Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/nutritional-labeling-and-education-act-nlea-requirements-894-295
Timestamp: 2019-06-26 18:56:37
Document Index: 742936074

Matched Legal Cases: ['art\n7', 'art\n10', 'art 1', 'ART 1', 'art 2', 'ART 2']

Nutritional Labeling and Education Act (NLEA) Requirements (8/94 - 2/95) | FDA
GUIDE TO NUTRITION LABELING AND EDUCATION ACT (NLEA) REQUIREMENTS
(Editorial Changes - February 1995)
Guide for Review of Nutrition Labels 2
Label Review 4
Location of Nutrition Facts Panel 4
General/Format and Print Size 5
Nutrient Declaration 6
Footnote 8 Layout 8
Shortened Format 9 Simplified Format 9
Separately Packaged Ingredients or
Ingredients are Added by the User 11
Bilingual Label 11
Aggregate Label 11 Nutrient Content Claims 12
Referral Statement 12
Disclosure Statements 13
Relative Claims 13
Percent and Amount Claims 14
Meals and Main Dishes 14
Health Claims 15
3. Definitions for Nutrient Content Claims Chart
7. Rounding Rules for Declaring Nutrients
8. Daily Value Chart
10. Full Format - Vertical Display with Footnote to the Side
11. Tabular Display for Packages > 40 sq. in
13. Vertical Label for Packages with 40 or less sq. in.
16. Simplified Format, Vertical Display
17. Simplified Tabular Display
18. Linear Displays - Full, Simplified and Shortened
19. Shortened Format, Vertical Display
20. Bilingual Label
22. Children Less Than 4 Years of Age
23. Children Less than 2 Years of Age
24. CFR Required Type Size-All Formats
27. Important NLEA Dates
28. Contact Persons for Food Labeling Questions
29. Information Sheet on Misleading Containers; Non-Functional Slack Fill-Final Rule
31. Prime Connection Information and Registration Application
32. Model Small Business Food Labeling Exemption Notices
33. Chart for Previous Labeling Regulations (Pre-NLEA)
GUIDE FOR REVIEW OF NUTRITION LABELS
The Following information is provided as assistance for reviewing food labels for compliance with new requirements for nutrition labeling and nutrient claims. These new requirements are in addition to the previously established labeling requirements for statement of identity (21 CFR 101.3), net contents declaration (21 CFR 101.105), ingredient list (21 CFR 101.4) and name and place of manufacturer or distributor (21 CFR 101.5).
The Nutrition Labeling and Education Act of 1990 (NLEA) provides FDA with specific authority to require nutrition labeling of most foods regulated by the Agency; and to require that all nutrient content claims (i.e., 'high fiber', 'low fat', etc.) and health claims be consistent with agency regulations. Regulations implementing the NLEA labeling provisions issued on January 6, 1993, with technical amendments published on August 18, 1993.
The regulations became effective for health claims, ingredient declarations, and percent juice labeling on May 8, 1993 (percent juice labeling was subsequently exempted until May 8, 1994). The regulations for nutrition labeling and other provisions became effective on May 8, 1994. However, by an Act of Congress, these provisions do not apply to certain products until after August 8, 1994.
Compliance with the nutrition labeling regulations is based on the date the product was labeled, not the date the product is offered for entry into interstate commerce. Products labeled prior to effective dates referenced above must comply with the agency's previous regulations (See chart Attachments # 33 for pre-NLEA requirements).
Exemptions from the nutrition labeling regulations are outlined in this guide. Two exemptions from the regulations address products manufactured by firms that meet the small business exemptions provided under the regulations. Firms that believe they meet the requirements for a small business exemption must file a Notice of Eligibility and provide the information necessary to verify their exempt status to FDA/CFSAN/Office of Food Labeling (OFL), (HFS-150), 200 C Street S.W., Washington, D.C., 20204.
Additionally when it is not technologically feasible, or some other circumstance makes it impracticable for firms to comply with required declaration of nutrients identified in section 101.9, then, per section 101.9(g)(9), firms seeking alternative approaches for compliance must submit a request to OFL. OFL will respond to each request.
Copies of Model Small Business Food Labeling Exemption Notices are attached (Attachment # 32). OFL will have no objections if a firm has submitted all required information, but in a different format than the model exemption notices.
If a firm is granted an exemption or special labeling provisions, a copy of the response will be sent to the home district. Exemption information for small businesses will also be available on Prime Connection. See Attachment #31-Information Registration Application for Prime Connection. To access the Prime Connection labeling menu from the main menu; at the prompt type B (space) FL (enter key).
If nutrition labeling does not appear on the label, determine if the product is exempt. If the product was labeled prior to May 8, 1994 or August 8, 1994 was applicable, it may comply with either the 'old' or 'new regulations. If the product is not exempt, examine the label to determine if nutrition labeling is present; if it appears in a manner that is in compliance; and if present, defined terms or approved health claims are properly used.
NOTE: Pertinent CFR references are noted after each heading in this document. In the CFR the old (non-NLEA) nutrition labeling regulations appear under 21 CFR section 101-Food Labeling, identified with the section number followed by 'Note.'
EXEMPTIONS AND SPECIAL LABELING PROVISIONS [21 CFR 101.9(i)]
A product is exempt from nutrition labeling if no nutrition information is declared on the label or labeling, if no nutrient content claim (Attachment #3) or health claim (Attachment #4) is made and if the manufacturer/packer or distributor meets one or more of the following provisions:
Small Business Exemption based on value of gross sales (Note: after May 8, 1995, this exemption based on value of gross sales will apply only to retailers).
