21 CFR 101.77 - Health claims: fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease.

Title 21: Food and Drugs

CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER B: FOOD FOR HUMAN CONSUMPTION

PART 101: FOOD LABELING

Subpart E: Specific Requirements for Health Claims

101.77 - Health claims: fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease.

(a) Relationship between diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease. (1) Cardiovascular disease means diseases of the heart and circulatory system. Coronary heart disease is the most common and serious form of cardiovascular disease and refers to diseases of the heart muscle and supporting blood vessels. High blood total- and low density lipoprotein (LDL)- cholesterol levels are major modifiable risk factors in the development of coronary heart disease. High coronary heart disease rates occur among people with high blood cholesterol levels of 240 milligrams per deciliter (mg/dL) (6.21 (mmol/L)) or above and LDL-cholesterol levels of 160 mg/dL (4.13 mmol/L) or above. Borderline high risk blood cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol. Dietary lipids (fats) include fatty acids and cholesterol. Total fat, commonly referred to as fat, is composed of saturated fat (fatty acids containing no double bonds), and monounsaturated and polyunsaturated fat (fatty acids containing one or more double bonds).

(2) The scientific evidence establishes that diets high in saturated fat and cholesterol are associated with increased levels of blood total- and LDL-cholesterol and, thus, with increased risk of coronary heart disease. Diets low in saturated fat and cholesterol are associated with decreased levels of blood total- and LDL-cholesterol, and thus, with decreased risk of developing coronary heart disease.

(3) Populations with relatively low blood cholesterol levels tend to have dietary patterns that are not only low in total fat, especially saturated fat and cholesterol, but are also relatively high in fruits, vegetables, and grain products. Although the specific roles of these plant foods are not yet fully understood, many studies have shown that diets high in plant foods are associated with reduced risk of coronary heart disease. These studies correlate diets rich in fruits, vegetables, and grain products and nutrients from these diets, such as some types of fiber, with reduced coronary heart disease risk. Persons consuming these diets frequently have high intakes of dietary fiber, particularly soluble fibers. Currently, there is not scientific agreement as to whether a particular type of soluble fiber is beneficial, or whether the observed protective effects of fruits, vegetables, and grain products against heart disease are due to other components, or a combination of components, in these diets, including, but not necessarily limited to, some types of soluble fiber, other fiber components, other characteristics of the complex carbohydrate content of these foods, other nutrients in these foods, or displacement of saturated fat and cholesterol from the diet.

(b) Significance of the relationship between diets low in saturated fat and cholesterol, and high in fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease. (1) Coronary heart disease is a major public health concern in the United States, primarily because it accounts for more deaths than any other disease or group of diseases. Early management of risk factors for coronary heart disease is a major public health goal that can assist in reducing risk of coronary heart disease. There is a continuum of mortality risk from coronary heart disease that increases with increasing levels of blood LDL-cholesterol. Individuals with high blood LDL-cholesterol are at greatest risk. A larger number of individuals with more moderately elevated cholesterol also have increased risk of coronary events; such individuals comprise a substantial proportion of the adult U.S. population. The scientific evidence indicates that reducing saturated fat and cholesterol intakes lowers blood LDL-cholesterol and risk of heart disease in most individuals, including persons with blood cholesterol levels in the normal range. Additionally, consuming diets high in fruits, vegetables, and grain products, foods that contain soluble fiber, may be a useful adjunct to a low saturated fat and low cholesterol diet.

(2) Other risk factors for coronary heart disease include a family history of heart disease, high blood pressure, diabetes, cigarette smoking, obesity (body weight 30 percent greater than ideal body weight), and lack of regular physical exercise.

(3) Intakes of saturated fat exceed recommended levels in many people in the United States. Intakes of cholesterol are, on average, at or above recommended levels. Intakes of fiber-containing fruits, vegetables, and grain products are about half of recommended intake levels. One of the major public health recommendations relative to coronary heart disease risk is to consume less than 10 percent of calories from saturated fat, and an average of 30 percent or less of total calories from all fat. Recommended daily cholesterol intakes are 300 mg or less per day. Recommended total dietary fiber intakes are about 25 grams (g) daily, of which about 25 percent (about 6 g) should be soluble fiber.

