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Fda Health Claim and Qualified Health Claim Guidelines

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Fda Health Claim and Qualified Health Claim Guidelines FDA HEALTH CLAIM AND QUALIFIED HEALTH CLAIM GUIDELINES AG BM 302 – Food Products Marketing Prof. Colby Penn State University From Guidance for Industry: A Food Labeling Guide (Appendix C: Health Claims and Appendix D: Qualified Health Claims) Appendix C: Health Claims Requirements for Health Claims Made in Labeling Approved Claims Requirements for the Food Claim Requirements Model Claim, Statements Calcium and For calcium and osteoporosis claim-high Calcium and Osteoporosis: Adequate The claim makes clear the importance of Osteoporosis and in calcium calcium throughout life, as part of a well- adequate calcium intake, or when calcium, vitamin D, For calcium, vitamin D and osteoporosis balanced diet, may reduce the risk of appropriate, adequate calcium and vitamin D and osteoporosis claim-high in calcium and vitamin D osteoporosis. intake, throughout life, in healthful diet, are -assimilable (Bioavailable) Calcium, vitamin D and osteoporosis: essential to reduce osteoporosis risk. The (21 CFR 101.72) Supplements must disintegrate and Adequate calcium and vitamin D, as part of a claim does not imply that adequate calcium dissolve, and well balanced diet, along with physical intake, or when appropriate, adequate calcium and vitamin D intake, is the only Phosphorus content cannot exceed activity, may reduce the risk of osteoporosis. recognized risk factor for the development of calcium content 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. 1 Dietary Fat and Low fat Required terms: Development of cancer depends on many factors. A diet low in total fat may reduce the Cancer (Fish & game meats: "Extra lean") "Total fat" or "Fat" risk of some cancers. (21 CFR 101.73) "Some types of cancers" or "Some 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 may reduce the risk of Hypertension high blood pressure, a disease associated "Sodium", "High blood pressure" with many factors. (21 CFR 101.74) Includes physician statement (Individuals with high blood pressure should consult their physicians) if claim defines high or normal blood pressure Dietary Saturated Fat Low saturated fat, Required terms: While many factors affect heart disease, diets and Cholesterol, and low in saturated fat and cholesterol may Low cholesterol, and Saturated fat and cholesterol, risk of Coronary Heart reduce the risk of this disease. Low fat Disease "Coronary heart disease" or heart disease Includes physician statement (individuals (21 CFR 101.75) 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 that Required terms: Low fat diets rich in fiber-containing grain Products, Fruits, and products, fruits, and vegetables may reduce contains dietary fiber; "Fiber", "Dietary fiber", or "Total dietary fiber" Vegetables and Low fat, and the risk of some types of cancer, a disease Cancer "Some types of cancer" or "Some cancers" associated with many factors. Good source of dietary fiber (without Does not specify types of dietary fiber that fortification) (21 CFR 101.76) may be related to risk of cancer. Fruits, Vegetables and A fruit, vegetable, or grain product that Required terms: Diets low in saturated fat and cholesterol and Grain Products that rich in fruits, vegetables, and grain products contains fiber; "Fiber", "Dietary fiber", "Some types of contain Fiber, that contain some types of dietary fiber, Low saturated fat, dietary fiber", "Some dietary fibers", or particularly Soluble particularly soluble fiber, may reduce the risk Low cholesterol, "Some fibers" Fiber, and Risk of V of heart disease, a disease associated with Coronary Heart Low fat, "Saturated fat" and "Cholesterol" many factors. Disease At least 0.6 grams of soluble fiber per "Heart disease" or "Coronary heart disease" RACC (without fortification), and, Includes physician statement ("Individuals (21 CFR 101.77) Soluble fiber content provided on label with elevated blood total--or LDL--cholesterol should consult their physicians") if claim defines high or normal blood total--and LDL-- cholesterol. 