For foreign firms importing foods, this exemption is based on the total amount of sales to consumers in the United States. The product is exempt from nutrition labeling if the firm whose name appears on the label has annual gross sales of food to consumers of not more than $50,000; or has total annual gross sales to consumers of not more than $500,000 [101.9(j)(1)] (See Chart 1, below).
Small Business Exemption for low volume food products based on the average number of full time equivalent employees (FTE's) and approximate units (of sale) of food products sold in the United States. The following is provided for your information, but only those products listed with the Office of Food Labeling are eligible for the exemption, (NOTE: a firm with less than 10 employees and less than 10,000 units does not have to apply to FDA for an exemption).
For products marketed prior to May 8, 1994, there are the following provisions:
the effective date is delayed until May 8, 1995 providing that the firm had fewer than 300 FTE's and less than 600,000 units of the product sold between 5/8/93 and 5/7/94.
the effective date is further delayed from May 8, 1995 until May 8, 1996 providing that the firm had fewer than 300 FTE's and less than 400,000 units of the product sold between 5/8/94 and 5/7/95.
the effective date is further delayed from May 8, 1996 until May 8, 1997 providing the firm had fewer than 200 FTE's and less than 200,000 units of the product were sold between 5/8/95 and 5/7/96.
the effective date is delayed after May 8, 1997 providing the firm had fewer than 100 FTE's and less than 100,000 units were sold in the previous year.
Products initially marketed after May 8, 1994 are exempt providing the firm has fewer than 100 FTE's and less than 100,000 units are projected for marketing in the first 12 months.
Foods served or sold in restaurants are exempt unless a claim is made on a label available to the consumer, (e.g., fat free salad dressing)[101.9(j)(2)(i)].
Foods served and sold for immediate consumption (e.g., schools, cafeterias, trains, airplanes, and retail stores, such as bakeries and deli's), where there are facilities for immediate consumption[101.9(j)(2)(ii)].
CHART 1: SMALL BUSINESS EXEMPTION
SALES IN FOOD
TOTAL SALES FOOD & (NON-FOOD)
Foods that are not for immediate consumption, that are processed and prepared primarily in a retail establishment and not offered for sale outside that
establishment (e.g., bakeries and deli's)[101.9(j)(3)].
Foods that are not for immediate consumption and are not processed or prepared on the premises, but are packaged and portioned on a consumers' request [101.9(j)(3)].
Foods that contain insignificant amounts of all nutrients required to be listed in nutrition labeling (e.g., coffee and most spices) [101.9(j)(4)].
Infant formula subject to the Infant Formula Act [101.9(j)(7)].
dietary supplements of vitamins and minerals not in conventional food form [101.9(j)(6)]. NOTE: After July 1, 1995 these must comply with the requirements of 101.36.
Medical Foods [101.9(j)(8)].
Bulk foods for further manufacturing or repacking [101.9(j)(9)].
Raw fruits, vegetables, and fish (covered by voluntary program for display at retail level; however, when a claim is made, nutrition information must be displayed
by the retailer) [101.9(j)(10)].
The key to the inclusion of fish in the voluntary program is the product, as sold to the consumer, is packaged at the retail establishment. In addition, raw shellfish, in or out of the shell is under the voluntary program; as is refrigerated or iced pasteurized crab meat that is not shelf-stable.
custom processed fish and game meat [101.9(j)(11)(ii)]. All game meats may provide nutrition information on labelling.
Foods in packages with available label space of less than 12 square inches (e.g. pack of gum), provided that the label provides a means for consumers to obtain nutrition information (e.g., address, phone number). If a claim is made a nutrition label must be provided in accordance with 101.9(j)(13).
Food sold from bulk containers, provided that nutrition information is provided at point of sale [101.9(j)(16)].
Shell eggs packed in a carton that has a top lid designed to conform to the shape of the eggs are exempt from outer carton label requirements when the required information is presented inside the carton lid or in an insert. The agency does not object to presenting the required nutrition label inside theheading 3d of any egg carton [101.9(j)(14)].
17. FOODS FOR INFANTS AND CHILDREN LESS THAN 4 YEARS OF AGE: Nutrient names and quantitative amounts must be presented in two separate
columns. Also percent Daily Values may only be listed for protein, vitamins and minerals. The footnote is prohibited. This is illustrated in Attachment #22- format for Foods for Children Less Than 4 years of age [101.9(j)(5)(ii)].
FOODS FOR INFANTS AND CHILDREN LESS THAN 2 YEARS OF AGE: In addition to the referenced restrictions for children less than 4; foods intended for children less than 2 years of age may not list calories from fat, saturated fat, polyunsaturated fat, monounsaturated fat, and cholesterol in the nutrition label. This is illustrated in Attachment 23-Format for Food Represented for Children Less Than 2 Years of Age [101.9(j)(5)(i)].
ADDITIONAL REFERENCES TO FOODS FOR INFANTS & CHILDREN IN THIS GUIDE: Refer to Nutrient Declaration 'Protein', 'Sodium', 'Simplified Format', and 'Nutrient Content Claims'.
Multi-unit packages (see page # 11) [101.9(j)(15)].
LABEL REVIEW [21 CFR 101.2]
Location of Nutrition Facts Panel:
The total surface area available to bear labeling is a prime factor in determining placement of nutrition information (see Attachment #1). In determining available label space: flanges and ends (tops and bottoms) of cans; shoulders, necks and caps of bottles and jars; and folded flaps and other unusable area may be excluded. However, if these areas are
used for labeling, they must be included when calculating available label space.
