There are four general categories of claims used on food labels to highlight their nutritional benefits, each with their own regulatory requirements and implications. These include nutrient content claims, health claims, structure/function claims, and dietary guidance statements.
Nutrient Content Claims. Nutrient content claims are the most frequently used nutrition claims on food labels. These claims characterize the level of a nutrient or dietary component in a serving of food, using terms such as free, high, or low, or they compare the level of a nutrient in one food to the level in another similar food, using terms such as less, reduced, or lite. The Nutrition Labeling and Education Act (NLEA) of 1990 permits the use of nutrient content claims made in accordance with FDA regulations. Most nutrient content claims regulations apply only to those nutrients or dietary substances that have an established Daily Value (DV). The manufacturer must ensure that the exact wording of the claim, including specific descriptive words, is consistent with FDA’s regulations, as only authorized nutrient content claims are permitted for use.
The requirements that govern the use of nutrient content claims help ensure that descriptive terms are used consistently for all types of food products and are therefore meaningful to consumers.
For example, “an excellent source of [nutrient]” may be used when a food contains at least 20% of the DV of a nutrient per reference amount. The term “a good source of [nutrient]” may be used when the claimed nutrient is present in the food between 10% and 19% of the DV per reference amount (7). Definitions of nutrient content claims may be found in Appendices A and B of the FDA’s The Food Labeling Guide (www.cfsan.fda.gov/~dms/flg-6a.htmland www.cfsan.fda.gov/~dms/flg-6b.html). Table 1 presents some examples of nutrient content claims for qualifying fluid milk products.
Because of dairy foods’ unique nutritive package, several different types of nutrition claims – nutrient content claims, health claims, structure/function claims, and dietary guidance statements – can be found on qualifying dairy products.
Health Claims.A health claim is a statement describing a relationship between a food or food component (substance) and a disease or health-related condition (e.g., calcium and reduced risk of osteoporosis). These claims must represent both the substance and the disease. Health claims are regulated by the FDA and permitted for use on the labels of foods that meet certain scientific and regulatory criteria (e.g., not too much fat, saturated fat, cholesterol, or sodium). These criteria can be found at www.cfsan.fda.gov/~dms/lab-ssa.html. As shown in Table 2, there are five health claims authorized by the FDA that can be used on the labels of some dairy products, typically those lower in fat, such as low-fat and fat-free milk, yogurt, and other dairy products. For a summary of all health claims that have been approved for use on food labels, refer to Appendix C in the FDA’s The Food Labeling Guide (www.cfsan.fda.gov/~dms/flg-6c.html).
Health claims can be authorized by the FDA in one of the following three ways (www.cfsan.fda.gov/~dms/hclaims.html).
- Authorized Health Claims. These claims are based on significant scientific agreement (SSA) among qualified experts as set forth in the 1990 NLEA. The FDA authorizes these types of claims based on an extensive evidence-based review of the scientific literature, generally submitted in a health claim petition, using SSA standards to determine that the nutrient/disease relationship is well established. Authorized health claims are sometimes called SSA health claims, or NLEA health claims, or unqualified health claims (i.e., because qualifying statements about the state of the science are not required). The first four health claims in Table 2 are examples of authorized health claims that are appropriate for use on qualifying dairy products.
- Authoritative Statements. As a result of the 1997 FDA Modernization Act, health claims based on authoritative statements from a scientific body of the U.S. government or the National Academy of Sciences may be allowed. These claims may be used after submission of a health claim notification to FDA. The last claim in Table 2, “diets containing foods that are a good source of potassium and that are low in sodium may reduce the risk of high blood pressure and stroke” is an example of a health claim based on an authoritative statement, which in this case is a report from the National Academy of Sciences (8).
