U.S. Food and Drug Administration
FDA Consumer
November - December 1998

Staking a Claim to Good Health

FDA and Science Stand Behind Health Claims on Foods

by Paula Kurtzweil

Health claims authorized by the Food and Drug Administration are one of several ways food labels can win the attention of health-conscious consumers.

These claims alert shoppers to a product's health potential by stating that certain foods or food substances--as part of an overall healthy diet--may reduce the risk of certain diseases. Examples include folic acid in breakfast cereals, fiber in fruits and vegetables, calcium in dairy products, and calcium or folic acid in some dietary supplements. But food and food substances can qualify for health claims only if they meet FDA requirements.

"Health claims are not your fad-of-the-week," says Jim Hoadley, Ph.D., a senior regulatory scientist in FDA's Office of Food Labeling. Instead, he says, for health claims to be used, there needs to be sufficient scientific agreement among qualified experts that the claims are factual and truthful.

FDA initially authorized seven health claims in 1993 as part of the 1990 Nutrition Labeling and Education Act (NLEA). Since 1993, FDA has authorized three more.

Under NLEA, companies petition FDA to consider new health claims through rule-making. However, this process may require more than a year to complete because of the necessary scientific review and the need to issue a proposed rule to allow for public comment. And, in an effort to speed more of this kind of information to consumers, the Food and Drug Administration Modernization Act of 1997 includes a provision that is intended to expedite the process that establishes the scientific basis for health claims.

Although food manufacturers may use health claims to market their products, the intended purpose of health claims is to benefit consumers by providing information on healthful eating patterns that may help reduce the risk of heart disease, cancer, osteoporosis, high blood pressure, dental cavities, or certain birth defects.

What Is a Health Claim?

Health claims are among the various types of claims allowed in food labeling. They show a relationship between a nutrient or other substances in a food and a disease or health-related condition. They can be used on conventional foods or dietary supplements.

They differ from the more common claims that highlight a food's nutritional content, such as "low fat," "high fiber," and "low calorie."

Health claims are different from so-called "structure/function" claims, which also may appear on conventional food or dietary supplement labels. Manufacturers may make statements about a food substance's effect on the structure or function of the body--for example, "calcium builds strong bones." Unlike health claims, structure/function claims do not deal with disease risk reduction. Also, FDA does not pre-approve or authorize structure/function claims. Rather, when the manufacturer uses a structure/function claim, the company is responsible for making sure that the claim is truthful and not misleading.

Health claims can include implied claims, which indirectly assert a diet-disease relationship. Implied claims may appear in brand names (such as "Heart Healthy"), symbols (such as a heart-shaped logo), and vignettes when used with specific nutrient information. However, all labels bearing implied claims must also bear the full health claim.

Public Confidence

Health claims became a hot issue in the 1980s, when food marketing strategies began reflecting increased recognition of the role of nutrition in promoting health. At that time, some of the claims used were considered misleading, and many consumers began to doubt their truthfulness. NLEA's intent, in part, was to rein in exaggerated claims by reinforcing FDA's authority to regulate health claims and to require that claims be supported by sufficient scientific evidence.

According to an FDA study, consumer confidence in health claims grew in the months following implementation of NLEA. Thirty-one percent of consumers contacted by phone in November 1995--17 months after implementation of NLEA--said they believed health claims were accurate, compared with 25 percent in March 1994, two months before NLEA went into effect. And fewer respondents--39 percent in 1995 compared with 47 percent in 1994--agreed with the statement "Claims are more like advertising than anything else."

FDA's phone survey also indicated more consumers were using health claims to make more informed food choices: 25 percent in 1995 said they were using health claims, compared with 20 percent in March 1994.

According to Brenda Derby, a statistician in the consumer studies branch of FDA's Center for Food Safety and Applied Nutrition, a 1996 FDA label-reading study of more than 1,400 grocery shoppers found that, in general, the effectiveness of health claims is similar to that of nutrient claims and had no greater effect than nutrient claims alone in influencing shoppers' purchasing decisions. Health claims are most effective when they provide consumers with new information, the study found.

Expediting New Claims

A provision in the Food and Drug Administration Modernization Act of 1997 can speed up the process. The new law allows companies to notify FDA of their intent to use a new health claim based on an authoritative statement of one or more federal scientific bodies. It gives FDA 120 days to respond. If the agency does not act to prohibit or modify the claim within that time, the claim can be used.

In a guidance document for industry, FDA earlier this year established interim criteria for determining the adequacy of health claims submitted under the new procedure. Under these criteria, which will remain in place until FDA publishes final regulations, the authoritative statement, which is the basis for the health claim, must:

  • come from a federal scientific body (for example, the National Institutes of Health, national Centers for Disease Control and Prevention, U.S. Department of Agriculture, or National Academy of Sciences)
  • be published by the scientific body and be currently in effect
  • state a relationship between a nutrient and a disease or health-related condition
  • not be a statement made individually by an employee of a federal scientific body but rather reflect a consensus within the scientific body
  • be based on the scientific body's deliberative review of the scientific evidence.

FDA said it would consult with the scientific body when appropriate to determine whether a statement is an authoritative one.

With the new alternative approach for determining the scientific basis for a health claim, interest in health claims is likely to remain high, and newer claims are likely to hit food labels within the foreseeable future.

"This is a new frontier for industry," says Anna Matz, a spokeswoman for the Grocery Manufacturers of America. "A lot of [consumers] are looking for solid information about the products they buy. Health claims are a perfect way to provide this information."


Authorized Health Claims

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."

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."

g = gram
mg = milligram
mcg = microgram

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