On packages with 40 or less square inches of available label space the Nutrition Facts panel may appear on any label panel.
On packages with more than 40 square inches of available label space, the Nutrition Facts panel may appear:
On either the principal display panel (PDP) or information panel.
On any label panel if the PDP or information panel is too small to accommodate all required information (proposed August 1993).
General/Formal & Print Size [21 CFR 101.9(d)]
Nutrition information must be set off in a box. The format requires that headings and nutrients be separated by "bars". Attachment 9 and 10 are, respectively, examples of Full Format-Vertical Display, and Full Format Vertical Display with Footnote to the Side.
There are a variety of different formats that can be used as referenced in Attachment # 1-Display Style Chart for Nutrition Labelling. Additional information on display styles are contained in this guide.
Print must be in both upper and lower case in an easy to read type style and with sufficient contrast to assure readability. all nutrients listed must be printed in at least 8 point type. Column headings for "Amount Per Serving", "% Daily Value", footnote and caloric conversion information can be no smaller than 6 point. Required type size is illustrated in Attachment # 2-Illustration of Type and Point size. Attachment # 24 are copies of all label formats in actual CFR required type size. Smaller type size is permitted on packages < 12="" square="" inches="" of="" available="" space="">
"Nutrition Facts" must be presented in bold print and in print larger than any other printed information in the nutrition label.
All values expressed must be in terms of the stated "Serving Size" and, except for fish or game meat, must be based on the product as packaged.
Serving Size [21 CFR 101.9(b)(1)]
Serving size must be based on the established reference amount referenced in 21 CFR Section [section] 101.12(b) (See Attachment # 5) except:
Food available only through a weight control or weight maintenance program, may determine a serving size that is consistent with the meal plan for their program. The principal display panel for such products must bear the statement "for sale only through the _____ program" with the blank filled in with the name of the program. However, they must use the established reference amounts to determine if the product qualifies to make a claim.
Serving size is expressed in common household measure (i.e., cup; tablespoon, teaspoon; piece, slice, fraction (e.g., 1/4 pizza); ounce, fluid ounce) and followed by the equivalent metric quantity in parenthesis. When ounces are used a visual unit must be provided after the metric equivalent (e.g. 1 oz (28g/1" X 1" CUBE) The metric quantity is not required for single serving containers unless nutrition information is required on a drained weight basis [101.9(b)(5)].
A package that is sold individually and contains less that 200% of the applicable reference amount is considered to be one serving. However, for products that have reference amounts of 100 g (or ml) of larger, manufacturers may decide whether a package that contains more than 150% but less than 200% of the reference amount is 1 or 2 servings. When a product contains 200% or more of the reference amount, the manufacturer may label the product as a single serving if the entire package can reasonably be consumed at one sitting [101.9(b)(6)].
"Servings per Container" [21 CFR 101.9(b)(8)]
If the number of servings is between 2 and 5 servings it is rounded to the nearest .5 servings. Attachment #6 provides rounding rules for serving size.
The term "about" may be used to qualify the
number of servings in a multi-serving container.
When serving size is expressed on a drained weight basis, and the number of servings vary because of a natural variation in the product, the manufacturer may state the typical number of servings per container (e.g., maraschino cherries; usually 5 servings).
"Amount Per Serving" [21 CFR 101.9(c)]
Rounding rules for expressing the quantitative amount of a nutrient are included in Attachment #7 -Rounding rule table for nutrients. NOTE: Nutrients are listed in
the order in which they must be listed on the nutrition label. Nutrients are listed in a column and immediately followed by the quantitative amount with a "g" for grams, "mg" for milligrams and "I.U." for International Units.
"Calories" [21 CFR 101.9(c)(1)]
Calories must be in bold print. "Calories from Fat" must be declared unless the product contains < 0.5="" g="" total="" fat.="" "calories"="" may="" be="" followed="" by="" the="" optional="" term="" "energy"="" in="">
A listing of "Calories from Saturated Fat" is voluntary.
If both "Calories from Fat" and "Calories from Saturated Fat" are declared they should be indented and listed in a line under "Calories".
"% Daily Value" [21 CFR 101.9(c)(7)&(8)&(9) and (d)(6)&(7)]
Numbers must be in bold print. Declaration of the % DV is required for nutrients for which Daily Values (Recommended Daily Intakes (RDIs) or Daily Reference Values DRVs) have been established. Reference Attachment #8 - Daily Value chart. Note that nutrients not referenced on the chart do not have Daily Values.
For calculation of % DV of RDI see 101.9(c)(8)(iv). For calculation of % DV of DRV see 101.9(c)(9).
"% Daily Value", can also be listed as "Percent Daily Value", "Percent DV" or "% DV".
"Fat" [21 CFR 101.9(c)(2)]
Total fat must be in bold print and listed in grams. Saturated fat must be listed in grams, but is not required if the food contains less than 0.5 grams of total fat per serving and if no claims are made about fat or cholesterol content. If not required and not declared, the statement "Not a significant source of saturated fat" must be icluded at the bottom of the nutrient table.
"Polyunsaturated Fat" or "Polyunsaturated" in grams voluntary unless monounsaturated fat is declared, or a cholesterol or saturated fat claim is made and the total fat declared is greater than zero. 'Monounsaturated Fat' or 'Monounsaturated' in grams is voluntary unless polyunsaturated fat is declared, or a cholesterol or saturated fat claim is made and the total fat declared is greater than zero.
"Cholesterol" [21 CFR 101.9(c)(3)]
Must be in bold print and listed in milligrams.
