When can a health claim be made for a food? Here are some excerpts from a Feb., 1998 FDA summary of food labeling rules for health claims:
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. ...
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. ...
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. ...
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." ...
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