21 CFR 101.75 - Health claims: dietary saturated fat and cholesterol and risk of coronary heart disease.
(a) Relationship between dietary saturated fat and cholesterol 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/decaliter (mg/dL) (6.21 millimoles per liter (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.
(b) Significance of the relationship between dietary saturated fat and cholesterol 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. There is also evidence that reducing saturated fat and cholesterol intakes in persons with blood cholesterol levels in the normal range also reduces risk of heart disease.
(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. 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.
(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 with reduced risk of coronary 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 “may” or “might” reduce the risk of heart disease;
(B) In specifying the disease, the claim uses the terms “heart disease” or “coronary heart disease;”
(C) In specifying the nutrient, the claim uses the terms “saturated fat” and “cholesterol” and lists both;
(D) The claim does not attribute any degree of risk reduction for coronary heart disease to diets low in dietary saturated fat and cholesterol; and
(E) The claim states that coronary heart disease risk depends on many factors.
(ii) Nature of the food. The food shall meet all of the nutrient content requirements of § 101.62 for a “low saturated fat,” “low cholesterol,” and “low fat” food; except that fish and game meats (i.e., deer, bison, rabbit, quail, wild turkey, geese, and ostrich) may meet the requirements for “extra lean” in § 101.62.
(d) Optional information.
(1) The claim may identify one or more of the following risk factors in addition to saturated fat and cholesterol about which there is general scientific agreement that they are major risk factors for this disease: 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 saturated fat and cholesterol 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 dietary saturated fat and cholesterol and risk of 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 include information on the number of people in the United States who have coronary 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,” U.S. Department of Health and Human Services (DHHS) and U.S. Department of Agriculture (USDA), Government Printing Office.
(6) The claim may indicate that it is consistent with “Nutrition and Your Health: Dietary Guidelines for Americans,” DHHS and USDA, Government Printing Office.
(7) The claim may state that individuals with elevated blood total- or LDL-cholesterol should consult their physicians for medical advice and treatment. If the claim defines high or normal blood total- or LDL-cholesterol levels, then the claim shall state that individuals with high blood cholesterol should consult their physicians for medical advice and treatment.
(e) Model health claims.The following are model health claims that may be used in food labeling to describe the relationship between dietary saturated fat and cholesterol and risk of heart disease:
(1) While many factors affect heart disease, diets low in saturated fat and cholesterol may reduce the risk of this disease;
(2) Development of heart disease depends upon many factors, but its risk may be reduced by diets low in saturated fat and cholesterol and healthy lifestyles;
(3) Development of heart disease depends upon many factors, including a family history of the disease, high blood LDL-cholesterol, diabetes, high blood pressure, being overweight, cigarette smoking, lack of exercise, and the type of dietary pattern. A healthful diet low in saturated fat, total fat, and cholesterol, as part of a healthy lifestyle, may lower blood cholesterol levels and may reduce the risk of heart disease;
(4) Many factors, such as a family history of the disease, increased blood- and LDL-cholesterol levels, high blood pressure, cigarette smoking, diabetes, and being overweight, contribute to developing heart disease. A diet low in saturated fat, cholesterol, and total fat may help reduce the risk of heart disease; and
(5) Diets low in saturated fat, cholesterol, and total fat may reduce the risk of heart disease. Heart disease is dependent upon many factors, including diet, a family history of the disease, elevated blood LDL-cholesterol levels, and physical inactivity.
Title 21 published on 2015-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 101 after this date.