Is not required, if the product contains less than 2 milligrams cholesterol per serving and makes no claim about fat, saturated fat or cholesterol; and if not declared, the statement "Not a significant source of cholesterol" must be included at the bottom of the nutrient table.
"Sodium" [21 CFR 101.9(c)(4)]
Foods for infants and children under 4 years of age may list the mg. amount, but may not list the % Daily Value for sodium.
"Potassium" [21 CFR 101.9(c)(5)]
Is voluntary unless a claim is made about potassium. If listed it must be in bold print and listed in milligrams.
Carbohydrates and Dietary Fiber [21 CFR 101.9(c)(6)]
The term 'Total Carbohydrate' or 'Carbohydrate Total' in bold print must be used and expressed in grams.
"Dietary Fiber" in grams is not required if the serving contains less than 1 gram. If not declared, the statement "Not a significant source of dietary fiber" must be included at the bottom of the nutrient table. 6
"Soluble Fiber" in grams is voluntary unless a claim is made about soluble fiber. A Daily Value has not been established.
"Insoluble Fiber" in grams is voluntary unless a claim is made about insoluble fiber. A Daily Value has not been established.
"Sugars" is not required if a serving contains less than 1 gram of sugar and no claims are made about sweeteners, sugars, or sugar alcohol content, and if not declared, the statement "Not a significant source of sugars" must be included at the bottom of the nutrient table. A Daily Value has not been established.
"Sugar Alcohol" is voluntary unless a claim is made about sugar alcohol or sugar when sugar alcohols are present in the food. When listed and only one sugar alcohol is present in the food, the name of the sugar alcohol may be given in lieu of the term "sugar alcohol (e.g. xylitol). Daily value has not been established.
"Other Carbohydrates" is voluntary. A Daily Value has not been established.
Protein [21 CFR 101.9(c)(7)]
Must be in bold print and expressed in grams.
Declaration of % Daily Value is not required when the food is for adults or children over 4 years of age unless a protein claim is made.
However, when the food is for adults or children over 1 year of age and the protein is of poor quality, the label should state "0%" in % DV column or state "Not a significant source of protein."
The statement "Not a significant source of protein" is required if the food is purported to be for infants and has a Protein Efficiency Ratio (PER) of less than 40 percent of the reference standard (casein).
Declaration of Vitamins and Minerals [21 CFR 101.9(c)(8)]
Nutritional information as the percent of the Reference Daily Intake (RDI) [listed in 101.9(c)(8)(iv)] for the following nutrients is MANDATORY and must be declared in the order listed:
"Vitamin A, Vitamin C (Ascorbic Acid)(*), Calcium, Iron" * Parenthetical listing of ascorbic acid is optional They may be listed horizontally or in two columns.
The percent of Vitamin A that is present as beta carotene is voluntary and may be listed parenthetically. b. Mandatory vitamins and minerals present at levels below 2% of the DV may be declared as: (i) 2% if actual amount is 1.0% or more, or (ii) As zero, or (iii) by use of an asterisk that refers to a statement at the bottom of the table which says "Contains less than 2 percent of the Daily Value of this (these nutrient(s)"; or (iv) by omitting the nutrient and including the following statement at the bottom of the table: "Not a significant source of _____ (listing the vitamin(s) and/or mineral(s) omitted)".
The order for listing optional vitamins and minerals is as follows:
Thiamin (Vitamin B[sub]1)(*)
Riboflavin (Vitamin B[sub]2)(*)
Niacin Vitamin B[sub]6
Folate (Folacin)(*)
Vitamin B[sub]12
((*) These parenthetical listing's are optional_
The nutrient must be declared when it is added as a nutrient supplement, or when it is the subject of a claim. In January 94 FDA proposed a DV for 7 additional nutrients (reference Attachment # 8, bottom of chart).
No other nutrients may be declared in the "Nutrition Facts" panel and those listed must
follow the order presented.
"Footnote" [21 CFR 101.9(d)(9)]
The full footnote is not required whenever the package has less than 40 square inches available for labeling or when a simplified format is used. Except for foods for infants or children less than 4 years of age, if the footnote is not present, the statement "Percent Daily Values are based on a 2,000 calorie diet" is required.
The Footnote should read: Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs:
If the % Daily Value for potassium or protein are provided under % Daily Value, they must be included in the footnote chart. b. If the term Daily Value is not spelled in the heading, the footnote should indicate that "DV" represents "Daily Value". c. The footnote should not be included in nutrition labeling for foods for infants and children under 4 years of age.
Caloric conversion information is voluntary and if provided, is the last entry in the nutrition label. The information may be presented horizontally (i.e., "Calories per gram: Fat 9, Carbohydrate 4, Protein 4") or vertically in columns [101.9(d)(10)].
Layout [21 CFR 101.9(d)(11)]
For package with more than 40 square inches of available label space if there is not sufficient vertical space (i.e., approximately 3 inches) to accommodate all required information up to and including declaration of iron, the nutrition label may be presented in the tabular display.
(Attachment # 11 - Tabular Display for Packages >40 sq. inches). This format does not have to be parallel to the bottom of the package.
DUAL NUTRITION LABELING [21 CFR 101.9(3)]
It is required when a product is promoted for use(s) that differs in quantity by two fold or more from the use upon which the reference amount is based. A second column of % Daily Values based upon the amount customarily consumed in the promoted use must be provided. Non-discreet bulk products that are primarily used as ingredients or have traditionally had multipurpose uses, such as baking mixes, are exempt from this requirement [101.9(b)(11)].
