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ATTACHMENT 1 DISPLAY STYLE CHART FOR NUTRITION LABELING Display Style/ More than 40 40 or less Square Less than 12 Available Label Square Inches Inches Square Inches Space Full Vertical Yes Yes Yes display with footnote Full Vertical No Yes Yes display no footnote Simplified Yes Yes Yes vertical display no footnote Tabular display Yes Yes Yes with footnote(2) Tabular display No Yes Yes No footnote(1) Linear Display(3) No Yes Yes Phone number or No No Yes, if no address for claims or other obtaining nutrition nutrition information information Note: For discussion of "available label space" see August 18, 1993 Federal Register (58 FR 44075, comment 42). 1. "No footnote" as used in above table is to indicate that the footnote of 101.9(d)(9) is needed. However, the statement "Percent Daily Value (DV) is based on a 2,000 calorie diet" is required on all labels, except on foods for children under four years of age. 2. The tabular display may only be used if there is not sufficient continuous space for the vertical display of the full, shortened, or simplified formats. 3. The linear display may only be used if the package size and shape cannot accommodate a column display (i.e., vertical or tabular display). 17 ATTACHMENT 2 ILLUSTRATION OF TYPE AND POINT SIZES LABEL Page 18
[58 FR 17332, Apr. 2, 1993] EFFECTIVE DATE NOTE: At 58 FR 2189, Jan. 6, 1993, Appendix B to part 101 was added, effective February 14, 1994. At 58 FR 17328, Apr. 2, 1993 the effective date was corrected to May 8, 1994, and at 58 FR 17332, Apr. 2, 1993 Appendix B was correctly revised, effective May 8, 1994. 18
ATTACHMENT 3
DEFINITIONS OF NUTRIENT CONTENT CLAIMS (1/6 & 8/18/93)
NUTRIENTS FREE LOW REDUCED/LESS COMMENTS
* Synonyms for "Free" : "Zero", * Synonyms for "Low" : "Little", "Synonyms for "Reduced"/"Less": "For "Free", "Very Low", or "Low", must indicate if foods
*No", "Without", "Trivial Source ("Few" For Calories), "Contains a "Lower" ("Fewer" for calories) meets a definition without benefit of special processing,
of*, "Negligible Source of", Small Amount of", "Low Source *"Modified" may be used in alteration, formulation, or reformulation; e.g., "broccoli, a fat
*Dietarily Insignificant Source of", of" statement of identity free food", or "celery, a low calorie food"
"non-fat is an approved synonym "Definitions for meals and main
for fat free" dishes are same as for individual
*Definitions for "Free" for meals food on a per 100g basis
and main dishes are the stated
values per labeled serving
Calories *Less than 5 cal per reference *40 cal or less per reference *At lease 25% fewer calories per *"Light" or "Lite": if 50% or more of the calories are from Fat,
101.30(b) amount and per labeled serving amount (and per 50 g if a reference reference amount than an fat must be reduced by at least 50% per reference amount. If
*Not defined for meals or main amount is small) appropriate reference food less than 50% of calories from fat, fat must be reduced at
dishes "Meals and main dishes: 120 cal "Reference food may not be "Low least 50% or calories reduced at least 1/3 per reference
or less per 100g Calorie" amount
"Uses term "Fewer" rather than *"Light" or "Lite" meal or main dish product meets definition
"Less" for "Low Calorie" or "Low Fat" meal and is labeled to indicate
which definition is met
*For dietary supplements: calorie claims can only be made
when the reference product is greater than 40 calories per
serving
Total Fat *Less than 0.5g per reference *3g or less per reference amount "At least 25% less fat per *"__%_Fat Free": OK if meets the requirements for "Low Fat"
101.62(b) amount and per labeled serving (or (and per 50g if reference amount reference amount than an *"100% Fat Free: food must be "Fat Free"
for meals and main dishes, less is small appropriate reference food *"Light" see above
than 0.5g per labeled serving "Meals and main dishes: 3g or *Reference food may not be "Low *For dietary supplements: fat claims cannot be made for
*No ingredient that is fat or less per 100g and not more than Fat" products that are 40 calories or less per serving
understood to contain fat except 30% of calories from fat