- Qualified Health Claims. FDA’s 2003 Consumer Health Information for Better Nutrition Initiative provides for qualified health claims based on scientific evidence that is credible, but that does not meet the “significant scientific agreement” standard required by the FDA to support an authorized health claim. The FDA requires qualified health claims to include a disclaimer or other qualifying language to prevent consumers from being misled about the nature of supporting science. After a qualified health claim petition is received, the FDA evaluates the quality and strength of the scientific evidence before approving or denying the claim. Qualified health claim petitions that are submitted to the FDA are available for public review and comment. A summary of qualified health claims can be found at www.cfsan.fda.gov/~dms/lab-qhc.html.
As research continues to identify and support the nutrition and health benefits of foods (e.g., dairy foods), nutrition claims on food labels can be expected to play an increasingly important role in communicating these benefits to consumers.
Structure/Function Claims. These claims describe the effect of a nutrient or dietary ingredient on normal structures or functions in the body. Unlike health claims, structure/function claims cannot explicitly or implicitly state a relationship between preventing, curing, or mitigating a disease or health-related condition and are not subject to FDA authorization or pre-market review. However, the manufacturer is responsible for ensuring that any structure/function claim on labels, like all information on food labels, is based on competent and reliable scientific research and is truthful and not misleading. More information about structure/function claims can be found at www.cfsan.fda.gov/~dms/sclmguid.html.
Because milk and other dairy foods support various physiological functions that have been scientifically substantiated and because they contain many nutrients at “good” (>10% of the DV) or “excellent” (>20% of the DV) levels, many dairy foods are candidates for structure/function claims. Examples of some possible structure/function claims for dairy products include the following (9):
- The vitamin A in [reduced-fat milk, low-fat milk, fat-free milk] helps promote normal vision;
- The vitamin B12 in [whole milk, reduced-fat milk, low-fat milk, and fat-free milk] helps maintain the body’s red blood cells;
- The calcium and phosphorus in [whole milk, reduced-fat milk, low-fat milk, fat-free milk, plain whole milk yogurt, plain low-fat yogurt, plain fat-free yogurt] help build strong bones;
- The vitamin D in [whole milk, reduced-fat milk, low-fat milk, fat-free milk] helps build strong bones;
- The potassium in [whole milk, reduced-fat milk, low-fat milk, fat-free milk, plain whole milk yogurt, plain low-fat yogurt, plain fat-free yogurt] helps maintain normal circulation;
- The protein in [whole milk, reduced-fat milk, low-fat milk, fat-free milk, plain whole milk yogurt, plain low-fat yogurt, plain fat-free yogurt, cottage cheese] helps maintain strong muscles.
Although not specifically required by FDA regulations, it is recommended that when using a structure/function claim for potassium, phosphorus, or vitamin B12, the quantitative amount and percent DV of that nutrient should be voluntarily declared in the Nutrition Facts Panel of the label.
Examples of structure/function claims provided by the 3-A-DayTM of Dairy program (www.3aday.org) include promotion of the health benefits of consuming 3 servings of dairy products a day for stronger bones and for healthy weight loss.
The 3-A-Day™ of Dairy program (www.3aday.org), a nutrition-based marketing and consumer education initiative managed by Dairy Management Inc., is an example of the use of structure/function claims on dairy products. This program utilizes two structure/function claims to communicate the health benefits of dairy foods. One points out the need for 3 servings of dairy (milk, cheese, or yogurt) a day for stronger bones. More recently, as scientific evidence has accumulated, an additional claim indicates that 3 servings a day of milk, cheese, or yogurt in a reduced calorie diet supports weight loss.
Dietary Guidance Statements.Unlike health claims which target a specific substance (food or food component) and a specific disease or health-related condition, dietary guidance statements make reference to a substance or disease, but not both. Instead, dietary guidance statements focus on general dietary patterns, practices, and recommendations that promote health. These statements typically describe the health effects of a broad category of foods (e.g., fruits, vegetables, dairy foods, grains), rather than a specific nutrient or substance. An example of a dietary guidance statement provided by the FDA is “diets rich in fruits and vegetables may reduce the risk of some types of cancer.” One element (i.e., disease) is present, but because a specific substance (e.g., nutrient) is not present, this is not a health claim. Dietary guidance statements may be made on food labels without FDA review and authorization. However, the information must be truthful and non-misleading.
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