Regulations provide the following provisions for voluntarily including another column(s) of figures to declare nutrient values:
The food is commonly combined with one or more ingredients before eating or is cooked or otherwise prepared before eating, and directions for that combination are provided. In this case, additional column(s) may present the nutrient content per serving for the food as prepared. [101.9(e)]
Per 100 g or 100 ml or per 1 oz or 1 fl oz of the food as packaged or purchased [101.9(b)(10)(i)].
Per one unit if the serving size of a product in discreet units in a multi-serving container is more than one unit (e.g., per cookie)[101.9(b)(10)(ii)].
Per cup popped for popcorn in a multi-serving sertainer [101.9(b)(10)(ii)]. e. For two or more population groups for which different RDI's are established, for example; foods for adults and lactating women [101.9(e)].
Format for Dual Nutrition labeling (see (Attachments # 14 - & - 15 - , Dual Declaration as Packaged/Prepared, and Combined with Another Food, respectively):
When dual labeling is provided, equal prominence must be given to both sets of values and be presented in the full format, except that:
a. Following the heading of "Amount Per 8 Serving" there must be two or more column headings describing the form of the food, the combination of food, the units or the RDI group. Information on the % Daily Value for each form of the food must be provided under the appropriate heading. b. The values for the packaged food based n the labeled serving size must be to the left of the numeric column. c. Calories, calories from fat, and when declared, calories from saturated fat, shall be listed in a column and the values for each form of the food presented under the appropriate heading. d. Quantitative information by weight about each nutrient, based on the serving size for the food as packaged is required. Quantitative Quaormation may be included for other forms of the product represented in the nutrition label. This additional information may be presented in one of the following formats: (i) Immediately follwing and differentiated from the required quantitative information for each nutrient. A separate column may not be used. (ii) As a footnote and declared in the same order as the nutrients appear in the nutrition label. The nutrient content may be expressed as (1) the total nutrient content of the product identified in the second column or (2) the amount of nutrient(s) added to the product as packaged for only those nutrients that are present in amounts that differ from the amounts declared in the required quantitative information. The footnote must identify which amounts are declared. Any sub-components declared are listed parenthetically after the principal component. e. Total fat and its quantitative amount by weight must be followed by a symbol that refers to a statement at the bottom of the listing for vitamins/minerals that identifies the form(s) of the product for which quantitative information is provided.
SHORTENED FORMAT [CFR References - See (Attachment # 19 - ]
The shortened format allows nutrients that are present at insignificant levels to be listed following the statement. Not a significant source of ____. This statement can be used with any format to list one or more of the nutrients that qualify for such a declaration. The Therients qualifying for this declaration include, calories from fat, saturated fat, cholesterol, dietary fiber, sugars, and vitamins/and minerals. The nutrients are listed in the order in which they would have been listed in the regular format.
Reference (Attachment # 19 - -Shortened Format.
SIMPLIFIED FORMAT [21 CFR 101.9(f)]
The simplified format is an abbreviated listing of nutrients that can be used on any size package provided that the food contains insignificant amounts of seven or more of the following: Calories, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron. (Attachments # 16 - & # 17 - illustrate the simplified format and simplified tabular display, respestively.
An "insignificant amount" is the amount of a nutrient that permits a declaration of zero in nutrition labeling, except that for total carbohydrate, dietary fiber, and protein, it is the amount that allows a declaration of "less than 1 gram." 1. Information required to be presented in the simplified format shall be presented in the same manner as the full format; except that the footnote is not required. When the footnote is omitted, an asterisk must be placed at the bottom of the label followed by the statement: "Percent Daily Values are based on a 2,000 calorie diet" If the term "Daily Value" is not spelled out in the heading, this statement should indicate that "DV" represents "Daily Value". 2. The simplified format must include the following nutrients: a. Total calories, total fat, sodium, total 9 and protein, regardless of the amount present in the food. b. Calories from fat and any other nutrient required in the full format that are present at more than insignificant amounts. c. Any vitamins or minerals, for which a Daily Value has been establsihed, that are voluntarily added, or are required to be added, as a nutrient supplement to foods for which a standard of identify exists. 3. Nutrient that may be voluntarily listed in the full format may be voluntarily declared in the simplified format, if present in more than insignificant amounts. 4. When nutrition claims are made, added vitamins and minerals are listed, or voluntary nutrients are declared in the simplified format, the following statement must be included at the bottom of the nutrition label. "Not a significant source of _____" (with the blank filled in with the names of any nutrients required in the full format and calories from fat that are present in insignificant amounts). 5. Foods intended for children less than 2 years og age qualify for use of the simplified format when a food contains an insignificant amounts of six or more of the following: Calories, total fat, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron. The simplified format may be used on any size package.
