0515-AttachB-21 CFR 101 9c2

Attachment B

21 CFR 101.9(c)(2)

[Code of Federal Regulations]

[Title 21, Volume 2]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR101.9]

[Page 19-46]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN

SERVICES (CONTINUED)

PART 101_FOOD LABELING--Table of Contents

Subpart A_General Provisions

Sec. 101.9 Nutrition labeling of food.

(a) Nutrition information relating to food shall be provided for all

products intended for human consumption and offered for sale unless an

exemption is provided for the product in paragraph (j) of this section.

* * *

(b) Except as provided in Sec. 101.9(h)(3), all nutrient and food

component quantities shall be declared in relation to a serving as

defined in this section.

* * *

(c) The declaration of nutrition information on the label and in

labeling of a food shall contain information about the level of the

following nutrients, except for those nutrients whose inclusion, and the

declaration of amounts, is voluntary as set forth in this paragraph. No

nutrients or food components other than those listed in this paragraph

as either mandatory or voluntary may be included within the nutrition

label. Except as provided for in paragraphs (f) or (j) of this section,

nutrient information shall be presented using the nutrient names

specified and in the following order in the formats specified in

paragraphs (d) or (e) of this section.

(1) ``Calories, total,'' ``Total calories,'' or ``Calories'':

* * *

(2) ``Fat, total'' or ``Total fat'': A statement of the number of

grams of total fat in a serving defined as total lipid fatty acids and

expressed as triglycerides. Amounts shall be expressed to the nearest

0.5 (1/2) gram increment below 5 grams and to the nearest gram increment

above 5 grams. If the serving contains less than 0.5 gram, the content

shall be expressed as zero.

(i) ``Saturated fat,'' or ``Saturated'': A statement of the number

of grams of saturated fat in a serving defined as the sum of all fatty

acids containing no double bonds, except that label declaration of

saturated fat content information is not required for products that

contain less than 0.5 gram of total fat in a serving if no claims are

made about fat, fatty acid, or cholesterol content, and if ``calories

from saturated fat'' is not declared. Except as provided for in

paragraph (f) of this section, if a statement of the saturated fat

content is not required and, as a result, not declared, the statement

``Not a significant source of saturated fat'' shall be placed at the

bottom of the table of nutrient values. Saturated fat content shall be

indented and expressed as grams per serving to the nearest 0.5 gram (1/

2) gram increment below 5 grams and to the nearest gram increment above

5 grams. If the serving contains less than 0.5 gram, the content shall

be expressed as zero.

(ii) ``Trans fat'' or ``Trans'': A statement of the number of grams

of trans fat in a serving, defined as the sum of

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all unsaturated fatty acids that contain one or more isolated (i.e.,

nonconjugated) double bonds in a trans configuration, except that label

declaration of trans fat content information is not required for

products that contain less than 0.5 gram of total fat in a serving if no

claims are made about fat, fatty acid or cholesterol content. The word

``trans'' may be italicized to indicate its Latin origin. Trans fat

content shall be indented and expressed as grams per serving to the

nearest 0.5 (1/2)-gram increment below 5 grams and to the nearest gram

increment above 5 grams. If the serving contains less than 0.5 gram, the

content, when declared, shall be expressed as zero. Except as provided

for in paragraph (f) of this section, if a statement of the trans fat

content is not required and, as a result, not declared, the statement

``Not a significant source of trans fat'' shall be placed at the bottom

of the table of nutrient values.

(iii) ``Polyunsaturated fat'' or ``Polyunsaturated'' (VOLUNTARY): A

statement of the number of grams of polyunsaturated fat in a serving

defined as cis,cis-methylene-interrupted polyunsaturated fatty acids may

be declared voluntarily, except that when monounsaturated fat is

declared, or when a claim about fatty acids or cholesterol is made on

the label or in labeling of a food other than one that meets the

criteria in Sec. 101.62(b)(1) for a claim for ``fat free,'' label

declaration of polyunsaturated fat is required. Polyunsaturated fat

content shall be indented and expressed as grams per serving to the

nearest 0.5 (1/2) gram increment below 5 grams and to the nearest gram

increment above 5 grams. If the serving contains less than 0.5 gram, the

content shall be expressed as zero.

(iv) ``Monounsaturated fat'' or ``Monounsaturated'' (VOLUNTARY): A

statement of the number of grams of monounsaturated fat in a serving

defined as cis-monounsaturated fatty acids may be declared voluntarily

except that when polyunsaturated fat is declared, or when a claim about

fatty acids or cholesterol is made on the label or in labeling of a food

other than one that meets the criteria in Sec. 101.62(b)(1) for a claim

for ``fat free,'' label declaration of monounsaturated fat is required.

Monounsaturated fat content shall be indented and expressed as grams per

serving to the nearest 0.5 (1/2) gram increment below 5 grams and to the

nearest gram increment above 5 grams. If the serving contains less than

0.5 gram, the content shall be expressed as zero.

* * *