Inspections, Compliance, Enforcement, and Criminal Investigations

NUTRITION LABELING AND EDUCATION ACT (NLEA) REQUIREMENTS-ATTACHMENT 1

ATTACHMENT 1

DISPLAY STYLE CHART FOR NUTRITION LABELING

Display Style / Available Label Space More than 40 Square Inches 40 or less Square Inches Less than 12 Square Inches
Full Vertical display with footnoteYesYesYes
Full Vertical display no footnoteNoYesYes
Simplified vertical display no footnoteYesYesYes
Tabular display with footnote(2)YesYesYes
Tabular display No footnote(1)NoYesYes
Linear Display(3)NoYesYes
Phone number or address for obtaining nutrition informationNoNoYes, if no claims or other nutrition 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).

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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.

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ATTACHMENT 3

DEFINITIONS OF NUTRIENT CONTENT CLAIMS (1/6 & 8/18/93)

NUTRIENTS FREE LOW REDUCED/LESS COMMENTS  
  * Synonyms for "Free"; "Zero", *No", "Trivial Source of*, *Dietarily Insignificant Source of", "non-fat is an appproved synonym for fat free" * Synonyms for "Low": "Little", ("Few" Forr Calories), "Contains a Small Amount of", "Low Source of" "Synonyms for "Reduced"/"Less"; "Lower" ("fewer" for Calories) *"Modified"may be used in statement of identity "For "Free", "Very Low", or "Low", must indicate if foods meets a definition without benefit of special processing, alteration, formulation, or reformulation; ee.g., "broccoli, a fat free food", or "celery, a low calorie food"  
  *Definitions for "Free" for meals and main dishes are the stated vaalues per labeled serving   "Ddifinitions for meals and main dishes are same as for individual food on per 100g basis    
Calories
101.30(b)
*Less than 5 cal per reference amount and per lableed serving *Not Defined for meals or main dishes *40 cal or less per reference amount (and perr 50 g if a reference amount is small)
"Meeals and mian dishes: 120 cal or less per 100g
*At lease 25% fewer calories per reference amount than an aappropriate refference food "Reference food may not be "Low Calorie"
"Use ter "Fewer" rather than "Less"
*"Light" or "Lite": if 50% or more of the calories are from Fat, fat must bee reduced by at leaast 50% pere reference amount. If less than 50% of caalories from fat, fat must be reduced at leat 50% or calories reduced at leeast 1/3 per reference amount
*"Light" or "Lite" meal or main dish product meets definition for "Low Calorie" or "Low Fat" meal and is labeled to indicate which definition is met
*For dietary suppleemeents: calorie claims can only be made when the reference product is greatere than 40 calories per serving
 
Total Fat
101.62(c)
*Less than 0.5g per reference amount and per labeled serving (or for meals and main dishes, less than 0.5g pere labeled serving 8No ingredient that is fat or understood to contain fat except as noted below 3g or less per reference amount (and per 50g if reference amount is small
"Meals and main dishes: 3g or less per 100g and not more than 30% of calories from fat
"At least 25% fat per referrence amount than an appropriate reference food * Reference food may not be "Low Fat" *"__%_Fat Free": OK of meets the requirements for "Low Fat" 8"100%Fat Free: food must be "Fat Free"
*"Light" see above
*For dietary supplements: fat claims cannot be made for products that aree 40 calories or less per serving
 
Saturated Fat
101.62(c)
*Less than 0.5g saturaated fat and less than 0.5g trans fatty acids per reference amount and per labeled serving ( or for meals and main dishes, less than 0.5g saturateed fat and less than 0.5g trans fatty acid per labeled serving)
No ingredient that is understood to contain saturated fat except as noted below
*1g or less reference amount and 15% or less calories from saturated fat
* Meals and main dishes: 1gd or less per 100g and less than 10% of calories from saturated fat
*At least 25% less saturateed fat per reference amount than an appropriate reference food *Reference food may net be "Low Saturateed Fat" *Next to all saturateed fat claaims, must declare the amount of cholesterol if 2mg or more per reference amount: and the amount of total fat if more than 3g per reference amount for 0.5g or more of tatl fat for "Saturateed Fat Free") "for dietary supplements: saturated fat claims cannot be made for products that are 40 calories or less per serving  
 

