Authorized Health Claims

by Food and Drug Administration (FDA)

(Page 2 of 3)

Here are the FDA-authorized health claims and some specifics on their use.

Calcium and osteoporosis

Low calcium intake is one risk factor for osteoporosis, a condition of lowered bone mass, or density. 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.

Typical Foods: Low-fat and skim milks, yogurts, tofu, calcium-fortified citrus drinks, and some calcium supplements.

Requirements: 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 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 2,000 mg offers no added known benefit to bone health.

Sample Claim: "Regular exercise and a healthy diet with enough calcium helps teen and young adult white and Asian women maintain good bone health and may reduce their high risk of osteoporosis later in life."

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 2,400 mg. Typical U.S. intakes are 3,000 to 6,000 mg.

Typical Foods: Unsalted tuna, salmon, fruits and vegetables, and low-fat milks, low-fat yogurts, cottage cheeses, sherbets, ice milk, cereal, flour, and pastas (not egg pastas).

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."

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. While scientists don't 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. Typical U.S. intakes are 37 percent.

Typical Foods: Fruits, vegetables, reduced-fat milk products, cereals, pastas, flours, and sherbets.

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."

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 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 to 400 mg cholesterol a day.

Typical Foods: Fruits, vegetables, skim and low-fat milks, cereals, whole-grain products, and pastas (not egg pastas).

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."

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.

Typical Foods: Whole-grain breads and cereals, fruits, and vegetables.

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."

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.)

Typical Foods: Fruits, vegetables, and whole-grain breads and cereals.

Requirements: 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.

Sample Claim: "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."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.