that the nutrient/disease relationship is well established.
Claims can be made in several ways: through third‐party references (such as the National Cancer Institute), statements, symbols (such as a heart), and vignettes or descriptions. Whatever the type, the claim must meet the requirements for authorized health claims. For example, the claim cannot state the degree of risk reduction and can only use “may” or “might” in discussing the nutrient or food–disease relationship. And the claim must state that other factors play a role in that disease. The claims also must be phrased so that consumers can understand the relationship between the nutrient and the disease, and the nutrient’s importance in relation to a daily diet. An example of an appropriate claim is: “While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease.”
The following are some of the FDA‐authorized health claims and some (but not all) of the specific requirements on their use.15
5.4.1 Calcium and Osteoporosis16
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.
Claim Requirements
Food or supplement must meet or exceed for a “high” level of calcium, the calcium content must be assimilable, and the product must not contain more phosphorus than calcium. The claim must make clear the importance of adequate calcium intake throughout life, in a healthful diet, is essential to reduce osteoporosis risk. The claim does not imply that adequate calcium intake is the only recognized risk factor for the development of osteoporosis. The claim may not attribute any degree of reduction in risk of osteoporosis to maintaining an adequate dietary calcium intake. Claims for products with more than 400 mg of calcium per day must state that a daily intake over 2,000 mg offers no added known benefit to bone health.
Model Claims: “Adequate calcium throughout life, as part of a well‐balanced diet, may reduce the risk of osteoporosis.”
“Adequate calcium as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life.”
5.4.2 Dietary Fat and Cancer17
Diets high in fat increase the risk of some types of cancer, such as cancers of the breast, colon, and prostate. While scientists do not know how total fat intake affects cancer development, low‐fat diets reduce the risk. Experts recommend that Americans consume 30 percent or less of daily calories as fat.
Requirements
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.
Sample Claim: “Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers.”
5.4.3 Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease18
Diets high in saturated fat and cholesterol increase total and low‐density (bad) blood cholesterol levels and, thus, the risk of coronary heart disease (CHD). Diets low in saturated fat and cholesterol decrease the risk. Guidelines recommend that American diets contain less than 10 percent of calories from saturated fat and less than 300 mg cholesterol daily. The average American adult diet has 13 percent saturated fat and 300–400 mg cholesterol a day.
Requirements
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.
Sample Claim: “While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease.”
5.4.4 Sodium and Hypertension (High Blood Pressure)19
Hypertension is a risk factor for CHD 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 2,400 mg.
Requirements
Foods must meet criteria for “low sodium.” Claims must use “sodium” and “high blood pressure” in discussing the nutrient–disease link.
Sample Claim: “Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.”
5.4.5 Fiber‐Containing Grain Products, Fruits, and Vegetables and Cancer20
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.
Requirements
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.
Sample Claim: “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.”
5.4.6 Fruits, Vegetables, and Grain Products that Contain Fiber, Particularly Soluble Fiber, and Risk of Coronary Heart Disease21
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 CHD. (It is impossible to adequately distinguish the effects of fiber, including soluble fiber, from those of other food components.)
Requirements
Foods
