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Health Claim
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Requirements
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Sample Claim
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Calcium and osteoporosis Low calcium intake is one risk factor for osteoporosis. Lifelong adequate calcium intake helps maintain bone health by increasing, as much as genetically possible, the amount of bone formed in the teens and early adult life and by helping to slow the rate of bone loss that occurs later in life. |
Food or supplement must be “high” in calcium and must not contain more phosphorus than calcium. Claims must cite other risk factors; state the need for regular exercise and a healthful diet; explain that adequate calcium early in life helps reduce fracture risk later by increasing, as much as genetically possible, a person's peak bone mass; and must indicate that those at greatest risk of developing osteoporosis later in life are white and Asian teenage and young adult women who are in their bone-forming years. Claims for products with more than 400 mg of calcium per day must state that a daily intake over 2000 mg offers no added known benefit to bone health. |
Regular exercise and a healthy diet with enough calcium help teen and young adult white and Asian women maintain good bone health and may reduce their high risk of osteoporosis later in life.
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Dietary fat and cancer Diets high in fat increase the risk of some types of cancer, such as cancers of the breast, colon, and prostate. Although scientists don't know how total fat intake affects cancer development, low-fat diets reduce the risk. Experts recommend that Americans consume 30% or less of daily calories as fat. Typical U.S. intakes are 37%. |
Foods must meet criteria for “low fat.” Fish and game meats must meet criteria for “extra lean.” Claims may not mention specific types of fats and must use “total fat” or “fat” and “some types of cancer” or “some cancers” in discussing the nutrient-disease link. |
Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers.
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Dietary saturated fat and cholesterol and risk of coronary heart disease Diets high in saturated fat and cholesterol increase total and low-density (bad) blood cholesterol levels and, thus, the risk of coronary heart disease. Diets low in saturated fat and cholesterol decrease the risk. Guidelines recommend that American diets contain less than 10% of calories from saturated fat and less than 300 mg cholesterol daily. The average American adult diet has 13% saturated fat and 300 to 400 mg cholesterol a day. |
Foods must meet criteria for “low saturated fat,” “low cholesterol,” and “low fat.” Fish and game meats must meet criteria for “extra lean.” Claims must use “saturated fat and cholesterol” and “coronary heart disease” or “heart disease” in discussing the nutrient-disease link. |
Although many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease.
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Dietary soluble fiber, such as that found in whole oats and psyllium seed husk, and coronary heart disease When included in a diet low in saturated fat and cholesterol, soluble fiber may affect blood lipid levels, such as cholesterol, and thus lower the risk of heart disease. However, because soluble dietary fibers constitute a family of very heterogeneous substances that vary greatly in their effect on the risk of heart disease, FDA has determined that sources of soluble fiber for this health claim need to be considered case-by-case. To date, FDA has reviewed and authorized two sources of soluble fiber eligible for this claim: whole oats and psyllium seed husk. |
Foods must meet criteria for “low saturated fat,” “low cholesterol,” and “low fat.” Foods that contain whole oats must contain at least 0.75 g of soluble fiber per serving. Foods that contain psyllium seed husk must contain at least 1.7 g of soluble fiber per serving. The claim must specify the daily dietary intake of the soluble fiber source necessary to reduce the risk of heart disease and the contribution one serving of the product makes toward that intake level. Soluble fiber content must be stated in the nutrition label. Claims must use “soluble fiber” qualified by the name of the eligible source of soluble fiber and “heart disease” or “coronary heart disease” in discussing the nutrient-disease link. Because of the potential hazard of choking, foods containing dry or incompletely hydrated psyllium seed husk must carry a label statement telling consumers to drink adequate amounts of fluid, unless the manufacturer shows that a viscous adhesive mass is not formed when the food is exposed to fluid. |
Diets low in saturated fat and cholesterol that include 3 g of soluble fiber from whole oats per day may reduce the risk of heart disease. One serving of this whole-oats product provides [number] grams of this soluble fiber.
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Fiber-containing grain products, fruits, and vegetables and cancer Diets low in fat and rich in fiber-containing grain products, fruits, and vegetables may reduce the risk of some types of cancer. The exact role of total dietary fiber, fiber components, and other nutrients and substances in these foods is not fully understood. |
Foods must meet criteria for “low fat” and, without fortification, be a “good source” of dietary fiber. Claims must not specify types of fiber and must use “fiber,” “dietary fiber,” or “total dietary fiber” and “some types of cancer” or “some cancers” in discussing the nutrient-disease link. |
Low-fat diets rich in fiber-containing grain products, fruits, and vegetables may reduce the risk of some types of cancer, a disease associated with many factors.
