ATTACHMENT 4 HEALTH CLAIMS CHART Approved Food Claim Model Claim Claims Requirements Requirements Statements
Calcium and High in calcium, Assimilable Indicated disease depends on many factors by listing risk Regular exercise and a healthy diet with Osteoporosis 101.72 Bioavailable, Supplement must factors for the disease. enough calcium helps teens and young disintegrate and dissolve, and Gender - Female adult white and Asian women maintain Phosphorus content cannot Race - Caucasian and Asian good bone health and may reduce their exceed calcium content. Age - Growing older high risk of osteoporosis later in life. Primary target population Females Caucasian and Asian races Teens and young adults in their bone forming years Additional factors necessary to reduce risk Eating healthful meals Regular exercise Mechanism relating calcium to osteoporosis Optimizes peek bone @@@ Foods or supplement containing more than 400 mg calcium Must state that total intakes of greater than 2,000 mg calcium provide no added benefit to bone health Sodium and low sodium Required terms Diets low in sodium may reduce the risk of Hypertension 101.74 "Sodium" high blood pressure, a disease associated "High blood pressure" with many factors. Includes physician statement (Individuals with high blood pressure should consult their physicians) If claim defines high or normal blood pressure Dietary fat and Cancer Low fat Required terms Development of cancer depends on many 101.73 Fish & game meats: "Extra lean" "Total fat" or "Fat" factors. A diet low in total fat may reduce "Some types of cancers" or "Some cancers" the risk of some cancers. Does not specify types of fats or fatty acids that may be related to risk of cancer Dietary Saturated Fat Low saturated fat, Required terms: White many factors affect heart disease, and Cholesterol and Risk Low cholesterol, and "Saturated fat and cholesterol" diets low in saturated fat and cholesterol of Coronary Heart Low fat "Coronary heart disease" or "Heart disease" may reduce the risk of this disease. Disease 101.75 Fish & game meats: "Extra lean" Includes physician statement (Individuals with elevated blood total - or LDL - cholesterol should consult their physician) If claim defines high or normal blood total and LDL-cholesterol Fiber-Containing Grain A grain product, fruit, or Required terms: Low fat diets rich in Fiber- Products, Fruits, and vegetable that contains dietary "Fiber", "Dietary fiber", or "Total dietary fiber" containing grain products, fruits, and Vegetables and Cancer fiber, Low fat, and "Some types of cancer" or "Some cancers" vegetables may reduce the risk of some 101.76 Good source of dietary fiber Does not specify types of dietary fiber that may be related types of cancer, a disease associated with (without fortification) to risk of cancer. many factors. ATTACHMENT 4 24 HEALTH CLAIMS CHART Approved Food Claim Model Claim Claims Requirements Requirements Statements Fruits, A Fruit, vegetable, or grain Required terms: Diets low in saturated fat and Vegetables, and product that contains fiber, "Fiber", "Dietary fiber", "Some types of dietary fiber", cholesterol and rich in fruits, vegetables, Grain Products That Low saturated fat, "Some dietary fibers", or "Some fibers" and grain products that contain some types Contain Fiber, Low cholesterol, Low fat, "Saturated fat" and "Cholesterol" of dietary fiber, particularly soluble fiber, Particularly Soluble At least 0.6 grams of soluble fiber "Heart disease" or "Coronary heart disease" may reduce the risk of heart disease, a Fiber, and Risk of per RA (without fortification), and Includes physician statement (individuals with elevated blood disease associated with many factors Coronary Heart Disease Soluble fiber constant provided on Total - or LDL - cholesterol should consult their physicians) 101.77 label if claim defines high or normal blood total - and LDL - cholesterol Fruits and Vegetables A fruit or vegetable, Required terms: Low fat diets rich in fruits and vegetables and Cancer 101.78 Low fat, end Good source "Fiber", "Dietary fiber", or "Total dietary fiber" {foods that are low in fat and may contain {without fortification} of "Total fat" or "Fat" dietary fiber, Vitamin A, or Vitamin C} may at least one of the following: "Some types of cancer" or "Some cancers" reduce the risk of some types of cancer, a Vitamin A, Vitamin C, or dietary Characterizes fruits and vegetables as "Foods that are low disease associated with many factors. fiber in fat and may contain Vitamin A, Vitamin C, and dietary Broccoli is high in vitamins A