11 - Natural Health Research Institute



11. Appendix C: Health Claims

October 2009.

The FDA had allowed the claims listed below as of Oct. 2009. Additional claims are also approved from time to time. Labels displaying these claims help consumers choose healthy options.

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|Requirements for Health Claims Made in Labeling |

|Approved Claims |Requirements for the Food |Claim Requirements |Model Claim, Statements |

|Calcium and Osteoporosis |For calcium and osteoporosis |Calcium and Osteoporosis: Adequate|The claim makes clear the |

|and calcium, vitamin D, |claim-high in calcium |calcium throughout life, as part |importance of adequate calcium|

|and osteoporosis |For calcium, vitamin D and |of a well-balanced diet, may |intake, or when appropriate, |

| |osteoporosis claim-high in calcium and|reduce the risk of osteoporosis. |adequate calcium and vitamin D|

|(21 CFR 101.72) |vitamin D |Calcium, vitamin D and |intake, throughout life, in |

| |-assimilable (Bioavailable) |osteoporosis: Adequate calcium and|healthful diet, are essential |

| |Supplements must disintegrate and |vitamin D, as part of a well |to reduce osteoporosis risk. |

| |dissolve, and |balanced diet, along with physical|The claim does not imply that |

| |Phosphorus content cannot exceed |activity, may reduce the risk of |adequate calcium intake, or |

| |calcium content |osteoporosis. |when appropriate, adequate |

| | | |calcium and vitamin D intake, |

| | | |is the only recognized risk |

| | | |factor for the development of |

| | | |osteoporosis. |

| | | |The claim does not attribute |

| | | |any degree of reduction in |

| | | |risk of osteoporosis to |

| | | |maintaining an adequate |

| | | |dietary calcium intake, or |

| | | |when appropriate, an adequate |

| | | |dietary calcium and vitamin D |

| | | |intake, throughout life. |

|Dietary Fat and Cancer |Low fat |Required terms: |Development of cancer depends |

| |(Fish & game meats: "Extra lean") |"Total fat" or "Fat" |on many factors. A diet low in|

|(21 CFR 101.73) | |"Some types of cancers" or "Some |total fat may reduce the risk |

| | |cancers" |of some cancers. |

| | |Does not specify types of fats or | |

| | |fatty acids that may be related to| |

| | |risk of cancer. | |

|Sodium and Hypertension |Low sodium |Required terms: |Diets low in sodium may reduce|

| | |"Sodium", "High blood pressure" |the risk of high blood |

|(21 CFR 101.74) | |Includes physician statement |pressure, a disease associated|

| | |(Individuals with high blood |with many factors. |

| | |pressure should consult their | |

| | |physicians) if claim defines high | |

| | |or normal blood pressure | |

|Dietary Saturated Fat and |Low saturated fat, |Required terms: |While many factors affect |

|Cholesterol, and risk of |Low cholesterol, and |Saturated fat and cholesterol, |heart disease, diets low in |

|Coronary Heart Disease |Low fat |"Coronary heart disease" or heart |saturated fat and cholesterol |

| | |disease |may reduce the risk of this |

|(21 CFR 101.75) | |Includes physician statement |disease. |

| | |(individuals with elevated blood | |

| | |total--or LDL--cholesterol should | |

| | |consult their physicians) if claim| |

| | |defines high or normal blood | |

| | |total--and LDL--cholesterol. | |

|Fiber-Containing Grain |A grain product, fruit, or vegetable |Required terms: |Low fat diets rich in |

|Products, Fruits, and |that contains dietary fiber; |"Fiber", "Dietary fiber", or |fiber-containing grain |

|Vegetables and Cancer |Low fat, and |"Total dietary fiber" |products, fruits, and |

| |Good source of dietary fiber (without |"Some types of cancer" or "Some |vegetables may reduce the risk|

|(21 CFR 101.76) |fortification) |cancers" |of some types of cancer, a |

| | |Does not specify types of dietary |disease associated with many |

| | |fiber that may be related to risk |factors. |

| | |of cancer. | |

|Fruits, Vegetables and |A fruit, vegetable, or grain product |Required terms: |Diets low in saturated fat and|

|Grain Products that |that contains fiber; |"Fiber", "Dietary fiber", "Some |cholesterol and rich in |

|contain Fiber, |Low saturated fat, |types of dietary fiber", "Some |fruits, vegetables, and grain |

