Food Regulation. Neal D. Fortin

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СКАЧАТЬ which is diet related, taking into account the significance of the food in the total daily diet …”⁶ Under this requirement, the FDA has disqualified foods from bearing health claim if they contain more than the following amount per reference amount customarily consumed (RACC) or per label serving⁷:

       13 grams fat

       4 grams saturated fat

       60 mg cholesterol

       480 mg sodium

      The above amounts apply to most foods, but there are different disqualifying levels for main dish and meal products.

      5.2.4 Jelly Bean Rule

The “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 HEALTH‐RELATED CLAIMS THAT ARE NOT REGULATED AS HEALTH CLAIMS

      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.

Structure–function claims may appear on the labels of foods and dietary supplements without any formal review or premarket approval by FDA.⁹ However, the general Food, Drug, and Cosmetic Act (FD&C Act) requirements still apply, and the claims must be truthful and nonmisleading.

Structure/function claims have historically appeared on the labels of conventional foods and dietary supplements¹⁰ as well as drugs. When used with conventional foods, structure–function claims must be based on the “nutritive” value of the food. However, FDA has not defined “nutritive value” in the context of structure–function claims.¹¹

      5.3.3 Dietary Guidance

Dietary guidance consists of statements that address a role of general dietary patterns or general categories of foods in maintaining good health. For example, “A diet rich in fruits and vegetables is good for your health,” is dietary guidance. “Five servings of fruits and vegetables a day are recommended for good health,” is 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).

Claims that relate to a disease or a specific health‐related condition are likely to be health claims rather than dietary guidance.¹² For example, the statement, “Diets rich in fruits and vegetables may reduce the risk of some types of cancer,” on the labeling of fruits and vegetables is a health claim.¹³ (However, sometimes a specific determination whether a statement is a health claim may have to be made based on the specific wording and the context of use. For example, the above claim on a vitamin C supplement labeling is dietary guidance.)

On the other hand, statements about a role of a specific food or substance in maintaining good health are likely to be structure/function claims rather than dietary guidance. For example, “Calcium is good for you,” is a structure/function claim.¹⁴

      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.

5.4 PREAPPROVED HEALTH CLAIMS (NLEA)

      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 СКАЧАТЬ