as noted below
Saturated Fat *Less than 0.5g saturated fat and *1g or less per reference amount *At least 25% less saturated fat *Next to all saturated fat claims, must declare the amount of
101.62(c) less than 0.5g trans fatty acids per and 15% or less calories from per reference amount than an cholesterol if 2mg or more per reference amount: and the
reference amount and per labeled saturated fat appropriate reference food amount of total fat if more than 3g per reference amount for
serving (or for meals and main *Meals and main dishes: 1g or *Reference food may not be "Low 0.5g or more of total fat for "Saturated Fat Free")
dishes, less than 0.5g saturated less per 100g and less than 10% Saturated Fat" "For dietary supplements: saturated fat claims cannot be made
fat and less than 0.5g trans fatty of calories from saturated fat for products that are 40 calories or less per serving
acid per labeled serving)
No ingredient that is understood to
contain saturated fat except as
noted below
Notes: Except if the ingredient listed in the ingredient statement has an asterisk that refers to footnote (for e.g., "*adds a trivial amount of fat") Reference Amount* = reference amount customarily consumed. "Small Reference Amount" = reference amount of 30g or less or 2 tablespoons or less (for dehydrated foods that are typically consumed when rehydrated with water or a diluent containing an insignificant amount, as defined in 101.9(f)(1) of all nutrients per reference amount, the per 50g criterion refers to the prepared form of this food). Statement "See ___panel for nutrition information" must accompany all content claims. When levels exceed: 13g Fat, 4g Saturated Fat, 60mg Cholesterol, and 480mg Sodium per reference amount, per labeled serving or, for food with small reference amounts, per 50 g, disclosure statement is required as part of claim (e.g., "See side panel for information on fat and other nutrients").
ATTACHMENT 3
19
DEFINITIONS OF NUTRIENT CONTENT CLAIMS (1/6 & 8/18/93)
NUTRIENTS FREE LOW REDUCED/LESS COMMENTS
Cholesterol *Less than 2 mg per reference *20 mg or less per reference *At least 25% less cholesterol per *CHOLESTEROL CLAIMS ONLY ALLOWED WHEN FOOD
101.62(d) amount and per labeled serving amount {and per 50g of food if reference amount than an CONTAINS 2g OR LESS SATURATED FAT PER REFERENCE
(or for meals and main dishes, less reference amount is small} appropriate reference food AMOUNT' OR FOR MEALS AND MAIN DISHES PRODUCTS
than 2mg per labeled serving) *If qualifies by special professing *Reference food may not be "Low PER LABELED SERVING SIZE FOR "FREE" CLAIMS OR PER
No ingredient that contains and total fat exceeds 13g per Cholesterol" 100g FOR "LOW" AND "REDUCED/LESS" CLAIMS
cholesterol except as noted below(1) reference and labeled serving, the *Must declare the amount of total fat next to cholesterol claim
*If less than 2mg per reference amount of cholesterol must be when fat exceeds 13g per reference amount and labeled
amount by special processing and *Substantially Less(*) {25%} than in serving {or per 50g of food if reference amount is small}, or
total fat exceeds 13g per a reference food with significant when the fat exceeds 19.5g per labeled serving for main
reference and labeled serving, the market share [5% of market] dishes or 26g for meal products
amount of cholesterol must be Meals and main dishes: 20mg or *For dietary supplements; cholesterol claims cannot be made
"Substantially Less" {25%} than in less per 100g for products that are 40 calories or less per serving
a reference food with significant
market share {5% of market}
Sodium *Less than 5mg per reference *140mg or less per reference *At least 25% less sodium per *"Light {for sodium reduced products}: if food is "Low Calorie"
101.61 amount and per labeled serving {or amount {and per 50g if reference reference amount than an and "Low Fat" and sodium is reduced by at least 50%
for meals and main dishes, less amount is small} appropriate reference food *"Light In Sodium": If sodium is reduced by at least 50% per
than 5 mg per labelled serving} *Made and main dishes: 140mg *Reference food may not be "Low reference amount. Entire term "High In Sodium" must be used
