11. Appendix C: Health Claims

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.

Requirements for Health Claims Made in Labeling

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

Calcium and For calcium and Calcium and The claim makes Osteoporosis osteoporosis claim-high in Osteoporosis: Adequate clear the importance and calcium, calcium calcium throughout of adequate calcium vitamin D, and life, as part of a well- intake, or when osteoporosis For calcium, vitamin D balanced diet, may appropriate, and osteoporosis claim- reduce the risk of adequate calcium (21 CFR high in calcium and osteoporosis. and vitamin D 101.72) vitamin D intake, throughout Calcium, vitamin D life, in healthful diet, -assimilable and osteoporosis: are essential to (Bioavailable) Adequate calcium and reduce osteoporosis vitamin D, as part of a Supplements must risk. The claim does well balanced diet, disintegrate and dissolve, not imply that along with physical and adequate calcium activity, may reduce intake, or when Phosphorus content the risk of osteoporosis. appropriate, cannot exceed calcium adequate calcium content 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 Low fat Required terms: Development of Cancer cancer depends on (Fish & game meats: "Total fat" or "Fat" many factors. A diet (21 CFR "Extra lean") low in total fat may "Some types of 101.73) reduce the risk of cancers" or "Some some cancers. cancers" Does not specify types of fats or fatty acids that may be related to risk of cancer.

Sodium and Low sodium Required terms: Diets low in sodium Hypertension may reduce the risk "Sodium", "High blood of high blood (21 CFR pressure" pressure, a disease 101.74) associated with Includes physician many factors. statement (Individuals with high blood pressure should consult their physicians) if claim defines high or normal blood pressure

Dietary Low saturated fat, Required terms: While many factors Saturated Fat affect heart disease, and Cholesterol, Low cholesterol, and Saturated fat and diets low in saturated and risk of cholesterol, fat and cholesterol Coronary Heart Low fat may reduce the risk Disease "Coronary heart of this disease. disease" or heart (21 CFR disease 101.75) Includes physician statement (individuals with elevated blood total--or LDL-- cholesterol should consult their physicians) if claim defines high or normal blood total--and LDL-- cholesterol.

Fiber- A grain product, fruit, or Required terms: Low fat diets rich in Containing vegetable that contains fiber-containing Grain Products, dietary fiber; "Fiber", "Dietary grain products, Fruits, and fiber", or "Total dietary fruits, and vegetables Vegetables and Low fat, and fiber" may reduce the risk Cancer of some types of Good source of dietary "Some types of cancer" cancer, a disease (21 CFR fiber (without or "Some cancers" associated with 101.76) fortification) many factors. Does not specify types of dietary fiber that may be related to risk of cancer.

Fruits, A fruit, vegetable, or grain Required terms: Diets low in Vegetables and product that contains saturated fat and Grain Products fiber; "Fiber", "Dietary cholesterol and rich that contain fiber", "Some types of in fruits, vegetables, Fiber, Low saturated fat, dietary fiber", "Some and grain products particularly dietary fibers", or that contain some Soluble Fiber, Low cholesterol, "Some fibers" types of dietary and Risk of V fiber, particularly Low fat, Coronary Heart "Saturated fat" and soluble fiber, may "Cholesterol" Disease At least 0.6 grams of reduce the risk of heart disease, a soluble fiber per RACC "Heart disease" or (21 CFR disease associated (without fortification), "Coronary heart 101.77) with many factors. and, disease" Soluble fiber content Includes physician provided on label statement ("Individuals with elevated blood total--or LDL-- cholesterol should consult their physicians") if claim defines high or normal blood total--and LDL-- cholesterol. Fruits and A fruit or vegetable, Required terms: Low fat diets rich in Vegetables and fruits and vegetables Cancer Low fat, and "Fiber", "Dietary (foods that are low fiber", or "Total dietary in fat and may (21 CFR Good source (without fiber"; contain dietary fiber, 101.78) fortification) of at least Vitamin A, or one of the following "Total fat" or "Fat", Vitamin C) may reduce the risk of  Vitamin A, "Some types of cancer" some types of or "Some cancers"  Vitamin C, or cancer, a disease Characterizes fruits and associated with  Dietary fiber vegetables as "Foods many factors. that are low in fat and Broccoli is high in may contain Vitamin vitamin A and C, A, Vitamin C, and and it is a good dietary fiber." 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 "Good source" of folate Required terms: Healthful diets with Neural Tube (at least 40 mcg folate per adequate folate may Defects serving) Terms that specify the reduce a woman's relationship (e.g., risk of having a child (21 CFR Dietary supplements, or women who are with a brain or spinal 101.79) foods in conventional capable of becoming cord defect. food form that are pregnant and who naturally good sources of consume adequate folate (i.e., only non- amounts of folate) fortified food in "Folate", "folic acid", conventional food form) "folacin","folate a B vitamin", "folic acid, a The claim shall not be B vitamin," "folacin, a made on products that B vitamin," "neural contain more than 100% tube defects", "birth of the RDI for vitamin A defects, spinal bifida, as retinol or preformed or anencephaly", "birth vitamin A or vitamin D defects of the brain or spinal cord -- Dietary supplements shall anencephaly or spinal meet USP standards for bifida", "spinal bifida disintegration and or anencephaly, birth dissolution or otherwise defects of the brain or bioavailable spinal cord". Amount of folate required Must also include in Nutrition Label information on the multifactorial nature of neural tube defects, and the safe upper limit of daily intake.