(4) Current dietary guidance recommendations encourage decreased consumption of dietary fat, especially saturated fat and cholesterol, and increased consumption of fiber-rich foods to help lower blood LDL-cholesterol levels. Results of numerous studies have shown that fiber-containing fruits, vegetables, and grain products can help lower blood LDL-cholesterol.

(c) Requirements. (1) All requirements set forth in ? 101.14 shall be met.

(2) Specific requirements?(i) Nature of the claim. A health claim associating diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, with reduced risk of heart disease may be made on the label or labeling of a food described in paragraph (c)(2)(ii) of this section, provided that:

(A) The claim states that diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber ?may? or ?might? reduce the risk of heart disease;

(B) In specifying the disease, the claim uses the following terms: ?heart disease? or ?coronary heart disease;?

(C) The claim is limited to those fruits, vegetables, and grains that contain fiber;

(D) In specifying the dietary fiber, the claim uses the term ?fiber,? ?dietary fiber,? ?some types of dietary fiber,? ?some dietary fibers,? or ?some fibers;? the term ?soluble fiber? may be used in addition to these terms;

(E) In specifying the fat component, the claim uses the terms ?saturated fat? and ?cholesterol;? and

(F) The claim indicates that development of heart disease depends on many factors; and

(G) The claim does not attribute any degree of risk reduction for coronary heart disease to diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber.

(ii) Nature of the food. (A) The food shall be or shall contain a fruit, vegetable, or grain product.

(B) The food shall meet the nutrient content requirements of ? 101.62 for a ?low saturated fat,? ?low cholesterol,? and ?low fat? food.

(C) The food contains, without fortification, at least 0.6 g of soluble fiber per reference amount customarily consumed;

(D) The content of soluble fiber shall be declared in the nutrition information panel, consistent with ? 101.9(c)(6)(i)(A).

(d) Optional information. (1) The claim may identify one or more of the following risk factors for heart disease about which there is general scientific agreement: A family history of coronary heart disease, elevated blood-, total- and LDL-cholesterol, excess body weight, high blood pressure, cigarette smoking, diabetes, and physical inactivity.

(2) The claim may indicate that the relationship of diets low in saturated fat and cholesterol, and high in fruits, vegetables, and grain products that contain fiber to heart disease is through the intermediate link of ?blood cholesterol? or ?blood total- and LDL-cholesterol.?

(3) The claim may include information from paragraphs (a) and (b) of this section, which summarize the relationship between diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber and coronary heart disease, and the significance of the relationship.

(4) In specifying the nutrients, the claim may include the term ?total fat? in addition to the terms ?saturated fat? and ?cholesterol.?

(5) The claim may indicate that it is consistent with ?Nutrition and Your Health: Dietary Guidelines for Americans,? U.S. Department of Agriculture (USDA) and Department of Health and Human Services (DHHS), Government Printing Office (GPO).

(6) The claim may state that individuals with elevated blood total- and LDL-cholesterol should consult their physicians for medical advice and treatment. If the claim defines high or normal blood total- and LDL-cholesterol levels, then the claim shall state that individuals with high blood cholesterol should consult their physicians for medical advice and treatment.

(7) The claim may include information on the number of people in the United States who have heart disease. The sources of this information shall be identified, and it shall be current information from the National Center for Health Statistics, the National Institutes of Health, or ?Nutrition and Your Health: Dietary Guidelines for Americans,? USDA and DHHS, GPO.

(e) Model health claims. The following model health claims may be used in food labeling to characterize the relationship between diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain soluble fiber:

(1) Diets low in saturated fat and cholesterol and rich in fruits, vegetables, and grain products that contain some types of dietary fiber, particularly soluble fiber, may reduce the risk of heart disease, a disease associated with many factors.

(2) Development of heart disease depends on many factors. Eating a diet low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber may lower blood cholesterol levels and reduce your risk of heart disease.

[58 FR 2578, Jan. 6, 1993]