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."

Tags: Nutrition

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