*No ingredient that is sodium or less per 100g Sodium" in the same type size, color & prominence. Light In Sodium for
chloride or generally understood to meals = "Low in Sodium"
contain sodium except as noted *"Very Low Sodium": 35 mg or less per reference amount {
below and per 50g if reference amount in small}. For meals and main
dishes: 35mg or less per 100g
*"Salt Free" must meet criterion for "Sodium Free"
*"No Salt Added" and "Unsalted" must meet conditions of use
and must declare "This Is Not A Sodium Free Food" on
information panel if food is not "Sodium Free"
"Lightly Salted": 50% less sodium than normally added to
reference food and if not "Low Sodium" so labeled on
information panel
Sugars *"Sugar Free": Less than 0.5g *Not Defined. No basis for a *At least 25% less sugars per *"No Added Sugars" and "Without Added Sugars" are allowed
101.60(o) sugars per reference amount and recommended Intake reference amount than an if no sugar or sugar containing ingredient is added during
per labeled serving {or for meals appropriate reference food processing. State if food is not "Low " or "Reduced Calorie"
and main dishes, less than 0.5g *May not use this claim on dietary *The terms "Unsweetened" and "No Added Sweeteners"
per labeled serving} supplements of vitamins and remains as factual statements
*No ingredient that is a sugar or minerals *Claims about reducing dental caries are implied health claims
generally understood to contain *Does not include sugar alcohols
sugars except as noted below"
*Disclose calorie profile (e.g,
*Low Calorie")
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DEFINITIONS OF NUTRIENT CONTENT CLAIMS (1/6 & 8/18/93)
IMPLIED CLAIMS
* Claims about a food ingredient that suggests that the nutrient or ingredient
are absent or present in a certain amount or claims about a food that suggests
a food may be useful in maintaining healthy dietary practices and which
are made with an explicit claim (e.g. "healthy, contains 3 grams of
fat") are implied claims and are prohibited unless provided for in
regulation by FDA. In addition, the Agency has devised a petition system
whereby specific additional claims may be considered.
* Claims that a food contains or is made with an ingredient that is known
to contain a particular nutrient may be made if product is "Low"
in or a "Good Source" of the Nutrient associated with the claim
(e.g., "good source of oath bran").
* Equivalence claims: "contains as much [nutrient] as [food"
may be made if both reference food and labeled food are "Good Source"
of nutrient on a per serving basis. (e.g. "Contains as much vitamin
C as an 8 ounce of glass of orange juice").
* The following label statements are generally not considered implied
claims unless they are made in nutrition context: 1) avoidance claims
for religious, food intolerance, or other non-nutrition related reasons
{e.g. "100% milk free"}; 2} statements about non-nutritive substances
(e.g. "no artificial colors)' 3) added value statement (e.g. "made
with real butter"); 4) statements of identity (e.g. "corn oil"
or "corn oil margarine"); and 5) special dietary statements made
in compliance with a specific Part 105 provision.
CLAIMS ON FOODS FOR INFANTS AND CHILDREN LESS THAN 2 YEARS OF AGE
Nutrient content claims are not permitted on foods intended specifically
for infants and children less than 2 years of age except:
1) Claims describing the percentage of vitamins and minerals in food in
relation to a Daily Value.
2) Claims on infant formulas provided for in Part 107.
3) The terms "Unsweetened" and "Unsalted" as taste
claims.
4) "Sugar Free" and "No Added Sugar" claims on dietary
supplements only.
TERMS COVERED THAT ARE NOT NUTRIENT CONTENT CLAIMS
"Fresh" | A raw food that has not been frozen, heat processed, or otherwise preserved
"Fresh Frozen" | Food was quickly frozen while still fresh
RELATIVE (OR COMPARATIVE) CLAIMS
* For all relative claims, percent (or fraction)_of change and identity
of reference food must be declared in immediate proximity to the most prominent
claim. Quantitative comparison of the amount of the nutrient in the product
per labeled serving with that in the reference food must ne declared on
information panel.