|particularly Soluble |Low cholesterol, |dietary fibers", or "Some fibers" |products that contain some |

|Fiber, and Risk of V |Low fat, |"Saturated fat" and "Cholesterol" |types of dietary fiber, |

|Coronary Heart Disease |At least 0.6 grams of soluble fiber |"Heart disease" or "Coronary heart|particularly soluble fiber, |

| |per RACC (without fortification), and,|disease" |may reduce the risk of heart |

|(21 CFR 101.77) |Soluble fiber content provided on |Includes physician statement |disease, a disease associated |

| |label |("Individuals with elevated blood |with many factors. |

| | |total--or LDL--cholesterol should | |

| | |consult their physicians") if | |

| | |claim defines high or normal blood| |

| | |total--and LDL--cholesterol. | |

|Fruits and Vegetables and |A fruit or vegetable, |Required terms: |Low fat diets rich in fruits |

|Cancer |Low fat, and |"Fiber", "Dietary fiber", or |and vegetables (foods that are|

| |Good source (without fortification) of|"Total dietary fiber"; |low in fat and may contain |

|(21 CFR 101.78) |at least one of the following |"Total fat" or "Fat", |dietary fiber, Vitamin A, or |

| |Vitamin A, |"Some types of cancer" or "Some |Vitamin C) may reduce the risk|

| |Vitamin C, or |cancers" |of some types of cancer, a |

| |Dietary fiber |Characterizes fruits and |disease associated with many |

| | |vegetables as "Foods that are low |factors. Broccoli is high in |

| | |in fat and may contain Vitamin A, |vitamin A and C, and it is a |

| | |Vitamin C, and dietary fiber." |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 | |

| | |fiber that may be related to risk | |

| | |of cancer. | |

|Folate and Neural Tube |"Good source" of folate (at least 40 |Required terms: |Healthful diets with adequate |

|Defects |mcg folate per serving) |Terms that specify the |folate may reduce a woman's |

| |Dietary supplements, or foods in |relationship (e.g., women who are |risk of having a child with a |

|(21 CFR 101.79) |conventional food form that are |capable of becoming pregnant and |brain or spinal cord defect. |

| |naturally good sources of folate |who consume adequate amounts of | |

| |(i.e., only non-fortified food in |folate) "Folate", "folic acid", | |

| |conventional food form) |"folacin","folate a B vitamin", | |

| |The claim shall not be made on |"folic acid, a B vitamin," | |

| |products that contain more than 100% |"folacin, a B vitamin," "neural | |

| |of the RDI for vitamin A as retinol or|tube defects", "birth defects, | |

| |preformed vitamin A or vitamin D |spinal bifida, or anencephaly", | |

| |Dietary supplements shall meet USP |"birth defects of the brain or | |

| |standards for disintegration and |spinal cord -- anencephaly or | |

| |dissolution or otherwise bioavailable |spinal bifida", "spinal bifida or | |

| |Amount of folate required in Nutrition|anencephaly, birth defects of the | |

| |Label |brain or spinal cord". | |

| | |Must also include information on | |

| | |the multifactorial nature of | |

| | |neural tube defects, and the safe | |

| | |upper limit of daily intake. | |

|Dietary Noncariogenic |Sugar free, and |Required terms: |Full claim: Frequent |

|Carbohydrate Sweeteners |When a fermentable carbohydrate is |"does not promote," "may reduce |between-meal consumption of |

|and Dental Caries |present, the food must not lower |the risk of," "useful [or is |foods high in sugars and |

| |plaque pH below 5.7. |useful] in not promoting" or |starches promotes tooth decay.|

|(21 CFR 101.80) |Eligible substances |"expressly [or is expressly] for |The sugar alcohols in [name of|

| |1) The following sugar |not promoting" dental caries; |food] do not promote tooth |

| |alcohols:xylitol, sorbitol, mannitol, |"dental caries" or "tooth decay." |decay. |

| |maltitol, isomalt, lactitol, |"sugar alcohol" or "sugar |Shortened claim(on small |

| |hydrogenated starch hydrolysates, |alcohols" or the name or names of |packages only): Does not |

| |hydrogenated glucose syrups, |the sugar alcohols; or D-tagatose,|promote tooth decay. |