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

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DEFINITIONS OF NUTRIENT CONTENT CLAIMS (1/6 & 8/18/93)

NUTRIENTS FREE LOW REDUCED/LESS COMMENTS  
Cholesterol
101.62(d)
*Less than 2 mg per reference amount and per labeled serving (or for meals and main dishes, less No ingredient that contains cholesterol except as noted below(1) *If less than 2mg per reference amount by special processing and total fat exceeds 13g per reference and labeled serving, the amount of cholesterol must be "Substantially Less" {25%} than in a reference food with significant market share {5% of market} *20 mg or less per reference amount {and per 50g of food if reference amount is small} *If qualifies by special professing and total fat exceeds 13g per reference and labeled serving, the amount of cholesterol must be *Substantially Less(*) {25%} than in a reference food with significant market share [5% of market] Meals and main dishes: 20mg or less per 100g *At least 25% less cholesterol per reference amount than an appropriate reference food *Reference food may not be "Low Cholesterol" *CHOLESTEROL CLAIMS ONLY ALLOWED WHEN FOOD CONTAINS 2g OR LESS SATURATED FAT PER REFERENCE AMOUNT' OR FOR MEALS AND MAIN DISHES PRODUCTS PER LABELED SERVING SIZE FOR "FREE" CLAIMS OR PER 100g FOR "LOW" AND "REDUCED/LESS" CLAIMS *Must declare the amount of total fat next to cholesterol claim when fat exceeds 13g per reference amount and labeled serving {or per 50g of food if reference amount is small}, or when the fat exceeds 19.5g per labeled serving for main dishes or 26g for meal products *For dietary supplements; cholesterol claims cannot be made for products that are 40 calories or less per serving  
Sodium 101.61 *Less than 5mg per reference amount and per labeled serving {or for meals and main dishes, less than 5 mg per labelled serving} *No ingredient that is sodium chloride or generally understood to contain sodium except as noted below *140mg or less per reference amount {and per 50g if reference amount is small} *Made and main dishes: 140mg or less per 100g *At least 25% less sodium per reference amount than an appropriate reference food *Reference food may not be "Low Sodium" *"Light {for sodium reduced products}: if food is "Low Calorie" and "Low Fat" and sodium is reduced by at least 50% *"Light In Sodium": If sodium is reduced by at least 50% per reference amount. Entire term "High In Sodium" must be used in the same type size, color & prominence. Light In Sodium for meals = "Low in Sodium" *"Very Low Sodium": 35 mg or less per reference amount { 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 101.60(o) *"Sugar Free": Less than 0.5g sugars per reference amount and per labeled serving {or for meals and main dishes, less than 0.5g per labeled serving} *No ingredient that is a sugar or generally understood to contain sugars except as noted below" *Disclose calorie profile (e.g, *Low Calorie") *Not Defined. No basis for a recommended Intake *At least 25% less sugars per reference amount than an appropriate reference food *May not use this claim on dietary supplements of vitamins and minerals *"No Added Sugars" and "Without Added Sugars" are allowed if no sugar or sugar containing ingredient is added during processing. State if food is not "Low " or "Reduced Calorie" *The terms "Unsweetened" and "No Added Sweeteners" remains as factual statements *Claims about reducing dental caries are implied health claims *Does not include sugar alcohols
 

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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

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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" (or "fortified" and "enriched)
  1. An established regular product or average representative product and
  2. similar food
 
"More" and "Less" for "Fewer")
  1. An established regular product or average representative product and a dissimilar food in the 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 100 (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 "Excellent Source of"(*)
Contains 20% or more of the Daily Value (DV) to describe protein, vitamins, minerals, dietary fiber, or 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

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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 480mg/ls, and
LE 480mg/50g if RA small(**)
LE 480 mg/RA
LE 480mg/ls, and
LE 480mg/50g if RA small(**)
LE 600mg/ls
Sodium (after 1/98) LE 360mg/RA LE 360mg/ls, and LE 360mg/50g if RA small(**) LE 360mg/RA LE 360mg/ls, and LE 360mg/50g if RA small(**) LE 480mg/ls
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, C, calcium, iron, protein or fiber   10%DV/ls of 2 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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