Neal D. Fortin

Food Regulation


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“jelly bean” rule prohibits health claims for conventional foods based solely on fortification. Basically, a food must contain 10 percent or more of the Reference Daily Intake (RDI) or the Daily Reference Value (DRV) for vitamin A, vitamin C, iron, calcium, protein, or fiber per reference amount customarily consumed (RACC) before any nutrient addition in order to be eligible to make a health claim.8

      5.3.1 General Well‐Being Claims

      General well‐being claims are statements that describe general well‐being from consumption of a nutrient or dietary ingredient. A key to general well‐being claims is they do not mention a disease or disease‐related condition. An example of a general well‐being claim would be a claim that a multivitamin contributes to general good health.

      5.3.2 Structure–Function Claims

      Structure–function claims describe the role of an ingredient in affecting or maintaining the normal structure or function in humans; for example, “antioxidants maintain cell integrity.” While health claims characterize the relationship between a substance and its ability to reduce the risk of a disease or health‐related condition, structure–function claims describe the effect that a substance has on the normal structure or function of the body. The critical distinction here centers on normal versus disease. For example, “calcium builds strong bones” is a structure–function claim about normal bone development. Mention of osteoporosis or other disease (or even implying relationship to disease) would create a health claim.

      The line between structure–function claims and drug–health claims can be extremely thin. For example, “supports the immune system” would be viewed as a structure–function claim—on the other hand, “supports your body’s anti‐viral capabilities” would be questioned as a veiled heath claim. Structure–function claims may not explicitly or implicitly link the relationship to a disease or health‐related condition.

      Other examples of structure–function claims are, “fiber maintains bowel regularity,” and “antioxidants maintain cell integrity.” These claims focus on maintaining or supporting normal body structures or functions, and do not focus on disease.

      5.3.3 Dietary Guidance

      “Dietary guidance” is not a legal term, so you will find it used in a variety of ways in different contexts, which can be confusing. In the literal sense, all food‐related health claims are a form of dietary guidance. For the sake of clarity, consider “dietary guidance” as being only claims that do not satisfy either element of the “health claim” definition (do not mention a specific substance or food and do not mention a disease or health‐related condition).

      While dietary guidance may be used on food labels without FDA approval, bear in mind that dietary guidance statements must meet the requirements for being truthful and nonmisleading.

      5.3.4 Nutrient Content Claims

      Nutrient content claims are statements that characterize or imply the level of a nutrient in a food. For example, “high in fiber” or “low sodium” are nutrient content claims. The NLEA permits the use of label nutrient content claims when the claims are made in accordance with the FDA’s authorizing regulations.

      The preapproved or authorized health claims are those health claims expressly authorized by an FDA regulation under the authority provided by NLEA and the Dietary Supplement Health and Education Act of 1994 (DSHEA). These are sometimes referred to as NLEA health claims in addition to authorized health claims. Under the authorized health claims provisions of the FD&C Act, no food may make such a claim unless:

      1 expressly authorized by a specific regulation and

      2 the claim complies with the terms of the regulation.

      These preapproved health claims characterize a relationship between a food, a food component, dietary ingredient, or dietary supplement and risk of a disease (for example, “diets high in calcium may reduce the risk of osteoporosis”). FDA authorizes these types of health claims based on an extensive review of the scientific literature, generally as a result of the submission of a health claim petition, using the significant scientific agreement standard to determine that the nutrient/disease relationship is well established.

      Claims can be made in several ways: through third‐party references (such as the National Cancer Institute), statements, symbols (such as a heart), and vignettes or descriptions. Whatever the type, the claim must meet the requirements for authorized health claims. For example, the claim cannot state the degree of risk reduction and can only use “may” or “might” in discussing the nutrient or food–disease relationship. And the claim must state that other factors play a role in that disease. The claims also must be phrased so that consumers can understand the relationship between the nutrient and the disease, and the nutrient’s importance in relation to a daily diet. An example of an appropriate claim is: “While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease.”