| |erythritol, or a combination of these.|or sucralose | |

| |2) The following sugar:D-tagatose |Note: D-tagatose may be identified| |

| |3) The following non-nutritive |as "tagatose" | |

| |sweetener:sucralose |When the substance that is the | |

| | |subject of the claim is a | |

| | |noncariogenic sugar (i.e., | |

| | |D-tagatose)  the claim shall | |

| | |identify the substance as a sugar | |

| | |that, unlike other sugars, does | |

| | |not promote the development of | |

| | |dental caries. | |

| | |Includes statement that frequent | |

| | |between meal consumption of foods | |

| | |high in sugars and starches can | |

| | |promote tooth decay. | |

| | |Packages with less than 15 square | |

| | |inches of surface area available | |

| | |for labeling may use a shortened | |

| | |claim. | |

|Soluble Fiber from Certain|Low saturated fat |Required terms: |Soluble fiber from foods such |

|Foods and Risk of Coronary|Low cholesterol |"Heart disease" or "coronary heart|as [name of soluble fiber |

|Heart Disease |Low fat, and |disease." |source, and, if desired, name |

| |The food product must include one or |"Saturated fat" and "cholesterol."|of food product], as part of a|

|(21 CFR 101.81) |more of the following whole oat or |In specifying the substance the |diet low in saturated fat and |

| |barley foods: 1) oat bran, 2) rolled |claim uses the term "soluble |cholesterol, may reduce the |

| |oats, 3) whole oat flour, 4) whole |fiber" qualified by the name of |risk of heart disease. A |

| |grain barley or dry milled barley, and|the eligible source of the soluble|serving of [name of food |

| |the whole oat or barley foods must |fiber, which is either whole oat |product] supplies __ grams of |

| |contain at least 0.75 g of soluble |or barley or psyllium seed husk. |the [necessary daily dietary |

| |fiber per RACC of the food product; or|Claim specifies the daily dietary |intake for the benefit] |

| |Oatrim that contains at least 0.75 g |intake of the soluble fiber source|soluble fiber from [name of |

| |of beta-glucan soluble per RACC of the|necessary to reduce the risk of |soluble fiber source] |

| |food product; or |CHD |necessary per day to have this|

| |Psyllium husk that contains at least |Claim specifies the amount of |effect. |

| |1.7 g of soluble fiber per RACC of |soluble fiber in one serving of | |

| |food product. |the product. | |

| |Eligible Sources of Soluble Fiber |Additional Required Label | |

| |Beta-glucan soluble fiber from the |Statement | |

| |following whole oat and barley |Foods bearing a psyllium seed husk| |

| |sources: |health claim must also bear a | |

| |1) Oat bran |label statement concerning the | |

| |2) Rolled Oats |need to consume them with adequate| |

| |3) Whole Oat Flour |amounts of fluids; e.g., "NOTICE: | |

| |4) Oatrim |This food should be eaten with at | |

| |5) Whole Grain Barley and Dry Milled |least a full glass of liquid. | |

| |Barley |Eating this product without enough| |

| |6) Barley Beta Fiber |liquid may cause choking. Do not | |

| |7) Soluble fiber from psyllium husk |eat this product if your have | |

| |with purity of no less than 95% |difficulty in swallowing." | |

| |The amount of soluble fiber per RACC |(21 CFR 101.17(f)) | |

| |must be declared in nutrition label. | | |

|Soy Protein and Risk of |At least 6.25 g soy protein per RACC |Required terms: |(1) 25 grams of soy protein a |

|Coronary Heart Disease |Low saturated fat, |"Heart disease" or "coronary heart|day, as part of a low in |

| |Low cholesterol, and |disease" |saturated fat and cholesterol,|

|(21 CFR 101.82) |Low fat (except that foods made from |"Soy protein" |may reduce the risk of heart |

| |whole soybeans that contain no fat in |"Saturated fat" and "cholesterol" |disease. A serving of [name of|

| |addition to that inherent in the whole|Claim specifies daily dietary |food] supplies __ grams of soy|

| |soybean are exempt from the "low fat" |intake levels of soy protein |protein. |

| |requirement) |associated with reduced risk |(2) Diets low in saturated fat|

| | |Claim specifies amount of soy |and cholesterol that include |

| | |protein in a serving of food |25 grams of soy protein a day |

| | | |may reduce the risk of heart |

| | | |disease. One serving of [name |

| | | |of food] provides __ grams of |

| | | |soy protein. |

|Plant Sterol/stanol esters|At least 0.65 g plant sterol esters |Required terms: |(1) Foods containing at least |

