Health Claims

Some claims for relationships between a nutrient or a food and the risk of a disease or health-related condition are allowed. They 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 case, the claim must meet the requirements for authorized health claims - for example, they cannot state the degree of risk reduction and can only use “may” or “might” in discussing the nutrient or food-disease relationship. And they must state that other factors play a role in that disease. 

The claims must be phrased so consumers can understand the relationship between the nutrient and the disease and the nutrient’s importance in relationship 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 general overviews of health claims. Please see the Center for Food Safety and Applied Nutrition website for complete information: www.cfsan.fda.gov/~dms/flg-6c.html

The allowed nutrient-disease relationship claims and rules for their use are:

Calcium and osteoporosis

To carry this claim, a food must contain 20 percent or more of the Daily Value for calcium (200 mg) per serving, have a calcium content that equals or exceeds the food’s content of phosphorus, and contain a form of calcium that can be readily absorbed and used by the body. The claim must name the target group most in need of adequate calcium intakes (that is, teens and young adult white and Asian women) and state the need for exercise and a healthy diet. A product that contains 40 percent or more of the Daily Value for calcium must state on the label that a total dietary intake greater than 200 percent of the Daily Value for calcium (that is, 2,000 mg or more) has no further known benefit.

Fat and cancer

To carry this claim, a food must meet the nutrient content claim requirements for “low-fat” or, if fish and game meats, for “extra lean.” 

Saturated fat and cholesterol and coronary heart disease (CHD)

This claim may be used if the food meets the definitions for the nutrient content claim “low saturated fat,” “low- cholesterol,” and “low-fat,” or, if fish and game meats, for “extra lean.” It may mention the link between reduced risk of CHD and lower saturated fat and cholesterol intakes to lower blood cholesterol levels.

Fiber-containing grain products, fruits and vegetables and cancer

To carry this claim, a food must be or must contain a grain product, fruit or vegetable and meet the nutrient content claim requirements for “low-fat,” and, without fortification, be a “good source” of dietary fiber.

Fruits, vegetables and grain products that contain fiber and risk of CHD

To carry this claim, a food must be or must contain fruits, vegetables and grain products. It also must meet the nutrient content claim requirements for “low saturated fat,” “low-cholesterol,” and “low-fat” and contain, without fortification, at least 0.6 g soluble fiber per serving.

Sodium and hypertension (high blood pressure)

To carry this claim, a food must meet the nutrient content claim requirements for “low-sodium.”

Fruits and vegetables and cancer

This claim may be made for fruits and vegetables that meet the nutrient content claim requirements for “low-fat” and that, without fortification, for “good source” of at least one of the following: dietary fiber or vitamins A or C. This claim relates diets low in fat and rich in fruits and vegetables (and thus vitamins A and C and dietary fiber) to reduced cancer risk. FDA authorized this claim in place of an antioxidant vitamin and cancer claim.

Folate and neural tube defects

This claim is allowed on dietary supplements that contain sufficient Folate and on conventional foods that are naturally good sources of Folate, as long as they do not provide more than 100 percent of the Daily Value for vitamin A as Retinol or preformed vitamin A or vitamin D. A sample claim is “healthful diets with adequate Folate may reduce a woman’s risk of having a child with a brain or spinal cord defect.”

Dietary sugar alcohols and dental caries (cavities)

This claim applies to food products, such as candy or gum, containing the sugar alcohols xylitol, sorbitol, mannitol, maltitol, isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated glucose syrups, or a combination of any of these. If the food also contains a fermentable carbohydrate, such as sugar, the food cannot lower the pH of plaque in the mouth below 5.7. Besides the food ingredient’s relationship to dental caries, the claim also must state that frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. A shortened claim is allowed on food packages with less than 15 square inches of labeling surface area.

Soluble fiber from certain foods, such as whole oats and psyllium seed husk, and heart disease

This claim must state that the fiber also needs to be part of a diet low in saturated fat and cholesterol, and the food must provide sufficient soluble fiber. The amount of soluble fiber in a serving of the food must be listed on the Nutrition Facts panel. 

Soy Protein and risk of coronary heart disease

This claim may for foods containing at least 6.25 g of soy protein per RA, are low in saturated fat, low in cholesterol and low in fat (except that foods made from whole soybeans that contain no fat in addition to that inherent in the whole soybean are exempt from the “low fat” requirement). The claim must specify daily dietary intake levels of soy protein associated with reduced risk.

Plant Sterol/stanol esters and risk of coronary heart disease

This claim may be used if the food contains at least 0.65 g plant sterol esters per RA of spreads and salad dressings or at least 1.7 g plant stanol esters per RA of spreads, salad dressings, snack bars, and dietary supplements, is low in both saturated fat and cholesterol.  The claim must specify plant stero/stanol esters are part of a diet low in saturated fat and cholesterol.