SMALL AND INTERMEDIATE PACKAGES [21 CFR 101.9(j)(13]
For packages with 40 or less square inches of available label space the footnote may be dropped. When such packages can not accommodate a column display on any label panel, nutrition information may appear on any label panel and modify the full or simplified formats by one or more of the following ways:
Tabular or Vertical display (Attachments # 12 - & # 13 - ): The footnote may be omitted when an asterisk is placed at the bottom of the label followed by the following statement "Percent Daily Values" are based on a 2,000 calorie diet". If the term "Daily Value" is not spelled out in the heading the statement must indicate that "DV" represents "Daily Value". 2. Linear display Attachment # 18 - ); This may be used only when there is insufficient space of the tabular or vertical display (Percent Daily Values are listed parenthetically (e.g. "5% DV"). The statement "Percent Daily Values (DV) are based on a 2,000 calorie diet" must be placed after the last nutrient listed. 3. When a package with less than 12 square inches of available label space bears nutrition labeling, either voluntarily or because of the presence of a claim or other nutrition information, all required information must be in a type size not smaller than 6 point or all upper case type of 1/16 inches minimum height. Individual serving-size packages of food served with meals in restaurants, institutions, and on board passenger carriers, and not intended for retail sale, may use 1/32 inch type. Such packages may also use all of the provisions provided for packages with 40 or less square inches [101.2(f)]. 4. Use of the following abbreviations are permitted:
Serving size/Serv. size
Servings per container/Servings
Calories from fat/Fat cal
Calories from saturated fat/Sat fat cal
Saturated fat/Sat fat
Monounsaturated fat/Monounsat fat
Polyunsaturated fat/Polyunsat fat
Cholesterol/Cholest
Total carbohydrate/Total carb
Dietary fiber/Fiber
Soluble fiber/Sol fiber
Insoluble fiber/Insol fiber
Sugar alcohol/Sugar alc
Other carbohydrate/Other carb
MULTI-UNTI RETAIL PACKAGES [21 CFR 101.9(j)(15)]
Individual containers in a multi-unit retail food package are not required to bear function
labeling when:
the label for the multi-unit package contains all required nutrition information; 2. the individual containers are securely enclosed and not intended for individual retail sale; and 3. each unit is labeled with the statement "This Unit Not Labeled For Retail Sale" in at least 1/16-inch height type size. The word "individual" may be used instead of or immediately preceding the word "Retail". This statement is not required when the inner units bear no labeling.
SEPARATELY PACKAGED INGREDIENTS OR FOODS, ASSORTMENTS AND FOODS TO WHICH INGREDIENTS ARE ADDED BY THE USER [21 CFR101.9(h)]
Food falling into this category may utilize any applicable format for nutrition labeling.
Two or more separately packaged foods enclosed in an outer container or single containers containing assortments of the same type of food must have nutrition labeling on the outside of the container. a. When foods are intended to be eaten individually, nutrition information must be clearly visible to the consumer at point of purchase using the format for multiple nutrition labeling (i.e. Aggregate Format - (Attachment # 21 - ). b. When foods are intended to be eaten at the same time, the nutrition information may be provided as a composite value or for each component using the format for multiple nutrition labeling. 2. Gift packs, containing an assortment of foods, may present nutrition information on the label of the outer package or in labeling within or attached to the outer package (inserts, hang tags). When the reference amounts do not apply to the assorted package sizes in a gift packs, the following serving sizes may be used: solid foods - 1 ounce non-beverage liquids - 2 fluid ounces beverages - 8 fluid ounces The serving size reference amounts established in 101.12(b) must be used to determine if a food qualifies for a nutrient content claim. Nutrition information may be provided per serving for individual foods in the package or as a composite for "reasonable categories" of foods that have similar nutritional profiles and dietary uses. "Reasonable categories" of food may only be used if accepted by FDA (e.g., cheese spread in one category and hard cheese in another). 3. If a food in a gift package has less than 12 square inches of available label space, the food does not have to be included in the determination of nutrition labeling provided that it is not specifically listed in a promotional catalogue as present in the gift pack; and a. It is used in small quantities to enhance appearance; or b. It is included as a free gift or promotional; or 4. When two or more food products are combined together and no outer container or label is used each product must carry nutrition labeling.
BILINGUAL LABEL [21 CFR 101.9(d)(14)]
If a label contains any required information in a foreign language, then nutrition labeling, if present, must also be presented in the foreign language.
The nutrition information may be presented in a separate nutrition label for each language, or in one label with the second language; with a translation of all required information following that in English. Numeric characters that are identical in both languages do not have to be repeated (See (Attachment # 20 - ).
AGGREGATE LABEL [21 CFR 101.9(d)(13)-contained in 8/18/93 technical amendments]
An aggregate label may be used on the outer label of packages that contain two or
more separately packaged foods that are intended to be eaten individually or on packages that are used interchangeably for the same type of food. To the maximum extent possible, all required information must be presented in the required format ( (attachment # 21 - ), except that:
The identity of each food must be specified under the "Nutrition Facts" heading; and 2. Both the quantitative amount and the % Daily Value of each nutrient must be listed in separate columns under the name of each food.
NUTRIENT CONTENT CLAIMS [21 CFR 101.13]
Nutrient content claims, are claims that expressly or implicitly characterize the level of a nutrient of the type required in nutrition labeling under 101.9. No nutrient content claim may be made on foof offered for sale for human consumption that has not been defined in a regulation. An expressed nutrient content claim is any direct statement about the level or range of a nutrient in the food (e.g., "low sodium" or "contains 100 calories"). An implified nutrient content claim does the following: describes the food or an ingredient therein in a manner that suggests that a nutrient is absent or present in a certain amount (e.g., "high in oat bran"); or Suggests that the food, because of its nutrient content, may be useful in maintaining healthy dietary practices and is made in association with an explicit claim or statement about a nutrient (e.g., healthy, "contains 3 grams of fat"). Except for claims regarding %RDI of vitamins and minerals, no nutrient content claim may be made on food intended specifically for use by infants and children less than 2 years of age unless the claim is specifically provided for [101.13(b)(3)]. Core terms may be used as follows (see attachment # 3 - -Nutrient content claims chart for additional information, including CFR cites): 1. Free of fat, saturated fat, cholesterol, sodium, salt, sugars and calories; 2. Very Low in sodium; 3. Low in fat, saturated fat, cholesterol, sodium and calories; 4. Lean and Extra Lean defined for meat, poultry, seafood, game meat and meal type products (definition includes criteria for fat, saturated fat and cholesterol); 5. High and Good Source of a beneficial nutrient with a DV; 6. Reduced and Less in fat, saturated fat, cholesterol, sodium, sugar and calories; 7. More of a beneficial nutrient with a DV; and 8. Light for fat or calories or in sodium.