|and Risk of Coronary Heart|per RACC of spreads and salad |"May" or "might" reduce the risk |0.65 gram per of vegetable oil|

|Disease |dressings, or |of CHD |sterol esters, eaten twice a |

| |At least 1.7 g plant stanol esters per|"Heart disease" or "coronary heart|day with meals for a daily |

|(21 CFR 101.83) |RACC of spreads, salad dressings, |disease" |total intake of least 1.3 |

| |snack bars, and dietary supplements. |"Plant sterol esters" or "plant |grams, as part of a diet low |

| |Low saturated fat, |stanol esters"; except "vegetable |in saturated fat and |

| |Low cholesterol, and |oil" may replace the term "plant" |cholesterol, may reduce the |

| |Spreads and salad dressings that |if vegetable oil is the sole |risk of heart disease. A |

| |exceed 13 g fat per 50 g must bear the|source of the sterol/stanol ester |serving of [name of food] |

| |statement "see nutrition information |Claim specifies plant stero/stanol|supplies __ grams of vegetable|

| |for fat content" |esters are part of a diet low in |oil sterol esters. |

| |Salad dressings are exempted from the |saturated fat and cholesterol. |(2) Diets low in saturated fat|

| |minimum 10% DV nutrient requirement |Claim does not attribute any |and cholesterol that include |

| |(see General Criteria below) |degree of CHD risk reduction. |two servings of foods that |

| | |Claim specifies the daily dietary |provide a daily total of at |

| | |intake of plant sterol or stanol |least 3.4 grams of plant |

| | |esters necessary to reduce CHD |stanol esters in two meals may|

| | |risk, and the amount provided per |reduce the risk of heart |

| | |serving. |disease. A serving of [name of|

| | |Claim specifies that plant sterol |food] supplies __ grams of |

| | |or stanol esters should be |plant stanol esters. |

| | |consumed with two different meals | |

| | |each a day. | |

      

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|FDAMA (FDA Modernization Act) Health Claims (Health Claims Authorized Based on an Authoritative Statement by Federal Scientific |

|Bodies) |

|Approved Claims |Food Requirements |Claim Requirements |Model Claim |

| | | |Statements |

|Whole Grain Foods and Risk |Contains 51 percent or more whole grain|Required wording of the claim: |NA |

|of Heart Disease and |ingredients by weight per RACC, and |"Diets rich in whole grain foods and | |

|Certain Cancers |Dietary fiber content at least: |other plant foods and low in total fat, | |

|(Docket No. 1999P-2209) |3.0 g per RACC of 55 g |saturated fat, and cholesterol may reduce| |

| |2.8 g per RACC of 50 g |the risk of heart disease and some | |

| |2.5 g per RACC of 45 g |cancers." | |

| |1.7 g per RACC of 35 g | | |

| |Low fat | | |

|Potassium and the Risk of |Good source of potassium |Required wording for the claim: |NA |

|High Blood Pressure and |Low sodium |"Diets containing foods that are a good | |

|Stroke |Low total fat |source of potassium and that are low in | |

|(Docket No. 2000Q-1582) |Low saturated fat |sodium may reduce the risk of high blood | |

| |Low cholesterol |pressure and stroke." | |

|Fluoridated Water and |Bottled water meeting the standards of |Required wording for the claim: |NA |

|Reduced Risk of Dental |identity and quality set forth in 21 |"Drinking fluoridated water may reduce | |

|Carries |CFR 165.110 |the risk of [dental caries or tooth | |

|(Docket No. 2006Q-0418) |Meet all general requirements for |decay]". | |

| |health claims in 21 CFR 101.14) with | | |

| |the exception of the minimum nutrient | | |

| |contribution (21 CFR 101.14(e)(6)), | | |

| |Total Fluoride: >0.6 to 1.0 mg/L | | |

| |Excluding bottled water products | | |

| |specifically marketed for use by | | |

| |infants | | |

|Saturated Fat, Cholesterol,|Low saturated fat |Required wording for the claim: |NA |

|and Trans Fat, and Reduced |Low cholesterol |"Diets low in saturated fat and | |

|Risk of Heart Disease |Bear quantitative trans fat labeling |cholesterol, and as low as possible in | |

|(Docket No. 2006Q-0458) |Contain less than 0.5 g trans fat per |trans fat, may reduce the risk of heart | |

| |RACC |disease." | |

| |Contain less than 6.5 g total fat | | |

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