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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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

 

                     
 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
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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")                                                                                                                                                                              
                                                                                                                                                                                                             
20

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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