Type Size: A nutrient content claim be in a type size no larger than two times that of the statement of identity and not unduly prominent in type style [21 CFR 101.13(f)].
Additional Requirement and Provisions
Most claims are based on the reference amount customarily consumed and for small servings (30 g or less or 2 tablespoons or less) per 50 g. Claims for meal type products are usually based on a per 100 g basis. "Free" claims are also based on a labeled serving basis. If a product is inherently "free" of, or "low" or "very low" in a nutrient without benefit of special processing alteration, formulation or reformulation, the claim must indicate that all foods of that type meet the definition e.g., "corn oil, a sodium free food." (The name of the food need to be repeated as part of the claim.) If the labeled serving of a food differs from the reference amount and the amount of nutrient in a labeled serving does not meet the minimum/maximum criterion for the definition, the claim must be followed by the requirements of the claim e.g., "very low sodium, 35 mg or less per 240 ml (8 fl oz) [101.13(p)].
Referral Statement [21 CFR 101.13(g)]
The lable or labeling of a food for which a nutrient content claim is made must contain prominently and in immediate proximity to such claim the following referral statement: "See ___ for nutrition information" with the blank filled in with the identity of the panel on which nutrition labeling is located.
1. The referral statement "See [appropriate panel] for nutrition information" must be in easily legible boldface print or type, in 12 distinct contrast to other printed or graphic matter, that is no less than that required by 101.105(l) for net quantity of contents, except where the size of the claim is less than two times the required size of the net quantity of contents statement, in which case the referral statement, in which than one-half the size of the claim but no smaller than on-sixteenth of and inch. 2. The referral statement must be immediately adjacent to the nutrient content claim and may have no intervening material other than, if applicable, other information in the statement of identity or any other information that is required to be presented with the claim. If the nutrient content claim appears on more thna one panel of the label, the referral statement must be adjacent to the claim on each panel except for the panel that bears the nutrition information where it may be omitted. 3. If a single claim of a food label or labeling contains multiple nutrient content claims or a single claim repeated several times, a single referral statement may be made. The statement must be adjacent to the claim that is printed in the largest type on that panel.
Disclosure Statements [21 CFR 101.13(h)]
Some products which are permitted to bear nutrient content claims contain certain other nutrients that increase the risk of disease or health related conditions which are diet related. On these products, instead of the referral statement, the label must bear a disclosure statement, such as "See side panel for information about sodium and other nutrients", which highlights the nutrient that exceeds the levels specified in Chart 2 below.
In three circumstances a different disclosure statement is required. 1) If a claim is made about fiber on a product that is not low fat; 2) if a claim is made about cholesterol on a product that exceeds the disclosure level of fat; and 3) if a free claim is made about saturated fat on a product that is not cholesterol and fat free (less than 2 mg cholesterol and less than 0.5 fat); or a low or reduced saturated fat claim is made on a product that is not cholesterol free and low fat (3 g or less) then the label must disclose the amount of the specified nutrient adjacent to the referral statement, e.g., "High in fiber, Contains 5 g of fat. See side panel for nutrition information."
Relative Claims [21 CFR 101.13(j)(2)]
Relative claims compare the nutrient level of the labeled product to the nutrient level of a reference food. Relative claims are "reduced," "less," "more," "enriched, " "fortified," "added," and "light." See attachment # 3 for the various definitions.
Depending on the claim, the reference food for a relative claim must meet two of the following criteria. It must be a representative food, with a nutrient value representative of a broad base of foods of that type, or an individual food. It must also be a food that is similar to the labeled food (potato chips for potato chips) or a food that is dissimilar, but in the same product category as the labeled food for which it may be substituted (e.g. pretzels for potato chips). These are not meant to be the same product categories as are used for serving size, but the product categories referenced in Attachment # 26 .
When making a relative claim the percent difference and the reference food must be stated adjacent to the most prominent claim. The quantitative nutrient information for the labeled and reference food must also be stated but it may be on the information panel [101.13(j)(2)].
In addition to the nutrient definitions for light (see Attachment # 3 , comments section of calories and sodium), light may be used in the following circumstances:
If the claim describes some physical or organoleptic attribute of the food such as texture or color (e.g., "light in color," or "light in tasts"); and the described attribute is in the same style and color, and at least 1/2 size of the word "light" and in immediate proximity thereto.
If the term has been widely used with a particular food to reflect a physical or organoleptic attribute of the food (e.g., "light brown sugar, " or "light corn syrup.")
CHART 2: DISCLOSURE STATEMENTS
Individual food(*)
Meals(**)
Main Dishes(**)
fat 13.0 g 26.0 g 19.5 g
saturated fat 4.0 g 8.0 g 6.0 g
cholesterol 60 mg 120 mg 90 mg
sodium 480 mg 960 mg 720 mg
(*) per reference a mount, per labeled serving and, if the reference amount is small (30 g or less or 2 tbls or less), per 50 g
(**) per labeled serving [101.13(h)]
Percent and Amount Claims [21 CFR 101.13(i)]
A label may make a statement outside the nutrition facts panel about the amount or percentage of a nutrient "of the type" found in nutrition labeling. Three different options may be used. (While these statements will generally be about the nutrients in the nutrition labeling, option 3 may also be used for other similar nutrients such as omega 3 fatty acids.)