2 Fruits and Vegetables A fruit or vegetable, Required terms: Low fat diets rich in fruits and vegetables and Cancer (foods that are low in fat and may contain Low fat, and "Fiber", "Dietary fiber", or "Total dietary dietary fiber, Vitamin A, or Vitamin C) may Good source (without fortification) of at fiber"; (21 CFR 101.78) reduce the risk of some types of cancer, a least one of the following "Total fat" or "Fat", disease associated with many factors. Vitamin A, "Some types of cancer" or "Some cancers" Broccoli is high in vitamin A and C, and it is a Vitamin C, or Characterizes fruits and vegetables as good source of dietary fiber. Dietary fiber "Foods that are low in fat and may contain Vitamin A, Vitamin C, and 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 "Good source" of folate (at least 40 mcg Required terms: Healthful diets with adequate folate may Tube Defects reduce a woman's risk of having a child with folate per serving) Terms that specify the relationship (e.g., a brain or spinal cord defect. Dietary supplements, or foods in women who are capable of becoming (21 CFR 101.79) conventional food form that are naturally pregnant and who consume adequate good sources of folate (i.e., only non- amounts of folate) "Folate", "folic acid", fortified food in conventional food form) "folacin","folate a B vitamin", "folic acid, a B The claim shall not be made on products vitamin," "folacin, a B vitamin," "neural tube that contain more than 100% of the RDI defects", "birth defects, spinal bifida, or for vitamin A as retinol or preformed anencephaly", "birth defects of the brain or vitamin A or vitamin D spinal cord -- anencephaly or spinal bifida", Dietary supplements shall meet USP "spinal bifida or anencephaly, birth defects of standards for disintegration and the brain or spinal cord". dissolution or otherwise bioavailable Must also include information on the Amount of folate required in Nutrition multifactorial nature of neural tube defects, Label and the safe upper limit of daily intake. Dietary Noncariogenic Sugar free, and Required terms: Full claim: Frequent between-meal Carbohydrate When a fermentable carbohydrate is "does not promote," "may reduce the risk of," consumption of foods high in sugars and Sweeteners and present, the food must not lower plaque "useful [or is useful] in not promoting" or starches promotes tooth decay. The sugar Dental Caries pH below 5.7. "expressly [or is expressly] for not promoting" alcohols in [name of food] do not promote Eligible substances dental caries; tooth decay. (21 CFR 101.80) 1) The following sugar alcohols:xylitol, "dental caries" or "tooth decay." Shortened claim(on small packages only): Does not promote tooth decay. sorbitol, mannitol, maltitol, isomalt, "sugar alcohol" or "sugar alcohols" or the lactitol, hydrogenated starch name or names of the sugar alcohols; or D- hydrolysates, hydrogenated glucose tagatose, or sucralose syrups, erythritol, or a combination of these. Note: D-tagatose may be identified as "tagatose" 2) The following sugar:D-tagatose 3 3) The following non-nutritive When the substance that is the subject of the sweetener:sucralose 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 Low saturated fat Required terms: Soluble fiber from foods such as [name of Certain Foods and soluble fiber source, and, if desired, name of Low cholesterol "Heart disease" or "coronary heart disease." Risk of Coronary Heart food product], as part of a diet low in Low fat, and Disease "Saturated fat" and "cholesterol." saturated fat and cholesterol, may reduce the The food product must include one or In specifying the substance the claim uses risk of heart disease. A serving of [name of (21 CFR 101.81) more of the following whole oat or barley the term "soluble fiber" qualified by the name food product] supplies __ grams of the foods: 1) oat bran, 2) rolled oats, 3) of the eligible source of the soluble fiber, [necessary daily dietary intake for the benefit] whole oat flour, 4) whole grain barley or which is either whole oat or barley or soluble fiber from [name of soluble fiber dry milled barley, and the whole oat or psyllium seed husk. source] necessary per day to have this effect. barley foods must contain at least 0.75 g of soluble fiber per RACC of the food Claim specifies the daily dietary intake of the product; or soluble fiber source necessary to reduce the risk of CHD Oatrim that contains at least 0.75 g of beta-glucan soluble per RACC of the Claim specifies the amount of soluble fiber in food product; or one serving of the product. Psyllium husk that contains at least 1.7 g Additional Required Label Statement of soluble fiber per RACC of food Foods bearing a psyllium seed husk health product. claim must also bear a label statement Eligible Sources of Soluble Fiber concerning the need to consume them with Beta-glucan soluble fiber from the adequate amounts of fluids; e.g., "NOTICE: following whole oat and barley sources: This food should be eaten with at least a full glass of liquid.
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