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.”
5.4.8 Folate and Neural Tube Birth Defects23
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.
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.”
5.4.9 Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries (Cavities)24
Between‐meal eating of foods high in sugar and starches may promote tooth decay. Sugarless candies made with certain sugar alcohols do not.
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 Claims: 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.”
5.4.10 Dietary Soluble Fiber, Such As That Found in Whole Oats and Psyllium Seed Husk, and Coronary Heart Disease25
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.
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 grams of soluble fiber per serving. Foods that contain psyllium seed husk must contain at least 1.7 grams 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 grams 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.”
5.4.11 Soy Protein and Coronary Heart Disease26
There is an association between soy protein and reduced risk of CHD when included in a diet low in saturated fat and cholesterol through the lowering of blood cholesterol levels.
Requirements
In order to qualify for this health claim, a food must contain at least 6.25 grams of soy protein per serving, the amount that is one‐fourth of the effective level of 25 grams per day.
Sample Claim: “Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of (name of food) provides ____ grams of soy protein.”
5.4.12 Coronary Heart Disease and Plant Sterols and Plant Stanols27
Evidence indicates that plant sterol or plant stanol esters may help to reduce the risk of CHD. Plant sterols are present in small quantities in many fruits, vegetables, nuts, seeds, cereals, legumes, and other plant sources. Plant stanols, which occur naturally in even smaller quantities, are obtained from refined plant sources, such as vegetable oils.
Requirements
In order to qualify for this health claim, a food must contain at least 0.65 grams of plant sterol esters per serving or at least 1.7 grams of plant stanol esters per serving. The claim must specify that the daily dietary intake of plant sterol esters or plant stanol esters should be consumed in two servings eaten at different times of the day with other foods. To qualify, foods must also meet the requirements for low saturated fat and low cholesterol, and must also contain no more than 13 grams of total fat per serving and per 50 grams. However, spreads and salad dressings are not required to meet the limit for total fat per 50 grams if the label of the food bears a disclosure statement referring consumers to the Nutrition Facts section of the label for information about fat content. In addition, except for salad dressing and dietary supplements, the food must contain at least 10% of the RDI or DRV for vitamin A, vitamin C, iron, calcium, protein, or fiber. FDA is also requiring, consistent with other health claims to reduce the risk of CHD, that the claim state that plant sterol and plant stanol esters should be consumed as part of a diet low in saturated fat and cholesterol.
Sample Claim: “Foods containing