* For Light claims: % reduction for both fat and calories must be stated
but % reduction need not be specified if product is low in the nutrient.
Quantitative comparisons must be stated for both fat and calories.
ATTACHMENT 3
21
DEFINITIONS OF NUTRIENT CONTENT CLAIMS (1/6 & 8/18/93)
REFERENCE FOODS
"Light"/"Life" (1) A food representative of the type of food bearing the claim, e.g. average value of top three brands
for representative value from valid data base; (2) similar food (e.g., potato chips for potato chips); and
(3) not low calorie and low fat (except light sodium foods which must be low calorie and low fat).
"Reduced" and "Added" (1) An established regular product or average representative product and (2) similar food
(or "fortified" and
"enriched)
"More" and "Less" for (1) An established regular product or average representative product and (2) a dissimilar food in the
"Fewer") same product category which may be generally substituted for labeled food (e.g., potato chips for
pretzels) or a similar food.
OTHER NUTRIENT CONTENT CLAIMS
"Lean" On a seafood or game meat that contains < 10g total fat, 4.5g or less saturated fat and 95mg
cholesterol/reference amount and per 100g (for meals & main dishes, meets criteria per 100 g and per
labeled serving).
"Extra Lean" On seafood or game that contains < 5g total fat, < 2g saturated fat and <95mg cholesterol per
reference amount and per 100g (for meals and main dishes, meets criteria per 100g and per label
serving).
"High", "Rich In", or Contains 20% or more of the Daily Value (DV) to describe protein, vitamins, minerals, dietary fiber, or
"Excellent Source of"(*) potassium per reference amount
May be used on meals or main dishes to indicate that product contains a food that meets definition.
May not be used for total carbohydrates
"More"(*) 10% or more of the DV per reference amount
May only be used for vitamins, minerals, protein, dietary fiber and potassium.
"Modified" May be used in statement of identity that bears a relative claim, e.g. "Modified Fat Cheese Cake,
Contains 35% Less Fat Than Other Regular Cheese Cake.(*)
Any Fiber Claim If a food is low in total fat, must state total fat in conjunction with claim such as mor"More Fiber".
(*) Dietary supplements of vitamins and minerals cannot use these claims
to describe any nutrient or ingredient (e.g., fiber protein, psyllium,
bran) other than vitamins or minerals.
ATTACHMENT 3
22
Attachment 3
OTHER NUTRIENT CONTENT CLAIMS
HEALTHY
In order to use the term "Healthy", an individual food,
seafood/game meat, or meal/main dish must meet all the
requirements listed below
INDIVIDUAL FOOD SEAFOOD/GAME MEAT MEAL/MAIN DISH
Total Fat low fat <5g fat/RA & per 100g(*) low fat
Saturated Fat low sat. fat <2g sat. fat/RA & per 100g(*) low sat. fat
Sodium (before 1/98) LE 480 mg/RA LE 480 mg/RA LE 600mg/ls
LE 480mg/ls, and LE 480mg/ls, and
LE 480mg/50g if RA small(**) LE 480mg/50g if RA small(**)
Sodium (after 1/98) LE 360mg/RA LE 360mg/RA LE 480mg/ls
LE 360mg/ls, and LE 360mg/ls, and
LE 360mg/50g if RA small(**) LE 360mg/50g if RA small(**)
Cholesterol LE disclosure(***) < 95mg/RA & per 100g(*) LE 90mg/ls
Beneficial Nutrients Except raw fruits or veg., at least 10% of DV/RA of Vitamins A, 10%DV/ls of 2
C, calcium, iron, protein or fiber nutrients for main
dish; 3 nutrients
for meal
Fortification Fortification per 104.20 Fortification per 104.20 Fortification per
104.20
OTHER CLAIMS: Food complies with established definition and declaration
requirements for any specified nutrient content claim.
LE = less than or equal to
ls = labeled serving
DV = daily value
RA = reference amount
small RA = 30g or less or 2 tbls or less
(*) must meet both criteria
(**) must meet all three criteria
(***) See Chart 2 in the manual, section 'Nutrient Content
Claims', subsection 'Disclosure Statements'.
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