This article is no longer current. For the most recent information about health claims on food, see "Staking a Claim to Good Health" in the November-December 1998 issue of FDA Consumer.

Look for 'Legit' Health Claims on Foods

by Dixie Farley

Planning a healthy diet will soon be easier. Beginning this May 8, food labels may provide not only the nutrient content of products but also claims about certain relationships between diet and disease.

As mandated by the Nutrition Labeling and Education Act of 1990, the Food and Drug Administration has issued final food labeling rules for health claims. The rules, published in the Jan. 6, 1993, Federal Register, allow claims about seven relationships:

calcium and a reduced risk of osteoporosis (a condition of lowered bone mass)
sodium and an increased risk of hypertension (high blood pressure)
dietary saturated fat and cholesterol and an increased risk of coronary heart disease
dietary fat and an increased risk of cancer
fiber-containing grain products, fruits, and vegetables and a reduced risk of cancer
fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and a reduced risk of coronary heart disease
fruits and vegetables and a reduced risk of cancer.

"These rules allow information on food labels that can help to educate the public about recognized diet-disease relationships," says Elizabeth Yetley, Ph.D., acting director of FDA's Office of Special Nutritionals. "Authorized claims must meet requirements to prevent label information that would be false or misleading." Yetley coordinated the agency's health claims evaluation.

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. A 1984 ad campaign by the Kellogg Company for All Bran cereal advised consumers to maintain proper weight and eat a well-balanced diet including low-fat, high-fiber foods, fresh fruits, and vegetables. Stating the National Cancer Institute "believes eating the right foods may reduce your risk of some kinds of cancer," the health message was both attributed to and approved by NCI.

According to an FDA survey by Alan Levy, Ph.D., and Raymond Stokes, Ph.D., sales of high-fiber cereals increased 37 percent within a year as consumers apparently discriminated between high- and low-fiber products.

Under the provisions of the Federal Food, Drug, and Cosmetic Act in effect at that time, FDA took the position that information about a disease on a food label implied that eating the food could beneficially affect the course of the disease. The agency considered such statements to be drug claims.

In 1987, however, in response to developing scientific data on the relationship between diet and disease, FDA proposed changing its policy to permit appropriate health messages on food labels. The agency noted that the rapid increase in information and of public interest in nutrition "argues for recognition and dissemination of such new knowledge, and food labels offer one appropriate vehicle for this dissemination."

Soon, many claims appeared on foods--often only partly meeting FDA's proposed criteria. For this reason and because of widely divergent comments on the proposal, FDA solicited additional comments and held a public hearing. The agency withdrew the 1987 proposal and reproposed regulations in February 1990 to more narrowly define health claims and more clearly state its criteria for claims.

Scientific support for diet-disease relationships and public interest in health continued to grow, encouraging Congress in the fall of 1990 to pass the Nutrition Labeling and Education Act. The new law confirmed FDA's authority to regulate health claims on food. Among other things, it required that the agency determine whether health claims were appropriate for 10 relationships:

calcium and osteoporosis
sodium and hypertension
lipids (fats and fat-like substances) and cardiovascular (heart and blood vessel) disease
lipids and cancer
dietary fiber and cardiovascular disease
dietary fiber and cancer
folic acid and neural tube defects
antioxidant vitamins and cancer
(antioxidants inhibit or prevent oxidation--a chemical reaction whose effect in the body is not well-understood)
zinc and immune function in the elderly
omega-3 fatty acids and heart disease.

FDA evaluated the scientific evidence and published its tentative findings in the Nov. 27, 1991, Federal Register food labeling proposal. The health claims proposals garnered more than 6,000 letters. To reach its final decisions about health claims, FDA reviewed more than 1,400 scientific studies and authoritative reports.

Definitions, Restrictions

According to the final rule, a "health claim" is any claim on the package label or other labeling (such as an ad) of a food, including fish and game meats, that characterizes the relationship of any nutrient or other substance in the food to a disease or health-related condition.

An example of a health claim is, "Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers." This claim associates the two necessary components: a specific nutrient or food substance and a specific health problem.

Health claims include implied claims, which indirectly assert a relationship. Implied claims may appear as third-party references, such as "The National Cancer Institute recommends a high-fiber diet." Brand names (such as "Heart Smart"), symbols (such as heart-shaped logos), and vignettes (descriptions), when used with specific nutrient information, may within the context of the label result in a health claim.

In contrast, claims about general health or food classes are not health claims. Some examples: the Food Guide Pyramid logo (a pyramid-shaped depiction of the Dietary Guidelines for Americans), valentine candy in a heart-shaped box, and "Eat five servings of fruits and vegetables a day for good health." FDA would consider those examples health claims if a specific nutrient and disease were introduced--the term "low fat" and a heart logo, for instance. Context is the key.

The definition does not cover nutrient-deficiency diseases--such as scurvy, caused by lack of vitamin C. Such diseases, which are no longer of major public health significance in the United States, are adequately regulated under other portions of the FD&C Act. Thus, FDA believes it would be inappropriate to subject these relationships to the health claims rules.