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Fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease Diets low in saturated fat and cholesterol and rich in fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, may reduce the risk of coronary heart disease. (It is impossible to adequately distinguish the effects of fiber, including soluble fiber, from those of other food components.) |
Foods must meet criteria for “low saturated fat,” “low fat,” and “low cholesterol.” They must contain, without fortification, at least 0.6 g of soluble fiber per reference amount, and the soluble fiber content must be listed. Claims must use “fiber,” “dietary fiber,” “some types of dietary fiber,” “some dietary fibers,” or “some fibers” and “coronary heart disease” or “heart disease” in discussing the nutrient-disease link. The term “soluble fiber” may be added. |
Diets low in saturated fat and cholesterol and rich in fruits, vegetables, and grain products that contain some types of dietary fiber, particularly soluble fiber, may reduce the risk of heart disease, a disease associated with many factors.
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Folate and neural tube birth defects Defects of the neural tube occur within the first six weeks after conception, often before the pregnancy is known. The U.S. Public Health Service recommends that all women of childbearing age in the United States consume 0.4 mg (400 μg) of folic acid daily to reduce their risk of having a baby affected with spina bifida or other neural tube defects. |
Foods must meet or exceed criteria for “good source” of folate—that is, at least 40 μg of folic acid per serving (at least 10% of the Daily Value). A serving of food cannot contain more than 100% of the Daily Value for vitamin A and vitamin D because of their potential risk to fetuses. Claims must use “folate,” “folic acid,” or “folacin” and “neural tube defects,” “birth defects such as spina bifida or anencephaly,” “birth defects of the brain or spinal cord, anencephaly, or spina bifida,” “spina bifida and anencephaly, birth defects of the brain or spinal cord,” “birth defects of the brain and spinal cord,” or “brain or spinal cord birth defects” in discussing the nutrient-disease link. Folic acid content must be listed on the Nutrition Facts panel. |
Healthful diets with adequate folate may reduce a woman's risk of having a child with a brain or spinal cord birth defect.
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Fruits and vegetables and cancer Diets low in fat and rich in fruits and vegetables may reduce the risk of some cancers. Fruits and vegetables are low-fat foods and may contain fiber or vitamin A (as beta-carotene) and vitamin C. (The effects of these vitamins cannot be adequately distinguished from those of other fruit or vegetable components.) |
Foods must meet criteria for “low fat” and, without fortification, be a “good source” of fiber, vitamin A, or vitamin C. Claims must characterize fruits and vegetables as foods that are low in fat and may contain dietary fiber, vitamin A, or vitamin C; characterize the food itself as a “good source” of one or more of these nutrients, which must be listed; refrain from specifying types of fatty acids; and use “total fat” or “fat,” “some types of cancer” or “some cancers,” and “fiber,” “dietary fiber,” or “total dietary fiber” in discussing the nutrient-disease link. |
Low-fat diets rich in fruits and vegetables (foods that are low in fat and may contain dietary fiber, vitamin A, or vitamin C) may reduce the risk of some types of cancer, a disease associated with many factors. Broccoli is high in vitamins A and C, and it is a good source of dietary fiber.
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Sodium and hypertension (high blood pressure) Hypertension is a risk factor for coronary heart disease and stroke deaths. The most common source of sodium is table salt. Diets low in sodium may help lower blood pressure and related risks in many people. Guidelines recommend daily sodium intakes of not more than 2400 mg. Typical U.S. intakes are 3000 to 6000 mg. |
Foods must meet criteria for “low sodium.” Claims must use “sodium” and “high blood pressure” in discussing the nutrient-disease link. |
Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.
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Dietary sugar alcohol and dental caries (cavities) Eating foods high in sugar and starches between meals may promote tooth decay. Sugarless candies made with certain sugar alcohols do not. |
Foods must meet the criteria for “sugar free.” The sugar alcohol must be xylitol, sorbitol, mannitol, maltitol, isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated glucose syrups, erythritol, or a combination of these. When the food contains a fermentable carbohydrate, such as sugar or flour, the food must not lower plaque pH in the mouth below 5.7 while it is being eaten or up to 30 minutes afterwards. Claims must use “sugar alcohol,” “sugar alcohols,” or the name(s) of the sugar alcohol present and “dental caries” or “tooth decay” in discussing the nutrient-disease link. Claims must state that the sugar alcohol present “does not promote,” “may reduce the risk of,” “is useful in not promoting,” or “is expressly for not promoting” dental caries. |
Full claim: Frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. The sugar alcohols in this food do not promote tooth decay. On small packages only:Does not promote tooth decay.
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