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40 Part I General Information

recommended in comments, serving size used bymanufactures and grocers, or serving sizes used byother countries. Adjustments in the reference amountscan be initiated by the FDA or in response to a peti-tion. The labeled serving size and reference amountare important since the use of nutrient content claims

is dependent on the serving size and the referenceamount. The use of nutrient content claims is outlinedin Sect. 3.2.3.

3.2.1.3 Simplified Format

A simplified format for nutrition information on FDA-regulated foods may be used if seven or more of the13 required nutrients are present in only insignificantamounts (but does not include Calories from fat) (e.g.,soft drinks) [21 CFR 101.9 (f)]. For such foods, infor-mation on five core nutrients (Calories, total fat, total

carbohydrate, protein, and sodium) must be given.However, if other mandatory nutrients are present inmore than insignificant amounts they must be listed.Insignificant is defined generally as the amount thatallows a declaration of zero on the nutrition label.However, in the cases of protein, total carbohydrate,and dietary fiber, insignificant is the amount thatallows a statement of less than 1 gram. The footnotesrequired with the basic format are not required for thesimplified format label, except that the statement Per-cent Daily Values are based on a 2000 Calorie dietmust be included. The statement Not a significant

source of _____ is optional on the simplified formatlabel of an FDA-regulated product, unless a nutrientclaim 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 addedas a nutrient supplement to foods for which a standardof identity exists.

For USDA-regulated foods, a simplified nutritionlabel format may be used when any required nutrientother than a core nutrient (Calories, total fat, sodium,carbohydrate, or protein) is present in an insignifi-cant 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 amountmay be omitted from the tabular listing if it is listed ina footnote, Not a significant source of _____. Thisoption also exists for FDA-regulated foods, but it isknown as a shortened format [21 CFR 101.9 (c); seelisting for each noncore nutrient].

3.2.1.4 Exemptions

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

3-4table

Foods Exempt from Mandatory NutritionLabeling Requirements by the FDA

Food offered for sale by small businessFood 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 butare not for immediate consumption are primarily preparedon site and are not offered for sale outside that location

Foods that contain insignificant amounts of all nutrientssubject to this rule, e.g., coffee and tea

Dietary supplementsInfant formulaMedical foodsFoods shipped or sold in bulk form and not for sale to

consumersRaw fruits, vegetables, and fishPackaged single-ingredient products of fish or game meatGame meatsFood in small packagesShell eggs packaged in a carton

Unit containers in a multiunit retail food package that bearsa 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 isprovided. Special labeling provisions apply to certainother foods as specified in 21 CFR 101.9(j) (e.g., foodsin small packages; foods for young children; gamemeats, shell eggs; foods sold from bulk containers; unitcontainers in multiunit packages; foods in gift packs).Infant formula must be labeled in accordance with 21CFR 107, and raw fruits, vegetables, and fish accordingto 21 CFR 101.45. Dietary supplements must be labeledin accordance with 21 CFR 101.36.

Exemptions from mandatory nutrition labelingfor USDA-regulated foods ([9 CFR 317.400, 381.500])differ somewhat from those for FDA-regulated foodsregarding issues such as definitions of a smallbusiness, small package, and retail product.

3.2.1.5 Rounding Rules

Increments for the numerical expression of quantityper serving are specified for all nutrients (Table 3-5,as summarized by FDA) [21 CFR 101.9 (c); 9 CFR317.309 (c), 381.409 (c)]. For example, Calories are to bereported to the nearest 5 Cal up to and including 50 Caland to the nearest 10 Cal above 50 Cal. Calories can bereported as zero if there are less than 5 Cal per serving.

3.2.1.6 Caloric Content

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

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