory Nutrition

Labeling Requirements by the FDA

Food offered for sale by small business

Food sold in restaurants or other establishments in which
food is served for immediate human consumption
Foods similar to restaurant foods that are ready to eat but
are not for immediate consumption are primarily prepared
on site and are not offered for sale outside that location
Foods that contain insignificant amounts of all nutrients
subject to this rule, e.g., coffee and tea
Dietary supplements
Infant formula
Medical foods
Foods shipped or sold in bulk form and not for sale to
consumers
Raw fruits, vegetables, and fish
Packaged single-ingredient products of fish or game meat
Game meats
Food in small packages
Shell eggs packaged in a carton
Unit containers in a multiunit retail food package that bears
a nutrition label
Food products sold from bulk container
Summarized from 21 CFR 101.9 (j) (2009).
See details in regulations for foods exempt from mandatory nutrition
labeling requirements.

claim is made or any other nutrition information is

provided. Special labeling provisions apply to certain
other foods as specified in 21 CFR 101.9(j) (e.g., foods
in small packages; foods for young children; game
meats, shell eggs; foods sold from bulk containers; unit
containers in multiunit packages; foods in gift packs).
Infant formula must be labeled in accordance with 21
CFR 107, and raw fruits, vegetables, and fish according
to 21 CFR 101.45. Dietary supplements must be labeled
in accordance with 21 CFR 101.36.
Exemptions from mandatory nutrition labeling
for USDA-regulated foods ([9 CFR 317.400, 381.500])
differ somewhat from those for FDA-regulated foods
regarding issues such as definitions of a small
business, small package, and retail product.

3.2.1.5 Rounding Rules

Increments for the numerical expression of quantity
per serving are specified for all nutrients (Table 3-5,
as summarized by FDA) [21 CFR 101.9 (c); 9 CFR
317.309 (c), 381.409 (c)]. For example, Calories are to be
reported to the nearest 5 Cal up to and including 50 Cal
and to the nearest 10 Cal above 50 Cal. Calories can be
reported as zero if there are less than 5 Cal per serving.

3.2.1.4 Exemptions
Certain foods are exempt from FDA mandatory
nutrition labeling requirements [21 CFR 101.9 (j)]
(Table 3-4), unless a nutrient content claim or health

3.2.1.6 Caloric Content

Caloric conversion information on the label for fat, carbohydrate, and protein is optional. Calories can be