and C, and is fiber" a good source of dietary fiber. Characterizes specific food as a "Good source" of one or more of the following: Dietary fiber, Vitamin A, or Vitamin C Does not specify types of fats or Fatty acids or types of dietary fibers that may be related to risk of cancer. Folate and Neural Tube Dietary supplements, or Required terms: Woman who consume adequate amounts Defects 101.79 Foods in conventional food form Terms that specify the relationship - {e.g., woman who are of folate daily throughout their childbearing {responds to the Dietary that are naturally good sources of capable of becoming pregnant and who consume adequate years may reduce their risk of having a Supplement Act of folate (i.e., only non-fortified amounts of folate} child with a neural tube birth defects. Such 1992} food in conventional food form) "Folate", "folic acid", "folacin", "folate", "folate a B vitamin", "folio birth defects, while not widespread, are acid, a B vitamin", or "folacin, a B vitamin" very serious. They can have many causes. The claim shall not be made on "Neural tube defect", "birth defects, spinal bifida, or Adequate amounts of folate, a B vitamin, products that contain more than anencephaly", "birth defects of the brain or spinal cord can be obtained from diets rich in fruits, 100 percent of the RDI for vitamin anencephaly or spinal bifida", "spinal bifida or dark green leafy vegetables and legumes, A as retinol or preformed vitamin anencephaly, birth defects of the brain or spinal cord" enriched grain products, fortified cereals, or A or Vitamin D a supplement. Woman who have had a Dietary supplements shall meet Must also include Information on the multifactorial nature and child with a spinal cord birth defect should USP standards for disintegration prevalence of neural tube defects, dietary sources of folate, consult a physician before becoming and dissolution or otherwise and the safe upper limit of daily intake pregnant. Folate consumption should be bioavailable limited to 1,000 ug per day front all sources. General criteria all claims must meet: See following page.
ATTACHMENT 4 25 HEALTH CLAIMS CHART
General Criteria All Claims Must Meet: Only information on the value that intake or reduced intake, as part of a total dietary pattern, may have on a disease or health-related condition Enables public to understand information provided and significance of information in the context of a total daily diet Complete, truthful, and not misleading Food contains, without fortification, 10 percent or more of the Daily Value of one of six nutrients (Dietary supplements excepted) Vitamin A 500IU Calcium 100mg Vitamin C 6mg Protein 5g Iron 1.8mg Fiber 2.5g All information in one place without intervening material {Reference statement permitted) Not represented for infants or toddlers less than 2 years of age Uses "may" or "might" to express relationship between substance and diseases Does not quantify any degree of risk reduction Indicates disease depends on many factors Food contain less than the specified levels of four disqualifying nutrients Disqualifying Nutrient Foods Main Dishes Meal Products Fat 13g 19.5g 26 Saturated Fat 4g 6g 5g Cholesterol 60mg 90mg 120mg Sodium 480mg 720mg 960mg Low Fat Low Sodium Good source of Vitamin A < or = 3g per RA (And per 50 g If RA is small) < or = 140mg per RA (and per 50g if RA is small) food 500 to 950 IU per RA Meats and main dishes: < 3g per 100 g inf not Meals and main dishes: < or = 140mg per 100g Meals and main dishes: Contains food that is a more than 30% of calories from fat good source of Vitamin A and identifies food Low saturated fat "Extra Lean" Good source of Vitamin C < or = 1g per RA and < or = 15% of calories from < 5g total fat and < 2g saturated and 6 to 11.4 mg per RA saturated fat < 95 mg cholesterol per RA and per 100g Meals and Main dishes: Contains food that is a Meals and main dishes: < or = 1g per 100g and Meals and main dishes: <5g total fat and good source of Vitamin C and identifies food < 10% of calories from saturated fat < 2g saturated fat and < 95 mg cholesterol per 100 g and per SS Low cholesterol High in calcium Good source of dietary fiber < or = 20mg per RA (and per 50g if RA is small) > or = 200 mg per RA 2.5 to 4.75 per RA Meals and main dishes: < or = 20mg per 100g Meals and main dishes: Contains food that is high Meals and main dishes: Contains food that is a in calcium and identifies the food good source of dietary fiber and identifies food Abbreviations: RA = Reference Amount; SS = Serving Size; IU = International Units ATTACHMENT 4