Finally, health claims do not apply to:

exempt infant formulas
foods intended for children under 2 years
medical foods, which are foods formulated for dietary management of diseases or other medical conditions
foods regulated as drugs.

To qualify for labeling with a health claim, foods must contain:

a nutrient (such as calcium) whose consumption at a specified level as part of an appropriate diet will have a positive effect on the risk of disease or

a nutrient of concern (such as fat) below a specified level.

The foods must contribute nutrition to the diet by containing at least 10 percent of the Daily Value (DV) of one or more of the nutrients vitamin A, vitamin C, iron, calcium, protein, and fiber. These nutrients must occur naturally in the food at least at 10 percent of the DV.

The Nutrition Labeling and Education Act specifies that foods bearing health claims must not contain any nutrient or food substance in an amount that increases the risk of a disease or health condition. Because dietary guidance calls for people to limit intake of fat, saturated fat, cholesterol, and sodium, FDA identified these substances as risk nutrients and set disqualifying levels for them per serving and per reference amount and, when a food has a small reference amount (30 grams or two tablespoons or less), per 50 g of the food. (As stated in FDA's new rule, the "reference amount" is the amount customarily consumed on an eating occasion. The serving size will be close, but not necessarily identical, to the reference amount.) Foods bearing health claims, then, must contain 20 percent or less of the DV of: fat (13 g), saturated fat (4 g), cholesterol (60 milligrams), and sodium (480 mg).

Thus, whole milk, which is high in calcium, may not bear a calcium-osteoporosis claim because its fat content exceeds the disqualifying levels, and excess fat increases the risk of cancer and heart disease. Skim, 1 percent, and 2 percent milks and milk products generally qualify for calcium-osteoporosis health claims.

Main dish products (6 ounces or more with not less than 40 g of two foods from two or more of the four food groups) and meal products (10 ounces or more with not less than 40 g of three or more foods from two or more food groups) may not bear claims if they contain, respectively, 30 or 40 percent or more of the DV for a disqualifying nutrient. FDA may by regulation permit a claim on food that contains a nutrient in amounts that exceed the disqualifying level if the agency finds that the claim will help consumers maintain a healthy diet, and the labeling discloses the presence of the nutrient at that level. No such exceptions have yet been made.

Every statement, phrase or symbol on a food label (health claim or not) must be truthful and not misleading. Because many factors affect disease development, it would be misleading to overemphasize the role of the food substance in a claim, such as indicating it will prevent the disease. Claims that a substance will prevent a disease are drug claims. Thus, in discussing the diet-disease relationship, health claims may only say the substance "may" or "might" reduce the risk. Claims must indicate the disease depends on many factors and may be required to mention other factors that affect the benefit--such as regular exercise, in calcium-osteoporosis claims.

Health claims cannot substitute a disease risk indicator for the disease itself, unless authorized. Claims for fat and heart disease, for instance, may optionally include the link of lowering blood cholesterol--as in, "Development of heart disease depends upon many factors. A healthful diet low in saturated fat and cholesterol may lower blood cholesterol levels and may reduce the risk of heart disease."

Many claims will be consistent with certain recognized dietary guidelines and may state them. A sodium-hypertension health claim, for instance, may say it is consistent with dietary guidelines to "use salt and sodium in moderation." Some other optional information is allowed, such as the number of people affected by the disease.

New Claims

When petitioned, FDA will authorize new claims if specific requirements are met.

First, the nutrient or food substance must be related to a disease or health condition for which most people or a specific group of people, such as the elderly, are at risk.

Second, for a claim to be valid, the rules require significant agreement among qualified experts that the claim is supported by the "totality of publicly available scientific evidence." This evidence must include data from well-designed studies conducted with recognized scientific procedures and principles.

OTC Drugs with Food Health Claims

Over-the-counter drugs that are also foods present complicating concerns for FDA. One such case is calcium antacids, which have been used as dietary supplements as well.

As drugs, such products are labeled for short-term problems, which, if persistent, may indicate a more serious condition, such as an underlying ulcer. Consequently, the drug labeling directs users to see a doctor if symptoms persist. As food supplements, however, these products are labeled for long-term use at lower levels consistent with daily dietary guidelines. The labeling usually provides no directions to seek medical help and places no time limits on use.

Even though the label may separate such dual directions, FDA is concerned a person may incorrectly assume the medical dosage is safe for dietary usage.

"If firms want to market products with both food and drug instructions or with health claims," says FDA's Yetley, "they may need to provide data to show the agency that the labeling won't confuse consumers, that consumers can differentiate between drug instructions and food or health claim instructions, and that, therefore, the product won't be misused."

Guidelines for Using Health Claims

In labeling with approved health claims, all statements about the diet-disease relationship must be consistent with FDA conclusions. Claims must enable consumers to understand the relationship and the nutrient or food substance's importance in the relationship in terms of a total daily diet.

Required information must be of one type size and in one place, without intervening material. The main panel may refer to a claim located elsewhere, as in an attached pamphlet.