Dietary Sugar free, and Required terms: Full claim: Frequent Noncariogenic between-meal Carbohydrate When a fermentable "does not promote," consumption of Sweeteners and carbohydrate is present, "may reduce the risk foods high in sugars Dental Caries the food must not lower of," "useful [or is and starches plaque pH below 5.7. useful] in not promotes tooth (21 CFR promoting" or decay. The sugar Eligible substances 101.80) "expressly [or is alcohols in [name of expressly] for not 1) The following sugar food] do not promote promoting" dental alcohols:xylitol, sorbitol, tooth decay. caries; mannitol, maltitol, Shortened claim(on isomalt, lactitol, "dental caries" or small packages hydrogenated starch "tooth decay." only): Does not hydrolysates, promote tooth decay. hydrogenated glucose "sugar alcohol" or syrups, erythritol, or a "sugar alcohols" or the combination of these. name or names of the sugar alcohols; or D- 2) The following sugar:D- tagatose, or sucralose tagatose Note: D-tagatose may 3) The following non- be identified as nutritive "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 Low saturated fat Required terms: Soluble fiber from from Certain foods such as [name Foods and Risk Low cholesterol "Heart disease" or of soluble fiber of Coronary "coronary heart source, and, if Heart Disease Low fat, and disease." desired, name of food product], as The food product must (21 CFR "Saturated fat" and part of a diet low in include one or more of the 101.81) "cholesterol." saturated fat and following whole oat or cholesterol, may barley foods: 1) oat bran, In specifying the reduce the risk of 2) rolled oats, 3) whole substance the claim heart disease. A oat flour, 4) whole grain uses the term "soluble serving of [name of barley or dry milled fiber" qualified by the food product] barley, and the whole oat name of the eligible supplies __ grams of or barley foods must source of the soluble the [necessary daily contain at least 0.75 g of fiber, which is either dietary intake for the soluble fiber per RACC of whole oat or barley or benefit] soluble fiber the food product; or psyllium seed husk. from [name of Oatrim that contains at Claim specifies the soluble fiber source] least 0.75 g of beta-glucan daily dietary intake of necessary per day to soluble per RACC of the the soluble fiber source have this effect. food product; or necessary to reduce the risk of CHD Psyllium husk that contains at least 1.7 g of Claim specifies the soluble fiber per RACC of amount of soluble fiber food product. in one serving of the product. Eligible Sources of Soluble Fiber Additional Required Label Statement Beta-glucan soluble fiber from the following whole Foods bearing a oat and barley sources: psyllium seed husk health claim must also 1) Oat bran bear a label statement concerning the need to 2) Rolled Oats consume them with 3) Whole Oat Flour adequate amounts of fluids; e.g., "NOTICE: 4) Oatrim This food should be eaten with at least a full 5) Whole Grain glass of liquid. Eating Barley and Dry this product without Milled Barley enough liquid may 6) Barley Beta Fiber cause choking. Do not eat this product if your 7) Soluble fiber have difficulty in from psyllium husk swallowing." with purity of no less than 95% (21 CFR 101.17(f)) The amount of soluble fiber per RACC must be declared in nutrition label.