1. The statement may implicitly characterize the level of the nutrient and be consistent with the definition for a claim (e.g., "less than 140 mg sodium per serving.") 2. The statement may implicitly characterize the level of the nutrient but not be consistent with a definition, in which case it must disclose that it does not meet the definition of the claim (e.g. "only 200 mg of sodium per serving, not a low sodium food.") 3. The statement does not implicitly characterize the level of the nutrient and is not otherwise false or misleading (e.g., "200 mg sodium.") No disclosure statement is needed. (Although the word "contains" is a synonym for "good source," it may be used with the percent or amount statement, e.g., "contains 200 mg of sodium," without invoking the definition for "good source").
Claims may be made on meals and main dishes using different definitions than those used for individual foods:
Meal: The product must weigh at least 10 ounces per label serving; contain not less than 3/ 40 g portions of foods or combinations of food from 2 of the 4 food groups exclusive of sauces, gravies, condiments, relishes, pickles, olives, jams jellies, syrups, breading or garnished; and be represented as a breakfast, lunch, dinner or meal [101.13(l)].
Main dish: the product must weigh at least 6 ounces; contain not less than 40 grams of food or combinations of foods, from each of at least 2 of the 4 food groups except as noted above and be represented as a main dish (e.g., not a beverage or desert) [101.13(m)].
A food which substitutes for a standardized food may use the name of that standardized food and a defined nutrient content claim, even if the food no longer wholly complies with the original standard, if the deviation is adequately described by an approved nutrient content claim; the food meets the requirements of that defined term and other requirements of 101.13; and the food complies with the relevant standard in all other respects, e.g., "reduced fat cheddar cheese" [130.10].
In addition, nutrients shall be added to restore the nutrient levels so that the product is not nutritionally inferior. Performance characteristics shall remain the same or the difference shall be noted on the label (e.g., "not recommended for use in cooking.") The ingredients shall be those provided for by the standard except that safe and suitable ingredients may be used to improve texture, add flavor, prevent syneresis, extend shelf life, improve appearance, or add sweetness, so that the product is not inferior in performance
characteristics. Ingredients specifically required by the standard shall not be replaced or exchanged and shall be present in a significant amount (at least that required to achieve the technical effect of that ingredient) and ingredients specifically prohibited by the standard shall not be added. Additional ingredients shall be asterisked in the ingredient statement. All provisions of 101.13 and Subpart D of section 101 apply.
1. Nutrient content claims which have not been defined may continue to be used in a brand name that was in use before October 25, 1989. 2. Soft drinks using the term "diet" in their brand name in compliance with 105.66 as it existed before October 25, 1989, may continue to do so. These products do not need referral or disclosure statements. 3. Statements may describe the percentage of a vitamin or a mineral in a food (including infant and toddler food) in relation to the Daily Value (referral statements are needed). 4. Medical foods and "exempt" infant formulas are completely exempt. 5. Restaurant foods must comply with the various established definitions and many requirements for nutrient content claims. However, there are special provisions that restaurants may use in complying with these regulations. They included using "reasonable basis" for determining if a food qualifies to make a claim [see 101.13(q)(5)]. 6. Nutrient content claims that were part of a standard of identify before November 8, 1990, should comply with the requirements of the standard rather than the definitions established for the various claims. They als are not required to have a referral or disclosure statement. 7. Implied nutrient content claims may be used as part of a brand name provided they are authorized by FDA (this will not apply to grandfathered products). 8. "Fluoridated," "fluoride added" or "with added fluoride" may be used on bottled water that contains added fluoride. No other terms or statements may be used.
HEALTH CLAIMS [21 CFR 101.14]
Any claim made on the label or in labeling of a food that expressly or by implication characterizes the relationship of any substance (e.g., a specific food or component of food) to a disease or health-related condition.
A disease or health-related condition means damage to an organ, part, structure, or systme of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension).
Authorized health claims are as follows (see attachment # 4 - Health Claims Chart for additional information, including CFR cites):
1. Calcium and Osteoporosis; 2. Fat and Cancer; 3. Saturated Fat, Cholesterol and Coronary Heart Disease; 4. Fiber-Containing Grain Products, Fruits and Vegetables and Cancer; 5. Fruits, Vegetables and Grain Products that Contain Fiber and Risk of Coronary Heart Disease; 6. Sodium and Hypertension (High Blood Pressure); and 7. Fruits and Vegetables and Cancer. 8. Folic Acid and Neural Tube Defects
All information required to be included in the claim must appear in one place without other intervening material, except that principal display panel of the label or labeling may bear the reference statement, "See _____ for information about the relationship between _____ and _____," with the blanks filled in with the location of the labeling containing the health claim, the name of the substance, and the disease or health-related condition (e.g., "See attached pamphlet for information about calcium and osteoporosis"), with the entire claim appearing elsewhere on the other labeling, procided that, where any graphic material (e.g., a heart symbol) constituting an explicit or implied health claim appears on the label or labeling, the reference statement or the complete claim must appear in immediate proximity to such graphic material.
Note: A document developed by CFSAN, dated August 1993,' Food Labeling Questions and Answers for guidance to facilitate the process of developing or revising labels for foods other than dietary supplements, which provides answers to specific labeling questions is also available as a separate document. Copies of this document should be available in your district from anyone who has attended NLEA training.