When a health-claim graphic, such as a heart symbol, is used, the claim or a reference to its location must be nearby.

The food label must list the content of the nutrient for which a health claim is made.

If a claim is about reduced levels of a nutrient, such as cholesterol, the content must be low enough to qualify for the approved claim or must meet the FDA definition for "low."

If a claim is made about a nutrient at increased levels, the content must be in an appropriate form and high enough to justify the claim. If a definition exists for the nutrient, the content must meet that definition's "high," unless the approved health claim specifies an alternative level.

Denied Claims

FDA denied a claim for omega-3 fatty acids in reducing the risk of coronary heart disease. Omega-3s are found in oily fish and sea mammals. John Wallingford, Ph.D., who led FDA's review of this claim, noted, "Results of studies relating fish intake and risk of coronary heart disease were conflicting and inconsistent. The most compelling evidence was a well-controlled study that showed fish consumption may reduce the chance of death from a second heart attack. However, these studies did not establish that the effects were due specifically to omega-3 fatty acids."

Data revealed that omega-3s may raise the blood LDL-cholesterol (the bad type) of people with high blood fats and may interfere with blood glucose control in diabetics.

FDA also denied a claim about zinc (an essential trace mineral) and immune function in the elderly. Some studies had suggested that older people consume less zinc than recommended and that intake declines as people age. FDA concluded the evidence did not support the theory that increased dietary zinc would improve the immune function in older Americans.

Some studies appeared to show zinc supplements improved immunity to disease in older people. But the number of study participants was limited, many studies were flawed, and reported improvements were small. In larger, well-designed studies in which older patients received either zinc or placebos (inert pills) in addition to multi-vitamin and mineral preparations, the greatest immune function improvements were among those taking placebos. Zinc supplementation not only did not improve immune system function in the elderly, at 100 mg or more a day, it actually suppressed immunity.

FDA denied a claim for folic acid and neural tube birth defects. The agency continues, however, to consider this issue. Neural tube defects occur within the first six weeks after conception, often before the pregnancy is known. Adequate daily folic acid intake (at least 0.4 mg, or 400 micrograms, but not more than 1 mg) has been recommended for women from puberty through menopause to reduce the risks of having a baby with these severe birth defects.

The agency convened an advisory committee of outside experts to resolve the remaining issues. "We are proceeding as quickly as possible to evaluate several potential safety issues," Yetley explains. "We don't want to have a health claim if it might cause harm."

FDA denied claims for fiber and cancer, fiber and cardiovascular disease, and antioxidant vitamins and cancer because the scientific evidence was inconclusive. It is impossible to adequately distinguish effects of fiber or antioxidants from those of other food components, the agency said.

Nevertheless, in approving the claim for fruits and vegetables and cancer, FDA incorporated information on vitamin A (as beta-carotene) and vitamin C. These nutrients are found in fruits and vegetables whose use as part of total dietary patterns is associated with reduced cancer risks.

As stated in the 1991 proposal, FDA considers a health claim on a food label "a promise to consumers that including the food in a diet . . . will be helpful in attaining the claimed benefit and will not introduce a risk of another disease or health-related condition."

Dixie Farley is a staff writer for FDA Consumer. Ellen Anderson, Ph.D., a research chemist in FDA's Center for Food Safety and Applied Nutrition, also contributed to this article.

About Supplements ...

The Dietary Supplement Act, Title II of the Prescription Drug User Fee Act of 1992, prohibits FDA until at least Dec. 15, 1993, from making final labeling rules for supplements and from taking action against supplements for unauthorized health claims. The legislation became law Oct. 30, 1992.

As with conventional food, however, a supplement component may qualify for a health claim under the Nutrition Labeling and Education Act of 1990 if it confers a health benefit due to its nutritive value and meets other FDA health claims criteria.

"If a nutrient is shown to provide the benefit, then it's the nutrient content that's important, not its source," says Elizabeth Yetley, Ph.D., of FDA's Center for Food Safety and Applied Nutrition, who coordinated the agency's review of health claims.

Dietary supplements include products providing nutrition, such as vitamins, minerals, amino acids, and fatty acids. They also include substances such as herbs and bee pollen.

Under the Nutrition Labeling and Education Act, even when a supplement contains a nutrient in an amount in excess of that found in conventional food, the rule doesn't necessarily prevent a health claim. For example, a calcium-osteoporosis health claim would be permitted in supplements containing calcium in higher potencies than those found naturally in foods such as dairy products, provided the supplement meets the claim's other criteria. If the potency exceeds 400 milligrams a day, however, the labeling must state there's no known benefit from taking more than 2,000 mg a day.

Meanwhile, the new supplements act requires that, during 1993, the General Accounting Office study FDA's management of dietary supplements, and the Office of Technology Assessment study the relationship between supplements regulation (in other countries as well as the United States) and health outcomes. Under the act, FDA is to publish proposed rules (by June 15) and final rules (by Dec. 31, but no earlier than Dec. 15) that are responsive to the Nutrition Labeling and Education Act regarding supplements.

--D.F.