Soy Protein and At least 6.25 g soy protein Required terms: (1) 25 grams of soy Risk of per RACC protein a day, as part Coronary Heart "Heart disease" or of a low in saturated Disease Low saturated fat, "coronary heart fat and cholesterol, disease" may reduce the risk Low cholesterol, and (21 CFR of heart disease. A 101.82) "Soy protein" Low fat (except that foods serving of [name of made from whole "Saturated fat" and food] supplies __ soybeans that contain no "cholesterol" grams of soy protein. fat in addition to that (2) Diets low in inherent in the whole Claim specifies daily saturated fat and soybean are exempt from dietary intake levels of cholesterol that the "low fat" requirement) soy protein associated with reduced risk include 25 grams of soy protein a day Claim specifies amount may reduce the risk of soy protein in a of heart disease. One serving of food serving of [name of food] provides __ grams of soy protein.

Plant At least 0.65 g plant sterol Required terms: (1) Foods containing Sterol/stanol esters per RACC of at least 0.65 gram esters and Risk spreads and salad "May" or "might" per of vegetable oil of Coronary dressings, or reduce the risk of CHD sterol esters, eaten Heart Disease twice a day with "Heart disease" or At least 1.7 g plant stanol meals for a daily "coronary heart (21 CFR esters per RACC of total intake of least disease" 101.83) spreads, salad dressings, 1.3 grams, as part of snack bars, and dietary "Plant sterol esters" or a diet low in supplements. "plant stanol esters"; saturated fat and cholesterol, may Low saturated fat, except "vegetable oil" may replace the term reduce the risk of Low cholesterol, and "plant" if vegetable oil heart disease. A is the sole source of the serving of [name of Spreads and salad sterol/stanol ester food] supplies dressings that exceed 13 g __ grams of fat per 50 g must bear the Claim specifies plant vegetable oil sterol statement "see nutrition stero/stanol esters are esters. information for fat part of a diet low in content" saturated fat and (2) Diets low in cholesterol. saturated fat and Salad dressings are cholesterol that exempted from the Claim does not include two servings minimum 10% DV attribute any degree of of foods that provide nutrient requirement (see CHD risk reduction. a daily total of at General Criteria below) least 3.4 grams of Claim specifies the plant stanol esters in daily dietary intake of two meals may plant sterol or stanol reduce the risk of esters necessary to heart disease. A reduce CHD risk, and serving of [name of the amount provided food] supplies per serving. __ grams of plant Claim specifies that stanol esters. plant sterol or stanol esters should be consumed with two different meals each a day.

FDAMA (FDA Modernization Act) Health Claims (Health Claims Authorized Based on an Authoritative Statement by Federal Scientific Bodies) Approved Food Requirements Claim Requirements Model Claim Claims Statements

Whole Grain Contains 51 percent or Required wording of the NA Foods and Risk more whole grain claim: of Heart Disease ingredients by weight per and Certain RACC, and "Diets rich in whole grain Cancers foods and other plant foods Dietary fiber content at and low in total fat, (Docket least: saturated fat, and cholesterol No. 1999P-2209) may reduce the risk of heart  3.0 g per RACC of disease and some cancers." 55 g

 2.8 g per RACC of 50 g

 2.5 g per RACC of 45 g

 1.7 g per RACC of 35 g Low fat

Potassium and Good source of potassium Required wording for the NA the Risk of High claim: Blood Pressure Low sodium and Stroke "Diets containing foods that Low total fat are a good source of (Docket potassium and that are low Low saturated fat No. 2000Q-1582) in sodium may reduce the Low cholesterol risk of high blood pressure and stroke."

Fluoridated Bottled water meeting the Required wording for the NA Water and standards of identity and claim: Reduced Risk of quality set forth in 21 CFR Dental Carries 165.110 "Drinking fluoridated water may reduce the risk of (Docket Meet all general [dental caries or tooth No. 2006Q-0418) requirements for health decay]". 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, Low saturated fat Required wording for the NA Cholesterol, and claim: Trans Fat, and Low cholesterol Reduced Risk of "Diets low in saturated fat Bear quantitative trans fat Heart Disease and cholesterol, and as low labeling as possible in trans fat, may (Docket reduce the risk of heart Contain less than 0.5 g No. 2006Q-0458) disease." trans fat per RACC Contain less than 6.5 g total fat