Authorized Health Claims: Part 2

by Food and Drug Administration (FDA)

(Page 3 of 3)

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.)

Typical Foods: Fruits and vegetables.

Requirements: 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.

Sample Claim: "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."

Folate and neural tube birth defects

Defects of the neural tube (a structure that develops into the brain and spinal cord) 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 mcg) of folic acid daily to reduce their risk of having a baby affected with spina bifida or other neural tube defects.

Typical Foods: Enriched cereal grain products, some legumes (dried beans), peas, fresh leafy green vegetables, oranges, grapefruit, many berries, some dietary supplements, and fortified breakfast cereals.

Requirements: Foods must meet or exceed criteria for "good source" of folate — that is, at least 40 mcg of folic acid per serving (at least 10 percent of the Daily Value). A serving of food cannot contain more than 100 percent 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 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.

Sample Claim: "Healthful diets with adequate folate may reduce a woman's risk of having a child with a brain or spinal cord birth defect."

Dietary sugar alcohol and dental caries (cavities)

Between-meal eating of foods high in sugar and starches may promote tooth decay. Sugarless candies made with certain sugar alcohols do not.

Typical Foods: Sugarless candy and gum.

Requirements: 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.

Sample Claim: 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." Shortened claim (on small packages only): "Does not promote tooth decay."

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.

Typical Foods: Oatmeal cookies, muffins, breads and other foods made with rolled oats, oat bran or whole oat flour; hot and cold breakfast cereals containing whole oats or psyllium seed husk; and dietary supplements containing psyllium seed husk.

Requirements: 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.

Sample Claim: "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 ___ grams of this soluble fiber."

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.